08 Sep, 2022

GB261 Phase I/II Clinical Trial is officially launched in China

 

Shanghai, China, September 8, 2022 - Genor Biopharma (Stock code: 6998.HK) announced today that the first patient has been successfully dosed in a Phase I/II clinical trial of GB261(CD20/CD3, bispecific antibody) in China.

 

The clinical trial application was approved by the National Medical Products Administration (NMPA) on 23 May for the treatment of patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (B-NHL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The trial was then achieved first China patient dosed on September 8.

 

GB261 (a novel and innovative CD20/CD3 bispecific antibody) is in process of the dose escalation in the FIH (First in Human) study in Australia, and has demonstrated preliminary clinical efficacy, good safety and pharmacokinetic profile.

 

About GB261 (CD20/CD3, BsAb)

GB261 is the first T-Cell Engager with ultra-low affinity to bind CD3 and has Fc-enabled functions (ADCC and CDC). GB261 significantly inhibits rituximab-resistant cancer cell proliferation in both in vitro assays and in vivo models; meanwhile with T-cell activation, GB261 induces less cytokine release compared with compound in the same class. Thus, GB261 is a highly potent bispecific therapeutic antibody for B cell malignancies. It has potential to be a better and safer T-cell engager with competitive advantages over other CD3/CD20 agents.