Astellas and Seattle Genetics, Inc. (NASDAQ: SGEN) highlighted updated phase 1 data for enfortumab vedotin (ASG-22ME) studied as monotherapy treatment for metastatic urothelial cancer (mUC) in an oral presentation at the American Society of Clinical Oncology (ASCO) 52nd Annual Meeting in Chicago. Enfortumab vedotin is an investigational antibody-drug conjugate (ADC) that targets Nectin-4, a cell surface protein expressed in multiple solid tumors including mUC, ovarian cancer, and non-small cell lung cancer (NSCLC). Based on the data from the ongoing phase 1 clinical trial, the companies this year plan to initiate a registrational monotherapy phase 2 trial for locally advanced or mUC patients who have been previously treated with checkpoint inhibitor (CPI) therapy. A trial evaluating enfortumab vedotin in combination with CPIs is also planned for later this year as part of a broad clinical development program.
The EU medicines regulator has started its review of Astellas and Pfizer’s prostate cancer drug Xtandi in what looks likely to become a hotly contested indication - non-metastatic castration-resistant prostate cancer (nmCRPC).
Tokyo-based Astellas Pharma is buying Cambridge, Mass.-based Mitobridge for a total of $390 million. Astellas is pulling the trigger on an acquisition option from a partnership deal the two companies formed in 2013. Under that deal, the two companies collaborated on discovering and developing drugs that target mitochondrial function. The most advanced program from the collaboration is MA-0211, which is presently in Phase I clinical trials for Duchenne muscular dystrophy (DMD). Astellas is an equity investor in Mitobridge already, and is paying $165.5 million in cash in addition to the $60 million in equity it already owns. There is also an additional $225 million in potential milestone payments. John Carroll, with Endpoints News, writes, “For years now, Salk’s Ron Evans—a celebrated serial entrepreneur in scientific circles—has been concentrating on the potential of a new pathway for turning your average couch potato rodent into Mighty Mouse—without exercise…. A couple of ...
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