CARsgen Announces First Patient Enrollment in the Confirmatory Phase II Clinical Trial of CT041 in China

CARsgen Therapeutics Holdings Limited a company focused on innovative CAR T cell therapies for the treatment of hematologic malignancies and solid tumors, today announced that CT041, an autologous CAR T-cell product candidate against the protein Claudin18.2 (CLDN18.2), has completed the first patient enrollment in the confirmatory Phase II clinical trial in Beijing Cancer Hospital in China for the treatment of CLDN18.2 positive advanced gastric/gastroesophageal junction cancer (GC/GEJ) in patients who have failed at least 2 prior lines of therapies. CARsgen Therapeutics Holdings Limited, commented that, "The IIT data disclosed at the ESMO in September 2021 have shown promising efficacy and safety of CT041. In the following clinical trials, we will further explore the efficacy and safety of CT041 in the treatment of advanced gastric/gastroesophageal junction cancer, as well as pancreatic cancer. We hope that CT041, a potential first-in-class CAR T-cell therapy, could make considerable progress and meet the unmet medical needs as soon as possible 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 pancreatic cancer (PC). CT041 has demonstrated promising therapeutic efficacy and favorable safety in ongoing clinical trials. CT041 has the potential to become a backbone therapy for GC/GEJ and PC in the future and benefit a large population of patients worldwide. As of the date of the announcement, CT041 is the only CLDN18.2-targeted CAR T-cell product candidate globally that is being studied in clinical trials with IND/CTA approvals from the FDA, the NMPA, and Health Canada. In addition to the investigator-initiated trials in China, CARsgen has initiated a Phase Ib clinical trial for advanced GC/GEJ and PC, a confirmatory Phase II clinical trial for advanced GC/GEJ in China and initiated a Phase 1b clinical trial for advanced gastric or pancreatic adenocarcinoma in North America. In 2020 and 2021, CT041 received Orphan Drug designation from the U.S. FDA for the treatment of GC/GEJ and Orphan Medicinal Product designation from the EMA for the treatment of advanced gastric cancer. In November 2021, CT041 was granted PRIME Eligibility by the EMA for the treatment of advanced gastric cancer. In January 2022, CT041 was granted Regenerative Medicine Advanced Therapy (RMAT) Designation by the U.S. FDA for the treatment of advanced gastric or gastroesophageal junction adenocarcinoma with CLDN18.2 positive tumors. CARsgen also intends to conduct a pivotal Phase 2 clinical trial in North America in 2022. 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. The Company 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. The Company'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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