NEWS - IND Approval
GenFleet Receives IND Approval from China's NMPA for GFH375, an Oral KRAS G12D (ON/OFF) Inhibitor, in a Phase I/II Clinical Trial Treating Advanced Solid Tumor Patients with KRAS G12D Mutation
GenFleet Therapeutics has received approval from China's National Medical Products Administration (NMPA) for an open-label, multi-center phase I/II clinical trial of GFH375 (VS-7375), an oral KRAS G12D (ON/OFF) inhibitor, in patients with advanced solid tumors. This trial targets the prevalent KRAS G12D mutation, with no existing G12D-targeted therapies approved. GFH375 has shown promising preclinical safety, bioavailability, and efficacy, including potential for treating brain metastases.
The study will be conducted across ~40 hospitals, including Shanghai Chest Hospital. Phase I will assess safety, tolerability, and preliminary efficacy, determining the recommended phase II dose. Phase II will evaluate efficacy in cancers such as PDAC, CRC, and NSCLC, and investigate response/resistance mechanisms.
GenFleet's collaboration with Verastem Oncology, initiated in 2023, highlights the company's advances in RAS-targeted therapies, exemplified by previous success with KRAS G12C inhibitor fulzerasib.
The study will be conducted across ~40 hospitals, including Shanghai Chest Hospital. Phase I will assess safety, tolerability, and preliminary efficacy, determining the recommended phase II dose. Phase II will evaluate efficacy in cancers such as PDAC, CRC, and NSCLC, and investigate response/resistance mechanisms.
GenFleet's collaboration with Verastem Oncology, initiated in 2023, highlights the company's advances in RAS-targeted therapies, exemplified by previous success with KRAS G12C inhibitor fulzerasib.
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R30R : Hopefully this is good news that will help a few bag holders free some equity.