Verastem Oncology (NASDAQ:VSTM), a biopharmaceutical company with a market capitalization of $369 million focused on developing treatments for RAS/MAPK pathway-driven cancers, announced the FDA has cleared its Investigational New Drug (IND) application for VS-7375, a KRAS G12D inhibitor, for clinical evaluation. The company plans to initiate a Phase 1/2a study in mid-2025 to test the drug’s safety and efficacy in advanced solid tumors.
The trial will target advanced KRAS G12D mutant solid tumors, including pancreatic, colorectal, and non-small cell lung cancers. Verastem’s partner, GenFleet Therapeutics, is set to present initial results from the Phase 1/2 study of VS-7375 at the ASCO Annual Meeting from May 30-June 3, 2025, in Chicago, with data under embargo until May 22, 2025. The market has responded positively to recent developments, with the stock showing a remarkable 42% return over the past week and 115% over the last six months.
Dan Paterson, Verastem’s president and CEO, expressed optimism about the clinical program for VS-7375 in the U.S., citing promising initial results from GenFleet’s dose escalation work in China. Paterson highlighted the drug’s dual inhibition of KRAS G12D’s ON/OFF states and its potential for deep, durable cancer responses when combined with other agents.
The upcoming U.S. Phase 1/2a study will assess VS-7375’s safety and efficacy, building on GenFleet’s study findings that identified an efficacious starting dose and observed partial responses in patients with pancreatic and advanced lung cancers.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.