On October 23, 2014 Medivation and CureTech reported that Medivation has licensed exclusive worldwide rights to CureTech’s late-stage clinical molecule pidilizumab (CT-011), an immune modulatory anti-PD-1 monoclonal antibody (Press release Medivation, OCT 23, 2014, View Source [SID:1234500873]). Under the license agreement, Medivation will be responsible for all development, regulatory and commercialization activities for pidilizumab for all indications, including oncology.

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"Immuno-oncology is a significant area of interest for researchers in the development of anti-cancer therapies, marked by its potential to stimulate the body’s immune system to fight disease," said David Hung, M.D., President and Chief Executive Officer of Medivation. "Licensing rights to pidilizumab under this agreement marks an important step in our strategy to further diversify our portfolio."

"We believe that Medivation’s expertise and accomplishments in drug development will be a tremendous advantage in the highly competitive field of oncology immunotherapy," said Michael Schickler, Chief Executive Officer of CureTech. "We are pleased that Medivation will advance this molecule to the next stage of development and potential commercialization."

The arrangement with CureTech also includes a manufacturing and supply agreement, under which CureTech will manufacture and supply the antibody to Medivation over the next 3 years for clinical development purposes. In addition, the arrangement contemplates a guaranty agreement between Medivation and CureTech’s largest (53%) shareholder — Clal Biotechnology Industries Ltd. (CBI) — with respect to certain obligations of CureTech. The guaranty is subject to approval by CBI shareholders. If approval of the guaranty agreement is not obtained, Medivation has the option to terminate both the license agreement and the manufacturing and supply agreement or proceed with such agreements on reduced economic terms (i.e. a reduction of $2 million in the upfront payment and 1% from each tier of royalties). The shareholder vote on the guaranty and Medivation’s exercise of its option to continue to maintain the license are expected to occur in December 2014.

Under the terms of the license agreement, and depending on whether the guaranty from CBI is obtained, CureTech would receive an upfront payment of up to $5.0 million from Medivation and would also be entitled to payments upon the attainment of certain development and regulatory milestones totaling $85 million. In addition, CureTech would be eligible to receive sales based milestone payments totaling up to $245 million, upon the achievement of certain annual worldwide net sales thresholds, and tiered royalties ranging from 4%-11% based on annual worldwide net sales.

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

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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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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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On October 22, 2014 Astellas Pharma reported the revision of the package insert for the oral androgen receptor signaling inhibitor XTANDI Capsules 40mg (generic name: enzalutamide, "XTANDI") (Press release Astellas, OCT 21, 2014, View Source [SID:1234500855]).

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Based on the results of the Phase 3 AFFIRM trial for the treatment of advanced castration-resistant prostate cancer ("CRPC") in patients who have previously received docetaxel (chemotherapy), XTANDI, which is being jointly developed and commercialized with US-based company Medivation Inc. (NASDAQ MDVN), obtained the marketing approval in Japan for use in CRPC treatment in March 2014 and went on sale in May 2014.

The Phase 3 PREVAIL trial evaluating XTANDI as compared to placebo in chemotherapy-naïve metastatic CRPC patients recognized the clinical benefits and favorable tolerability of XTANDI for metastatic CRPC patients who have not received chemotherapy. The item "Indication" of the package insert has been revised based on the results of the PREVAIL trial, which means the sentence, "The efficacy and safety of the drug have not been established in patients with prostate cancer who have not received chemotherapy", has been deleted from the "Precautions regarding indication" item. Also, the items "Side effects" and "Clinical results" of the package insert have been revised.
In addition to the revisions, "thrombocytopenia" has been added to the "Significant side effects" in the "Side effects" item in accordance with Authorities’ instruction.

The revision of the "Precautions regarding indication" item of the package insert triggers a $45 million milestone payment to Medivation under its collaboration agreement with Astellas.