Sutro Biopharma and Celgene Corporation Enter Multi-Year Strategic Collaboration and Option to Acquire Agreement

On October 23, 2014 Sutro Biopharma reported it has entered into a strategic collaboration and option agreement with Celgene Corporation to discover and develop multispecific antibodies and antibody drug conjugates (ADCs) (Press release Sutro Biopharma, OCT 23, 2014, View Source [SID:1234500864]). This new agreement follows the December 2012 collaboration between the two companies and focuses on the field of immuno-oncology, while further broadening the Sutro platform for discovery, development, and manufacture of best-in-class biotherapeutics.

The scope of the collaboration allows the parties to systematically interrogate the immuno-oncology space, including established targets, such as PD-1 and PD-L1, as well as novel targets, using Sutro’s cell-free biologics development platforms, Xpress CF and Xpress CF+. During the collaboration, after an initial period, Celgene will have the exclusive option to acquire Sutro, including rights to all Sutro-owned programs at that time, on pre-specified terms. Under terms of the agreement, Sutro will receive upfront payments totaling $95 million, which includes an equity investment. Sutro may also receive up to an additional $90 million during the initial research term, including payments for manufacturing-related and productivity milestones. Celgene has the option to extend the collaboration beyond the initial research term in exchange for an additional payment. Across all product candidates Sutro is eligible to receive more than $1 billion in total payments, upon achievement of clinical and regulatory milestones for product candidates and royalties on product sales resulting from the collaboration.

During the collaboration, Sutro will be responsible for discovery and early pre-clinical development of all collaboration multispecific antibodies and ADCs, as well as the manufacturing of pre-clinical product candidates. The collaboration also contemplates a clinical and commercial supply agreement between Sutro and Celgene for collaboration products. Celgene may assume responsibility for global development and commercialization and will have worldwide rights to all collaboration products, with the exception of certain collaboration products for which Sutro retains U.S. development and commercialization rights, in the event Celgene does not exercise its option to acquire Sutro. For product candidates not licensed to Celgene under the collaboration, Sutro retains worldwide rights, in the event Celgene does not exercise its option to acquire Sutro.

“This multi-year collaboration agreement reflects Celgene’s commitment to our highly collaborative relationship, the significant progress we have made in exploring best-in class multispecific antibodies and ADCs using Sutro’s cell-free protein synthesis platform, and the value of our early pipeline of multispecific antibodies targeting immuno-oncology pathways,” said William Newell, chief executive officer of Sutro Biopharma. “Our platform and product development efforts bear enormous promise. We look forward to continuing and expanding our productive collaboration with Celgene and to accelerating the development of our own portfolio of mono- and bi-specific ADC pipeline candidates.”

Thomas Daniel, M.D., Celgene president, global research and early development, added, “Substantive progress and unique advantages of Sutro’s platform have led us to expand and extend our relationship, as a key capability supporting our emerging Immuno-Oncology pipeline. We see this collaboration as a unique opportunity to accelerate the evaluation and development of important products in this and other strategic areas of high potential impact. Sutro has been a strong partner expanding a potentially disruptive technology, and we look forward to building on the existing collaboration.”

In 2012, Sutro and Celgene entered into a collaboration to design and develop ADCs and bispecific antibodies for two undisclosed targets and to manufacture a proprietary Celgene antibody.

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

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Astellas Announces Revision of Package Insert in Japan for XTANDI® (enzalutamide) Capsules, a Prostate Cancer Treatment

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.

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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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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