CARsgen's CT011 achieves IND clearance from the NMPA for the GPC3-positive stage Ⅲa hepatocellular carcinoma at high risk of recurrence after surgical resection

SHANGHAI, Jan. 15, 2024 /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, announces that CT011, an autologous CAR T-cell product candidate against Glypican-3 (GPC3), has achieved Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) for patients with GPC3-positive stage IIIa hepatocellular carcinoma who are at high risk of recurrence after surgical resection.

Raffaele Baffa, MD, PhD, Chief Medical Officer of CARsgen Therapeutics, commented, "Hepatocellular carcinoma (HCC) stands as the predominant histologic subtype of primary liver cancer, ranking as the sixth most prevalent cancer type globally. We initially identified GPC3 as a viable target for CAR T-cell therapy and subsequently progressed it to clinical trials for the treatment of HCC. Case report has shown patients with advanced hepatocellular carcinoma have achieved disease-free survival for more than seven years. We will continue to explore the potential of CAR-T for solid tumors and bring new treatment options for patients."

About CT011

CT011 is an autologous GPC3 CAR T-cell product candidate for the treatment of hepatocellular carcinoma (HCC). CT011 received IND clearance from the NMPA in 2019 for the treatment of patients with GPC3-positive solid tumor which was China's first IND clearance for CAR T-cell therapy against solid tumors. CARsgen have completed enrollment of a Phase I trial in China.

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 established a comprehensive CAR T-cell research and development platform, encompassing target discovery, innovative CAR T-cell development, clinical trials, and commercial-scale production. 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.

Forward-looking Statements

All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group's control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading "Principal Risks and Uncertainties" in our most recent annual report and interim report and other announcements and reports made available on our corporate website, https://www.carsgen.com. No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release.

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SOURCE CARsgen Therapeutics