嘉和生物-B(06998.HK):GB261(CD20/CD3,BsAb)獲國藥監局授予I/II期臨牀試驗新批准
格隆匯5月24日丨嘉和生物-B(06998.HK)宣佈,旗下GB261(CD20/CD3雙特異性抗體)已獲得國家藥品監督管理局("NMPA")I/II期臨牀試驗許可。這項臨牀試驗申請於2022年3月18日獲得NMPA藥品審評中心(CDE)受理,用於復發或難治性B細胞非霍奇金淋巴瘤(B-NHL)和慢性淋巴細胞白血病╱小淋巴細胞淋巴瘤(CLL/SLL)患者的治療。
作為一個全球創新的雙特異性CD20/CD3 T細胞接合器(T Cell Engager),公司的GB261已於2021年10月在澳大利亞完成首次人體臨牀試驗(FIH)的首位患者給藥。
據悉,GB261是第一個與CD3低親和力結合並保持Fc功能(ADCC和CDC)的T細胞接合器。GB261通過體外測定和體內模型顯著抑制利妥昔單抗耐藥癌細胞的增長。因此,GB261對於B細胞惡性腫瘤是一款非常有潛力的雙特異性治療抗體。較其他CD3/CD20抑制劑具有顯著的競爭優勢,GB261最終有望成為一種更好更安全的T細胞接合器藥物。
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