Genmab Reaches USD 10 Million Milestone in Daratumumab Collaboration with Janssen

On October 23, 2014 Genmab reported that it has reached the fourth milestone in its daratumumab collaboration with Janssen Biotech (Press release Genmab, OCT 23, 2014, View Source [SID:1234500865]). The USD 10 million milestone payment was triggered by progress in the ongoing Phase III study ("CASTOR" MMY3004) of daratumumab in combination with bortezomib and dexamethasone compared to bortezomib and dexamethasone alone for the treatment of relapsed or refractory multiple myeloma.

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"We are very pleased with the firm progress being made in the daratumumab development program under the direction of our strategic partner Janssen. At Genmab we are committed to developing differentiated therapeutics to fight cancer, and it is therefore rewarding to see one of our antibodies moving rapidly through clinical development," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

This milestone payment is included in Genmab’s 2014 financial guidance as published on August 13, 2014.

Pfizer Wins SUTENT® Patent Case In Delaware District Court

On October 23, 2014 Pfizer reported that the U.S. District Court for the District of Delaware upheld its basic patent and the L-malate salt patent covering SUTENT (sunitinib malate) capsules (Press release Pfizer, OCT 23, 2014, http://www.pfizer.com/news/press-release/press-release-detail/pfizer_wins_sutent_patent_case_in_delaware_district_court [SID:1234500866]). This decision, which is subject to appeal, affirms Pfizer’s right to exclusively provide sunitinib malate as SUTENT to patients through the term of the patent, which expires in 2021.

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"The Court’s decision acknowledges the validity and infringement of our patents and affirms the value of SUTENT, a standard of care in the treatment of advanced renal cell carcinoma," said Douglas M. Lankler, executive vice president and general counsel for Pfizer. "Defending our intellectual property is crucial to our ability to discover and develop innovative new medicines, which is at the very core of what we do."

Pfizer filed suit in June 2010 after Mylan Pharmaceuticals Inc. applied to the U.S. Food and Drug Administration (FDA) to market a generic version of SUTENT prior to the expiration of the patents covering sunitinib malate and its uses. After a four-day trial, the Court agreed that Mylan infringed the valid patents covering SUTENT.

The patents at issue are U.S. Patent Nos.6,573,293 and 7,125,905.

(Press release, Novogen, OCT 22, 2014, View Source [SID:1234506859])

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Fidelity Biosciences and Atlas Venture Lead $12 Million Series A Funding to Launch Unum Therapeutics, a New Cellular Immunotherapy Company

On October 21, 2014 Unum Therapeutics reported that it has raised $12 million in Series A funding led by Fidelity Biosciences and Atlas Venture, with participation from Sanofi-Genzyme BioVentures (Press release Unum Therapeutics, OCT 21, 2014, View Source!21oct2014-unum-series-a-funding/cu46 [SID:1234500856]). Unum has built a platform for cancer treatment based upon an antibody-coupled T-cell receptor (ACTR). Genetically programming T-cells with ACTR allows them to efficiently attack and kill tumor cells using targeting antibodies. In contrast to other approaches that are limited to a single target and treat a narrow set of tumors, Unum’s approach is not restricted by antigen and may have applications for treating many types of cancers. Unum plans to use capital raised through this financing to advance its lead candidate through initial proof-of-concept clinical studies, further enhance the ACTR technology, and establish partnerships to access tumor-specific antibodies for a pipeline of novel combination therapies.

Industry veteran Charles "Chuck" Wilson, PhD, will serve as President & CEO. Before founding Unum, Dr. Wilson led the team responsible for partnering to support research and early development at Novartis. With many oncology and immuno-oncology deals to his credit, he brings extensive experience to Unum spanning from early drug discovery through Phase II clinical development. Prior to Novartis, Dr. Wilson held both scientific and business management roles in biotech.

"We’ve created Unum to rapidly develop this universal cell therapy platform and to explore its potential in a number of different cancer types," said Dr. Wilson. "With our Series A funding from Fidelity Biosciences, Atlas Venture, and Sanofi-Genzyme BioVentures, we will drive our lead program into Phase I testing and aim to quickly validate the ACTR approach in the clinic."

Dario Campana, MD, PhD, is the company’s Scientific Founder. Dr. Campana is an established leader in the field of cancer cell therapies. At the National University of Singapore (NUS), he developed the ACTR technology that forms the basis for Unum. At St. Jude Children’s Research Hospital (Memphis, TN), he created a chimeric antigen receptor (CAR) approach that is currently being pursued by several pharma and biotech companies. He currently oversees a number of cell therapy clinical trials in oncology.

In addition to Drs. Wilson and Campana, Unum Therapeutics’ management team also includes Chief Scientific Officer Seth Ettenberg, PhD, a cancer biologist and drug development scientist with extensive experience leading teams in biotechnology and large pharmaceutical drug discovery settings. Dr. Ettenberg most recently served as the Cambridge site head for Novartis Oncology Biotherapeutics.

The initial Board of Directors for Unum Therapeutics is comprised of:

Chuck Wilson, PhD, President & CEO, Unum Therapeutics

Ben Auspitz, Partner, Fidelity Biosciences

Bruce Booth, DPhil, Partner, Atlas Venture

"Unum combines a strong, experienced management team, a transformational technology that may revolutionize cancer treatment, and top scientific and business development talent," said Mr. Auspitz. "It has the right combination of resources to carry out its vision of bringing to market a single therapy that can augment the activity of many different antibodies to treat many different cancers."

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MabVax Therapeutics Nominates The Fully Human Antibody HuMab 5B1 As The Company’s Lead Clinical Development Candidate

On October 21, 2014 MabVax Therapeutics reported that it has formally nominated its HuMab 5B1 antibody as a clinical candidate for the diagnosis and treatment of pancreatic and colon cancer (Press release MabVax, OCT 21, 2014, View Source [SID:1234500854]). The fully human antibody, recovered from patients undergoing cancer vaccine treatment at Memorial Sloan-Kettering Cancer Center, has entered GMP manufacturing to produce clinical trial supplies for a planned Phase 1 program to begin in the second half of 2015. The development plan calls for dual Phase 1 clinical trials to take place simultaneously. One program will be aimed at demonstrating the utility of the radio-labeled antibody as a novel PET imaging agent for the diagnosis and management of pancreatic cancer. The second program will determine the safety and potential utility of the full-length antibody as a treatment for the same cancer.

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