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NewVac Presented Results of Quisinostat’s Phase II Clinical Trial at ASCO 2017

Viriom to Present Results of Pre-Clinical Pharmacokinetic Studies with Elsulfavirine and VM1500A Long Acting Injectable Formulations at the International AIDS Society (IAS) Conference 2017

TealTech Capital Invests in the Mobile Medical Office Technology Platform for Rapid On-Site Healthcare Services Based on Point-of-Care Diagnostics and Telemedicine

Torrey Pines Investment Establishes a $60 Million TealTech Fund to Support Point-of-Care Medicine

Avelas Biosciences Appoints Steven Chen as Chief Medical Officer

Leap Therapeutics to Present DKN-01 Clinical Data at American Society of Clinical Oncology (ASCO) 2017 Annual Meeting

Torrey Pines Investment Attends Inauguration of the German Center for Neurodegenerative Diseases (DZNE) in Bonn, Germany

Avelas Biosciences Appoints Alexey Vinogradov, Ph.D., to Board of Directors

Avelas Biosciences to Present at 29th Annual Roth Conference

Leap Therapeutics to Present at 2017 Barclays Global Healthcare Conference

Leap Therapeutics to Present Preclinical and Clinical Data at 2017 AACR Annual Meeting

Viriom Reports Positive Findings in 48 Week Study of Elsulfavirine as Compared to Efavirenz in Combination with TDF/FTC at CROI 2017

ChemDiv Announces Multi-Year Hit Identification Collaboration with Janssen

Viriom to Present Positive Clinical Findings for Elsulfavirine vs Efavirenz in Combination with TDF/FTC

ChemDiv Announces Key Milestones in Abbott Pharma Collaboration

Viriom Announces Collaboration with NIH on Zika and Other Major Viral Diseases

NewVac Reports Primary Endpoint Met in Phase II Clinical Trial of Quisinostat in Combination with Paclitaxel and Carboplatin in Platinum-Resistant Ovarian Cancer

Viriom Announces Appointment of New Scientific Advisory Board Member

ChemDiv, Torrey Pines Investment and DZNE Announce Research Collaboration

Leap Therapeutics and Macrocure Announce Definitive Merger Agreement

Avelas Biosciences Completes $20 Million Series C Financing

SatRx LLC Announces First Registration in Russia of SatRx® (gosogliptin), an Innovative Drug for Treatment of Type 2 Diabetes

BioIntegrator, LLC Announces the Second Market Registration of Nescler®, a First Generic of the Novartis MS Blockbuster Gilenya®

Viriom Announces Receipt of Funding from the Skolkovo Foundation, ChemRar and Torrey Pines Investment to Develop Elsulfavirine, a Novel Preventive and Long-acting Treatment of HIV/AIDS

Avelas Biosciences Announces Positive Interim Phase 1b Results and Advances to Dose Expansion Stage

The President of Tatarstan discussed cooperation with Torrey Pines Investment in the field of pharmaceuticals and novel agricultural products

Chromis Successfully Secures Seed Funding from Torrey Pines Investment

ChemDiv and Abbott expand collaboration to develop branded generic pharmaceuticals for high growth emerging markets

Tensha Therapeutics To Be Acquired By Roche

ChemDiv Announces Achievement of a Development Milestone in a Drug Discovery Collaboration With Janssen

BioIntegrator Announced Launch of Nescler® -- a Generic of Novartis MS Blockbuster Gilenya® in Emerging Markets

J.P. Morgan 34th Annual Healthcare Conference

Viriom presented the results of the safety and antiviral effect of its novel drug Elsulfavirine at the EACS-2015 conference in Barcelona

Avineuro LLC  advances its highly selective 5-HT6R antagonist program in Alzheimer Disease

TeaRx launches an innovative anticoagulant Tearexaban

Ron Demuth Interviewed for Nature Drug Discovery News Article

Avelas Biosciences Completes 7.4M Funding

T23 Announces Global License of SCRIPPS’ CD22 Siglec Oncoimmunological Platform for B-cell Tumors

Viriom is Expanding its Portfolio of Novel Antiviral Drugs

ChemRar HighTech Center is featured in Pharmaceutical Executive article “Russia’s Bet on Biopharma”

 

News

NewVac Presented Results of Quisinostat’s Phase II Clinical Trial at ASCO 2017

SAN DIEGO, CA, June 26, 2017 -- NewVac, LLC today announced detailed primary results of Phase II clinical trial of quisinostat, a novel selective oral histone deacetylase (HDAC1) inhibitor, in advanced ovarian cancer. Results were presented at the ASCO 2017 Annual Meeting. The clinical trial demonstrated quisinostat’s safety profile and high efficacy against platinum-resistant ovarian cancer in combination with paclitaxel and carboplatin. NewVac licensed quisinostat from Janssen Pharmaceutica NV.

The primary efficacy endpoint of the study - the objective response rate - was 51.6% and greatly exceeded the value of 30%, expected by the study protocol. Median duration of response was 5 months (4,2-5,7) with median progression free survival of 7 months (95%CI 4.8 - 9.2). SAE were observed in 16,1% of patients, mostly caused by background chemotherapy. The most frequent adverse events during the study were nausea and neutropenia.

As shown in previous preclinical studies, quisinostat amplifies HDAC-repressed expression of E-cadherin, leading to a reversal of epithelial to mesenchymal transition (EMT). The latter is associated with platinum-based chemotherapy resistance.

NewVac is preparing to study indications for quisinostat in combination with proteasome inhibitors to treat translocation-associated sarcomas in adolescents and young adults; and combination with checkpoint inhibitors to increase efficacy in solid tumors (gynecologic cancers and NSCLC).

About Phase II Trial

A multicenter, open-label study of safety and efficacy of quisinostat in combination with paclitaxel + carboplatin chemotherapy in patients with metastatic or locally advanced epithelial ovarian cancer, primarily peritoneal or fallopian tube carcinoma, resistant to first line platinum and paclitaxel-based chemotherapy. The study consists of a screening period of 3 weeks before the start of quisinostat administration, followed by the treatment period of approximately 18 weeks (up to 6 cycles and 21 days for each cycle), a safety follow-up of 4 weeks after the last administration of the study therapy and post-treatment follow-up aimed at the determination of progression-free survival, time to disease progression and overall survival rate in the study population.

About Ovarian Cancer

Ovarian cancer is one of the leading causes of death from malignant tumors amongst women in USA and Europe. With only 36.3% survival rate ovarian cancer takes more lives per year than any other female reproductive system cancer. The efficacy of the standard platinum- and paclitaxel-based chemotherapy is halted by a very high risk of recurrence with a very poor outcome. There is an urgent need to develop new and better treatment options both for first-line patients and those that relapse. The populations of patients who progress within 1-6 months are considered to be platinum-resistant patients. For these patients, re-treatment with the same chemotherapy regimen is futile (<10% response rate). However, by adding a potential resistance modifier, such as quisinostat, a re-treatment with the original regimen in combination with the experimental agent is the best test of proof of concept.

About NewVac

NewVac LLC, a ChemRar company, focuses on novel approaches to diagnosing and treating cancer. NewVac, is a private development stage biotech, a member of Skolkovo bio-cluster in Moscow, Russia.

Media Contacts:
Gelena Lifschitz
+1(858)-3534108
glifschitz@torreypinesinv.com

Viriom to Present Results of Pre-Clinical Pharmacokinetic Studies with Elsulfavirine and VM1500A Long Acting Injectable Formulations at the International AIDS Society (IAS) Conference 2017

SAN DIEGO, CA, May 22, 2017 -- Viriom Inc. today announced that the data from pre-clinical studies of Elsulfavirine/VM1500A Long Acting Injectable Formulations will be presented at the 9th IAS (International AIDS Society) Conference on HIV Science (IAS 2017), to be held July 23-26 in Paris, France. The studies evaluate new options for the treatment and prevention of HIV/AIDS that would allow for infrequent dosing, thus facilitating patients’ adherence, and likely improving long-term treatment outcomes. The results will be presented by Dr. Vadim Bichko, Viriom’s Chief Scientific Officer, during a poster viewing session on Wednesday, July 26, 12:30-14:30.

About Viriom

Viriom focuses on treatment, prophylaxis, and eradication of infectious diseases globally. Viriom is developing and commercializing the most innovative, yet affordable solutions to radically broaden global access to antiviral treatments. Viriom’s broad pipeline includes its most advanced drug Elpida®/Elsulfavirine, a once-daily oral prodrug of VM-1500A, a novel HIV non-nucleoside reverse transcriptase inhibitor (NNRTI). Viriom expects to obtain first market registration for Elpida in 2017. Development is underway for once-weekly oral and longer-acting parenteral formulations as well as drug combination formulations. Learn more here.

Safe Harbor Statement

This document may contain forward-looking statements. Such forward-looking statements are characterized by future or conditional verbs such as “may,” “will,” “expect,” “intend,” “anticipate,” believe,” “estimate” and “continue” or similar words. You should read statements that contain these words carefully because they discuss future expectations and plans, which contain projections of future results of operations or financial condition or state other forward-looking information. Such statements are only predictions and our actual results may differ materially from those anticipated in these forward-looking statements. We believe that it is important to publicly communicate future expectations. However, there may be events in the future that we are not able to accurately predict or control. Factors that may cause such differences include, but are not limited to, the uncertainties associated with product development, the market for our products, the risks associated with dependence upon key personnel and the need for additional financing. We do not assume any obligation to update forward-looking statements as circumstances change. The information in this document is not targeted at the residents of any particular country or jurisdiction and is not intended for distribution to, or use by, any person in any jurisdiction or country where such distribution or use would be contrary to local law or regulation. The future expectations, estimations, anticipated events, results, milestones, events, operating and financial information contained in the company’s financial projections and all other areas of this document are for illustrative purposes only and are based upon hypothetical assumptions and events over which the company has only partial or no control. All information about future events (projections) were developed by the company’s management and are based upon a variety of assumptions with or without benefit of an operating history. The projections are included solely to provide information concerning the company’s estimates of future operating results based on these assumptions and, although the company believes that these assumptions are reasonable, they may be incomplete or incorrect, and unanticipated events and circumstances may occur. Actual results will vary from the projections, and these variations may be material and adverse. The projections should be read in conjunction with the assumptions upon which the projections are based. No representation or warranty of any kind is or can be made with respect to the accuracy or completeness of, and no representation or warranty should be inferred from our projections or the assumptions underlying them.

TealTech Capital Invests in the Mobile Medical Office Technology Platform for Rapid On-Site Healthcare Services Based on Point-of-Care Diagnostics and Telemedicine

SAN DIEGO, CA, May 17, 2017 – TealTech Capital fund announced its first venture today for the TealNet Mobile Medical Office (MMO), a novel healthcare platform for rapid on-site services based on point-of-care diagnostics and telemedicine.

TealNet MMO, a San Diego-based startup company, developed the Mobile Medical Office to offer healthcare providers a technology platform for rapid on-site point-of-care diagnostics and telemedicine in urgent care pediatrics, cardiology, virology, and neurology, as well as other vital therapeutic areas. This platform enables qualified physicians to perform diagnostics and analyses at a patient’s home within 10–20 min. The quality and volume of these analyses are comparable to those performed in a regular hospital or an outpatient clinic in 1–3 days. The doctors of the TealNet MMO are dispatched to treat cases they specialize in and are fully equipped with medicines to begin treatment immediately. Moreover, the platform offers a variety of price differentiation points that enable patients to choose the type of consultation that best fits their needs and budgets, making it more convenient and affordable. The TealNet MMO platform also uses a service review system called “My Opinion Matters” to monitor client satisfaction, to allow patients to stay in touch with their physicians, and to maintain a high quality of service.

"The inconveniences associated with long wait times and service inefficiencies in regular hospitals and clinics make people look for alternative ways of satisfying their healthcare needs," commented Nikolay Savchuk, Managing Partner at Torrey Pines Investment, the leading investor of the TealTech Capital fund. "TealNet MMO aims at solving this problem by providing patients with a fast, convenient, and reliable way of seeing a qualified physician, being diagnosed and treated, all without leaving the house. We believe that home health services platforms like TealNet MMO are the future of healthcare, and we created the fund to help advance innovative start-ups that bring convenient, digitalized, modern solutions to patients."

About TealTech Capital

The $60 million fund of TealTech Capital focuses on financing innovative start-ups in the areas of point-of-care diagnostics and treatment that develop novel organizational and financial models for the delivery of health services, including in-home and virtual care, and that advance artificial intelligence and deep learning healthcare support systems. The main goal of the fund is to promote the development of these cutting-edge medical and healthcare technologies while providing patients with fast and convenient healthcare services. Learn more here.

Torrey Pines Investment Establishes a $60 Million TealTech Fund to Support Point-of-Care Medicine

SAN DIEGO, CA, May 16, 2017 – Torrey Pines Investment announced today the creation of a $60 million fund to finance innovative start-ups in the areas of point-of-care diagnostics and treatment, novel organizational and financial models of health services delivery, including in-home and virtual care, as well as artificial intelligence and deep learning healthcare support systems. The main goal of the fund is to promote the development of these cutting-edge medical and healthcare technologies while providing patients with fast and convenient healthcare services.

"Healthcare is moving towards digitized personalized care which gives patients the convenient and accessible medical services where and when they need it," commented Nikolay Savchuk, Managing Partner at Torrey Pines Investment. "The TealTech fund focuses on the three main directions of fundamental shifts in healthcare: the medical technologies innovations, digital care, and artificial intelligence tools. We believe that the future of healthcare lies in the accessibility and flexibility that digital care and point-of-care diagnostics and treatment provide, as well as in the precision and convenience that computer-assisted tools help deliver. Thus, we created the fund to help advance innovative start-ups that bring convenient, digitalized, modern solutions to patients."
Torrey Pines and its partners will invest up to $60 million over the next 5 years. The fund’s first venture will be a platform for rapid clinical-level diagnostics enabling medical care to move from a physician’s office to the patient’s home—the TealNet Mobile Medical Office.

About TealNet MMO

TealNet MMO is a San Diego-based start-up company providing technologies for rapid on-site healthcare services based on point-of-care express diagnostics and telemedicine. TealNet Mobile Medical Office platform enables qualified physicians to perform express diagnostic analyses that would take 1-3 days in a regular hospital or clinic within 10-15 minutes at a patient’s home. Learn more here.

About Torrey Pines

Torrey Pines Investment, founded in 2002, is a specialty life-science investment company located in San Diego that invests in early development-stage assets from international pharma and biotech partners in the CNS, oncology, and virology areas to bring them to commercial success through pharma partnering and M&A. Learn more at http://torreypinesinv.com/

Avelas Biosciences Appoints Steven Chen as Chief Medical Officer

SAN DIEGO, May 4, 2017 – Avelas Biosciences, Inc., a clinical stage oncology-focused company dedicated to improving cancer patient care from diagnosis through treatment, today announced the appointment of Steven Chen, M.D., as chief medical officer of the company. Dr. Chen originally joined Avelas Biosciences in July 2014 as the vice president of clinical affairs.

"Steven’s insight as a practicing oncology surgeon has been invaluable to Avelas and his promotion to chief medical officer is thoroughly deserved,” said Carmine Stengone, president and CEO of Avelas Biosciences. “He successfully oversaw our positive Phase 1b clinical trial of AVB-620 in breast cancer patients, and I’m confident he will continue to contribute materially to the future success of our company."

Dr. Chen previously served as the chief of breast surgery at UC Davis Medical Center, followed by a position as an associate professor of surgery and as the associate program director of the surgical oncology training program at City of Hope National Medical Center in Duarte, California. He maintains an active surgical oncology clinical practice in San Diego, while also maintaining clinical research interests in quality of care measures, health outcomes, and cost-effectiveness. Dr. Chen also was recently elected as the president of the American Society of Breast Surgeons, the country’s largest organization for breast surgery.

Dr. Chen received his medical degree and completed general surgery and critical care residencies at the University of Michigan, followed by a surgical oncology fellowship at the John Wayne Cancer Institute. He obtained an MBA at the University of Michigan’s Ross School of Business.

About Avelas Biosciences

Avelas Biosciences is a San Diego-based biotechnology company focused on developing technologies that advance a new standard-of-care for cancer surgery and therapeutic intervention. The company’s lead candidate, AVB-620, has completed a Phase 1b clinical trial assessing safety, pharmacokinetics and fluorescence properties using tissue image analysis. The initiation of a Phase 2 clinical trial for AVB-620 in breast cancer is expected in the first half of 2017. In addition, the company is advancing a therapeutic program, which utilizes the same technology platform. Avelas was founded by Avalon Ventures on technology from Roger Y. Tsien, Ph.D., co-winner of the 2008 Nobel Prize in chemistry.

Leap Therapeutics to Present DKN-01 Clinical Data at American Society of Clinical Oncology (ASCO) 2017 Annual Meeting

CAMBRIDGE, Mass., April 20, 2017 (GLOBE NEWSWIRE) -- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, today announced that interim data from the Phase 1 study of DKN-01 in combination with standard of care chemotherapy in patients with advanced biliary tract cancers will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting held June 2 - 6, 2017 in Chicago, Illinois. The presentation is entitled, "A phase I study of DKN-01 (D), an anti-DKK1 monoclonal antibody, in combination with gemcitabine (G) and cisplatin (C) in patients (pts) for first-line therapy with advanced biliary tract cancer (BTC)." The data will be presented during the gastrointestinal cancer poster session.

About the DKN-01 P103 Clinical Trial

The open-label, dose-escalation study enrolled 27 patients with treatment-naïve advanced biliary tract cancer. Patients received two dose levels of DKN-01 in combination with gemcitabine and cisplatin. The primary objective of this study is to evaluate the safety, pharmacokinetics, and efficacy of DKN-01 in combination with gemcitabine and cisplatin. The study has recently been expanded to enroll an additional 20 patients to enhance biomarker collection and analysis.

Leap Poster Presentation Details:

Abstract Number: 4075

Title: "A phase I study of DKN-01 (D), an anti-DKK1 monoclonal antibody, in combination with gemcitabine (G) and cisplatin (C) in patients (pts) for first-line therapy with advanced biliary tract cancer (BTC)."

Session Title: Poster Session: Gastrointestinal (Noncolorectal) Cancer

Date: June 3, 2017

Time: 8:00AM-11:30AM Central Time

About Leap Therapeutics

Leap Therapeutics’ (NASDAQ:LPTX) most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is in clinical trials in patients with gastroesophageal cancer in combination with paclitaxel and in patients with biliary tract cancers in combination with gemcitabine and cisplatin. DKN-01 has demonstrated single agent activity in non-small cell lung cancer patients. Leap’s second clinical candidate, TRX518, is a novel, humanized GITR agonist monoclonal antibody designed to enhance the immune system’s anti-tumor response. For more information about Leap Therapeutics, visit http://www.leaptx.com or our public filings with the SEC that are available via EDGAR at http://www.sec.gov or via http://www.investors.leaptx.com/.

FORWARD LOOKING STATEMENTS

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements include statements relating to Leap’s expectations with respect to the development and advancement of DKN-01, TRX518, and other programs, including the initiation, timing and design of future studies, enrollment in future studies, business development, and other future expectations, plans and prospects. Leap has attempted to identify forward looking statements by such terminology as ‘‘believes,’’ ‘‘estimates,’’ ‘‘anticipates,’’ ‘‘expects,’’ ‘‘plans,’’ ‘‘projects,’’ ‘‘intends,’’ ‘‘may,’’ ‘‘could,’’ ‘‘might,’’ ‘‘will,’’ ‘‘should,’’ or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although Leap believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates; our plans to research, develop, and commercialize our drug product candidates; our ability to achieve market acceptance of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our drug product candidates; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially will be included in Leap Therapeutics’ periodic filings with the Securities and Exchange Commission (the "SEC"), including Leap Therapeutics’ Form 10-K that Leap filed with the SEC on March 31, 2017. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors. Any forward looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

CONTACT:
Douglas E. Onsi/ Chief Financial Officer/ Leap Therapeutics, Inc./ donsi@leaptx.com/ 617-714-0360

Torrey Pines Investment Attends Inauguration of the German Center for Neurodegenerative Diseases (DZNE) in Bonn, Germany

Ron Demuth, on behalf of Torrey Pines Investment, attended the inauguration of the German Center for Neurodegenerative Diseases (DZNE) in Bonn, Germany, on March 15-16, 2017. The Center’s new research cluster in Bonn, on the campus of the University Hospital of Bonn, is the central hub for DZNE’s activities, spread across nine sites and over thirty clinics throughout Germany.

The inauguration was hosted by Professor Dr. Pierluigi Nicotera, Director of DZNE, and attended by German Chancellor Angela Merkel and Minister Svenja Schulze of North Rhine-Westphalia.

Following the inauguration on March 15, DZNE sponsored a day-long International Symposium “New perspectives for Neurodegenerative Diseases”, at which the leaders of most national and international brain health and disease programmes presented their most recent achievements and future plans.

Torrey Pines is DZNE’s partner in an integrated collaboration focused on bringing academic-stage translational treatments into commercial development of clinical therapies for neurodegeneration diseases.

The partners in this project, announced in 2016, include DZNE, Afraxis, Chemical Diversity, and Torrey Pines Investment, see here.

DZNE contributes its early-stage expertise in translational medicine to the collaboration, while ChemDiv and Afraxis bring commercial drug development expertise and project management, and Torrey Pines Investment brings seed stage funding and investor networks to bear on the problems of delivering new clinical therapies to combat neurodegeneration and improve the lives of patients suffering from the broad family of neurodegenerative diseases.

Learn more about the event https://www.dzne.de/en/about-us/public-relations/news/2017/press-release-no-4.html

Avelas Biosciences Appoints Alexey Vinogradov, Ph.D., to Board of Directors

SAN DIEGO, March 14, 2017 /PRNewswire/ -- Avelas Biosciences, Inc., a clinical stage oncology-focused company dedicated to improving cancer patient care from diagnosis through treatment, today announced the appointment of Alexey Vinogradov, Ph.D., to its board of directors. Dr. Vinogradov currently serves as Head of Pharmstandard Ventures, a corporate venture fund of Pharmstandard Group, until recently known as Inbio Ventures, where he served as a Managing Partner and CEO. Dr. Vinogradov replaces Dr. Andrei Petrov as a director of the company.

"We are excited to have Alexey join our board during this exciting time of Avelas' corporate development," said Carmine Stengone, president and CEO of Avelas Biosciences. "Alexey has considerable experience in research and development, operations and business development, and I'm confident he will contribute meaningfully to our future success."

Dr. Vinogradov has over 15 years of experience at different positions in the biotech industry. He has served as a board member at Argos Therapeutics, as a board observer at Protagonist Therapeutics and Aquinox, and currently serves as a board observer at Allena Pharmaceuticals. Prior to joining Inbio Ventures in 2012, as co-founding partner and CBO, Dr. Vinogradov was involved in portfolio building at Bioprocess Capital Partners. He also led the fundraising and served in the executive management of Promogene, Tartis-Oncology and Everon. In addition, Dr. Vinogradov was involved in a range of business development activities at Bioprocess Group.

Dr. Vinogradov held a postdoctoral position at the Laboratory of Biomolecular Sciences, Wageningen University, Netherlands. He obtained his Ph.D. degree in Biochemistry and MS degree in Chemistry from Moscow State University.

About Avelas Biosciences

Avelas Biosciences is a San Diego-based biotechnology company focused on developing technologies that advance a new standard-of-care for cancer surgery and therapeutic intervention. The company's lead candidate, AVB-620, has completed a Phase 1b clinical trial assessing safety, pharmacokinetics and fluorescence properties using tissue image analysis. The initiation of a Phase 2 clinical trial for AVB-620 in breast cancer is expected in the first half of 2017. In addition, the company is advancing a therapeutic program, which utilizes the same technology platform. Avelas was founded by Avalon Ventures on technology from Roger Y. Tsien, Ph.D., co-winner of the 2008 Nobel Prize in chemistry. For additional information, please visit www.avelasbio.com.

Related Links

http://www.biospace.com/news_story.aspx?StoryID=449553&full=1

Avelas Biosciences to Present at 29th Annual Roth Conference

SAN DIEGO, March 7, 2017 /PRNewswire/ -- Avelas Biosciences, Inc., a clinical stage oncology-focused company dedicated to improving cancer patient care from diagnosis through treatment, today announced that Carmine N. Stengone, president and chief executive officer, will present an overview of the company at the 29th Annual Roth Conference on Tuesday, March 14, 2017, at 4:00 p.m. PT at The Ritz Carlton, Laguna Nigel, California.

About Avelas Biosciences

Avelas Biosciences is a San Diego-based biotechnology company focused on developing technologies that advance a new standard-of-care for cancer surgery and therapeutic intervention. The company's lead candidate, AVB-620, has completed a Phase 1b clinical trial assessing safety, pharmacokinetics and fluorescence properties using tissue image analysis. The initiation of a Phase 2 clinical trial for AVB-620 in breast cancer is expected in the first half of 2017. In addition, the company is advancing a therapeutic program, which utilizes the same technology platform. Avelas was founded by Avalon Ventures on technology from Roger Y. Tsien, Ph.D., co-winner of the 2008 Nobel Prize in chemistry. For additional information, please visit www.avelasbio.com.

Source

http://www.avelasbio.com/

Leap Therapeutics to Present at 2017 Barclays Global Healthcare Conference

CAMBRIDGE, Mass., March 07, 2017 (GLOBE NEWSWIRE) -- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, today announced that Christopher K. Mirabelli, Ph.D, Chairman, President, and Chief Executive Officer, will present a corporate overview at the 2017 Barclays Global Healthcare Conference, being held in Miami on March 14-16, 2017.

Dr. Mirabelli’s presentation will be webcast live and may be accessed under the investors tab on http://www.investors.leaptx.com.

About Leap Therapeutics

Leap Therapeutics’ (NASDAQ:LPTX) most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is in clinical trials in patients with gastroesophageal cancer in combination with paclitaxel and in patients with biliary tract cancers in combination with gemcitabine and cisplatin. DKN-01 has demonstrated single agent activity in non-small cell lung cancer patients. Leap’s second clinical candidate, TRX518, is a novel, humanized GITR agonist monoclonal antibody designed to enhance the immune system’s anti-tumor response. For more information about Leap Therapeutics, visit http://www.leaptx.com or our public filings with the SEC that are available via EDGAR at http://www.sec.gov or via http://www.investors.leaptx.com/.

FORWARD LOOKING STATEMENTS

Some of the statements in this release are forward looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements relate to future events of Leap’s development of DKN-01, TRX518, and other programs, future expectations, plans and prospects. Although Leap believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Leap has attempted to identify forward looking statements by terminology including ‘‘believes,’’ ‘‘estimates,’’ ‘‘anticipates,’’ ‘‘expects,’’ ‘‘plans,’’ ‘‘projects,’’ ‘‘intends,’’ ‘‘potential,’’ ‘‘may,’’ ‘‘could,’’ ‘‘might,’’ ‘‘will,’’ ‘‘should,’’ ‘‘approximately’’ or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors. Any forward looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contact
Douglas E. Onsi
Chief Financial Officer
Leap Therapeutics, Inc.
donsi@leaptx.com
617-714-0360

Source

http://www.investors.leaptx.com/phoenix.zhtml?c=254460&p=irol-newsArticle&ID=2251981

Leap Therapeutics to Present Preclinical and Clinical Data at 2017 AACR Annual Meeting

CAMBRIDGE, Mass., March 01, 2017 (GLOBE NEWSWIRE) -- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, today announced preclinical and clinical data presentations will be made during the 2017 American Association for Cancer Research (AACR) Annual Meeting, being held April 1 - 5, 2017, in Washington, D.C. Data on TRX518 will be presented as an oral presentation in a clinical trials plenary session by Roberta Zappasodi, Ph.D., Parker Institute Scholar and Research Scholar in the Ludwig Collaborative Laboratory at Memorial Sloan Kettering Cancer Center from the lab of Taha Merghoub, Ph.D., Associate Attending Lab Member of the Ludwig Collaborative Laboratory at the Memorial Sloan Kettering Cancer Center and Jedd Wolchok, M.D. Ph.D., Chief of Melanoma and Immunotherapeutics Service at Memorial Sloan Kettering Cancer Center.

Abstract Number and Title: #CT018, Intratumor and peripheral Treg modulation as a pharmacodynamic biomarker of the GITR agonist antibody TRX-518 in the first in-human trial
Session Title: Immuno-oncology Biomarkers in Clinical Trials
Session Date and Time: Sunday Apr 2, 2017 3:28 PM - 3:43 PM
Session Location: Hall D-E, Level 2, Washington Convention Center

Abstract Number and Title: #369, Therapeutic targeting of the Wnt antagonist DKK1 with a humanized monoclonal antibody in oncology indications
Session Title: Cell Growth Signaling Pathways 2
Session Date and Time: Sunday Apr 2, 2017 1:00 PM - 5:00 PM
Session Location: Convention Center, Halls A-C, Poster Section 15

About Leap Therapeutics

Leap Therapeutics’ (NASDAQ:LPTX) most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is in clinical trials in patients with gastroesophageal cancer in combination with paclitaxel and in patients with biliary tract cancers in combination with gemcitabine and cisplatin. DKN-01 has demonstrated single agent activity in non-small cell lung cancer patients. Leap’s second clinical candidate, TRX518, is a novel, humanized GITR agonist monoclonal antibody designed to enhance the immune system’s anti-tumor response. For more information about Leap Therapeutics, visit http://www.leaptx.com or our public filings with the SEC that are available via EDGAR at http://www.sec.gov or via http://www.investors.leaptx.com/.

FORWARD LOOKING STATEMENTS

Some of the statements in this release are forward looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements relate to future events of Leap’s development of DKN-01, TRX518, and other programs, future expectations, plans and prospects. Although Leap believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Leap has attempted to identify forward looking statements by terminology including ‘‘believes,’’ ‘‘estimates,’’ ‘‘anticipates,’’ ‘‘expects,’’ ‘‘plans,’’ ‘‘projects,’’ ‘‘intends,’’ ‘‘potential,’’ ‘‘may,’’ ‘‘could,’’ ‘‘might,’’ ‘‘will,’’ ‘‘should,’’ ‘‘approximately’’ or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors. Any forward looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Contact
Douglas E. Onsi
Chief Financial Officer
Leap Therapeutics, Inc.
donsi@leaptx.com
617-714-0360

Source

http://www.nasdaq.com/press-release/leap-therapeutics-to-present-preclinical-and-clinical-data-at-2017-aacr-annual-meeting-20170301-01883

Viriom Reports Positive Findings in 48 Week Study of Elsulfavirine as Compared to Efavirenz in Combination with TDF/FTC at CROI 2017

SAN DIEGO, CA, February 17, 2017 -- Viriom, Inc. announced the top-line results of its comparator study of Elsulfavirine (ESV) versus Efavirenz (EFV) in combination with Tenofovir/Emtracitabine (TDF/FTC) at the Conference on Retroviruses and Opportunistic Infections (CROI 2017).

The study was presented by Professor Robert Murphy, Northwestern University, Chicago, as a late-breaker poster. In this randomized, placebo-controlled, double-blind, multicenter study, 120 antiretroviral therapy (ART)-naïve HIV-1-infected patients were treated with once-daily oral dosing with either 20 mg Elsulfavirine or 600 mg Efavirenz in combination with TDF/FTC for 48 weeks. Sixty patients were assigned to each of the ESV and EFV treatment groups.

Both 20 mg ESV and 600 mg QD EFV treatment groups showed an acceptable decrease in HIV-1 viral loads compared to baseline. More ESV patients (91.7%) completed treatment than EFV patients (78.3%), and ESV patients had fewer adverse events (AEs), including central nervous system and skin adverse events.

"We are excited about these clinical results," commented Dr. Vadim Bichko, Viriom’s Chief Scientific Officer."This 48-week study demonstrated equivalent virologic and immunologic efficacy of ART regimens including 20 mg ESV or 600 mg EFV in ART-naive HIV-1 infected patients. Elpida was significantly better tolerated than EFV-based therapy, offering a safer alternative to EFV-based ART."

About Viriom
Viriom is an emerging leader in the development of innovative antiviral drugs and drug combinations, as well as treatment and diagnosis methods. Viriom's most advanced drug is elsulfavirine, a once-daily oral prodrug of VM-1500A, a novel HIV non-nucleoside reverse transcriptase inhibitor (NNRTI). Viriom expects to obtain first market registration for Elsulfavirine in 2017. Development is underway for once-weekly oral and longer-acting parenteral formulations of elsulfavirine, as well as drug combination formulations. Learn more http://viriom.com/

ChemDiv Announces Multi-Year Hit Identification Collaboration with Janssen

SAN DIEGO, Jan. 31, 2017 /PRNewswire/ — ChemDiv Inc. announced today that it has entered into a hit identification collaboration with Janssen Research & Development, LLC (Janssen) to identify potent hit series for a range of targets across multiple therapeutic areas. Under the terms of the agreement, Janssen is granted open-ended access to ChemDiv’s discovery chemistry platform. In return, ChemDiv will receive access fees and will be eligible for undisclosed milestone payments based on successful identification of new chemical hit series.

Ron Demuth, General Manager of ChemDiv, commented, "The fact that this is ChemDiv’s fifth major collaboration under this innovative model highlights its scientific and commercial advantages, and serves as a testament to the value ChemDiv consistently delivers to the industry partners. Opening up highly relevant new chemistry space and expansion of its broad discovery resources has been ChemDiv’s laser focus for the past two decades. We are extremely pleased to be recognized as an industry leader by long-standing and trustworthy partners such as Janssen. In contrast to traditional unit-pricing models and fee-for-service arrangements common to discovery and synthetic chemistry library procurement, this new economic model minimizes the Janssen cost of acquiring a key research resource, while appropriately rewarding ChemDiv based on the productivity of our chemistry. The arrangement fulfills our goal of helping Janssen, and all our partners, to develop potent medicines and remain at the forefront of drug discovery and development."

About ChemDiv and ChemDiv Research Institute:

ChemDiv is a fully integrated discovery and development CRO serving the life science industry for 26 years. To date ChemDiv has carried out numerous successful innovative open-access platform collaborations with Sanofi, Eli Lilly, Novartis and other pharma and biotech partners. The ChemDiv Research Institute R&D facilities are located at Torrey Pines Center in San Diego, CA, ChemRar High Tech Center and Skolkovo Life Science Cluster in Moscow. ChemDiv accelerates and enables pharma and biotech R&D programs from research concepts to clinic and market registration, covering the complete range of disciplines, in CNS, oncology, inflammation, cardio metabolic, infectious diseases, and other therapeutic areas.

Viriom to Present Positive Clinical Findings for Elsulfavirine vs Efavirenz in Combination with TDF/FTC

SAN FRANCISCO, Jan. 13, 2017 -- J.P. Morgan 35th Annual Healthcare Conference 2017 -- Viriom, Inc. (San Diego, CA) today announced positive 48 week clinical findings for Elsulfavirine vs Efavirenz (EFV) in combination with tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC). The Elsulfavirine 20 mg-based ART regimen was equally efficacious but significantly better tolerated than EFV 600 mg-based regimen. The results will be presented at a major scientific conference next month.

About Viriom, Inc.

Hope - Health - Happiness

We are an emerging leader in the development of innovative antiviral drugs, drug combinations and diagnostics. Viriom is passionate about bringing effective and affordable cures for life threatening viral infections such as HIV, viral hepatitis, and tropical fevers to patients around the globe. Viriom's most advanced drug, Elsulfavirine, is a once-daily oral prodrug of VM1500A, a novel, potentially best in class HIV NNRTI. Viriom expects to obtain first market authorizations for Elsulfavirine outside of the US in 2017. Development is underway for once-weekly oral PrEP and long-acting injectable (subcutaneous and intramuscular) formulations for Elsulfavirine/VM1500A, as well as fixed drug combination formulations. Viriom sponsors and conducts joint research programs on immunotherapies and epigenetic approaches to combat viral infections with NIH intramural research laboratories, The Scripps Research Institute (La Jolla, CA), Heidelberg University (Germany) and Fox Chase Cancer Center (Philadelphia, PA)
Learn more: viriom.com @viriominc #hopehealthhappiness #accessforeverybody

ChemDiv Announces Key Milestones in Abbott Pharma Collaboration

SAN DIEGO, Jan. 11, 2017 -- ChemDiv, Inc (ChemDiv) – a global research organization, announced achieving several key milestones in collaboration with Abbott's branded generics pharmaceutical business. The collaboration, begun in 2012 and expanded in 2015, is aimed at development and registration of a pipeline of new branded generic pharmaceutical products across key therapeutic areas for high growth emerging markets.

ChemDiv and Abbott submitted one product to first market authorization, submitted one product for phase 3 clinical studies and selected multiple prototype products for further development, triggering multiple milestone payments.

Other projects in the collaboration are progressing on schedule and are on track to achieve further project milestones for which ChemDiv will receive additional payments from Abbott. Financial details of the milestones were not disclosed.

Nikolay Savchuk, CEO of ChemDiv, commented, "We are delighted to be able to register a number of successful joint developments with our strategic partner.

We are extremely pleased to achieve these next milestones in our long term relationship. This is an excellent validation of our research and regulatory contribution to Abbott's generics strategy, as further manifested by the recent expansion of the collaboration. Our strategic relationship with Abbott is extremely important and valuable to us. We are committed to supporting the expansion of Abbott product pipeline that will help improve the lives and health outcomes of many people around the globe."

About ChemDiv:
ChemDiv is a global research organization headquartered in San Diego, California. For 25 years ChemDiv has accelerated and enabled pharma and biotech R&D programs from research concepts to registered drugs, targeting a broad spectrum of unmet medical needs.

Viriom Announces Collaboration with NIH on Zika and Other Major Viral Diseases

SAN DIEGO, CA, January 6, 2017 -- Viriom Inc. announced today that it has entered into a collaboration with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) to identify new drug candidates for treatment of the Zika and other important virus infections. Under the collaboration agreement, Viriom and Dr. Leo Margolis of NICHD will study and improve the antiviral properties of Viriom’s lead compounds against the Zika virus, HBV, HCV, HIV, RSV and other clinically relevant viruses.

Zika virus is spread predominantly by the bite of an infected Aedes species mosquito. During pregnancy, the Zika virus infection can cause severe fetal abnormalities, including microcephaly and Guillain-Barré syndrome. As of January 2017, about 40,000 Zika virus infection cases were reported in the US with no treatment currently available. The new collaboration aims at capitalizing on Viriom’s existing antiviral platform to provide an innovative solution to the Zika virus outbreaks, and to curb global spread of the established and emerging viral diseases.

"This collaboration is a valuable opportunity for Viriom to test and improve the efficacy of its lead candidates for a variety of indications,” said Dr. Nikolay Savchuk, Chairman of the Board at Viriom. “We look forward to our collaboration with NICHD and believe that their expertise in laboratory research, clinical trials, and epidemiological studies will allow us to strengthen our antiviral portfolio and develop more effective treatments for Zika virus infections and other socially significant viral diseases."

About Viriom
Viriom is a leader in the development of innovative antiviral drugs and drug combinations, as well as treatment and diagnosis methods. Viriom's most advanced drug is a once-daily oral prodrug of elsulfavirine, a novel HIV NNRTI. Viriom expects to obtain first market registration for elsulfavirine in 2017. Development is underway for once-weekly oral and long acting parenteral formulations of elsulfavirine, as well as drug combination formulations. Learn more http://viriom.com/

NewVac Reports Primary Endpoint Met in Phase II Clinical Trial of Quisinostat in Combination with Paclitaxel and Carboplatin in Platinum-Resistant Ovarian Cancer

SAN DIEGO, CA, January 3, 2017 – NewVac LLC reported meeting all primary endpoints in the Phase II Clinical Trial of Quisinostat, novel selective oral histone deacetylase (HDAC1) inhibitor, which NewVac licensed from Janssen Pharmaceutica NV. The clinical trial is evaluating the efficacy and safety of Quisinostat in platinum-resistant ovarian cancer in combination with Paclitaxel and Carboplatin. The detailed results will be presented in an upcoming clinical research meeting in 2017.

The main advantage of Quisinostat – its unique pharmacokinetic (PK) properties, particularly the ability to selectively accumulate in target tissues, providing high potential in treatment of solid tumors, which has been demonstrated in the Phase II trial. Quisinostat may present a safe and effective therapeutic solution to patients by restoring sensitivity to chemotherapy in platinum-resistant cases. The efficacy and safety of Quisinostat will be further explored in clinic. In 2016 chemistry, manufacturing, and control (CMC) activities were initiated to support a Phase III clinical trial.

The results of a Quisinostat Phase Ib clinical trial were recently presented at the European Society for Medical Oncology (ESMO) 2016 scientific congress in Copenhagen, Denmark. Quisinostat demonstrated good safety profile and promising efficacy in metastatic platinum-resistant ovarian cancer, showing the highest objective response rate (ORR) among other patient groups within the trial.
Preclinical studies have shown that Quisinostat amplifies HDAC-repressed expression of E-cadherin, leading to a reversal of epithelial to mesenchymal transition (EMT). The latter is associated with platinum-based chemotherapy resistance.

Quisinostat has been investigated in six clinical trials conducted by NewVac or Janssen Pharmaceutica in Europe and the US. Overall, it has been tested in more than 200 patients with hematological and solid malignancies.

NewVac is preparing to study additional indications of Quisinostat in combination with proteasome inhibitors to treat translocation-associated sarcomas in adolescents and young adults; and in combination with check-point inhibitors to increase efficacy in solid tumors (gynecologic cancers and NSCLC).

About Phase II Trial
This is a multicenter, open-label study of safety and efficacy of Quisinostat in combination with Paclitaxel + Carboplatin chemotherapy in patients with metastatic or locally advanced epithelial ovarian cancer, primarily peritoneal or fallopian tube carcinoma, resistant to first-line platinum and Paclitaxel based chemotherapy. The study consists of a screening period of 3 weeks before the start of Quisinostat administration, followed by the treatment period of approximately 18 weeks (up to 6 cycles and 21 days for each cycle), a safety follow-up of 4 weeks after the last administration of the study therapy and post-treatment follow-up aimed at the determination of progression-free survival, time to disease progression and overall survival rate in the study population.

About Ovarian Cancer
Ovarian cancer ranks 5th in the world list of causes of death of women from malignant tumors. Among the countries are USA, West and North Europe. Ovarian cancer is also a leading cause of death from tumors of gynecological nosologies, i.e. it causes more deaths per year than any other type of female reproductive system cancer. The average age at diagnosis is 58 years, and 90% of diagnoses are established in women over 40 years old. In the case of ovarian cancer, the median 5-year survival rate is 36.3%. After a debulking surgery, the standard of care for first-line diagnosed ovarian cancer is platinum- and paclitaxel-based chemotherapy. However, there is still a very high risk of recurrence with a very poor outcome. There is an urgent need to develop new and better treatment options both for first-line patients and those that relapse. The populations of patients who progress within 1-6 months are considered to be platinum-resistant patients. For these patients, re-treatment with the same chemotherapy regimen is futile (<10% response rate). However, by adding a potential resistance modifier such as Quisinostat, a re-treatment with the original regimen in combination with the experimental agent is the best test of proof of concept.

About NewVac
NewVac LLC, a ChemRar Group company, focuses on novel therapeutic and diagnostic approaches to detecting and treating cancer. NewVac, a privately owned biotech, is a member of Skolkovo innovative biocluster in Moscow, Russia.

Viriom Announces Appointment of New Scientific Advisory Board Member

SAN DIEGO, October 24, 2016 – Viriom Inc. is pleased to announce the appointment of Janet Hammond, MD, PhD as a member of its Scientific Advisory Board. Dr. Hammond most recently served as Senior VP and Global Head of Infectious Diseases at F. Hoffmann-La Roche managing early clinical development strategy and implementation.

Dr. Hammond brings to the board her extensive knowledge in the areas of virology and infectious diseases, sound clinical expertise as well as ample regulatory experience. Dr. Hammond began her career as a Clinical Program Head of Clinical Discovery in Virology at GlaxoSmithKline (GSK), where she oversaw founding and development of a new department and its medical strategy, IND submissions, and clinical development of small molecules and vaccines. Subsequently she led the Early Clinical research team at Bristol-Myers Squibb responsible for HIV Early Development and Virology Life Cycle management. Dr. Hammond also served as CMO - Medical Affairs at Valeant, where she was responsible for clinical and pharmacovigilance activities around the globe.

"Dr. Hammond’s knowledge and experience in the fields of virology and infectious diseases will serve as an invaluable addition to Viriom’s efforts in developing innovative HIV treatments and will enrich its Scientific Advisory Board with a unique perspective," said Nikolay Savchuk, PhD, Chairman of Viriom’s Scientific Advisory Board. "We believe that Dr. Hammond’s clinical expertise as well as experience in drug development and regulatory affairs will help support Viriom's quest to provide more effective solutions for HIV patients."

"Viriom’s innovative research aims at bringing to live the next generation of antiviral treatments that will not only be effective but also affordable, and I am delighted to become a part of the company’s renown team and contribute to advancing its novel therapies," said Janet Hammond. After receiving her MD and PhD from the University of Cape Town, South Africa, Dr. Hammond has been an exceptionally active contributor to infectious disease therapies, leading the submission of three New Drug Applications (NDA) and Marketing Authorization Applications, more than ten supplemental NDAs, and more than ten Investigational New Drug (IND) applications in the past thirteen years.

Viriom’s Scientific Advisory Board members are prominent medical practitioners and scientists with extensive experience in virology and infectious diseases, working together to provide scientific and clinical advice on the development of novel and affordable therapies against life threatening infections including HIV and hepatitis B.

About Viriom
Viriom Inc. is a late-stage biotech company developing, manufacturing and distributing novel and affordable therapies against life threatening infections such as HIV and HBV. Viriom holds exclusive worldwide rights from F. Hoffmann-La Roche for VM1500, which it is presently developing as an oral AIDS treatment elsulfavirine for active HIV infections; and as innovative longer-acting formulations of elsulfavirine for PrEP and PEP in high-risk patient populations. Viriom is also developing a proprietary therapeutic for chronic HBV infections. Viriom believes its drug candidates are capable of achieving breakthroughs in treatment and prevention of HIV and chronic HBV infections in both developing and developed countries. For more information, please visit www.viriom.com.

ChemDiv, Torrey Pines Investment and DZNE Announce Research Collaboration

SAN DIEGO, Oct. 17, 2016 -- DZNE, the German Center for Neurodegenerative Diseases, ChemDiv, Inc. and Torrey Pines Investment jointly announced today an agreement initiating a Research and Development collaboration targeting pathways and molecular mechanisms underlying neurological health and disease.

DZNE, the preeminent neurosciences Research Center within Germany's Helmholtz Association, will work with ChemDiv and Torrey Pines on multiple joint projects to commercialize early stage technologies arising from DZNE's researchers and physician-scientists. By drawing together ChemDiv's capacity in chemistry and pharmaceutical drug development with DZNE's advanced research and clinical capabilities focused on understanding commonalities and differences between various brain pathologies, this partnership aims at developing innovative preventive and therapeutic approaches for treatment of neurodegenerative diseases. Torrey Pines Investment will provide financial and network resources supporting pre-commercial research, as well as early stage venture investments in developing brain medicines up and into the clinical phase, which may be established within the broad collaborative framework.

"I believe that ChemDiv researchers share the same core values and commitment in public-private partnering with DZNE scientists. The combination of ChemDiv's focused commercial approach to R&D with DZNE's excellence in fundamental and clinical sciences will yield a rich pipeline of preclinical and clinical research platforms allowing to support new therapeutic approaches to diagnosis of neurodegenerative diseases," said Ronald Demuth, General Manager ChemDiv.

"Torrey Pines Investment looks forward to nurturing the collaboration's early stage projects and validating their commercial feasibility for the larger investment community, that could work alongside research and industry and take these opportunities further to success," added Nikolay Savchuk, Managing Partner, Torrey Pines Investment.

"By collaborating with ChemDiv and Torrey Pines, DZNE opens another pathway to develop and translate scientific innovation into value for patients and society. We are looking forward to work with professional partners with complementary technologies and expertise," stated Pierluigi Nicotera, MD, PhD, Scientific Director and Chairman of the Executive Board of the DZNE.

The DZNE is already implementing translational approaches to research to tap into the expertise of its multidisciplinary partners and the new partnership with ChemDiv and Torrey Pines will provide all parties with an opportunity to nourish each other's multilateral resources and capabilities.

About DZNE
The German Center for Neurodegenerative Diseases (DZNE) investigates the causes of diseases of the nervous system and develops strategies for prevention, treatment and care. It is an institution within the Helmholtz Association of German Research Centres with nine sites across Germany (Berlin, Bonn, Dresden, Göttingen, Magdeburg, Munich, Rostock/Greifswald, Tübingen and Witten). The DZNE cooperates closely with universities, their clinics and other research facilities. www.dzne.de

About ChemDiv
ChemDiv, Inc. (San Diego, CA) is a target-to-market Research Organization. Over the past 25 years the ChemDiv team has delivered hundreds of leads, drug candidates and drug approvals in CNS, oncology, virology, inflammation, cardio and metabolic diseases to its pharma and biotech customers around the globe. ChemDiv's integrated platforms allow for accelerated, cost-effective R&D aimed at rapidly bringing projects from target ID to Phase 3 clinical candidate and beyond. www.chemdiv.com

Leap Therapeutics and Macrocure Announce Definitive Merger Agreement

Combined company to advance Leap's two first-in-class immuno-oncology monoclonal antibodies targeting aggressive cancers

CAMBRIDGE, Massachusetts and PETACH TIKVA, Israel, August 29, 2016 - Leap Therapeutics, Inc., a clinical stage immuno-oncology company, and Macrocure Ltd. (NASDAQ: MCUR) today announced the signing of a definitive merger agreement. Under the terms of the agreement, Macrocure will become a wholly owned subsidiary of Leap, and Leap will become a public company. In connection with the transaction, Leap will apply to have the shares of the combined entity listed for trading on NASDAQ upon completion of the merger.

Under the terms of the agreement, Macrocure shareholders will exchange their Macrocure shares for newly issued shares of Leap common stock. In addition, existing Leap investors, including entities affiliated with HealthCare Ventures, have committed to invest an additional $10 million at the closing of the transaction. On a pro forma basis, after giving effect to the merger and the investment, Macrocure equity holders are expected collectively to own approximately 31.8%, and Leap equity holders are expected collectively to own approximately 68.2%, of the combined company, subject to certain possible adjustments based on Macrocure's net cash level at closing. Existing Leap shareholders will receive the right to a royalty, under certain circumstances, based on future net sales. The combined company is expected to have a minimum of $30 million of cash at closing to finance future operations.

"The combination with Macrocure positions our organization as a leading immuno-oncology company with sufficient capital to advance our pipeline of first-in-class monoclonal antibodies through significant value-creating events," commented Christopher K. Mirabelli, PhD, CEO of Leap. "Importantly, we anticipate achieving substantial clinical milestones over the course of 2016 and 2017. We plan to present data and initiate randomized studies for DKN-01, our lead development candidate, which has demonstrated clinical activity in esophageal cancer and cholangiocarcinoma when combined with chemotherapy; and we expect to report data from a repeat-dose study of TRX518, a novel GITR agonist monoclonal antibody which is believed to enhance an immune anti-tumor response."

"After careful review of many alternatives, the executive team and Board of Directors of Macrocure believe this transaction provides great potential for our shareholders," said Nissim Mashiach, President and Chief Executive Officer of Macrocure Ltd. "Leap Therapeutics has a maturing pipeline of novel drug candidates focused on key immuno-oncology targets that are designed to provide new and valuable treatment options for patients suffering from aggressive cancers. Furthermore, Leap's experienced management team has a track record relating to public and private companies and drug development success."

The executive team of Leap Therapeutics will remain in their positions in the combined entity that will be based out of Leap Therapeutics' current corporate office in Cambridge, Massachusetts. The combined entity's leadership team will consist of Christopher K. Mirabelli, PhD, who will serve as Chief Executive Officer and Chairman of the Board of Directors, Augustine Lawlor as Chief Operating Officer, and Douglas E. Onsi as Chief Financial Officer. At the closing, two Macrocure designated individuals, including Nissim Mashiach, will join Leap's Board of Directors.

The Board of Directors of both companies have unanimously approved the proposed merger. Macrocure's shareholders who hold approximately 51% of Macrocure's voting shares, have entered into agreements in support of the proposed transaction. While these agreements assure the approval of the merger, all Macrocure shareholders will be asked to vote on the merger at a meeting of shareholders. Additionally, entities affiliated with HealthCare Ventures and Eli Lilly, which own all of Leap's outstanding voting shares, have entered into agreements in support of the proposed transaction. The transaction is expected to close near year-end, subject to shareholder approval and other customary closing conditions which are set forth in the merger agreement.

Raymond James is serving as exclusive financial advisor to Macrocure Ltd.

Leap expects to file a registration statement on Form S-4 with the U.S. Securities and Exchange Commission to register the shares of common stock to be issued in the merger. The registration statement will contain more detailed information about the transaction, as well as information about the respective companies. In addition, Macrocure expects to file a current report on Form 6-K shortly regarding the transaction. Macrocure also will be mailing a proxy statement to its shareholders, which will be filed on a current report on Form 6-K and attached as an appendix to Leap's Form S-4 registration statement.

About DKN-01
DKN-01 is a humanized monoclonal IgG4 monoclonal antibody with neutralizing activity against the Dickkopf-1 protein. DKN-01 is currently being studied in clinical trials in esophageal cancer and cholangiocarcinoma. DKN-01 demonstrated clinical activity as a single agent in patients with non-small cell lung cancer in a Phase 1 dose escalation study that was presented at the American Society for Clinical Oncology (ASCO) 2014 Annual Meeting and in combination with paclitaxel in patients with esophageal cancer in a study that was presented at the European Society for Medical Oncology (ESMO) World GI Congress in 2016. Additional data from the study of DKN-01 plus the combination of gemcitabine and cisplatin in patients with cholangiocarcinoma will be presented at the ESMO Annual Meeting in October 2016.

About TRX518
TRX518 is a humanized aglycosyl IgG1 monoclonal antibody with agonist activity targeting GITR. TRX518 has been shown to bind and activate GITR through bivalent binding to the receptor. TRX518 was engineered to remove Fc-receptor interactions to prevent complement-mediated cytolysis and antibody-mediated depletion of leukocytes expressing GITR. TRX518 surrogate antibodies have been effective in preclinical animal models, prolonging survival or enhancing immune responses when combined with chemotherapeutics and checkpoint inhibitors. Initial clinical data on TRX518 was presented at the ASCO 2016 Annual Meeting.

About Leap Therapeutics
Leap Therapeutics is an immuno-oncology company with two clinical stage programs. Leap's most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is in clinical trials in esophageal cancer and cholangiocarcinoma. Leap's second clinical candidate, TRX518, is a novel, humanized GITR agonist monoclonal antibody designed to enhance the immune system's anti-tumor response. TRX518 is in clinical trials in patients with advanced solid tumors. For more information about Leap Therapeutics, please visit http://www.leaptx.com.

About Macrocure Ltd.
Macrocure Ltd. is a clinical-stage biotechnology company that was focused on developing a novel therapeutic platform to address chronic and hard-to-heal wounds. For more information, please visit www.macrocure.com.

Cautionary Note Regarding Forward-Looking Statements

This press release includes forward-looking statements that are not historical facts, such as statements regarding assumptions and results related to financial results, forecasts, clinical trials, and regulatory authorizations. Words such as "will," "expect," "anticipate," "plan," "believe," "design," "may," "future," "estimate," "predict," "objective," "goal," or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on Macrocure's and/or Leap's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties, and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, the expected timing and likelihood of completion of the proposed merger, the occurrence of any event, change, or other circumstance that could result in the termination of the merger agreement or the anticipated financing, receipt and timing of any required governmental or regulatory approvals relating to the registration and listing of Leap's common stock or otherwise relating to the merger, the anticipated amount needed to finance the combined company's future operations, unexpected results of clinical trials, delays or denial in regulatory approval process, or additional competition in the market. The forward-looking statements made herein speak only as of the date of this release and Macrocure and Leap undertake no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

Additional Information and Where to Find It

This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval with respect to the proposed Merger or otherwise. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, and otherwise in accordance with applicable law.In connection with the proposed merger, Leap intends to file with the U.S. Securities and Exchange Commission (SEC) a registration statement on Form S-4 containing a prospectus and other relevant documents relating to the proposed merger and combined company. Macrocure intends to file a current report on Form 6-K containing its proxy statement and other documents relating to the proposed merger. This communication is not a substitution for the registration statement, final prospectus, proxy statement, or any other documents that Leap and Macrocure may file with the SEC or send to shareholders in connection with the proposed transaction. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE REGISTRATION STATEMENT, THE PROSPECTUS, THE PROXY STATEMENT AND ANY OTHER RELEVANT DOCUMENTS FILED, OR TO BE FILED, WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT LEAP, MACROCURE, AND THE PROPOSED MERGER. Investors and security holders will be able to obtain free copies of the registration statement, the prospectus, the proxy statement, and any other documents filed by Leap and Macrocure with the SEC (when available) at the SEC's website at www.sec.gov. Copies of documents filed by Leap may be obtained for free by contacting Leap Investor Relations by mail at Leap Therapeutics, Inc., 47 Thorndike Street, Suite B1-1, Cambridge, MA 02141, Attention: Investor Relations or by telephone at (617)-714-0360. Copies of documents filed by Macrocure may be obtained for free by contacting Macrocure Investor Relations by mail at Macrocure Ltd., 25 Hasivim Street, Kiryat Matalon, Petach Tikva 4959383, Israel, Attention: Investor Relations, by telephone at +(972)-54-565-6011, or by going to Macrocure's Investor Relations page at http://investor.macrocure.com/. The contents of Macrocure's website are not deemed to be incorporated by reference into the registration statement, the prospectus, or the proxy statement.

Avelas Biosciences Completes $20 Million Series C Financing.

Proceeds to advance AVB-620 and therapeutic programs in oncology.

SAN DIEGO, August 18, 2016 – Avelas Biosciences, Inc., a clinical stage oncology-focused company dedicated to improving cancer patient care from diagnosis through treatment, today announced it has completed a Series C financing which raised $20 million in new funds. The investment was led by Pharmstandard International, S.A. and includes new investors Ervington Investments Limited and Alexandria Venture Investments. Existing investors Avalon Ventures, Bregua Corporation, and WuXi Healthcare Ventures participated in the financing as well. Avelas Biosciences plans to use the proceeds to advance AVB-620, a "cancer illuminator," into late-stage clinical trials, to develop new targeted therapeutics for cancer and for general corporate purposes.

The company also announced today that, in conjunction with the financing, Andrei Petrov, Ph.D. has joined Avelas Biosciences’ board of directors. Dr. Petrov is the chief executive officer and managing partner at Inbio Ventures, a venture capital management company representing Pharmstandard International, S.A. At the same time, Kevin Kinsella and Nikolay Savchuk will be stepping down as directors of the company.

"I am delighted to have some of the world’s most prominent healthcare investors participate in our Series C financing, led by Pharmstandard," said Carmine N. Stengone, president and chief executive officer of Avelas Biosciences. "Strengthened by this fundraising, I believe Avelas is well-positioned to further the development of AVB-620  and advance new therapeutic candidates – two exciting product opportunities that could make meaningful contributions to cancer diagnosis and treatment."

Avelas’ core technology takes advantage of cancer’s inherent pathological biochemistry to deliver either therapeutic or imaging cargo to the cancer site. The first product candidate, AVB-620 , is a fluorescent, cancer-illuminating probe that "lights up" when it interacts with cancer tissue. The purpose of AVB-620  is to enable cancer surgeons to distinguish between tumor and healthy tissue during surgery. AVB-620  could offer the necessary real-time information needed by surgeons to visualize and excise cancerous tissue while they operate and avoid the need for additional surgeries.


About Avelas Biosciences
Avelas Biosciences is a San Diego-based biotechnology company focused on developing technologies that advance a new standard-of-care for cancer surgery and therapeutic intervention. The company’s lead product candidate, AVB-620, is in a Phase 1b trial in breast cancer to assess safety, pharmacokinetics and fluorescence properties using tissue image analysis. Avelas was founded by Avalon Ventures on technology from Nobel laureate Roger Y. Tsien, Ph.D. For additional information, please visit www.avelasbio.com.

SatRx LLC Announces First Registration in Russia of SatRx® (gosogliptin), an Innovative Drug for Treatment of Type 2 Diabetes.

SAN DIEGO, CA, June 9, 2016 – Today, at the largest global biotech forum, BIO International Convention, that took place in San Francisco, USA, SatRx LLC, a ChemRar company specializing in research and development in the fields of diabetes and cardiometabolic disorders, announced the first market registration of its innovative drug for the treatment of Type 2 diabetes, SatRx® (gosogliptin), in Russia.

According to the World Health Organization, diabetes is one of the four most socially significant diseases, responsible for 80% of deaths from non-communicable diseases worldwide. Diabetes affects one in ten people in the world, with Type 2 diabetes (or non-insulin-dependent diabetes) accounting for about 90% of all cases.

SatRx is a new drug for treatment of Type 2 diabetes that belongs to the class of inhibitors of dipeptidyl peptidase-4 (DPP-4, DPP-IV), the enzyme responsible for the fast inactivation of the incretin hormones that stimulate insulin secretion in response to food intake. By inhibiting the activity of DPP-4, SatRx prolongs the blood-life of incretin hormones, improving blood glucose control, enhancing the insulin secretory response, and increasing insulin sensitivity.

In 2012, SatRx LLC, a ChemRar company, obtained an exclusive global (excluding China) license for the development, registration and commercialization of the Phase 2 drug candidate as well as its combinations from Pfizer Inc. SatRx secured an equity investment from ChemRar and a development contract with the Ministry of Industry and Trade of the Russian Federation under the framework of the “PharmaMed-2020” program, initiated by the Russian government to promote domestic drug development and modernization of the pharmaceutical industry. Under the "PharmaMed-2020" program, the Russian government plans for 90% of essential drugs to be produced locally by 2020. 

"The first market registration of the SatRx drug is an important milestone for ChemRar in its commitment to developing breakthrough treatments, diagnostics, and mechanisms for monitoring and controlling diabetes,” stated Nikolay Savchuk, member of the Board of Directors of ChemRar High-Tech Center. "We are pleased to see that our cooperation with Pfizer will allow Russian patients with Type 2 diabetes to have access to new innovative medicines that have been developed internationally and will be manufactured domestically."

About SatRx LLC
SatRx LLC, a pharmaceutical company established in 2010 as part of the ChemRar High-Tech Center, is focused on the development and registration of innovative drugs for the treatment of Type 2 diabetes and metabolic syndrome. http://www.satrx.ru

About ChemRar
ChemRar High-Tech Center (HTC) is a group of research, manufacturing, and investment companies engaged in the development, manufacturing and commercialization of innovative drugs for the treatment of patients with life threatening diseases in Russia and worldwide. www.chemrar.ru

Contact

Nikolay Savchuk
Managing Partner
Torrey Pines Investment
Member of the Board at ChemRar HTC
18587944860

BioIntegrator, LLC Announces the Second Market Registration of Nescler®, a First Generic of the Novartis MS Blockbuster Gilenya®.

SAN DIEGO, CA, May 16, 2016 – BioIntegrator, LLC, a member of the ChemRar group of companies (Moscow, Russia), announced today the successful launch in Belorussia of Nescler®, a unique oral formulation of fingolimod, the blockbuster small molecule for treatment of remitting-relapsing multiple sclerosis. Following the initial registration of Nescler in Russia in 2014, the drug has been gaining access to other emerging markets, with subsequent registrations planned in the countries of the Eurasian Economic Union (EAEU), Middle East and North Africa region (MENA) and the Association of Southeast Asian Nations (ASEAN).

Belorussia, along with Russia, Kazakhstan, Kyrgyzstan and Armenia, is a part of the Eurasian Economic Union founded in 2000 (known as the Eurasian Economic Community until 2014) to create a single regional market with unified regulatory procedures for the territories of its member states. The EAEU pharmaceutical market has been growing rapidly ever since due to the increase in average income, aging population and extensive government support. Currently, the EAEU pharmaceutical market is one of the most profitable markets in the region, with the Belorussian, Kazakh and Russian markets experiencing some of the highest growth rates among the emerging markets in the world.

"The availability of Nescler, a generic drug developed by BioIntegrator for treatment of multiple sclerosis, is of tremendous importance for patients and health providers alike, especially in rapidly growing markets where the demand for affordable top-quality medicines is high," said Nikolay Savchuk, Ph.D., Board member of ChemRar. "By lowering the cost of therapy, generics make it more accessible, and we hope that Nescler’s regulatory and marketing success in the high growth markets will pave the way for other first generic and biosimilar drugs."

About Nescler
Nescler® (fingolimod hydrochloride 0.56 mg) is a unique oral formulation of fingolimod developed by BioIntegrator, a ChemRar Group company. It reduces the rate of relapses in relapsing-remitting multiple sclerosis by approximately one-half over a two-year period and has been approved for treatment of chronic MS. Additional therapeutic applications are under investigation in ongoing clinical trials. With its therapeutic efficacy for MS proven in bioequivalence clinical trials and confirmed by numerous comparative preclinical studies, Nescler is currently the first generic of the Novartis drug Gilenya® in regulated markets. . 

About BioIntegrator:
BioIntegrator, LLC is a Russian biotechnology company developing and manufacturing first generics, biosimilars, as well as protein and antibody conjugates for treatment of cancer, rare and autoimmune diseases. Nescler® is the first drug in the BioIntegrator’s pipeline of MS treatments for development and registration in multiple markets. For more information, visit www.biointegrator.com.
About Multiple Sclerosis (MS):
Multiple sclerosis is a severe progressive neurological disease that affects the central nervous system and may cause disability among young and middle-aged adults. According to the National Multiple Sclerosis Society, relapsing-remitting multiple sclerosis (RRMS) is thought to affect over 2.3 million people worldwide, with the U.S. alone spending about $9 billion on MS therapy annually.

Contact

Nikolay Savchuk
Managing Partner
Torrey Pines Investment
18587944860

Viriom Announces Receipt of Funding from the Skolkovo Foundation, ChemRar and Torrey Pines Investment to Develop Elsulfavirine, a Novel Preventive and Long-acting Treatment of HIV/AIDS.

SAN DIEGO, CA, May 11, 2016 – Viriom Inc., a late-stage biotech company developing novel and affordable therapies against life threatening infections, announced today that it raised $4,700,000 of equity and non-equity financing, including a three-year grant of 150 million rubles ($2,350,000 US dollars) from The Skolkovo Foundation, for the development of fixed-dose combinations and long-acting injection formulations of Elsulfavirine, Viriom’s best-in-class non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV/AIDS. ChemRar and Torrey Pines Investment committed to this program on a pari passu basis and will provide matching funding in the form of capital investment. The drug’s unique pharmacokinetic properties, reinforced in the new formulations, allow it to offer a new approach to HIV prevention and treatment, potentially making it more effective and accessible, and eliminating the need for daily drug intake.

HIV is a pressing global issue, with 30 million patients infected worldwide. The main challenges facing effective HIV treatment today are low compliance rates and development of resistance to therapy. Efficacy and safety studies have demonstrated that Elsulfavirine has high virologic and immunologic efficacy in combinational therapy, significantly increased safety compared to currently used NNRTI drugs, as well as excellent virus mutation stability. Additional studies have shown that Elsulfavirine has a prolonged blood plasma half-life suitable for both a once weekly formulation and a new long-acting injectable formulation that is effective for at least 30 days of treatment and pre- and post-exposure prophylaxis. Therefore, Elsulfavirine has the potential to address the primary HIV treatment challenges and provide a new alternative to daily drug use for HIV patients.

The type of therapy anticipated by Elsulfavirine would allow increased availability of HIV treatments in inaccessible regions and could facilitate their use among populations at high risk for HIV/AIDS.

About Viriom
Viriom Inc. is a late-stage biotech company developing, manufacturing and distributing novel and affordable therapies against life threatening infections such as HIV and HBV (Hepatitis B virus). The company has an exclusive worldwide license to its Phase 2-3 HIV oral treatment Elsulfavirine from F. Hoffmann-La Roche and is developing a proprietary treatment for chronic HBV. Viriom believes its drug candidates are capable of making a breakthrough in treating and preventing HIV and chronic HBV infections in both developing and developed countries. For more information, please visit www.viriom.com. 

About Skolkovo Foundation
Charged with acting as the catalyst for the diversification of the Russian economy, the Skolkovo Foundation has an overarching goal of creating a sustainable environment for entrepreneurship and innovation, engendering a startup culture and encouraging venture capitalism. The Skolkovo Foundation identified five key areas of potential growth: energy efficiency, strategic computer technologies, biomedicine, nuclear technologies and space technologies.
About Torrey Pines Investment
Torrey Pines Investment, founded in 2002, is a specialty life-science investment company located in San Diego. Torrey Pines invests in discovery and early development stage assets working in therapeutic areas with unmet needs to develop breakthrough medications, diagnostic and healthcare system innovations. For more information, please visit http://torreypinesinv.com/.
About ChemRar
ChemRar Group is a unique pharma and biotechnology conglomerate built in the Russian Federation and focused on developing and commercializing novel drugs for partners in Russia and in other high growth pharmaceutical markets. ChemRar’s drug pipeline includes over 25 original, generic and biosimilar drugs on the market and in development. For more information, please visit http://www.chemrar.ru/.
Contact

Nikolay Savchuk
Managing Partner
Torrey Pines Investment
18587944860

Avelas Biosciences Announces Positive Interim Phase 1b Results and Advances to Dose Expansion Stage.

Initiates Stanford Cancer Center as Third Clinical Trial Site alongside UCSD Moores Cancer Center and UCSF Helen Diller Cancer Center.

SAN DIEGO, May 9, 2016 – Avelas Biosciences, Inc., a clinical stage oncology-focused company dedicated to improving cancer patient care from diagnosis through treatment, today announced positive interim results from a Phase 1b trial of its AVB-620 surgical marker in women with primary, non-recurrent breast cancer undergoing surgery.

Fifteen patients were enrolled at UCSD Moores Cancer Center in the initial dose escalation part of the Phase 1b trial, the purpose of which was to evaluate safety and pharmacokinetics and to determine the dose for additional imaging analysis in the next stage of the study. Interim analysis showed no toxicity issues, differentiated fluorescence between cancerous and non-cancerous tissue and identified a preferred dose to take forward into the expansion phase of the trial.

"I’m delighted to announce that our Phase 1b trial is proceeding as planned," said Carmine N. Stengone, president and chief executive officer of Avelas Biosciences. "We are seeing a clearly differentiated signal from cancerous versus non-cancerous tissue with no safety concerns and a selected dosage, based on fluorescence performance, with which we can proceed. Given these results, we look forward to presenting data from the completed study later this year."  

"Fluorescent surgical markers like AVB-620 have the potential to transform cancer surgery by finally enabling surgeons to see cancer and make real-time decisions to improve surgical treatment, " said Anne Wallace, M.D., Director of the Comprehensive Breast Health Center at Moores Cancer Center at UC San Diego Health. " Long term, this technology could lead to decreased surgical time and a reduction in the number of re-operations, both of which could result in better outcomes for patients and substantial cost savings."  

Avelas is now advancing the dose-expansion stage of the Phase 1b trial, for which several patients have already been enrolled, where the focus remains on safety, pharmacokinetics, and the timing of imaging after AVB-620 administration. The company expects to announce data from its completed Phase 1b trial later this year, by which time a total of 27 patients is expected to have been enrolled. Coincident with advancing to the dose-expansion stage, a third clinical site for the trial has been initiated, the Stanford Cancer Center Palo Alto, with Irene Wapnir, M.D., Professor of Surgery at the Stanford University Medical Center, serving as the site’s principal investigator. 
About AVB-620

AVB-620 is an intravenously administered in vivo fluorescent protease-activatable peptide that detects, labels, and visualizes cancer. The initial indication is intraoperative identification of primary tumor extent and metastatic lymph nodes in breast cancer patients. AVB-620 displayed outstanding preclinical data with sensitivity of >95% in preclinical breast cancer models and 100% in ex vivo analysis of human breast cancer tissue. AVB-620 is currently being evaluated in a phase 1b clinical study in breast cancer patients.
About Avelas Biosciences
Avelas Biosciences is a San Diego-based biotechnology company focused on developing technologies that advance a new standard-of-care for cancer surgery and therapeutic intervention. The company’s lead candidate, AVB-620, is in a Phase 1b trial planned for enrollment of 27 breast cancer patients, assessing safety, pharmacokinetics and fluorescence properties using tissue image analysis. Avelas was founded by Avalon Ventures on technology from Nobel laureate Roger Y. Tsien, Ph.D. For additional information, please visit www.avelasbio.com.

Contact

Robert H. Uhl
Managing Director
Investor Inquiries
Westwicke Partners
858.356.5932

 

The President of Tatarstan discussed cooperation with Torrey Pines Investment in the field of pharmaceuticals and novel agricultural products.

Today (04/21/2016) the President of Tatarstan Rustam Minnikhanov met Nikolay Savchuk, the managing partner of venture capital firm Torrey Pines Investment (USA).

The meeting took place at the Government House of the Republic of Tatarstan, and it was attended by Deputy Prime Minister of the Republic of Tatarstan, Minister of Agriculture and Food - Marat Akhmetov, Industry and Trade Minister - Albert Karimov, Head of Investment Development Agency of the Republic of Tatarstan - Talya Minullina, Assistant to the President - Radik Gimatdinov, General Director of JSC "Tatchempharmdrugs" - Timur Khannanov and others. 

During the meeting the sides discussed the partnership in the pharmaceutical, agro tech and health care areas.Torrey Pines Investment plans to organize a co-developmemt and manufacturing  of a variety of generic and innovative medicines at the site in Tatarstan. Nikolay Savchuk suggested  to organize a joint venture to manage critical bio - and agro-technologies' transfer and to raise capital. He believes that it will help to increase productivity in agricultural and food production sectors of the Republic. 

According to the President of Tatarstan, this initiative may help to solve specific issues of Tatarstan's agriculture. "First of all, drought-resistant crops need to be cultivated, as the climate and temperature conditions are changing every year. Therefore, all new projects must meet the specific conditions and local requirements," said Rustam Minnikhanov.Also the parties discussed the possibility of business acceleration program to bring pharmaceutical, medical and biotech products of the Republic of Tatarstan to the foreign markets.

 

Chromis Successfully Secures Seed Funding from Torrey Pines Investment.

SAN DIEGO, CA., Feb. 23, 2016 - Chromis Therapeutics Inc., an antiviral drug discovery company focused on the development of novel curative treatments for chronic HBV infection, announced that it has completed $3M seed financing round, led by Torrey Pines Investment. The funding will advance Chromis’ innovative platform of antivirals including cccDNA inhibitors, entry inhibitors and capsid assembly inhibition candidate drugs for the treatment of the Hepatitis B virus (HBV).

"With estimated 400 million people suffering from chronic HBV infection, which is a leading cause of cancer-related morbidity and mortality worldwide, chronic Hepatitis B is a serious global problem," said Jennifer G. Cayer a Director of the Board at Chromis Therapeutics. "We are grateful to have the support of investors who share our desire to eradicate HBV and can help advance our novel capsid assembly inhibition technology ". 

"Current available antiviral options suppress viral replication and improve patient survival but they do not eradicate the virus," said Nikolay Savchuk, a Managing Partner at Torrey Pines Investment. "This is why Chromis’ antiviral drugs have such a significant potential, they aim at not only treating, but eradicating the HBV virus". 
Chromis’ antiviral drugs have a novel target – HBV cccDNA (covalently closed circular DNA). HBV cccDNA formation and recycling are central to establishing and maintaining persistent infection, limiting efficacy of current antiviral treatments, as those drugs do not directly target cccDNA. Chromis’ leading HBV program is using its proprietary in vitro HBV core assembly model, superior to those currently used by others, to discover and develop small molecules that reduce or eliminate HBV cccDNA from the nuclei of infected liver cells and block the mechanisms of their re-infection. The secured funding will be crucial in allowing these novel drugs to proceed to clinical trials.
About Chromis Therapeutics, Inc.
Chromis www.chromistherapeutics.com is a San Diego based biopharmaceutical company, focused on the development of novel curative treatments for chronic HBV infection. Chromis uses its cutting-edge proprietary drug design and discovery platform to advance its novel cccDNA inhibitor (CHR101), inhibitor of viral entry and inhibitor of viral capsid assembly lead candidate drugs that have the potential to eradicate HBV virus.
About Torrey Pines Investment
Founded in 2002, Torrey Pines Investment is a specialty life-science investment company located in San Diego. Torrey Pines is investing in early and development stage assets from international pharma and biotech partners in CNS, oncology, and virology area to bring them to commercial success through pharma partnering and M&A. Torrey Pines' bottom line is to help its portfolio companies achieve growth, build value and realize wealth.
Contact
Nikolay Savchuk

 

ChemDiv and Abbott expand collaboration to develop branded generic pharmaceuticals for high growth emerging markets.

January 14th, 2016 – The Chemical Diversity Research Institute of ChemDiv, Inc (ChemDiv), San Diego, CA – based global research organization and Abbott’s branded generics pharmaceutical business have extended their existing collaboration to develop and register a pipeline of new branded generic pharmaceutical products for high growth emerging markets.

The expansion is the result of the successful existing partnership between Abbott and ChemDiv for the discovery and development of new pharmaceutical products and treatment alternatives in multiple therapeutic areas.

As part of this renewed collaboration, ChemDiv is developing product formulations and undertakes pre-clinical and clinical studies on a number of products. It also enables product registration and technology transfer to the manufacturing of new products that Abbott will market in Russia, CIS, and other high growth emerging markets in Asia, Africa and Latin America.

Nikolay Savchuk, Chairman of the Board for ChemDiv Research Institute said: “We are extremely pleased that our strategic partnership with Abbott has progressed so well. Through our global development expertise and strong regional regulatory expertise, we support the development of a product pipeline that will help improve the lives of people and improve their health outcomes.”

About ChemDiv and ChemDiv Research Institute:
ChemDiv a global research organization based in San Diego, California. The ChemDiv Research Institute R&D facilities are located at Torrey Pines Center in San Diego, while the ChemRar High Tech Center and Skolkovo Life Science Cluster are located in Moscow. For 25 years ChemDiv accelerates and enables pharma and biotech R&D programs from research concepts to registered drugs, targeting broad spectrum of unmet medical needs.

 

Tensha Therapeutics To Be Acquired By Roche

Lead molecule, TEN-010, in clinical development in cancer
TEN-010 arising from pioneering work by Dr. James Bradner
Tensha Therapeutics funded and managed by HealthCare Ventures

January 11, 2016 07:00 AM Eastern Standard Time

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Tensha Therapeutics, a privately-held company based in Cambridge, MA, announced today it will be acquired by Roche. Founded by James E. Bradner, MD, of the Dana-Farber Cancer Institute, and managed and funded by HealthCare Ventures, Tensha has developed a pioneering epigenetic technology that disrupts bromodomain and extra terminal domain (BET) proteins in order to develop potential treatments for cancer. The lead product, TEN-010, is a small molecule BET inhibitor that is currently in two Phase 1b clinical trials for the treatment of patients with cancer.

Under the terms of the agreement, Tensha’s shareholders will receive an upfront cash payment of $115 million, plus additional contingent payments of up to $420 million based on the achievement of certain predetermined clinical and regulatory milestones. The transaction is subject to customary closing conditions and anticipated to close in the first quarter of 2016.

“BET proteins are a highly promising class of therapeutic targets in cancer,” said James Bradner, MD, Founder of Tensha, Associate Professor at Harvard Medical School, and Investigator at the Dana-Farber Cancer Institute. “BET inhibitors function as targeted therapy in rare cancers with BET gene rearrangements (NUT midline carcinoma), and in common cancers as a means of inhibiting the function of the master growth control genes, such as MYC.”

“We selected TEN-010 as a highly selective, potent BET inhibitor, and we moved rapidly and strategically to advance its development,” said Steven Landau, MD, Chief Medical Officer of Tensha and Director of Clinical and Scientific Analysis for HealthCare Ventures. “Our initial clinical data demonstrating the potential of TEN-010 in patients with NUT midline carcinoma was presented at the AACR/NCI/EORTC conference in November.”

“We are very excited about this acquisition, as it moves TEN-010 into the pipeline of a world leader in the development of novel cancer therapeutics. With leadership in solid and hematological tumors and deep understanding of BET biology, Roche is the ideal company to explore the broad clinical potential of TEN-010,” said Douglas E. Onsi, Chief Executive Officer of Tensha and Managing Director of HealthCare Ventures. “We appreciate the work of the Bradner lab, the Tensha and HealthCare Ventures employees, and the clinical teams at our trial sites for their important roles in bringing TEN-010 to studies in patients.”

About BET Proteins

Bromodomain and extra terminal domain (BET) proteins are central mediators of gene control and cellular memory. In cancer, BET proteins activate growth and survival genes. Further, they contribute to cancer cell memory by binding to the genome as molecular bookmarks. Tensha’s Founder, James Bradner, MD, Associate Professor at the Dana-Farber Cancer Institute and Harvard Medical School, was the first to recognize the broad potential of BET inhibitors as anti-cancer agents. The Bradner lab first reported BET inhibitors in 2010 in Nature magazine, and established the potential of BET inhibitors in solid tumors and blood cancers. With chemist Jun Qi, Bradner thereafter invented TEN-010, a best-in-class BET inhibitor, for clinical development. BET inhibitors function as targeted therapy in rare cancers with BET gene rearrangements (NUT midline carcinoma), and in common cancers as a means of inhibiting the function of the master growth control genes, such as MYC. BET inhibition represents a new paradigm of targeting cellular memory, or epigenetics, in cancer, inflammation, and fibrosis.

About Tensha Therapeutics

Tensha was founded based on discoveries from the laboratory of Dr. James E. Bradner at the Dana-Farber Cancer Institute. Tensha has been managed and funded by HealthCare Ventures as part of its Focused Company strategy, which has included Shape Pharmaceuticals (sold to TetraLogic in April 2014), Adheron Therapeutics (sold to Roche in October 2015), and Leap Therapeutics. For more information on Tensha, visit www.tenshatherapeutics.com.

Contacts

Tensha Therapeutics
Douglas E. Onsi, 617-218-1116
President & CEO, Tensha Therapeutics
Managing Director, HealthCare Ventures

 

ChemDiv Announces Achievement of a Development Milestone in a Drug Discovery Collaboration With Janssen

SAN FRANCISCO, CA--(Marketwired - Jan 11, 2016) - J.P. Morgan 34th Annual Healthcare Conference -- ChemDiv, Inc. of San Diego, CA announced today the achievement of a development milestone in a research and development collaboration initiated in December 2011with Janssen Pharmaceutica NV and Janssen Sciences Ireland UC (formerly Tibotec Pharmaceuticals) of Cork, Ireland, both part of the Janssen Pharmaceutical Companies (Janssen).

During the collaboration, ChemDiv was to identify and develop novel small molecule drug candidates against jointly agreed targets in multiple therapeutic areas using its integrated discovery platforms in San Diego and its Moscow based ChemDiv Research Institute. Progress from the multiyear collaboration with Janssen has led to the selection of a candidate molecule (to an undisclosed target) and ChemDiv is eligible to receive a success milestone.

About ChemDiv and ChemDiv Research Institute:
ChemDiv is a fully integrated discovery and development CRO serving life science industry for 25 successful years . The ChemDiv Research Institute R&D facilities are located at Torrey Pines Center in San Diego, CA, ChemRar High Tech Center and Skolkovo Life Science Cluster in Moscow. ChemDiv accelerates and enables pharma and biotech R&D programs from research concepts to clinic and market registration, covering the complete range of disciplines, in CNS, oncology, inflammation, cardiometabolic, infectious diseases, and other therapeutic area.

Contact Information

Ron Demuth
ChemDiv, Inc.
Email: Email Contact
Phone: +1-858-794-4860

Elena Surina
ChemRar Group
Email: Email Contact
Phone: +7-495-995-4944

 

BioIntegrator Announced Launch of Nesñler® -- a Generic of Novartis MS Blockbuster Gilenya® in Emerging Markets

SAN FRANCISCO, CA--(Marketwired - Jan 11, 2016) - BioIntegrator LLC (a ChemRar company) of Moscow, Russia announced that it has successfully launched Nesñler® -- the first generic of fingolimod in regulated pharmaceutical markets. Fingolimod, the blockbuster small molecule for remitting-relapsing multiple sclerosis treatment, is currently marketed as Gilenya® by Novartis. Following Nesñler® registration in Russia in 2014 BioIntegrator prevailed over Novartis in a series of court hearings including the Appeal Committee of the Arbitrary tribunal for Intellectual Property of Moscow. In the most recent decision of December 17th, 2015 the court decided to reject all Novartis claims against Biointegrator LLC and the Russian Ministry of Health. In addition to expanding Nesñler® sales in Russia and several countries of EuroAsian Economic Union, BioIntegrator sought partnerships in development of new formulations and indications of fingolimod including market registration and sales in international markets including United States, European Union and other countries.

After four years of development Nesñler® has proven to be safe and effective in comparative clinical trials. Russian Ministry of Health approved Nesñler for marketing and sales in Russia in November 2014. Multiple sclerosis patient organizations and healthcare providers supported this decision, as BioIntegrator offered a significant advantage in access to drug for patients compared to Gilenya. BioIntegrator had to defend its right to manufacture and market Nesñler after Novartis had accused it and the Russian Ministry of Health of breaching Novartis data exclusivity and violating WHO regulations.

"This regulatory and marketing milestone is important for BioIntegrator and ChemRar as it establishes the precedent for other first generics, bio similars and me-better drugs that will appear on the Russian and other high growth markets soon. We believe it will bring a tremendous benefit to both patients and healthcare providers," said Nikolay Savchuk, Board member of ChemRar and Managing Partner of Torrey Pines Investment of San Diego CA.

About Nesñler®:

An oral medication for the treatment of relapsing forms of Multiple Sclerosis in adults. Used to reduce the frequency of flare-ups (clinical exacerbations) and delay physical disability.

About Multiple Sclerosis: Multiple sclerosis is a chronic inflammatory disorder of the central nervous systemand is one of the most common causes of nontraumatic disability among young and middle-aged adults. According to National Multiple Sclerosis Society, relapsing-remitting multiple sclerosis (RRMS) is thought to affect 400,000 people in the US and more than 2.3 million people worldwide. MS-related healthcare costs are estimated to be more than $10 billion annually in the United States.

About BioIntegrator:

BioIntegrator LLC is a ChemRar company engaged in a development and manufacturing of first generics, biosimilars and protein and antibody conjugates for treatment of cancer, rare and autoimmune diseases.

About ChemRar:

ChemRar is Russia's premier pharma enterprise focused on innovation to deliver affordable health care solutions to patients, partners and health care systems across the globe. Selebrating its 25th anniversary ChemRar is committed to reduce therapy costs of chronic diseases such as HIV and viral hepatitis, diabetes, cancer and autoimmune diseases to provide access to affordable treatment to patients globally. ChemRar drug pipeline includes Elpida® best in class ART for treatment of HIV, Aurixim® antibody conjugate for treatment of hematological cancers, gosogliptin for treatment of diabetes, Nesñler® S1P1 agonist for treatment of Multiple Sclerosis. With a risk-balanced business model and product portfolio comprising small and large molecules, biosimilars and generics, branded formulations and research services, ChemRar Group is serving its patients and customers globally.

www.chemrar.ru

About Eurasian Economic Union:

Eurasian Economic Union (EAEU or EEU) is an economic union of states located primarily in northern Eurasia. A treaty aiming for the establishment of the EEU was signed on 29 May 2014 by the leaders of Belarus, Kazakhstan and Russia, and came into force on 1 January 2015. Treaties aiming for Armenia's and Kyrgyzstan's accession to the Eurasian Economic Union were signed on 9 October 2014 and 23 December, respectively. Armenia's accession treaty came into force on 2 January 2015.

Contact Information

Contacts:

Elena Surina
ChemRar Group
Email: Email Contact
Phone: +1-495-995-4944

 

J.P. Morgan 34th Annual Healthcare Conference

Monday January 11, 2016 12:00:00 AM through Friday January 15, 2016 12:00:00 AM

Title J.P. Morgan 34th Annual Healthcare Conference
Date and Time Monday January 11, 2016 12:00:00 AM through Friday January 15, 2016 12:00:00 AM
Location San Francisco, CA

 

Viriom presented the results of the safety and antiviral effect of its novel drug Elsulfavirine at the EACS-2015 conference in Barcelona

October 24th, 2015 - Barcelona, Spain - Viriom presented the results of a randomized, placebo-controlled, double-blind dose-finding clinical trial of Elsulfavirine (VM-1500) in patients with HIV infection who are antiretroviral therapy-naïve at the EACS-2015 conference. The purpose of this clinical trials was to evaluate the impact of different dosage regimens of Elsulfavirine (VM-1500) in combination with drugs used for standard antiretroviral therapy (ART) versus a combination containing efavirenz (EFV) and standard ART (2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs/HtRTs)) on the efficiency of treatment in view of a reduction in viral load to an undetectable level (< 50 copies/ml) at 24 weeks in previously untreated HIV-1-infected patients.

At this study stage (II), an interim analysis of the efficiency and safety of therapy was performed after 12-week therapy. In treatment-naïve patients, Elsulfavirine 20 and 40 mg QD (with TDF/FTC) at week 12 demonstrated potent antiviral activity, comparable to EFV, and favourable safety/tolerability profile. Fewer drug-related AEs were observed for Elsulfavirine compared with EFV. The safety of 12-week ART regimens incorporating Elsulfavirine (VM-1500) was higher than that of the regimen containing EFV. Elsulfavirine (VM-1500) 20 mg daily was chosen to be further investigated.

 

Avineuro LLC  advances its highly selective 5-HT6R antagonist program in Alzheimer Disease

Avineuro LLC investigated the potential pro-cognitive and neuroprotective effects of its leading drug, AVN-211, in Alzheimer disease. During an extensive preclinical evaluation our compound demonstrated a relatively high therapeutic potential and improved selectivity towards 5-HT6R as compared to reference drug candidates. It was thoroughly examined in different in vivo behavioral models directly related to AD and showed evident improvements in cognition and learning. In addition, AVN-211 showed a similar or better anxiolytic efficacy than fenobam, rufinamide, lorazepam and buspirone in an elevated plus-maze model, elevated platform and open field tests. AVN-211 significantly delayed or partially halted the progressive decline in memory function associated with AD. The drug demonstrated low toxicity and no side effects in vivo, an appropriate pharmacokinetic profile as well as stability. 

In 2015 Avineuro LLC has completed a 80-patients Phase II clinical study of AVN-211 for amplifying the effects of antipsychotic drugs in patients with schizophrenia. The drug was safe and well-tolerated in patients, no serious adverse effects were reported,  which makes AVN-211a promising candidate for the treatment of neurodegenerative and psychiatric disorders. A. We plan to start clinical trials in AD and continue the trials in schizophrenia.

 

TeaRx launches an innovative anticoagulant Tearexaban

TeaRx, LLC, a company of High Tech Centre ChemRar announced today the successful completion of clinical studies and state contract for the development of new and innovative anticoagulant Tearexaban, a direct inhibitor of blood factor Xa. The contract was awarded and successfully completed within the Federal Targeted Program “Development of Pharmaceutical and Medical Industry in the Russian Federation until 2020″ and further perspectives.

Safety and effecacy of Tearexaban has been proven in a multicenter, randomized, open clinical trial in the indication of prevention of venous thromboembolic events after knee arthroplasty compared with enoxaparin. The study has been conducted in 6 centers in Russia with 200 patients enrolled.

 

Ron Demuth Interviewed for Nature Drug Discovery News Article

Commentary on Innovative EIB/UCB Partnership to Accelerate New Medicines Development

Ron Demuth, President of Torrey Pines Investment, was recently interviewed by Nature Drug Discovery for their news story and deal analysis of the ˆ75 million investment by the European Investment Bank towards UCB’s early stage pharmaceutical R&D programs. Demuth provides expert commentary and analysis on the ground-breaking risk-share investment.

The Nature Drug Discovery article can be found here, and the full-length commentary and analysis from the interview is provided below.

In a break from their conservative tradition of staid infrastructure investments, the European Investment Bank (EIB) is making a targeted ˆ75 million investment into the drug development portfolio of Belgian pharmaceutical company UCB; to help UCB turn their best R&D-stage drug candidates into new medicines on an accelerated timetable. The EU’s long-term funding institution is partnering with the biopharmaceutical company with the aim of accelerating advances in medical science by making up to ˆ75 million available for the development of selected UCB compounds through an inventive new approach in the world’s finance and research industries. Based in Brussels, UCB focuses on drugs for the treatment of conditions in the immune system and the central nervous system. It generated revenue of 3.4 billion euros ($4.5 billion) in 2013.

The European Investment Bank’s novel “at risk co-development funding” will be a new way to fund medical research. Through this partnership, EIB and UCB have co-designed an innovative way for both of them to share the risks and potential rewards inherent to drug development through a Joint Steering Committee. In return, EIB will receive payments when and if predefined milestones are successfully achieved. The partnership agreement between the EIB and UCB is the first ‘risk sharing’ transaction signed under the new InnovFin “EU finance for Innovators’ program set up jointly by the European Commission and the EIB Group. ‘InnovFin Large Projects’ is specifically dedicated to improve access to risk finance for research and innovation projects in the European Union.

Roch Doliveux, CEO of UCB commented on the agreement saying, “UCB’s strategy is to focus on bringing innovative medicines to people suffering from severe diseases in neurology and immunology. We’re happy that our cutting-edge research and innovation is yet again recognized by the EIB, and that they have chosen UCB as a first partner for their new “at risk co-development” approach. This will contribute to accelerate the development of several promising projects in UCB’s pipeline.”

Pim van Ballekom, Vice President of the EIB, also spoke out on the partnership saying, “We are pleased to partner with UCB for this break-through operation as its pipeline of compounds in development as well as its expertise to develop those compounds rank “best-in-class.” It showcases the direct intervention and risk-taking capacity of the EIB and its role in supporting key R&D activities. We are aiming to pave the way and demonstrate that innovative financial instruments such as risk sharing co-development funding can make a difference in boosting research and innovation in Europe and this is of utmost importance for the future of Europe.”

Interviewed by journalist Asher Mullard for a Nature Views Drug Discovery news commentary about the novel EIB-UCB risk-share partnership, Demuth’s full-length remarks about this new type of EIB investment business model is provided below:

“The European Investment Bank’s agreement with UCB, S.A. is a very interesting transaction and deal structure for several reasons. Foremost, the EIB will participate in strategic-level decision-making for development of the UCB programs; which is rather an unusual role for an investment bank. This will likely require the EIB to develop new kinds of in-house expertise. Also, this represents a portfolio investment approach by the EIB. While they are investing in only a selected subset or so-called ‘best of the best’ of UCB’s existing programs, the investment across multiple UCB early and later stage programs and candidates are clearly part of EIB’s risk management strategy.

Furthermore, the shared risk features of drug development are, of course, very familiar to drug developers and their external research partners. Most established Pharma and biotechnology companies are actively engaged in public-private partnerships and ‘open-innovation/pre-commercial collaboration’ frameworks, and many of their external R&D programs now include pay-for-success elements intended to extend R&D capital and minimize the cost of sorting out the winners and losers in early stage development.

Here at Torrey Pines Investment, we have been early innovators in many of these risk-share partnerships. Since 2006, we have been co-investing with strategic and venture capital partners, participating in a number of public-private partnerships, creating risk-shared development programs through special purpose vehicles, as well as co-investing with founders and owners of IP in single-asset projects intended to quickly validate the commercial feasibility of their very early stage assets. We have structured a number of these programs with embedded service research elements by our portfolio companies along with pre-defined exit strategies that depend on achievement of certain milestones.

Currently, we are very interested in opportunities where we can co-invest with partners in a number of programs simultaneously, and are actively seeking the right set of opportunities and partners for such an initiative. We have been quite successful in attracting investment partners for preclinical-to-clinical stage programs. Outstanding among these I would mention our partnership with Roche, with whom we helped to develop their clinical stage NNRTI quite successfully by Viriom, one of our portfolio companies; initially in Russia and the CIS, and now worldwide. We have also had success co-developing with Roche a factor IXa inhibitor for deep venous thrombosis, through one of our focused-program companies, TeaRx.

In the future, we would welcome co-investment opportunities comprising a number of related or even diverse therapeutic programs. Risk-sharing in R&D investments is a more novel role for the EIB, although direct sovereign funding for commercial innovation and RD& is not new. Examples of this include China’s 863 program, Russia’s “Pharma 2020” and Healthcare 2025 programs and India’s continuing national support for commercial R&D. I believe the verdict is not yet in on these kinds of direct government support for commercial R&D. Their success will depend on how one measures and prioritizes the outcomes resulting from sovereign investments in innovation and R&D.

On one hand, a large infusion of new capital into the innovation sectors of the European Union is excellent news for R&D-driven companies and institutions. After all, a rising tide lifts all boats. In addition, the financial stimulus created by 34 Billion Euros of new investment will help to revitalize the Common Market economies in the short term; a lesson made quite clear by those countries which enacted large stimulus program during the Great Recession. Finally, EIB stimulus should help companies deliver better health outcomes on a faster timetable than would be the case without the additional capital.

On the other hand, the goals of increasing R&D and innovation in the European Union are not necessarily fully compatible with the priorities of venture capital and purely financial investors; namely identifying and commercializing new opportunities as quickly and cost-effectively as possible; and maximizing the resulting investment returns.

For these reasons, among others, EIB’s R&D and innovation investments will be very interesting to follow in the coming years. I commend them for their willingness to try something quite new for them.

Additionally, the EIB is facing a challenge in one other respect; specifically, the capital requirements of early stage drug development programs are quite small relative to a multi-billion Euro investment fund. Consequently, it becomes necessary to scout and evaluate a large number of programs and opportunities. It takes large commitments of time and talent to seek out opportunities and perform necessary diligence. One might suspect that the EIB may look for opportunities to invest in more high-quality portfolios of programs, in order to put their capital to work more quickly and streamline their investment management responsibilities.

Examples of similar deals include the recent Avalon-GSK co-investment, wherein Avalon is identifying promising opportunities and organizing the development, with GSK co-investing with Avalon in each opportunity. Achieving certain agreed milestones can trigger GSK option rights with pre-defined valuations. Another recent example of portfolio-level investment with some risk-management attributes is RusNano’s investment in a number of Domain Ventures’ existing portfolio of companies.

From an investment portfolio perspective, UCB’s track record of successfully developing high-quality and market-leading medicines in neurology and immunology is an attractive opportunity. I would anticipate that in future the EIB may diversify their investment mix substantially, for example, in innovative medical devices, digital health, diseases, and case management.”

Overall, the global outlook on the deal between the European Investment Bank and UCB seems both very promising and lucrative on their mission to accelerate the drug development of new medicines. Right now, the EIB/UCB agreement is the first of the InnovFin Large Projects program, part of the European Union’s recently launched Horizon 2020 initiative for funding research and innovation over the next seven years. InnovFin guarantees and loans are backed by funds set aside under Horizon 2020 and the European Investment Bank Group for such purposes, with future plans to make available more than $32.5 billion (ˆ24 billion) of financing for investments in research and innovation. Time will only tell for this exciting new venture between the EIB and UCB.

 

Avelas Biosciences Completes 7.4M Funding

LA JOLLA, CA — September 3, 2014 — Cancer diagnostics developer Avelas Biosciences has wrapped up its latest stretch of financing, bringing the total raised during the Series B round to $7.4 million.

The San Diego company is working on a fluorescent product that outlines the extent of tumors, so that surgeons can remove more of a cancerous growth while leaving healthy tissue intact.

The latest infusion of money is meant to fund development of the product, called AVB-620, through a clinical trial in breast-cancer surgery patients.

AVB-620 is an intravenously administered in vivo fluorescent protease-activated peptide that detects, marks, and diagnoses cancer. The proposed indication is intraoperative staging of metastatic lymph nodes in breast cancer patients. AVB-620 will be administered to patients two hours prior to surgery and fluorescence imaging will be performed with a camera system attached to a movable arm that enables it to be positioned over the surgical field. The surgeon and/or pathologist will see the fluorescence image superimposed on to or separate from the normal surgical field displayed on a color monitor.

The fluorescence signal will enable the surgeon and/or pathologist to identify cancerous tissue, including such tissue contained within lymph nodes, during the surgical procedure. This capability will enable surgeons to make real-time decisions that may improve medical treatment and lead to significant cost savings by reducing surgical time and reducing the number of re-operations.

Avelas completed the first part of its Series B round in January, raising $6.85 million. The second part was finished this month.

Participants in the financing included Avalon Ventures, the founding investor, and existing investors Torrey Pines Investment and WuXi PharmaTech Investments.

The cancer illuminator emerged from the work of UC San Diego scientist Roger Tsien, who shared a 2008 Nobel Prize in chemistry for research about green fluorescent proteins. The fluorescent chemical in Avelas’ product is a protein fragment derived from the work of Tsien, a co-founder of the company.

Carmine Stengone, chief executive of Avelas Biosciences, said preclinical testing indicates the accuracy of AVB-620 in vivo is 95 percent. Surgeons will be able to easily incorporate the imaging method into their practice, he added.

“It will be delivered intravenously pre-op, either the evening before or a few hours before surgery, fitting into the current surgical practice,” Stengone said. “The really interesting feature is we’re using the pathology of the tumor itself to unmask it.”

Since the fluorescent chemical isn’t a drug that attacks tumors, the danger of tumors developing resistance to it won’t be an issue, Stengone said. “Unlike traditional therapies that cause resistance to build up over time, this is a single-injection-use product.
 

T23 Announces Global License of SCRIPPS’ CD22 Siglec Oncoimmunological Platform for B-cell Tumors

LA JOLLA, CA – June 20, 2014 – The Scripps Research Institute (TSRI) and T23 today announced a global agreement for the development and commercialization of ligands for CD22, one of the family of siglecs (sialic acid-binding immunoglobulin-type lectins), discovered and characterized by TSRI Professor James Paulson, PhD. Siglecs modulate cellular signaling and immune system activation and inhibition. CD22 is found uniquely on B-cells.

“This licensing agreement will enable the proof-of-principal clinical development and commercialization of selective immune cell targeting and cellular modulation using siglec targets,” said Paulson, whose laboratory at TSRI is an international leader in siglec biology. “This is a promising opportunity to develop more selective and effective treatments for B-cell neoplasms.”

Under the terms of the agreement, TSRI has granted to T23 exclusive worldwide rights to develop, manufacture, and commercialize certain complex formulations combining cytotoxins, siglec targeting ligands, and liposomal or other delivery systems. If successful, the new therapeutic would be an important new tool for treatment of a range of hematological tumors arising from B-cell lineages. In addition to the license, T23 will provide research support to the Paulson lab for three years.

“We are excited to be working with Dr. Paulson and The Scripps Research Institute to develop these groundbreaking therapeutics that may dramatically improve the cure rate for b-cell tumors” said Nikolay Savchuk, PhD, chairman of the board of T23.

B-cell neoplasms cause about 4% of all cancers and nearly 90% of all lymphomas (hematological tumors). They exhibit a range of aggressiveness and have varying degrees of treatability. Survival rates also vary for different subtypes, however 5-year survival rates are about 70%. The targeted therapy, enabled using cd22-targeting of b-cell cancers, should extend survival and, more importantly, offer substantially higher cure rates than current therapies.

Dr. Paulson and his collaborators have been leaders in the biology of siglecs and other glycoproteins for more than a decade, with several dozen influential and pioneering publications resulting from their work.

About The Scripps Research Institute

The Scripps Research Institute (TSRI) is one of the world’s largest independent, not-for-profit organizations focusing on research in the biomedical sciences. TSRI is internationally recognized for its contributions to science and health, including its role in laying the foundation for new treatments for cancer, rheumatoid arthritis, hemophilia, and other diseases. An institution that evolved from the Scripps Metabolic Clinic founded by philanthropist Ellen Browning Scripps in 1924, the institute now employs about 3,000 people on its campuses in La Jolla, CA, and Jupiter, FL, where its renowned scientists—including three Nobel laureates—work toward their next discoveries. The institute’s graduate program, which awards PhD degrees in biology and chemistry, ranks among the top ten of its kind in the nation. For more information, see www.scripps.edu.

About T23

T23 is pre-clinical and clinical stage Biopharmaceutical Company. Located at Torrey Pines Investment campus in San Diego, CA it is focused on development of novel targeted immunotherapies for treatment of patients with cancer and autoimmune disease. T101, our candidate conjugate of siglec ligand and nanosomal formulation is currently in pre-clinical development with other conjugates in discovery. For more information, visit
www.t23bio.com

Contact for media:
Olga Dmitrieva,
Director of Marketing Communications
Torrey Pines Investment
6605 Nancy Ridge Drive, San Diego, 92121
odmitrieva@torreypinesinv.com

 

Viriom is Expanding its Portfolio of Novel Antiviral Drugs

Viriom, a member of the ChemRar High-Technology Center, has established an antiviral program for the chronic hepatitis B.

The new program is focused on the discovery and development of small molecule antivirals, targeting HBV cccDNA. This form of the HBV genome is crucial for establishing and maintaining of the persistent HBV infection. The cccDNA inhibitors, in contrast to the currently available HBV drugs, would have a potential to eradicate HBV and to cure chronically-infected HBV patients.

The two classes of antivirals that are currently used to treat chronic hepatitis B are nucleoside analogues and interferons. However, resistance to nucleosides develops very often, and interferons are associated with serious side effects. These drugs help to control, but not to cure chronic hepatitis B.

Pre-clinical and clinical trials of novel HBV antivirals will be conducted in Russia, US, Central and Eastern Asia, North Africa and Latin America, under the leadership of the recognized HBV experts. Viriom plans to spend at least US$10M on the initial clinical development of these novel HBV antivirals.

The program is supported by the Russian Ministry for Industry and Trade as part of the Federal Target Program “Development of the Russian Pharmaceutical and Medical Industry before and after 2020”.

Hepatitis B

Hepatitis B is a potentially life-threatening liver infection, caused by HBV). Chronic HBV infection often leads to severe, sometimes fatal illness, including chronic inflammation of the liver (hepatitis), cirrhosis, fibrosis, and liver cancer (hepatocellular carcinoma)*.

Hepatitis B is a global health problem. According to the World Health Organization (WHO), approximately 2 billion people have been infected with the hepatitis B virus, some 360 million have a chronic form of hepatitis B, and approximately 600,000 people die from the disease annually. . The widespread HBV/HIV co-infections represent an additional problem for the global healthcare system. In Russia alone, there are estimated several million** chronic hepatitis B infections.

*(Sources: WHO – Hepatitis B – Information bulletin No. 204 – July 2013 – http://www.who.int/mediacentre/factsheets/fs204/ru/, Bulletin of Infectology and Parasitology – http://www.infectology.ru/nosology/infectious/viral/vg_gh_gb.aspx)

**(Sources: WHO – Hepatitis B – Information bulletin No. 204 – July 2013 – http://www.who.int/mediacentre/factsheets/fs204/ru/, “Organizing epidemiological surveillance of hepatitis viruses” – A.A. Melnikov, Deputy Director for Administration of Epidemiological Surveillance

About Viriom

Viriom, a member of the ChemRar High-Technology Center, is a leader in the development of innovative antiviral drugs and drug combinations, as well as treatment and diagnosis methods. The company conducts research in Russia, where it draws on the expertise and experience of Russian scientists, as well as in other countries. The Chemical Diversity Research Institute is Viriom’s key partner in conducting preclinical studies. Among its international partners, Viriom includes such companies and research organizations as Hoffmann-La Roche, the Fox Chase Cancer Center, the Scripps Research Institute, the Moscow Institute of Physics and Technology, the Moscow Municipal Center for AIDS Control and Prevention, and the M.P. Chumakov Institute for Poliomyelitis and Viral Encephalitis. Viriom’s project has been approved by the President of the Russian Federation’s Commission on Modernization. www.viriom.com

Media contacts: Tel. +7 (495) 925 30 74    E-mail: es@chemrar.ru

 

ChemRar HighTech Center is featured in Pharmaceutical Executive article “Russia’s Bet on Biopharma”

Winner, Prix Galien Moscow 2013 “Best Research in Russia award,” left to right: Vladimir Lunin, Alexander Sobolev, and Andrey Rosenkranz, for modular nanotransporters.

Russia’s post-Marxist economy is ailing and is long overdue for a reset­ — but will the visible hand of government in promoting a “world-class” biopharmaceuticals sector be enough to secure a future where innovation trumps ideology?

On the outskirts of Moscow, nestled in a grove of native birch trees, sits a gray, rather functional building whose modest profile belies its ambitions as the crucible for a new Russia—one whose prosperity is built on health, not hydrocarbons. Once the home of a Soviet-era state radio company, it now serves as the headquarters of ChemRar, a consortia of biotech start-ups and R&D venture investment companies, funded through a diverse combination of private capital and public funds, dedicated to a single goal: to develop and commercialize innovative medicines with therapeutic potential for Russia and ­—ultimately—the global market.

ChemRar is more than just an enterprise. Instead, it is the template for a new business model that merges the private incentive in finding new growth opportunities in a country that has historically underinvested in health, to the public interest in diversifying

Russia’s economy away from its reliance on volatile cyclical commodities like oil and gas.

Many business analysts contend the time to change that model is now. The International Monetary Fund [IMF] has real GDP growth slowing to an anemic 1.4 per cent in 2013, accentuated by declining oil revenues, a shrinking population base, and uncompetitive levels of fixed investment. In contrast to most other emerging countries, Russia’s share of world output is now falling, not rising.

ChemRar is not the only embodiment of the push for industry diversification. Another, perhaps more prominent example is the Skolkovo Foundation, a non-profit, government-backed technology “incubator” established in 2010 that, among other things, offers tax incentives for biotech start-ups that locate at its state-of-the-art research campus in the Moscow suburbs.

While ChemRar serves primarily as R&D real estate for biopharma start-ups, Skolkovo is one of the big publicly funded institutions established during Dmitry Medvedev’s presidency that pursue a much broader range of business and industrial policy objectives. The 200 companies with resident status at Skolkovo benefit from a partnership with the Massachusetts Institute of Technology [MIT], the centerpiece of which is the jointly run Skolkovo Institute for Science and Technology [SkTech]. Beginning this year SkTech will provide basic science, education and entrepreneurial support to Skolkovo resident companies and researchers in five multidisciplinary fields, including biomedicines. All told, some 30,000 workers are now engaged in activities linked to the Skolkovo innovation cluster — the government’s dream is that it will someday emerge as an eastern version of California’s Silicon Valley.

 

 

 

 

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