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.

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 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 20, 2014 Cancer Research Technology (CRT), the development and commercialisation arm of Cancer Research UK, reported the launch of Ximbio (www.ximbio.com), an online reagents portal for the life science community (Press release, Cancer Research Technology, OCT 20, 2014, View Source [SID1234523221]). Ximbio has been developed to change the way that research reagents are searched, sourced and shared, to broaden the range of tools available to scientists globally and support and advance life science research.

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Ximbio provides a portal for the life science community to exchange knowledge and trade reagents. Researchers and technology transfer offices can virtually deposit their reagents to Ximbio. Life science reagents companies can use the portal to easily source new products to augment their portfolios via a straightforward commercialisation process. Ximbio returns a share of product-based revenues to the depositing institution.

For scientists looking for specific reagents to use in their experiments, Ximbio offers a fully searchable database, extensive datasheets, and supplier options, and in future will also feature peer reviews of listed products. Each reagent record can be linked to the originating inventor, enabling scientists and institutions to be credited for their work. Ximbio will operate as a business unit of CRT, and will focus on all areas of biology.

Keith Blundy, Cancer Research Technology’s Chief Executive Officer, commented: "Over the past 25 years CRT has successfully built one of the world’s largest and most well-respected collections of life science reagents. Ximbio now provides us with the opportunity to extend our reach globally to provide an enhanced offering that better meets the needs of researchers, technology transfer offices, and life science companies."

Melanie Hardman, Head of Ximbio, commented: "Through in-depth analysis of our partnerships with technology transfer offices, life science reagents companies, and the research community, we recognised a real need for an easy to use, online reagents portal. This has been validated by the extensive stakeholder research we have undertaken over the past 8 months. We have created Ximbio to be a place where scientists and technology transfer offices can share their research, and reagents companies can source new products, in a streamlined process that saves both time and resource, maximising the visibility and impact of all research reagents. By unifying the reagent community in this way, to make tools more widely and easily available, we hope to accelerate life science research."