China-based chimeric antigen receptor (CAR)-T cell specialist CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its Claudin18.2 (CLDN18.2)-targeted monoclonal antibody (mAb) AB011 combined with Roche’s programmed death-ligand 1 (PD-L1) therapy Tecentriq (atezolizumab) alongside standard chemotherapy. This treatment is aimed at first-line CLDN18.2 positive unresectable locally advanced, recurrent, or metastatic gastric cancer/gastroesophageal junction carcinoma (GC/GEJC).
AB011: A Promising New Treatment for Gastric Cancer
The drug has previously earned clinical trial approvals from the NMPA in gastric cancer and pancreatic cancer combined with chemotherapies. CLDN18.2 is recognized as a promising therapeutic target for solid tumors, including gastric cancer and pancreatic cancer. CARsgen’s product pipeline is robust, focusing on CLDN18.2 with a variety of therapies, including CAR-T and AB011, which is noted as the first CLDN18.2 mAb to receive IND approval in China.
Implications for the Treatment of Gastric Cancer
The approval for the combination therapy of AB011 and Tecentriq marks a significant step forward in the treatment of gastric cancer. This combination aims to provide a new treatment option for patients with CLDN18.2 positive gastric cancer, potentially improving outcomes and offering hope for those facing unresectable locally advanced, recurrent, or metastatic disease.-Fineline Info & Tech
