Verastem exercises early option to license VS-7375 from GenFleet Therapeutics

Verastem (VSTM) announced it has exercised early the option to license from GenFleet Therapeutics VS-7375, an oral and selective KRAS G12D inhibitor. In addition, the company announced preliminary clinical data from the Phase 1 study being conducted by GenFleet in China. As 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 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. Enrollment in the Phase 1 dose-escalation study in China is ongoing. Verastem remains on track to file a U.S. investigational new drug 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. Under the terms of the license for VS-7375, Verastem receives an exclusive global license to VS-7375 outside of the GenFleet markets of mainland China, Hong Kong, Macau, and Taiwan.