Astellas Pharma said today it will shutter its Agensys research operations in Santa Monica, CA, and reduce its antibody–drug conjugate (ADC) focus, a decade after the Japanese drug developer bought the ADC developer for up to $537 million.

“The wind-down activities began on July 26 and will be completed in the first quarter of calendar year 2018,” the company said in a statement to GEN. “There are approximately 220 employees at Agensys. We will be retaining no employees past February 2018 unless they apply for and receive a position in other parts of the company. Certain employees essential to the wind-down process will be retained through first quarter 2018.”

Q1 2018 is when Astellas says it plans to complete its wind-down of Agensys research operations.

“Agensys has positively contributed to Astellas’ objective of developing innovative treatments for patients with cancer. 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,” Wataru Uchida, Ph.D., Astellas svp, drug discovery research, said in a statement.

“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,” Dr. Uchida added.

According to ClinicalTrials.gov, Agensys was sponsoring five clinical trials that have been recruiting patients. Astellas said it is shutting down Agensys “to further refine its oncology strategy by expanding its investment in the research in new technologies and modalities.”

Last year, Astellas reshaped its cancer portfolio by agreeing to acquire Ganymed Pharmaceuticals for up to €1.282 billion (about $1.5 billion), in a deal completed December 21, 2016. Ganymed focuses on developing a new class of cancer drugs called ideal monoclonal antibodies (IMABs) for solid cancers.


Ongoing ADC Collaboration to Continue

Astellas said its ongoing ADC collaboration with Seattle Genetics will not be affected by the shutdown of Agensys. Last month at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, the companies disclosed plans to launch a registrational Phase II trial for enfortumab vedotin (ASG-22ME), an ADC that is under study as a monotherapy for metastatic urothelial cancer, after trumpeting positive Phase I data.

Also being in-licensed by Astellas from Seattle Genetics is AGS-16C3F, a Phase II ADC targeting ENPP, or ectonucleotide pyrophosphatase/phosphodiesterase, in development to treat renal cell carcinoma.

Enfortumab vedotin is designed to target nectin-4, a cell-surface protein expressed in multiple solid tumors, including metastatic urothelial carcinoma (mUC), ovarian cancer, and non-small-cell lung cancer (NSCLC).

Astellas acquired Agensys in 2007 for $387 million upfront and up to $150 million in payments tied to achieving milestones.

Oncology is one of Astellas’ six therapeutic areas, along with cardiology, immunology, infectious disease, neuroscience, and urology.  The company says it focuses on targeted therapies for hard-to-treat cancers with few therapeutic options.

Astellas’ website lists a dozen cancer candidates, three of which are in Phase III development. The company is partnering with Medivation—now a Pfizer subsidiary—on new prostate cancer indications for the marketed cancer treatment Xtandi® (enzalutamide), including nonmetastatic castration-resistant prostate cancer (CRPC), nonmetastatic biochemical recurrent prostate cancer, and M1 hormone-sensitive prostate cancer. Xtandi is also in Phase II study for hepatocellular carcinoma.

Astellas’ other Phase III cancer candidates include gilteritinib (ASP2215), a FLT3/AXL tyrosine kinase inhibitor under study in patients with relapsed or refractory acute myeloid leukemia; and ASP3550, also known as degarelix acetate or Gonax®, an injectable gonadotrophin-releasing hormone receptor blocker also being developed as a three-month formulation against prostate cancer.

Astellas has halted development of another cancer candidate, ASP8273 (naquotinib), an irreversible, mutant-selective EGFR-TKI (epidermal growth factor receptor–tyrosine-kinase inhibitor) indicated for NSCLC. In May, Astellas ended its Phase III SOLAR trial comparing ASP8273 with erlotinib/gefitinib for the first-line treatment metastatic or advanced unresectable NSCLC, at the recommendation of the trial’s independent Data Monitoring Committee







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