CARsgen Initiates Phase 2 Clinical Trial for CLDN18.2 CAR T-cell Product CT041 in the U.S.

SHANGHAI,May 18,2023 -- 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 CARsgen has initiated patient enrollment for Phase 2 of the clinical trial for CT041 in the U.S.,for the treatment of CLDN18.2 positive advanced gastric cancer/gastroesophageal junction cancer (GC/GEJ) in patients who have failed at least 2 prior lines of systemic therapies.

Dr Raffaele Baffa,Chief Medical Officer of CARsgen,commented that,"Gastric cancer is a devastating disease that affects over a million people worldwide. Despite advances in treatment,the prognosis for patients with advanced gastric cancer remains poor,highlighting the urgent need for new and innovative therapies. CT041 has shown promising results in previous trials,demonstrating clinical efficacy and a manageable safety profile. We believe that CT041 has the potential to become an effective treatment option for patients with advanced gastric cancer. We would also like to express our gratitude to the patients,investigators,and our dedicated team at CARsgen for their commitment to advancing the field of cancer immunotherapy. We look forward to sharing updates on our clinical progress as we continue to work towards our goal of developing innovative CAR T-cell therapies for patients."

About CT041

CT041 is an autologous CAR T-cell product candidate against the protein CLDN18.2 that has the potential to be the first-in-class globally. CT041 targets the treatment of CLDN18.2 positive solid tumors with a primary focus on GC/GEJ and PC. Active trials in CARsgen include investigator-initiated trials (NCT03874897),a Phase Ib clinical trial for advanced GC/GEJ and PC and a confirmatory Phase II clinical trial for advanced GC/GEJ in China (CT041-ST-01,NCT04581473),and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02,NCT04404595). CT041 was granted Regenerative Medicine Advanced Therapy (RMAT) Designation by U.S. FDA for the treatment of advanced GC/GEJ with CLDN18.2-positive tumors in January 2022 and was granted PRIME eligibility by the EMA for the treatment of advanced gastric cancer in November 2021. CT041 received Orphan Drug designation from the U.S. FDA in 2020 for the treatment of GC/GEJ and Orphan Medicinal Product designation from the EMA in 2021 for the treatment of advanced gastric cancer.

About CARsgen Therapeutics Holdings Limited

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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