SHANGHAI, March 27, 2024 /PRNewswire/ -- March 27, 2024, 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 its 2023 Annual Results.

Business Highlights

• Zevorcabtagene autoleucel (CT053) NDA was approved by the NMPA.
• Satricabtagene autoleucel (CT041) IND was approved by the NMPA for the postoperative adjuvant therapy of Claudin18.2 positive pancreatic cancer.
• CT011 IND was approved by the NMPA for GPC3-positive stage IIIa hepatocellular carcinoma at high risk of recurrence after surgical resection.
• Two hepatocellular carcinoma patients treated with a combination of local therapy and GPC3 CAR-T cells achieved disease-free survival exceeding 7 years.
• CT071 IND was cleared by the FDA for relapsed/refractory multiple myeloma and relapsed/refractory primary plasma cell leukemia.
• Developed a proprietary CARcelerate^TM platform, shortening the manufacturing time to around 30 hours. The platform has been utilized for CT071.
• CARsgen and Huadong Medicine entered into a collaboration agreement for the commercialization of zevorcabtagene autoleucel in mainland China.
• CARsgen and Moderna initiated a collaboration agreement to investigate satricabtagene autoleucel in combination with an mRNA cancer vaccine.

Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, said, "In 2023, CARsgen remained dedicated to our vision, 'Making Cancer Curable' and were committed to reinforcing our team and improving operational efficiency. We made substantial progresses in the regulatory and clinical development of our innovative products and the advancement of new technology platforms. Multiple important milestones for different product candidates across clinical, regulatory, and business development were achieved. We are optimistic that we will navigate and overcome the challenges ahead with resilience and determination, advancing our innovative cell therapies."

Zevorcabtagene autoleucel (CT053) is an autologous fully human CAR T-cell product candidate against B-cell maturation antigen (BCMA) for the treatment of relapsed/refractory multiple myeloma (R/R MM). As informed by the NMPA on March 1, 2024, zevorcabtagene autoleucel was granted conditional approval on February 23, 2024 for the treatment of adult patients with relapsed or refractory multiple myeloma who have progressed after at least 3 prior lines of therapy (including a proteasome inhibitor and an immunomodulatory agent). An update from the Phase I study in China (NCT03975907) with 3-year follow-up was presented as a poster at the 2023 American Society of Hematology ("ASH") Annual Meeting in December 2023.

Satricabtagene autoleucel (CT041) is an autologous humanized CAR T-cell product candidate against Claudin18.2 (CLDN18.2), a membrane protein highly expressed in certain cancers. As of the date of the announcement, satricabtagene autoleucel, based on our information, is the world's first CAR T-cell candidate for the treatment of solid tumors entering a Phase II clinical trial. In April 2023, satricabtagene autoleucel IND was approved by the National Medical Products Administration (NMPA) for the postoperative adjuvant therapy of Claudin18.2 positive pancreatic cancer (PC) (CT041-ST-05, NCT05911217). In May 2023, the Phase 2 part of the Phase 1b/2 clinical trial (NCT04404595) in the U.S. and Canada was initiated for the treatment of Claudin18.2 positive advanced gastric cancer/gastroesophageal junction cancer (GC/GEJ) in patients who have failed at least 2 prior lines of systemic therapies. Updates from the Phase 1b study in the U.S. (NCT04404595) were presented as a poster at the 2024 American Society of Clinical Oncology Gastrointestinal Cancers Symposium ("ASCO GI").

CT011 is an autologous CAR T-cell product candidate against Glypican-3 (GPC3). In January 2024, CT011 IND was approved by the NMPA for GPC3-positive stage IIIa hepatocellular carcinoma at high risk of recurrence after surgical resection.

In July 2023, an article titled "Combined local therapy and CAR-GPC3 T-cell therapy in advanced hepatocellular carcinoma: a proof-of-concept treatment strategy" was published in Cancer Communication (London, England) demonstrating patients who received local therapy followed by sequential infusions of CAR-GPC3 T-cells achieved more than 7-year disease-free survival.

CT071 is an autologous fully human CAR T-cell therapy candidate against G protein-coupled receptor class C group 5 member D (GPRC5D) developed utilizing CARsgen's proprietary CARcelerate^TM platform for the treatment of R/R MM and relapsed/refractory primary plasma cell leukemia (R/R pPCL). The IND was cleared by the FDA on November 30, 2023 for R/R MM and R/R pPCL. An investigator-initiated trial (IIT) is ongoing in China to assess the safety and efficacy of CT071 in treating R/R MM and relapsed/refractory plasma cell leukemia (R/R PCL) (NCT05838131).

In January 2023, CARsgen and Huadong Medicine (Hangzhou) Co., Ltd., a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (SZ. 000963) entered into a collaboration agreement for the commercialization of zevorcabtagene autoleucel, in mainland China.

In August 2023, CARsgen and Moderna, Inc. (Nasdaq: MRNA, "Moderna") have initiated a collaboration agreement to investigate satricabtagene autoleucel in combination with Moderna's investigational Claudin18.2 mRNA cancer vaccine.

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 mission 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, 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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