CARsgen's CLDN18.2 mAb AB011 Achieves IND Clearance from the NMPA for the First-line Combination Treatment of Gastric Cancer
05 May 2023
Phase 1Cell TherapyINDImmunotherapy
SHANGHAI, May 5, 2023 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announced that AB011 in combination with atezolizumab monoclonal antibody, Roche's PD-L1 checkpoint inhibitor, along with chemotherapy (capecitabine and oxaliplatin) achieved IND clearance from the CDE for first-line treatment Claudin18.2 (CLDN18.2) positive unresectable locally advanced, recurrent or metastatic gastric cancerClaudin18.2 (CLDN18.2) positive unresectable locally advanced, recurrent or metastatic gastric cancer/gastroesophageal junction cancer.
About AB011
AB011 is a humanized CLDN18.2 monoclonal antibody (mAb) product that has received an investigational new drug (IND) approval from the National Medical Products Administration (NMPA) for the treatment of CLDN18.2 positive solid tumorsCLDN18.2 positive solid tumors. CARsgen is conducting a Phase I clinical trial of AB011 for the treatment of CLDN18.2 positive solid tumorsCLDN18.2 positive solid tumors in China to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of AB011 infusion. The company has completed the Phase I monotherapy and combination with chemotherapy cohorts enrollment. Data updates from the Phase Ib study (AB011-ST-01, NCT04400383) were reported as a poster presentation at the 2023 ASCO Gastrointestinal (GI) Cancers Symposium in January 2023.
CARsgen is a biopharmaceutical company with operations in China and the U.S. and is focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors. CARsgen has built an integrated cell therapy platform with in-house capabilities that span target discovery, antibody development, clinical trials, and commercial-scale manufacturing. CARsgen has internally developed novel technologies and a product pipeline with global rights to address major challenges of CAR T-cell therapies, such as improving the safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs. CARsgen's vision is to become a global biopharmaceutical leader that brings innovative and differentiated cell therapies to cancer patients worldwide and makes cancer curable.
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