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.
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.
This is the first therapy combining a KRASG12C inhibitor and cetuximab granted with CTA approval to treat advanced patients with KRASG12C-mutant NSCLC (non-small cell lung cancer) in the first-line setting.
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 advanced non-small cell lung cancer patients with KRASG12C mutation that have received at least one prior line of systemic therapy.