Protocols

Astellas, Pfizer scrap a PhIII breast cancer study using Xtandi; New $30M fund will back Israeli biotech startups

→ NanoString Technologies notes in an SEC filing that Astellas and Pfizer have decided to terminate the late-stage ENDEAR trial, which the company was involved with. The two companies revealed that decision in a footnote to a recent release. “Additionally, Pfizer and Astellas announced the discontinuation of the planned ENDEAR trial (A Phase III, Randomized, International Study Comparing the Efficacy and Safety of Enzalutamide (Xtandi) in Combination With Paclitaxel Chemotherapy or as Monotherapy Versus Placebo With Paclitaxel in Patients With Advanced, Diagnostic-Positive, Triple-Negative Breast Cancer); no patients were ever enrolled in the trial. Furthermore, the companies have decided that based on the data from the enzalutamide Phase 2 HER2+ and ER/PR+ breast cancer studies, there will not be follow-on Phase 3 studies at this time.”

→ AB Science touted Phase III data for masitinib at a scientific meeting on Thursday, claiming the drug slowed down progression of ALS. Investors, though, have been more focused on French regulators’ recent decision to force the biotech to halt all work in its home country until AB can prove it’s in compliance with all the rules on drug development. Over the years AB Science has been known to put out cheery releases on data and prospects only to be forced to walk it all back. The EMA rejected its marketing applications on masitinib for advanced inoperable pancreatic cancer and gastrointestinal stromal tumors in 2014 and 2013, hammering the company on poor trial design, safety as well as manufacturing shortcomings.

→ The life sciences investment bank RM Global has set up a $30 million fund to invest in the biotechs at Israel’s FutuRx, a biopharma incubator founded by Johnson & Johnson Innovation, Takeda and OrbiMed in cooperation with the Israel Innovation Authority.

→ The CHMP has recommended a slate of 11 new drugs for approval, including Veltassa (patiromer) from Relypsa and Sanofi’s insulin lispro.


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