On November 15, 2017 ONCODESIGN (Paris:ALONC) (ALONC – FR0011766229), a biopharmaceutical group specialized in , precision medicine, reported that it has obtained positive results opening the way for the ALK1 kinase inhibitor discovery program to move on to the lead optimization phase (Press release, Oncodesign, NOV 15, 2017, View Source [SID1234522101]).

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ALK1 is a kinase involved in angiogenesis. Tumoral angiogenesis is the mechanism by which new blood vessels form and infiltrate tumors to provide nutrients and oxygen and to dispose of the tumor’s cellular waste products. Inhibiting this mechanism is a promising line of research in the quest for new treatments for most types of cancer.

The ALK1 program has produced positive cellular results in a mechanistic model as part of the probe to lead phase. Oncodesign has thus decided to advance it to the lead optimization phase and commence an exhaustive series of in vivo biological tests, while conducting medicinal chemistry optimization of the inhibitor molecules identified. A medicinal chemistry team dedicated to the project will be set up to implement this decision.

"At the end of the Lead Optimization phase a drug candidate could be selected for preclinical trials and then clinical development", said Jan Hoflack, Oncodesign’s Chief Scientific and Operating Officer. "Today, our preclinical portfolio contains no fewer than 12 programs, and ALK1 is joining our most advanced programs. Our goal is to develop a best-in-class drug from this program with the potential to complement other anti-angiogenic approaches, currently a market worth over $10 billion. The addition of the drug discovery expertise of the François Hyafil research center in Paris-Saclay has enabled us to accelerate our most promising programs significantly. ALK1 is the first example of a project successfully moving on to a major new stage in its development by harnessing this new expertise."

After exploring molecules’ therapeutic potential in the probe qualification and probe orientation stages, molecules move on to the probe to lead phase. Molecules then undergo a further selection stage after medicinal chemistry optimization of their structure, and the programs are prioritized according to their activity in relevant cell models and their potential to become a drug.

The lead optimization phase aims to identify a drug candidate, a molecule meeting a large number of very exacting criteria to determine its suitability as a future drug. The selection of a drug candidate takes place at the end of the drug discovery phase, and the regulatory development phases then begin. Lead optimization can take up to 36 months, and the success rate is typically around 50%.

About kinases and Nanocyclix technology:

Kinases are a family of enzymes that play a key role in regulating most cell functions, such as proliferation, cell cycle progression, metabolism, survival/apoptosis, repair of damaged DNA, motility and response to the microenvironment.
Using its Nanocyclix technology module, Oncodesign identifies macrocyclic molecules capable of inhibiting both known and unexplored kinases in a powerful and targeted manner. A large variety of kinase inhibitors are thus explored continuously, and only the most promising inhibitor/targeted kinase combinations are selected for more in-depth investigations.
Oncodesign has built a project portfolio with tremendous potential to treat diseases with very substantial unmet medical needs. This portfolio contains both molecules already at an advanced stage of clinical development (a PET tracer for a specific type of lung cancer) and molecules at an earlier stage of development.

On November 15, 2017 Arvinas LLC, a private biotechnology company creating a new class of drugs based on protein degradation, reported it has expanded its ongoing license agreement with Genentech, a member of the Roche Group, for the development of new therapeutics using Arvinas’ novel PROTAC technology (Press release, Arvinas, NOV 15, 2017, View Source [SID1234558785]). The multi-year strategic license agreement, initiated in October 2015, will encompass additional disease targets and expand the collaboration.

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Under the revised terms of the agreement, Arvinas is eligible to receive development and commercialization milestone payments in excess of $650 million based on achievement of certain predetermined milestones. In addition, Arvinas is eligible to receive tiered-royalties on sales of products resulting from the license agreement. Full financial terms have not been disclosed.

"Genentech’s decision to expand our original agreement to include additional disease targets shows the promise seen in our first two years together and further supports our targeted protein degradation platform as a novel drug modality to treat a broad array of diseases," said John Houston, Ph.D., President and Chief Executive Officer of Arvinas. "This expansion also supports our initial decision to work with Genentech in 2015 and we look forward to this growing collaboration."

The PROTAC Platform offers potential improvements over traditional small molecule inhibitors using the ubiquitin and proteasome system within a cell to degrade disease causing proteins. By removing target proteins directly rather than inhibiting them, PROTACs can provide multiple advantages over small molecule inhibitors, which can require high systemic exposure to achieve sufficient inhibition, often resulting in toxic side effects and eventual drug resistance.

On November 15, 2017 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will webcast a management presentation at the 29th Annual Piper Jaffray Healthcare Conference at 4:00 p.m. ET on Tuesday, November 28, 2017 (Press release, Regeneron, NOV 15, 2017, View Source [SID1234522097]).

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The session may be accessed through the Company’s web site, www.regeneron.com, on the ‘Events and Presentations’ page. An archived version of the presentation will be available for 30 days.

On November 15, 2017 Pharma reported the initiation of a Phase 1 clinical trial for its novel immune-modulator, PIN-2 (Press release, PIN Pharma, NOV 15, 2017, View Source [SID1234522102]).

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This first-in-human, proof-of-concept study is being conducted in oncology patients with solid tumors by PIN Pharma’s wholly owned Australian subsidiary, PIN Pharma Pty Ltd. The study is designed to show changes in the human immune system utilizing specific biomarkers that will both demonstrate and support PIN-2’s ability to link the innate and adaptive immune systems via antigen presenting cell activation (monocyte-derived dendritic cells) resulting in the generation of endogenous killer T cell immunity (CD8 cells).

"This study is supported by physiological and immunological data generated in our preclinical studies as well as in silico. We are confident that the study will confirm PIN-2’s mechanism of action and validate our preclinical models," said Colin Bier, President and CEO. "We anticipate having interim data by the upcoming JP Morgan conference this January, and are already seeing interest from pharma and venture funds to discuss the potential of this next generation immune-oncology therapy."

With the recent issues arising out of the current generation of immune-oncology compounds both in the clinic and on the market, PIN-2 has the potential to improve response rates that will allow better safety and tolerability either alone or in combination with existing treatments by enhancing innate immunity.

On November 15, 2017 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD) ("Prima") reported that it held a Pre-Investigational New Drug Application (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) in November to discuss the regulatory pathway for the development of Eftilagimod Alpha (LAG-3Ig or IMP 321) in the United States (Press release, Prima Biomed, NOV 15, 2017, View Source [SID1234522106]).

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The FDA addressed Prima’s questions related to preclinical, nonclinical, and clinical data and design of clinical trials of Eftilagimod Alpha in a chemo-immunotherapy setting and in an immuno-oncology combination trial. Prima intends to file an investigational new drug application (IND) in the first half of calendar year 2018. After having successfully started clinical development of Eftilagimod Alpha in Australia and Europe, an IND would provide Prima with the opportunity to commence clinical studies and regulatory interactions in the United States.
"The U.S. is the largest pharmaceutical market in the world, so the pre-IND meeting regarding Eftilagimod Alpha was an important milestone. Our meeting with the FDA was very productive and their guidance will be most valuable in assessing the appropriate U.S. clinical and regulatory strategies for Eftilagimod Alpha," said Marc Voigt, Prima’s Chief Executive Officer.