First Patient Dosed in Phase IIa Combination Study of GFH009 with Venetoclax and Azacitidine Treating Acute Myeloid Leukemia Patients

Jul 03, 2023

GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, announced that the first patient was been dosed in a Phase IIa study of its novel and highly selective CDK9 inhibitor, GFH009, in combination with venetoclax and azacitidine (aza/ven) in patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) who did not respond or stopped responding to venetoclax-based therapies.

Developed by GenFleet, GFH009 is the first highly selective CDK9 inhibitor moving into clinical trial (NCT04588922) stage both in China and the US. GenFleet's received IND approval in 2020 for the GFH009 monotherapy to proceed into phase I trial treating relapsed/refractory patients with hematologic malignancies. In 2022, GenFleet and SELLAS Life Sciences entered into an exclusive license agreement that grants rights to SELLAS for the development and commercialization of GFH009, across all therapeutic and diagnostic uses worldwide outside of Greater China (the Chinese mainland, Hong Kong, Macau and Taiwan).  

Conducted by SELLAS, the Phase IIa clinical trial (NCT04588922) is an open label, single arm, multi-center study that is designed to evaluate safety, tolerability, and efficacy at two dose levels of GFH009 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 there are no dose limiting toxicities and no progression of disease. 

The Phase IIa study builds on strong data from the group of patients with AML in the Phase I study which demonstrated a favorable safety profile with strong early efficacy signals and evidence of anti-tumor activity increasing with higher doses. Durable complete remission (CR) with no minimal residual disease (MRD) was observed in one patient who had failed prior aza/ven therapy and is now lasting for more than six months.