CARsgen Therapeutics Holdings, a biopharmaceutical startup based in the US and China, has announced collaboration agreement with F. Hoffmann-La Roche to evaluate CARsgen's investigational drug AB011, the first humanised monoclonal antibody against Claudin18.2 (CLDN18.2) that received IND clearance globally, in combination with atezolizumab, Roche's PD-L1 checkpoint inhibitor, along with standard-of-care chemotherapy in patients with gastric or gastroesophageal junction carcinoma.

Under the terms of the agreement, Roche will be responsible for operation and conduct of the trial while both companies co-share the costs of the AB011 treatment arms in the study. As part of the clinical collaboration, CARsgen's proprietary CLDN18.2 IHC test kit, which has showed excellent specificity and sensitivity profiles, will be applied to evaluate CLDN18.2 expression in the gastric cancer patients.

The co-funded study of AB011 in combination with atezolizumab will be conducted as part of Roche's Morpheus Platform. The Morpheus Platform is a collection of Phase Ib/II clinical trials in multiple cancers with high unmet clinical needs including gastrointestinal cancer, designed to assess the safety and early efficacy to enable more rapid and efficient development of novel cancer treatment combinations.