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.
Favorable safety and tolerability and promising antitumor activity of GFH925 (KRASG12C inhibitor) monotherapy were observed in previously-treated advanced NSCLC harboring KRASG12C mutation.
The data of cerebrospinal fluid (CSF) analysis from subjects receiving 120 mg daily administration suggest that GFH312 has exposure in the CNS and may potentially be useful for treating neurological indications. The phase I study of GFH312 was completed in Australia and GenFleet has been granted with the FDA approval for phase II study of GFH312.
