At present, two phase II studies are actively underway in China and the US, focusing on the treatment of PTCL and AML respectively. A number of subjects in these GFH009 studies have shown partial or complete responses, which underscores the superior safety profile and efficacy of GFH009 in the global arena of CDK9 inhibitor development.
The abstract with results from GFH925 monotherapy treating NSCLC in the registrational phase II study (NCT05005234) was accepted as a LBA (Late-breaking abstracts) program in 2023 ESMO Asia, after the New Drug Application for GFH925 monotherapy treating NSCLC patients was recently accepted by National Medical Products Administration and granted with Priority Review Designation. The data demonstrated encouraging antitumor activity and favorable tolerability of GFH925 among NSCLC patients, with a
The data demonstrated promising anti-tumor activity and tolerability among patients with recurrent/metastatic nasopharyngeal carcinoma (R/M NPC). This trial (NCT04914286) is the first global multi-center study of a TGF-β R1 inhibitor combined with an anti-PD-1 antibody conducted by a Chinese biotech.
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.
