On January 31, 2023 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative therapies for the treatment of hematologic malignancies and solid tumors, has reported CARsgen’s execution of a collaboration agreement with F. Hoffmann-La Roche Ltd ("Roche") to evaluate CARsgen’s investigational drug AB011, the first humanized 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 (Press release, Carsgen Therapeutics, JAN 31, 2023, View Source [SID1234626685]). 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.

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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.

"We are glad to work with Roche, a global leader in oncology, to explore the potential of AB011 in combination with atezolizumab and chemotherapy for the treatment of gastric cancer," said Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen, "Gastric cancer is one of the most common cancer types worldwide and the treatment options for gastric cancer patients are still very limited. CLDN18.2 is a promising therapeutic target for the treatment of CLDN18.2 positive solid tumors, including gastric cancer, pancreatic cancer, etc. Since 2014, CARsgen team has developed several innovative medicines against CLDN18.2 in the pipeline including CAR T-cell therapies and AB011. AB011 is an important asset in the CLDN18.2 franchise of CARsgen and is the first monoclonal antibody against CLDN18.2 that received IND clearance in China. Through this collaboration, we are excited to evaluate the combination of AB011 and atezolizumab which can potentially bring greater clinical benefits to gastric cancer patients."

About AB011

AB011 is a humanized Claudin18.2 monoclonal antibody (mAb) product that has received an investigational new drug (IND) approval from the National Medical Products Administration (NMPA) for the treatment of Claudin18.2 positive solid tumors. CARsgen is conducting a Phase I clinical trial of AB011 for the treatment of Claudin18.2 positive solid tumors in China to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of AB011 infusion.