July 27, 2017
By Mark Terry, BioSpace.com Breaking News Staff


Tokyo – Astellas Pharma (ALPMY) announced that it is wrapping up its research operations with Santa Monica, Calif.-based Agenus (AGEN).

Astellas acquired Agensys in 2007, paying $387 million in cash. Agensys focuses on developing monoclonal antibodies for cancer treatment.

“Agensys has positively contributed to Astellas’ objective of developing innovative treatments for patients with cancer,” said Wataru Uchida, Astellas’ senior vice president of Drug Discovery Research (DDR), in a statement. “The team has provided post-Proof of Concept compounds and antibody-related technology that have been incorporated into our promising oncology pipeline. Yet, the field of research has evolved and led to a new frontier of treatment options. Expanding our investment in this new area of research and development will be critically important and help us to better address high unmet medical needs, as well as deliver innovative benefits to patients in the fight against many types of cancers.”

Astellas indicates it plans to continue some of its clinical trials and collaborations on antibody-drug conjugate (ADC) programs with Agensys, including its collaboration with Seattle Genetics (SGEN). Otherwise, it plans to “complete the wind-down” of Agensys operations in the first quarter of next year. No announcements have been made over job cuts.

In June 2013, Seattle Genetics and Agensys announced that Seattle Genetics had exercised an option to co-develop an additional antibody-drug conjugate under the companies’ existing ADC collaboration agreement. The ADC was ASG-15ME, which targets the tumor antigen SLITRK6, expressed on bladder and lung cancers.

The original collaboration deal between Seattle Genetics and Agensys started in January 2007 and was expanded in November 2009. Under that deal, Agensys had the right to obtain exclusive ADC licenses for multiple cancer targets. The companies then co-developed and globally co-commercialized and shared profits on a 50/50 basis for ASG-5ME, ASG-22ME and ASG-15ME.

More recently, on June 5, 2017, Seattle Genetics and Astellas presented data at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago about its Phase I trial for enfortumab vedotin (ASG-22ME). Based on that data, the companies plan to launch a registrational monotherapy Phase II clinical trial for locally advanced or metastatic urothelial cancer (mUC) in patients who have previously been treated with a checkpoint inhibitor.

“Our updated enfortumab vedotin monotherapy Phase I data at ASCO continue to show encouraging antitumor activity and a well-tolerated safety profile in patients with heavily pretreated metastatic urothelial cancer,” said Jonathan Drachman, Seattle Genetics’ chief medical officer and executive vice president, Research and Development, in a statement in June. “We plan to initiate this year a pivotal Phase II study in the CPI-pretreated setting with the intent of pursuing accelerated approval from the FDA. Enfortumab vedotin is our first late-stage clinical program for solid tumors, and these data demonstrate the potential for antibody-drug conjugates to provide therapeutic benefit across a wide array of cancers.”

Astellas noted at its latest research-and-development update that it still hopes to develop a leadership role in oncology, which it began when it acquired Agensys and then when it licensed enzalutamide for prostate cancer in 2009 and acquired OSI Pharma (OSIP) and Ganymed in 2010 and 2016, respectively. Uchida indicated then that targeted antibodies and ADCs met the company’s short-term and medium-term goals, but its long-term aim is a portfolio of immuno-oncology (IO) drugs for cancers that don’t respond to the current PD-1/PD-L1 IO inhibitor therapies. That goal was bolstered by deals with Potenza Therapeutics and The University of Texas MD Anderson Cancer Center.



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