Press release
Verastem Oncology Exercises Option Early to License VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, from GenFleet Therapeutics and Provides Preliminary Clinical Update on Phase 1 Study in China
VS-7375 is a potential best-in-class oral and selective KRAS G12D (ON/OFF) inhibitor currently in Phase 1 development in China in advanced KRAS G12D mutant
About this update from Verastem, Inc.
[{"type":"text","content":"\nVS-7375 is a potential best-in-class oral and selective KRAS G12D (ON/OFF) inhibitor currently in Phase 1 development in China in advanced KRAS G12D mutant solid tumors; Verastem anticipates filing a U.S. IND application for VS-7375 during Q1 2025 and expects to initiate a Phase 1/2a study mid-2025\n\n\nLicense establishes global development and commercialization rights for Verastem for VS-7375 outside of China, Hong Kong, Macau, and Taiwan\n\n\nVS-7375 demonstrated oral bioavailability, no dose-limiting toxicities across six dose levels, and partial responses, including patients with pancreatic and lung cancers in preliminary clinical data from the Phase 1 dose-escalation study in China\n\n\n BOSTON--(BUSINESS WIRE)--\nVerastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced it has exercised early the option to license from GenFleet Therapeutics VS-7375 (also known as GFH375), a potential best-in-class oral and selective KRAS G12D (ON/OFF) inhibitor. In addition, the Company announced preliminary clinical data from the Phase 1 study being conducted by GenFleet in China.\n\n\nAs previously announced by GenFleet, 26 patients have been treated with VS-7375 in a Phase 1 dose-escalation study being conducted in China. Both confirmed and unconfirmed partial responses have been observed, including patients with metastatic pancreatic cancer and advanced non-small cell lung cancer. In addition, six dose cohorts have been cleared with no dose-limiting toxicities (DLTs) observed. In the study, oral dosing of VS-7375 has achieved plasma levels in patients that correlate with efficacious exposures that induced deep tumor regressions across all preclinical KRAS G12D tumor models as presented in collaboration with GenFleet at the AACR 2024 annual meeting.\n\n\nEnrollment in the Phase 1 dose-escalation study in China is ongoing. Verastem remains on track to file 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 in mid-2025. The Companies expect to share updated preclinical and clinical data at upcoming medical meetings in mid-2025.\n\n\n“Bringing VS-7375 formally into our pipeline allows us to leverage our scientific and development expertise in t...