Claudin18.2 CAR T Cells (CT041) Receives Approval to Initiate A Confirmatory Phase II Clinical Trial for advanced GC/GEJ in China

SHANGHAI, March 3, 2022 /PRNewswire/ -- 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, today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China has approved the initiation of the CT041 confirmatory Phase II clinical trial for the treatment of patients with Claudin18.2 (CLDN18.2) positive advanced gastric /gastroesophageal junction cancer (GC/GEJ) who have failed at least 2 prior lines of systemic therapies. The trial aims to evaluate the efficacy and safety of CT041 for the treatment of advanced GC/GEJ.

As of this announcement, CT041 is the world's first and only CAR T-cell product candidate entering a confirmatory Phase II clinical trial for the treatment of solid tumors.

Professor Lin Shen M.D., Vice President of Peking University Cancer Hospital, Director of Department of Gastrointestinal Oncology, Director of Phase I Clinical Study Ward and Deputy Director of Beijing Institute for Cancer Research, the principal investigator, commented that, "Gastric cancer is one of the most common and deadly cancers in China, with an annual incidence about 500,000. However, the treatment options for gastric cancer patients who have failed at least two prior lines are very limited. The median progression-free survival (mPFS) of available therapies, including anti-PD-1 monoclonal antibody, is merely about two months^[1], indicating an urgent unmet medical need for more innovative and effective drugs. In the early study of CT041 led by our center, as presented in the ESMO 2021, the mPFS of CT041 was over 5 months, which is very promising data. We are eager to start the study and will try our best to develop effective cellular therapies for cancer patients."

Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics Holdings Limited, commented that, "I would like to thank all the investigators and patients for their efforts in the clinical trials of CT041. With the approval of CT041 to initiate the confirmatory Phase II clinical trial of gastric cancer, we are one step further to successfully obtain the CT041 marketing authorization. With our continuous research and development, we believe that CT041 has a great potential to change the treatment paradigm for advanced gastric cancer worldwide."

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 pancreatic cancer (PC). CT041 has demonstrated promising therapeutic efficacy and favorable safety in ongoing clinical trials. CARsgen believes that CT041 has the potential to become a backbone therapy for GC/GEJ and PC and benefit a large population of patients worldwide.

As of the date of this announcement, CT041 is the only CLDN18.2-targeted CAR T-cell product candidate that is being studied in clinical trials with IND approvals from the FDA and the NMPA and CTA approval from 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 in China and 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 FDA for the treatment of GC/GEJ and Orphan Medicinal Product designation from the EMA for the treatment of advanced GC. In November 2021, CT041 was granted PRIME Eligibility by the EMA for the treatment of advanced GC. In January 2022, CT041 was granted Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of advanced GC/GEJ with CLDN18.2 positive tumor. CARsgen 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.

Reference

[1]Yoon-Koo, Kang, Narikazu, et al. Nivolumab in patients with advanced gastric or gastro-oesophageal junction cancer refractory to, or intolerant of, at least two previous chemotherapy regimens (ONO-4538-12, ATTRACTION-2): a randomised, double-blind, placebo-controlled, phase 3 trial.[J]. Lancet, 2017.

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