China-based CAR-T cell specialist CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced a clinical cooperation agreement with Swiss pharmaceutical giant Roche. The partnership will focus on a clinical study assessing the combination of CARsgen’s Claudin18.2 (CLDN18.2)-targeted monoclonal antibody (mAb) AB011 with Roche’s PD-L1 therapy Tecentriq (atezolizumab) alongside standard chemotherapy for treating gastric cancer and gastroesophageal junction carcinoma (GC/GEJC).
Study Details and Roche’s Morpheus Platform
The study is part of Roche’s immunotherapy development platform Morpheus, a Phase Ib/II clinical study platform designed to assess the safety and preliminary efficacy of drugs in digestive tract tumors and other areas with significant unmet clinical needs. Under the agreement, Roche will be responsible for the operation, management, and promotion of the clinical trials, with CARsgen and Roche jointly bearing the costs associated with the study.
CARsgen’s CLDN18.2 IHC Test Kit
CARsgen’s independently developed CLDN18.2 immunohistochemical (IHC) test kit will be used to evaluate CLDN18.2 expression in enrolled patients. This highly specific and sensitive test kit is expected to enhance the precision of patient selection and treatment outcomes. No financial details of the partnership were disclosed.
AB011 and Tecentriq: Regulatory Milestones
CARsgen’s AB011 is currently undergoing a Phase I clinical study in CLDN18.2-expressing solid tumors in China, with initial approval granted in 2019. Roche’s Tecentriq was approved in China in February 2020 and has since received five indication approvals, including first-line treatments for various cancers such as extensive-stage small cell lung cancer (ES-SCLC), unresectable hepatocellular carcinoma (HCC), metastatic non-small cell lung cancer (NSCLC), and adjuvant treatment for stage II-IIIA NSCLC.-Fineline Info & Tech
