COHERUS BIOSCIENCES ANNOUNCES FDA ACCEPTANCE OF 351(K) BIOLOGICS LICENSE APPLICATION TO U.S. FOOD AND DRUG ADMINISTRATION FOR CHS-1701 (PEGFILGRASTIM BIOSIMILAR CANDIDATE)

On October 6, 2016 Coherus BioSciences, Inc. (NASDAQ:CHRS), a leading pure-play, global biosimilar company with late-stage clinical products, reported that the U.S. FDA has accepted the filing of 351(k) Biologics License Application for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate (Press release, Coherus Biosciences, OCT 6, 2016, View Source;p=irol-newsArticle&ID=2210016 [SID:SID1234515636]).

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The BLA submission is supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies comparing CHS-1701 and Neulasta. The biosimilar user fee act (BSUFA) action date is June 9, 2017.

PRIMA ABSTRACTS ACCEPTED FOR POSTER PRESENTATION
AT ESMO SYMPOSIUM ON IMMUNO-ONCOLOGY

On October 6, 2016 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD) ("Prima", the "Company") reported that an abstract for each of its two clinical trials for IMP321 has been accepted for Poster presentation (display) during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Symposium on ‘Immuno-Oncology—Advances in cancer immunotherapy; From vaccines to antibodies and cell therapies’ from 4-6 November 2016 in Lausanne, Switzerland (Filing, 6-K, Prima Biomed, OCT 6, 2016, View Source [SID:SID1234515644]).
The abstract titles are:

• TACTI-mel (Two ACTive Immunotherapeutics in melanoma): A Phase 1 trial in patients with unresectable or metastatic melanoma receiving IMP321 (LAG-3Ig fusion protein) as an adjunctive therapy to anti-PD-1 therapy with pembrolizumab (Poster #155); and

• AIPAC (Active Immunotherapy PAClitaxel): A Phase IIb trial in hormone receptor-positive metastatic breast carcinoma patients receiving IMP321 (LAG-3Ig fusion protein) or placebo as adjunctive to a standard chemotherapy regimen of paclitaxel (Poster #145).

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Both posters will be on display for the duration of the Symposium. The Poster viewing session will take place over lunch from 13:00-14:15 on Saturday 5 November 2016. The abstracts will also be published in the ESMO (Free ESMO Whitepaper) Symposium on Immuno-Oncology 2016 Abstract Book, a supplement to the official ESMO (Free ESMO Whitepaper) journal "Annals of Oncology".
For more schedule information see View Source

CRT and University of Manchester receive success payment from GlaxoSmithKline for cancer epigenetics research collaboration

On October 6, 2016 CANCER RESEARCH TECHNOLOGY (CRT) – the development and commercialisation arm of Cancer Research UK – reported that it has received a success payment from GlaxoSmithKline resulting from its collaboration developing molecules targeting cancer epigenetics (Press release, Cancer Research Technology, JUN 6, 2016, View Source [SID1234523177]).

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Under the agreement, scientists at the Drug Discovery Unit at the Cancer Research UK Manchester Institute at the University of Manchester received promising early molecules for the project from GlaxoSmithKline and created potential new drug development candidates that target a key protein involved in epigenetic regulation.

CRT will receive development milestones and royalties on sales of products from the collaboration, and has the right to develop the molecules further if GlaxoSmithKline declines to do so.

The Drug Discovery Unit at Cancer Research UK’s Manchester Institute will support GSK scientists developing these drugs and will continue to develop other compounds as part of the collaboration.

Epigenetics – the way cells control how and when genes are turned on or off – can be disrupted in many cancers meaning these drugs could be used to treat many cancers.

Dr Donald Ogilvie, head of the Drug Discovery Unit at Cancer Research UK’s Manchester Institute, said: "We’re extremely pleased with the success of this project, which has allowed us to research a challenging area and ensure that it’s an effective way of targeting cancer.

"The Drug Discovery Unit aims to develop new treatments ready for the clinic as efficiently as possible. By working alongside GlaxoSmithKline scientists we’ve been able to reduce the risk in the development of these drugs and make them more likely to progress through to clinic to achieve our goal of getting new treatments to cancer patients sooner."

Dr Phil L’Huillier, Cancer Research Technology’s director of business development, said: "We’re delighted that our Manchester Drug Development Unit’s work has been so successful, triggering an early success payment from GlaxoSmithKline. This showcases our world class drug development capabilities.

"Drugs targeting epigenetics are a growing area of research and we’re pleased to be making an impact in this area. Being at the forefront of this research alongside one of the world’s biggest pharmaceutical companies means we have a real opportunity to develop new drugs for cancer patients."

CRT and University of Manchester receive success payment from GlaxoSmithKline for cancer epigenetics research collaboration

On October 6, 2016 CANCER RESEARCH TECHNOLOGY (CRT) – the development and commercialisation arm of Cancer Research UK – reported that it has received a success payment from GlaxoSmithKline resulting from its collaboration developing molecules targeting cancer epigenetics (Press release, Cancer Research Technology, JUN 6, 2016, View Source [SID1234523177]).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the agreement, scientists at the Drug Discovery Unit at the Cancer Research UK Manchester Institute at the University of Manchester received promising early molecules for the project from GlaxoSmithKline and created potential new drug development candidates that target a key protein involved in epigenetic regulation.

CRT will receive development milestones and royalties on sales of products from the collaboration, and has the right to develop the molecules further if GlaxoSmithKline declines to do so.

The Drug Discovery Unit at Cancer Research UK’s Manchester Institute will support GSK scientists developing these drugs and will continue to develop other compounds as part of the collaboration.

Epigenetics – the way cells control how and when genes are turned on or off – can be disrupted in many cancers meaning these drugs could be used to treat many cancers.

Dr Donald Ogilvie, head of the Drug Discovery Unit at Cancer Research UK’s Manchester Institute, said: "We’re extremely pleased with the success of this project, which has allowed us to research a challenging area and ensure that it’s an effective way of targeting cancer.

"The Drug Discovery Unit aims to develop new treatments ready for the clinic as efficiently as possible. By working alongside GlaxoSmithKline scientists we’ve been able to reduce the risk in the development of these drugs and make them more likely to progress through to clinic to achieve our goal of getting new treatments to cancer patients sooner."

Dr Phil L’Huillier, Cancer Research Technology’s director of business development, said: "We’re delighted that our Manchester Drug Development Unit’s work has been so successful, triggering an early success payment from GlaxoSmithKline. This showcases our world class drug development capabilities.

"Drugs targeting epigenetics are a growing area of research and we’re pleased to be making an impact in this area. Being at the forefront of this research alongside one of the world’s biggest pharmaceutical companies means we have a real opportunity to develop new drugs for cancer patients."

Vaccinex Announces Clinical Collaboration with Merck KGaA, Darmstadt, Germany, to Evaluate the Combination of VX15/2503, and Avelumab in Non-Small Cell Lung Cancer

On October 6, 2016 Vaccinex, Inc. reported it has entered into a collaboration agreement with Merck KGaA, Darmstadt, Germany, to evaluate VX15/2503, an investigational humanized anti-semaphorin 4D IgG4 monoclonal antibody, in combination with avelumab*, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, in patients with advanced non-small cell lung cancer (NSCLC) who have not previously received immunotherapy (Press release, Vaccinex, OCT 6, 2016, View Source [SID:SID1234515654]). Vaccinex will be responsible for conducting the planned Phase Ib/II clinical trial.

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"Immunotherapies have shown promise in how we treat cancer, and the investigation of combination therapies may uncover additional possibilities. We look forward to working with Merck KGaA, Darmstadt, Germany to explore how we can bring the potential of immunotherapy to more patients, especially considering a
Phase 1 study of monotherapy with VX15/2503 in patients with solid tumors has already suggested its potential for use in combination therapies," said Dr. Maurice Zauderer, CEO of Vaccinex.

In preclinical studies, anti-semaphorin 4D antibodies have been shown to increase infiltration of tumoricidal immune cells while simultaneously reducing multiple types of immunosuppressive cells in tumors. Anti-semaphorin 4D antibody was found to synergize with a checkpoint inhibitor antibody to promote tumor eradication.

"Non-small cell lung cancer continues to be one of the most challenging of cancers worldwide, and we believe in investigating promising avenues to address this need," said Alise Reicin, M.D., Head of Global Clinical Development in the biopharma business of Merck KGaA, Darmstadt, Germany. "Through this partnership with Vaccinex, we are exploring an innovative combination with avelumab that we hope will provide a new option for patients with this deadly cancer."

Further details of the collaboration were not disclosed.

*Avelumab is jointly developed by Merck KGaA, Darmstadt, Germany and Pfizer.

About Non-Small Cell Lung Cancer

Globally, lung cancer is the most common cause of cancer-related deaths in men and the second most common in women1, responsible for more deaths than colon, breast and prostate cancer combined.2 NSCLC is the most common type of lung cancer, accounting for 80 to 85 percent of all lung cancers.3 The five-year survival rate for people diagnosed with late-stage lung cancer that has spread (metastasized) to other areas of the body is 4 percent.4

About Avelumab

Avelumab (also known as MSB0010718C) is an investigational, fully human antibody specific for a protein found on tumor cells called PD-L1, or programmed death ligand-1. Avelumab is thought to have a dual mechanism of action which may enable the immune system to find and attack cancer cells. By binding to PD-L1, avelumab is thought to prevent tumor cells from using PD-L1 for protection against white blood cells such as T-cells, exposing them to anti-tumor responses. Avelumab may also help white blood cells such as natural killer (NK) cells find and attack tumors in a process known as ADCC, or antibody-dependent cell-mediated cytotoxicity. In November 2014, Merck KGaA, Darmstadt, Germany, the science and technology company, and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.