CARsgen Therapeutics Announces Clinical Collaboration with Roche on January 31st on HKEX: CARsgen Therapeutics has entered into a clinical collaboration agreement with F. Hoffmann-La Roche Ltd (“Roche”) to conduct a clinical trial evaluating the combination of CARsgen’s AB011, the world's first IND-approved humanized Claudin18.2 (CLDN18.2) monoclonal antibody, with Roche’s PD-L1 immune checkpoint inhibitor atezolizumab and standard-of-care chemotherapy for the treatment of patients with gastric cancer or gastroesophageal junction cancer. Under the agreement, Roche will be responsible for the operational management and advancement of the clinical trial, while CARsgen Therapeutics and Roche will jointly cover the costs associated with the AB011 treatment arm in the clinical trial. In this clinical collaboration, CARsgen’s self-developed high-specificity and high-sensitivity CLDN18.2 immunohistochemistry (IHC) assay kit will be used to evaluate CLDN18.2 expression in patients with gastric cancer.
AB011 is a humanized Claudin18.2 monoclonal antibody (mAb) product that has received approval from the National Medical Products Administration (NMPA) for a new drug clinical trial application (IND) to treat Claudin18.2-positive solid tumors. CARsgen Therapeutics, Ltd is conducting a Phase I clinical trial in China to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of AB011 injection for the treatment of Claudin18.2-positive solid tumors.