December 21, 2020 (Shanghai, China) -- GenFleet Therapeutics, a clinical-stage biotechnology company developing cutting-edge therapies in oncology and immunology worldwide, today announced that the National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for GFH009, a highly selective CDK9 inhibitor treating recurrent & refractory hematological malignancies. GenFleet already received an IND approval by the U.S. Food and Drug Administration (FDA) in June and completed the Site Initiation Visit (SIV) meeting at MD Anderson Cancer Center in November, kicking off the company's first global multi-center clinical trial. GFH009 is the first highly selective CDK9 inhibitor proceeding into clinical trials in China whilest the third global-wise.
The primary objectives of this clinical research are to evaluate the safety and anti-tumor activity of GFH009 among patients with recurrent & refractory hematological malignancies, including chronic lymphocytic leukemia (CLL) & small lymphocytic lymphoma (SLL), other lymphomas, and acute myeloid leukemia (AML). GFH009 is a potent small-molecule inhibitor and acts on CDK9 with more than 100 times selectivity over every other CDK subtype.
"With reference to the clinical trial data of other CDK9 inhibitors, we will adopt an innovative clinical development plan. The clinical study has been launched in the US and is expected to conduct dose exploration among subjects in two countries simultaneously. Equally as important, being the first clinical trial from GenFleet approved in both China and America, GFH009 study will pave the way for our global multi-center clinical trials of first-in-class drugs. "said Yu Wang, M.D./Ph.D., Chief Medical Officer of GenFleet.
"There was no clinical proof of concept for CDK9 when we started the project, which is typical of GenFleet's globe-wise innovative pipeline with novel mechanisms. The IND approval by both NMPA and FDA represents an important company R&D milestone, and a solid evidence of our cutting-edge and diversified pipeline. We are deeply committed to developing more first-in-class therapies to serve significant unmet medical needs, and look forward to more advances in our discovery and clinical research." said Jiong Lan, Ph.D., Chief Executive Officer of GenFleet.
About Highly Selective CDK9 Inhibitor
As a family of serine & threonine kinases, cyclin-dependent kinase (CDK) plays an important role in cell cycle regulation and transcription. At present, dozens of non-selective CDK inhibitor pipeline have emerged worldwide. Among over 10 CDK subtypes, CDK9 is a subunit of positive transcription elongation factor B (P-TEFb) and participates in the transcription regulation of anti-apoptotic protein genes in various cancer cells. Thus, it’s one of the most potential targets for cancer therapeutics in the CDK family. Compared with non-selective CDK inhibitors, highly selective CDK9 inhibitors are developed to avoid the off-target toxicity against other CDK subtypes and reduce the risk of dose-limiting toxicity. So far there is no New Drug Application (NDA) approval for highly selective CDK9 inhibitors in the world.