Verastem Oncology Announces First Patient Dosed with GFH375/VS-7375, a KRAS G12D (ON/OFF) Inhibitor, in a Phase 1/2 Trial in China as Part of Collaboration with GenFleet Therapeutics
SHANGHAI, June 19, 2024 /PRNewswire/ -- GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, announced China's National Medical Products Administration (NMPA) has approved the clinical trial application for GFH375 (VS-7375) in an open-label, multi-center phase I/II study targeting advanced solid tumor patients with KRAS G12D mutation. G12D mutation is the most prevalent KRAS mutation detected in human cancers, and no G12D-targeted therapies have been approved yet.
SHANGHAI and CHICAGO, June 1, 2024 /PRNewswire/ -- GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, today announced the phase II trial data of KROCUS Study, fulzerasib (GFH925, KRAS G12C inhibitor) in combination with cetuximab for first-line non-small cell lung cancer (NSCLC) treatment?at the 2024 American Society of Clinical Oncology (ASCO) annual meeting.
SHANGHAI, April 19, 2024 /PRNewswire/ -- GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, announced US Food and Drug Administration (FDA) has granted the clinical trial approval for GFH925 (KRAS G12C inhibitor) in a multi-center, open-label, randomized and controlled phase III study treating refractory metastatic colorectal cancer (CRC) patients.
SHANGHAI and SAN DIEGO, April 9, 2024 /PRNewswire/ -- GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, today announced the latest findings of GFH547, an oral panRAS (ON) inhibitor, in a late-breaking research abstract at the 2024 American Association for Cancer Research (AACR) Annual Meeting.
SHANGHAI and SAN DIEGO, April 9, 2024 /PRNewswire/ -- GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, today unveiled the latest research findings of GFH375, an oral KRAS G12D (ON/OFF) inhibitor, at the poster presentation of the 2024 American Association for Cancer Research (AACR) Annual Meeting.
GenFleet Therapeutics Announces GFH009 Granted with FDA Fast Track
Verastem Oncology Selects Oral KRAS G12D Inhibitor GFH375/VS-7375
SHANGHAI, Nov. 24, 2023 /PRNewswire/ -- GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, today announced the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) for GFH925 (IBI351) and granted GFH925 with Priority Review designation, for the treatment of patients with advanced non-small cell lung cancer (NSCLC) harboring KRAS G12C mutation who have received at least one systemic therapy. It's the first China-developed KRAS G12C inhibitor that has its NDA submission accepted and granted with Priority Review Designation by NMPA. GFH925 also received Breakthrough Therapy Designations this year for treating advanced KRAS G12C-mutant NSCLC that have received at least one systemic therapy and colorectal carcinoma (CRC) patients who have received at least two systemic therapies.
SHANGHAI, Oct. 10, 2023 /PRNewswire/ -- GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, today announced the first subject was dosed in a phase Ib/II trial of GFH009 (a highly selective CDK9 inhibitor) treating relapsed/refractory PTCL (peripheral T-cell lymphomas) patients. Designed to enroll a total of 95 patients, this multi-center (close to 40 hospitals in China), open-label, single-arm study will include the prominent Sun Yat-Sen University Cancer Center and the First Affiliated Hospital of Zhengzhou University.