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Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company focused on developing new medicines for RAS/MAPK pathway-driven cancers, has exercised its early option to license VS-7375, a potential best-in-class oral and selective KRAS G12D (ON/OFF) inhibitor from GenFleet Therapeutics. This move comes after promising preliminary clinical data from a Phase 1 study conducted in China.

The license agreement, which Verastem announced on January 14, 2025, grants the company global development and commercialization rights for VS-7375 outside of China, Hong Kong, Macau, and Taiwan. The drug, currently in Phase 1 development, demonstrated oral bioavailability, no dose-limiting toxicities across six dose levels, and partial responses, including patients with pancreatic and lung cancers in the preliminary clinical data [1].

Verastem anticipates filing a U.S. investigational new drug (IND) application for VS-7375 during the first quarter of 2025 and expects to initiate a Phase 1/2a study mid-2025. The company aims to share updated preclinical and clinical data at upcoming medical meetings in mid-2025.

“Bringing VS-7375 formally into our pipeline allows us to leverage our scientific and development expertise in the RAS/MAPK-pathway to target KRAS G12D - the most prevalent KRAS mutation in human cancers,” said Dan Paterson, chief executive officer at Verastem Oncology. “Our decision to exercise the option early for VS-7375 was based on the safety, pharmacokinetics, and efficacy data to date in the Phase 1 study in China, which are in line with our expectations and, importantly, indicate that patients are generally achieving oral bioavailability with exposures that correlate with strong tumor regressions across KRAS G12D mutant preclinical models. We look forward to building on the work GenFleet has started in China to bring VS-7375 to the clinic in the U.S. in mid-2025.”

The collaboration between Verastem and GenFleet, which began in August 2023, was designed with a risk-sharing structure and flexibility for Verastem to exclusively license up to three compounds selected for collaboration after the successful completion of pre-determined milestones in Phase 1 trials. The license for VS-7375 is the first one from this collaboration [2].

References:
[1] https://www.businesswire.com/news/home/20250114621288/en/Verastem-Oncology-Exercises-Option-Early-to-License-VS-7375-an-Oral-KRAS-G12D-ONOFF-Inhibitor-from-GenFleet-Therapeutics-and-Provides-Preliminary-Clinical-Update-on-Phase-1-Study-in-China
[2] https://www.businesswire.com/news/home/20250114621288/en/Verastem-Oncology-Exercises-Option-Early-to-License-VS-7375-an-Oral-KRAS-G12D-ONOFF-Inhibitor-from-GenFleet-Therapeutics-and-Provides-Preliminary-Clinical-Update-on-Phase-1-Study-in-China