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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.

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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.

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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.

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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.

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