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.
The phase I, multi-center trial of GFH009 monotherapy for r/r hematological malignancies has completed its dose escalation portion in both China and the US. Clinical trials of GFH009 demonstrated significant reduction in expression of proto-oncogenes such as MYC, MCL1 among patients with hematological malignancies including PTCL. Four PTCL patients（36.4%）were observed with clinical response including one in a continuous treatment for over 56 weeks. GenFleet has started its phase Ib/II trial of G
Preliminary results from GFH009 monotherapy study for relapsed/refractory hematological malignancies demonstrated favorable safety/tolerability of GFH009 with no unexpected dose limiting toxicities or hematological toxicities difficult to determine in patients. With regard to efficacy, the study exhibited GFH009’s anti-tumor activity of up to 77.3% bone marrow blast reduction and desired levels of MCL1 & MYC suppression in peripheral blood with decrease in MCL1 or MYC observed in 97% (66/68)
The phase I, multi-center trial of GFH009 monotherapy for relapsed/refractory hematological malignancies has completed its dose escalation portion in both China and the US. Preliminary results demonstrated favorable safety/tolerability and promising clinical efficacy of GFH009. Complete or partial responses were observed in acute myeloid leukemia and lymphoma patients; four PTCL patients (36.4%) were observed with clinical response including one in a continuous treatment for over 48 weeks. The r
The terms of the agreement include combined upfront, research support and option payments to GenFleet of $11.5 million for the first program, with potential total deal size across all programs up to $625.5 million excluding royalties.
The Phase 2a clinical trial is an open label, single arm, multi-center study that is designed to evaluate safety, tolerability, and efficacy at two dose levels of GFH009 (once weekly 45 mg or 60 mg) in combination with aza/ven. The study will enroll up to 20 r/r AML patients, 10 patients per dose level, all of whom will receive standard doses of aza/ven after they became unresponsive to venetoclax combinations including aza/ven, with the addition of GFH009. Treatment will continue for as long as
Favorable safety/tolerability and promising antitumor activity of GFH925 monotherapy were observed among advanced colorectal cancer (CRC) patients harboring KRASG12C mutation according to preliminary results from a pooled analysis of two phase I studies（NCT05005234, NCT05497336）.
The Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI351 (GFH925) for the treatment of previously treated advanced colorectal carcinoma (CRC) patients with KRASG12C mutation.
