GenFleet Therapeutics is a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, founded in 2017 by veteran drug developers with the support from top-tier venture capital investors. Dedicated to serving significant unmet medical needs, GenFleet Therapeutics established its proprietary R&D platform based on the deep understanding of disease biology, translational medicine, as well as the research into latest biological mechanism of cancer pathways, tumor microenvironment and human immunoregulation. GenFleet's rich and diversified pipeline highlights multiple cutting-edge products with novel mechanisms and global IP.
Staff with Master or Doctoral Degrees
Since its inception in 2017, GenFleet has built up industry-leading capabilities and expertise in developing novel drug candidates - both small molecules and biologics. Its pipeline includes over 10 programs in development, many of which have entered clinical stages.
Among them, the TGF-β R1 (transforming growth factor-β receptor 1) inhibitor has entered phase Ib/II clinical trial and boasts broad prospects of treating solid tumors with lower response rates to PD-1 inhibitors; the CDK9（cyclin-dependent kinase 9） inhibitor has been granted with IND approval in China and US, marking the beginning of the company's global multi-center clinical trial strategy；besides, GenFleet is the first Chinese company that moves RIPK1 inhibitor development into clinical stage. In mid 2021, GenFleet also received IND approval to proceed with the clinical trials of its KRAS G12C inhibitor.
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.