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Leap Therapeutics Presents Nonclinical and Clinical Data on DKN-01 at AACR 2018 Annual Meeting

Viriom to Present Pre-Clinical Studies with Elsulfavirine/VM1500A Long-Acting Parenteral and Oral Formulations at the International Conference on HIV/AIDS, STDs & STIs 2018

i2020 to Accelerate Stelvio Therapeutics First-in-Class Epigenetic Platform for Glioblastoma

Leap Therapeutics Provides DKN-01 Program Update and Announces Scientific Presentations at AACR Annual Meeting

Torrey Pines Launches i2020 Accelerator for Early Therapeutics

Leap Therapeutics Announces First Patient Dosed with TRX518 Combination Therapy in Advanced Solid Tumors Trial

Torrey Pines Investment announced today the launch and initial funding of its i2020 Accelerator initiative.

ChemDiv, DZNE and Torrey Pines Investment Launch Inflammasome Discovery Program of Translational Collaboration on Neurodegeneration

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

ChemDiv, Context Therapeutics and Torrey Pines Investment Announce CNS Co-Development Agreement

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 Elpida® 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

Leap Therapeutics Presents Nonclinical and Clinical Data on DKN-01 at AACR 2018 Annual Meeting

CAMBRIDGE, Mass., April 16, 2018 (GLOBE NEWSWIRE) -- Leap Therapeutics, Inc. (NASDAQ:LPTX) today presented nonclinical and clinical data on DKN-01, Leap's anti-DKK1 monoclonal antibody, at the American Association for Cancer Research (AACR) 2018 Annual Meeting. The presentation highlighted the immunomodulatory activity of DKN-01 in nonclinical experiments and preliminary results from the dose escalation phase of the clinical study evaluating DKN-01 in combination with the Merck (known as MSD outside the United States and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with advanced esophagogastric cancer.

Nonclinical Data:

Nonclinical studies demonstrated the activity of DKK1 inhibition in enhancing innate immunity and the potential for combination with immune checkpoint inhibitors. mDKN-01, the murine form of DKN-01, reduced myeloid-derived suppressor cells (MDSCs), increased PD-L1 levels on MDSCs, and enhanced expression of T-cell chemoattractants. These innate mechanisms, promoting an inflammatory tumor microenvironment, are complementary to immune checkpoint inhibition. In a syngeneic tumor model, mDKN-01 had additive activity with anti-PD-1 therapy as compared to either antibody administered alone.

Clinical Data:

Preliminary results from the dose escalation phase of the clinical study evaluating the combination of DKN-01 and KEYTRUDA in patients with advanced esophagogastric cancer demonstrated that the combination was well tolerated with early signals of clinical activity:

  • Four out of five patients enrolled at the highest tested dose of DKN-01 were naïve to anti-PD-1/PD-L1 therapy and evaluable for response. One patient had a partial response with a 66% reduction in target tumor volume. This patient had progressed on two prior systemic therapies and had a tumor that was known to be KRAS amplified, microsatellite stable (MSS), and PD-L1 negative; a phenotype typically less responsive to anti-PD-1 therapy. Three patients had stable disease, two of whom remain on study through at least four cycles.
  • Two patients enrolled in the escalation phase were refractory to anti-PD-1/PD-L1 therapy and currently have had a best response of stable disease. One of these patients also had a tumor that was KRAS amplified, MSS, and PD-L1 negative and has been on study for six cycles with an initial 10% reduction in tumor burden.

The DKN-01 and KEYTRUDA expansion combination continues to enroll patients who are naïve to anti-PD-1/PD-L1 therapy (n=40) and patients who are refractory to anti-PD-1/PD-L1 therapy (n=15).

About Leap Therapeutics
Leap Therapeutics (NASDAQ:LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein, a Wnt pathway modulator. DKN-01 is in clinical trials in patients with esophagogastric cancer, biliary tract cancer, and gynecologic cancers, with an emerging focus on patients with defined mutations of the Wnt pathway and in combination with immune checkpoint inhibitors. Leap's second clinical candidate, TRX518, is a novel, humanized GITR agonist monoclonal antibody designed to enhance the immune system's anti-tumor response that is in two advanced solid tumor studies.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Contact

Douglas E. Onsi

Chief Financial Officer

Leap Therapeutics, Inc.

donsi@leaptx.com

617-714-0360

Viriom to Present Pre-Clinical Studies with Elsulfavirine/VM1500A Long-Acting Parenteral and Oral Formulations at the International Conference on HIV/AIDS, STDs & STIs 2018

New Formulations Could Potentially Substitute Daily HIV Treatment and Prevention Regimens for Once Weekly or Less Frequent Dosing

SAN DIEGO, April 16, 2018 /PRNewswire/ -- Viriom Inc. today announced that its study report "Elsulfavirine/VM1500A Long-Acting Parenteral and Oral Formulations for Treatment and Prevention of HIV-1 Infections" will be presented by Dr. Vadim Bichko, Viriom's Chief Scientific Officer, at the International Conference on HIV/AIDS, STDs & STIs on April 24th, 2018 in Valencia, Spain. The study evaluates new options for treatment and prevention of HIV/AIDS that would allow for infrequent dosing, thus facilitating patients' compliance and likely improving long-term treatment outcomes.

VM1500A is a new potent non-nucleoside HIV-1 reverse transcriptase inhibitor. Its orally-bioavailable prodrug, Elsulfavirine/Elpida®, is marketed in Eastern Europe as 20 mg oral QD regimen for HIV/AIDS treatment. The pre-clinical studies support further development of VM1500A long-acting injectable (once per 1-3 months) formulations and Elsulfavirine once weekly oral formulations to enable infrequent dosing for treatment and prevention of HIV-1 infections.

About Viriom

Viriom Inc. is a late-development and commercial-stage biotech company developing, manufacturing and distributing novel and affordable therapies and prophylaxis 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 HIV infections, and in the form of innovative long-acting formulations for PrEP and PEP in high-risk patient populations. Viriom is also developing proprietary therapeutics for chronic HBV infections. For more information, please visit www.viriom.com.

i2020 to Accelerate Stelvio Therapeutics First-in-Class Epigenetic Platform for Glioblastoma

SAN DIEGO, March 27, 2018 – i2020 Accelerator announced today that Stelvio Therapeutics has joined its early drug discovery ecosystem. i2020 aims to accelerate research programs with differentiated biology and established development paradigms towards advanced leads and clinical candidates. The i2020 Accelerator deploys a world-wide network of well-established R&D resources, financial and BD&L capabilities to help Stelvio Therapeutics advance its proprietary epigenetic platform for glioblastoma therapies.

i2020 received a startup funding commitment of $30 million from the specialty life science investor, Torrey Pines Investment. "With the risk of taking on projects at early development stages being very significant, i2020 has to be reasonably selective with the programs it supports," comments Nikolay Savchuk, Managing Director at Torrey Pines. "Stelvio Therapeutics' AI-driven epigenetic signature-based platform, which identifies compounds that trigger differentiation of cancer stem cells into benign cell types, matches i2020's target profile well. It is a first-in-class project with strong clinical hypothesis, a well-defined product profile and clear development milestones."

"i2020 aligns well with our overall goals, since it provides a robust network of relevant R&D, business strategy and scientific resources, together with an agile business model and flexible partnering options," comments Attila Hajdu, CEO at Stelvio Therapeutics. "This exciting partnership is a tremendous step towards our shared mission of delivering innovative medicines of value to the patients that need them. With our combined technology and resources, the traditional approaches of chemo and radiotherapy would be toppled and we could see a cure for glioblastoma within our lifetime."

About i2020

By rapidly de-risking novel science and enriching partner pipelines with best-in-class molecules, i2020 helps accelerate early stage drug discovery platforms towards advanced lead and clinical candidate level within a two-year framework. i2020's vast scientific and global resource network tailored specifically to the needs of early drug development programs allows it to take on projects in a wide array of therapeutic areas, from immunology to infectious diseases and beyond. By successfully leveraging agile development principles and flexible partnering business models, i2020 plans to co-create 15 diverse drug discovery programs in 2018. [www.i2020accelerator.com]

About Stelvio Therapeutics

Stelvio Therapeutics is a biotechnology company that focuses on developing a pipeline of alternative treatments for malignant glioblastoma multiforme (GBM), the most common and lethal brain tumor. Instead of trying to kill tumor cells, Stelvio Therapeutics is developing treatments that will induce differentiation of tumor propagating cells into non-tumorigenic cells -- a potent new strategy to fight GBM that could ultimately lead to more viable alternatives for patients.[www.stelvio-oncology.com]

Leap Therapeutics Provides DKN-01 Program Update and Announces Scientific Presentations at AACR Annual Meeting

CAMBRIDGE, Mass., March 14, 2018 (GLOBE NEWSWIRE) -- Leap Therapeutics, Inc. (NASDAQ:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, today presented promising clinical data from the study evaluating DKN-01, Leap's anti-DKK1 monoclonal antibody, as a monotherapy in patients with advanced esophagogastric cancer. In addition, Leap announced that the first patient has been enrolled in the study evaluating DKN-01 in patients with gynecological cancers. Leap also announced two upcoming scientific presentations at the American Association for Cancer Research (AACR) 2018 Annual Meeting.

DKN-01 Monotherapy in Patients with Esophagogastric Cancer Data presented today at the Barclays Global Healthcare Conference included 16 patients with advanced esophagogastric cancer who were treated with DKN-01 monotherapy. Central imaging review identified two patients (12.5%) with a best response of a partial response and five patients (31.3%) with stable disease, representing a total disease control rate of 43.8%. This cohort of patients had received many different lines of prior therapy. One patient who had failed prior investigational immunotherapies, including a PD-L1 antagonist and IDO inhibitor, had a partial response on DKN-01 monotherapy and remained on study for over a year.

"The results of the DKN-01 monotherapy cohort demonstrate promising single agent activity in a very difficult to treat population of heterogeneous esophagogastric cancer. This data, in addition to the encouraging activity we have seen with DKN-01 in preclinical models and in patients in combination with chemotherapy, provides a strong foundation for our ongoing study in combination with the anti-PD-1 therapy Keytruda®," commented Cynthia Sirard, MD, Vice President of Clinical Development for Leap."

DKN-01 Gynecologic Malignancies Study

Leap also announced that the first patient has been dosed in a Phase 2 clinical trial evaluating DKN-01 as a monotherapy and in combination with paclitaxel chemotherapy in patients with advanced endometrioid gynecologic malignancies. The study is part of Leap's strategy to treat cancer patients with documented mutations of the Wnt signaling pathway, a biomarker identified in patients who have responded to DKN-01 therapy. Data presented today by Leap demonstrates that uterine cancer patients with these mutations often have elevated intratumoral levels of DKK1.

"Mutations of the Wnt pathway, particularly beta-catenin, are highly prevalent in endometrioid gynecologic cancers, and often thought to be a driver of an aggressive subgroup of the disease," commented Michael Birrer, M.D., Ph.D., Director of the Comprehensive Cancer Center at the University of Alabama at Birmingham and an investigator on the study. "We are excited to begin this trial of DKN-01, which has shown promising activity in patients with Wnt signaling mutations in other solid tumor malignancies."

The study is a Phase 2 basket study evaluating DKN-01 as a monotherapy and in combination with paclitaxel in patients with relapsed/refractory endometrioid endometrial cancer (EEC) or endometrioid ovarian cancer (EOC). The study contains four groups and is designed to evaluate the efficacy, safety, and pharmacodynamics of DKN-01 monotherapy and combination therapy in both EEC and EOC, with each group following a 2-stage Simon Minimax design. The study will enroll approximately 94 patients, of which ~ 50% will be required to have documented activating mutations of beta-catenin or other Wnt signaling alterations.

About Leap Therapeutics

Leap Therapeutics (Nasdaq:LPTX) is developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein, a Wnt pathway modulator. DKN-01 is in clinical trials in patients with esophagogastric cancer, biliary tract cancer, and gynecologic cancers, with an emerging focus on patients with defined mutations of the Wnt pathway and in combinations with immune checkpoint inhibitors. Leap's second clinical candidate, TRX518, is a novel, humanized GITR agonist monoclonal antibody designed to enhance the immune system's anti-tumor response that is in two advanced solid tumor studies. 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/.

Torrey Pines Launches i2020 Accelerator for Early Therapeutics

SAN DIEGO, Jan. 4, 2018 /PRNewswire/ -- Torrey Pines Investment announced today the launch and initial funding of its i2020 Accelerator initiative. With Torrey Pines funding of up to US$30 million, i2020 implements agile development principles to accelerate small molecules with clearly established development paradigms and paths towards clear differentiation and competitive edge as advanced leads and clinical candidates.

The i2020 plan calls for multiple projects, sourced from international scouting and external partners, with selections based on first-in-class or best-in-class status, strong clinical hypothesis, well-defined Target Product Profile and development milestones, preference is given to validated biomarkers, established druggability and similar criteria.

i2020 projects will have an immunocentric focus, but will be broadly drawn from the areas of inflammation, oncology, CNS, and infectious diseases. Ten to fifteen programs are planned in the first generation of i2020.

Partners are sought to source qualified programs; participate through flexible business models including in-kind and financial resources; and options on pre-commercial projects, non-equity participation with predefined takeout, and out-licensing upon achievement of a Target Product Profile.

About Torrey Pines Investment

Torrey Pines Investment (San Diego, CA) is a specialty life-science investment firm. Torrey Pines invests in development stage molecules, diagnostics, and therapeutics in areas of high unmet medical need. [www.torreypinesinv.com]

Leap Therapeutics Announces First Patient Dosed with TRX518 Combination Therapy in Advanced Solid Tumors Trial

CAMBRIDGE, Mass., Jan. 16, 2018 (GLOBE NEWSWIRE) -- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, today announced that the first patient has been dosed in a Phase 1 clinical trial evaluating Leap’s GITR agonist, TRX518, in combination with gemcitabine chemotherapy or in combination with KEYTRUDA® (pembrolizumab) or Opdivo® (nivolumab), anti-PD-1 therapies marketed by Merck (known as MSD outside the United States and Canada) or Bristol-Myers Squibb, respectively.

"TRX518 has demonstrated the ability to reduce immunosuppressive regulatory T cells and to activate tumor-killing T effector cells in clinical and preclinical studies. The combination of TRX518 with anti-PD-1 immunotherapy has strong scientific rationale and could act synergistically, enabling improved responses without significant additional toxicity. We look forward to evaluating the safety and efficacy of TRX518 in combination with pembrolizumab or nivolumab," commented Diwakar Davar, M.D., Assistant Professor of Medicine of the University of Pittsburgh and an investigator on the study.

"There is strong preclinical evidence for synergistic efficacy when combining immune activators targeting GITR with chemotherapy," commented Cynthia Sirard, M.D., Vice President, Clinical Development of Leap Therapeutics. "This trial represents an important step in our strategy to evaluate the combination activity of TRX518 as a backbone immunotherapy."

The TRX518-003 study is a multipart study evaluating TRX518 as a monotherapy and in combination with gemcitabine, KEYTRUDA® (pembrolizumab), or Opdivo® (nivolumab) in patients with advanced solid tumor malignancies.

The combination arms evaluating TRX518 with gemcitabine includes both dose escalation and dose confirmation cohorts and are designed to evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of the combination. The study will enroll patients who have metastatic or locally advanced, incurable solid malignancies for which gemcitabine is clinically appropriate (e.g., non-small cell lung, breast, ovarian, pancreatic, and renal cancer). The TRX518 + gemcitabine study will enroll approximately 32 patients.

The combination arms evaluating TRX518 with pembrolizumab or nivolumab includes both dose escalation and dose confirmation cohorts and are designed to evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of the combinations. The study will enroll patients who have received treatment with pembrolizumab or nivolumab for ≥4 months with a best response of stable disease and plans to continue treatment in accordance with package insert; or are not currently taking, but eligible for treatment with, pembrolizumab or nivolumab in accordance with the approved indications for each as referenced in the package insert. The TRX518 + PD-1 antagonist study will enroll approximately 64 patients.

About TRX518

TRX518 is a humanized monoclonal antibody with agonist activity targeting glucocorticord-inducible TNF-superfamily receptor (GITR). TRX518 is engineered to enhance immune responses to cancer. TRX518 is being studied in two ongoing repeat-dose clinical trials in patients with advanced solid tumor malignancies. Data from the trials have shown that patients receiving TRX518 monotherapy achieved durable stable disease with signs of pharmacodynamic activity including CD8+ T cell activation and modulation of immunosuppressive regulatory T cells.

About Leap Therapeutics

Leap Therapeutics (Nasdaq:LPTX) is developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein, a Wnt pathway modulator. DKN-01 is in clinical trials in patients with esophagogastric cancer and biliary tract cancer, with an emerging focus on patients with defined mutations of the Wnt pathway and in combinations with immune checkpoint inhibitors. Leap's second clinical candidate, TRX518, is a novel, humanized GITR agonist monoclonal antibody designed to enhance the immune system’s anti-tumor response that is in two advanced solid tumor studies. 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 accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; the ability to complete a financing or form business development relationships to fund our expenses; 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; 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.

Torrey Pines Launches i2020 Accelerator for Early Therapeutics

SAN DIEGO, Jan. 4, 2018 /PRNewswire/ -- Torrey Pines Investment announced today the launch and initial funding of its i2020 Accelerator initiative. With Torrey Pines funding of up to US$30 million, i2020 implements agile development principles to accelerate small molecules with clearly established development paradigms and paths towards clear differentiation and competitive edge as advanced leads and clinical candidates.

The i2020 plan calls for multiple projects, sourced from international scouting and external partners, with selections based on first-in-class or best-in-class status, strong clinical hypothesis, well-defined Target Product Profile and development milestones, preference is given to validated biomarkers, established druggability and similar criteria.

i2020 projects will have an immunocentric focus, but will be broadly drawn from the areas of inflammation, oncology, CNS, and infectious diseases. Ten to fifteen programs are planned in the first generation of i2020.

Partners are sought to source qualified programs; participate through flexible business models including in-kind and financial resources; and options on pre-commercial projects, non-equity participation with predefined takeout, and out-licensing upon achievement of a Target Product Profile.

 

ChemDiv, DZNE and Torrey Pines Investment Launch Inflammasome Discovery Program of Translational Collaboration on Neurodegeneration

The German Center for Neurodegenerative Diseases (DZNE), ChemDiv and Torrey Pines Investment announced today the launch of a pre-commercial translational R&D program that will identify small molecule leads modulating NLRP3 inflammasome assembly and activation, under their 2016 collaboration agreement focused on pathways and molecular mechanisms underlying neurodegeneration, with the goal of delivering a pipeline of novel high quality development and drug candidates.

Abnormal NLRP3 function is implicated in multiple autoinflammatory and autoimmune diseases; and appears to be especially important in the pathophysiology of neuronal aging and its associated neurodegenerative diseases including Alzheimer's, Parkinson's, other forms of dementia, and multiple sclerosis. Modulators of inflammasome activation and assembly may be valuable tools for controlling early neuropathology, potentially preventing or ameliorating these devastating diseases.

The overall goal of the collaboration is to leverage DZNE's advanced research capabilities with ChemDiv's commercial expertise to efficiently design and validate new therapeutic candidates for treatment of Alzheimer's and other neurodegenerative diseases. The partners have identified four areas of biology having high promise for meaningful new therapeutic drugs. In addition to inflammasomes, these areas include innate immune signaling, mitochondrial physiology, and intracellular trafficking.

In the inflammasome program, the Partners will work on identifying modulators (leads) of assembly/activation of NLRP3 and on optimizing molecules through MedChem and early in-vitro/in-vivo profiling to deliver multiple development candidates. It is expected that the set of candidates will represent multiple NCEs interacting with different components of the inflammasome.

The pre-commercial stage of the program is jointly funded by DZNE and Torrey Pines Investment. The collaborators welcome participation by Pharma and Biotech partners for further acceleration and commercialization.

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.
(https://www.prnewswire.com/news-releases/chemdiv-dzne-and-torrey-pines-investment-launch-inflammasome-discovery-program-of-translational-collaboration-on-neurodegeneration-300577017.html)
About DZNE:

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]

ChemDiv, Context Therapeutics and Torrey Pines Investment Announce CNS Co-Development Agreement

  • Sigma1 is a high-value oncology and neurodegenerative disease target
  • Together, the partners will run the first ever high-throughput Sigma1 screen

SAN DIEGO, Nov. 15, 2017 /PRNewswire/ -- ChemDiv Inc., a fully integrated California-based CRO, announced that it has entered into a three-way co-development agreement with Context Therapeutics and Torrey Pines Investment to advance research and development in the area of Sigma1 dysfunction associated with early onset neurodegenerative diseases. Under the terms of the collaboration, ChemDiv will grant Context the access to its unique integrated discovery platform, while Torrey Pines Investment will invest in Context and provide network resources to support pre-commercial research and development.

Context has been engaged in the advancement of an alternative approach to treatment of various diseases in the fields of oncology and neurology that targets Sigma1 – an essential regulator of mechanisms and pathways of cellular protein homeostasis, trafficking, and immune system regulation. Within the framework of this partnership, ChemDiv will capitalize on its comprehensive resources and extensive experience in modern drug discovery to help Context expand its pipeline of treatments against Sigma1 mutations that are associated with severe early onset neurodegenerative diseases, such as ALS and Alzheimer's.

"Sigma1 provides a very exciting new R&D target that could offer an alternative to those patients whose needs cannot be met with existing treatments," comments Martin Lehr, Co-Founder and CEO at Context Therapeutics. "We are looking forward to the fruits of this collaboration, and hope that our collective efforts will streamline the development of a potent cure for Sigma1 associated neurodegenerative diseases around the globe."

"We at ChemDiv are happy to be involved in such a multifaceted project, where we can really put our R&D capabilities to use and help our partners accelerate from target ID to lead optimization and beyond," adds Rouslan Michtchenko, Sr. Director Business Development at ChemDiv. "Our aim here is to fully utilize our accelerated platform and expertise in drug discovery to deliver quality leads to our partners."

Ron Demuth, President of Torrey Pines Investment, comments, "In this collaboration, Torrey Pines is investing in Context's very promising CNS project based on significantly de-risked active molecules in the framework of a proven risk-share collaborative platform that consistently delivers cost-effective R&D results from the partners' joint potential. This investment is a bet on the Context team and a bet on ChemDiv as a proven outsource leader. Our role in this deal is as an investment partner, plus – we are also committed to adding value via our product knowledge, network, and execution expertise to help drive this collaboration to its ultimate goal of developing a novel safe and efficient treatment for Sigma1-related CNS indications."

About ChemDiv

ChemDiv is a recognized global leader in drug discovery solutions. Over the past 25+ years the ChemDiv team has delivered hundreds of leads, drug candidates and new drug approvals in the areas of CNS, oncology, virology, inflammation, immunology, cardio and metabolic diseases to its pharma, biotech and academic partners around the globe. ChemDiv's integrated drug discovery and risk-share collaborative platforms allow for an accelerated, cost-effective R&D process aimed at rapidly bringing a project from target ID to Phase 3 clinical candidate and beyond. http://www.chemdiv.com/

About Context Therapeutics

Context Therapeutics is a private, Philadelphia, PA-based biotechnology company dedicated to creating new medicines to treat hormone responsive cancers. We are building Context Therapeutics to become a global company that will discover, develop and market groundbreaking cancer treatments to patients around the world, eliminating the fear that comes with a cancer diagnosis. One of Context's programs, a Sigma1 inhibitor for prostate cancer, has also shown promise in ALS and dementia. Through a co-development partnership with ChemDiv Inc., Context will explore the potential of Sigma1 in ALS and dementia. For more information on Context, visit www.contexttherapeutics.com.

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 Neskler® -- 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 Neskler® -- 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 Neskler® 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 Neskler® 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 Neskler® has proven to be safe and effective in comparative clinical trials. Russian Ministry of Health approved Neskler 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, Neskler® 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 Elpida® 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 Elpida® (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 Elpida (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, Elpida 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 Elpida compared with EFV. The safety of 12-week ART regimens incorporating Elpida (VM-1500) was higher than that of the regimen containing EFV. Elpida (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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