CBT-501

  • CBT-501 is a novel IgG4 humanized monoclonal antibody against the Programmable Death-1 (PD-1) membrane receptor on immune cells with world-wide rights retained by CBT Pharmaceuticals, Inc. and China rights granted to Genor BioPharma, China (a Walvax company).
  • CBT-501 has a comparable efficacy profile in in-vitro and in-vivo studies to the marketed anti PD-1 antibodies, nivolumab and pembrolizumab, and has a favorable profile in with very low undesirable antibody-dependent cell-mediated cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) activity.
  • CBT-501 is under evaluation in a Phase 1 trial designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics in patients with advanced solid tumors, recurrent or refractory to standard of care therapies. The trial also aims to determine any dose limiting toxicities or biologically relevant dose and establish a recommended Phase 2 dose for future clinical studies. Once the dose and schedule is established, two or more select tumors will be evaluated for preliminary efficacy, and secondarily, progression free survival.
  • An investigational new drug application has been approved by the China Food and Drug Administration (CFDA), and a Phase 1 trial will be initiated in China by Genor BioPharma.