CARsgen Announced 2023 Interim Results

Rhea-AI Summary

CARsgen Therapeutics Holdings Limited announces its 2023 Interim Results with several positive developments.

Positive

• Collaboration agreement for zevor-cel commercialization in mainland China with Huadong Medicine.
• CT041 achieved IND clearance from the NMPA for the postoperative adjuvant therapy of Claudin18.2 positive pancreatic cancer.
• CT041 Phase 2 clinical trial initiated in the U.S. for the treatment of Claudin18.2 positive advanced gastric cancer/gastroesophageal junction cancer in patients who have failed at least 2 prior lines of systemic therapies.
• CARsgen and Moderna initiated a collaboration agreement to investigate CT041 in combination with Moderna's investigational Claudin18.2 mRNA cancer vaccine.

Negative

• None.

SHANGHAI, Aug. 22, 2023 /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, announced its 2023 Interim Results.

Business Highlights

• Collaboration agreement for zevor-cel commercialization in mainland China with Huadong Medicine.
• CT041 has achieved IND clearance from the NMPA for the postoperative adjuvant therapy of Claudin18.2 positive pancreatic cancer (PC).
• CT041 Phase 2 clinical trial has been initiated in the U.S. 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.
• CARsgen and Moderna have initiated a collaboration agreement to investigate CT041 in combination with Moderna's investigational Claudin18.2 mRNA cancer vaccine.

Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics Holdings Limited, said, "In the past six months, we have made significant progress in driving technological innovation, product development, and business operations. Our team has achieved remarkable accomplishments not only in the United States but also in China, continuously expanding the horizons of our scientific exploration and commercial boundaries. Looking ahead, we will persist in our commitment to innovation and strengthen international collaborations, aiming to rapidly translate cutting-edge scientific achievements into feasible treatment solutions. Our goal is to expedite the global availability of the innovative CAR T-cell therapy, benefiting cancer patients worldwide."

Zevorcabtagene Autoleucel (Zevor-cel, R&D code: 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). In October 2022, China National Medical Products Administration (NMPA) accepted the New Drug Application (NDA) and has granted the priority review for zevor-cel. Zevor-cel is expected to be approved by the NMPA for the treatment of R/R MM at the end of 2023 or the beginning of 2024. The enrollment in the Phase 2 clinical trial in the United States and Canada is underway. In January 2023, CARsgen and Huadong Medicine (Hangzhou) Co., Ltd., a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (Stock Code: SZ.000963) ("Huadong Medicine") entered into a collaboration agreement for the commercialization of CARsgen's lead drug candidate, zevor-cel, in mainland China. Since reaching the agreement, teams from CARsgen and Huadong Medicine have been working together closely to implement this collaboration and prepare for the approval and commercialization of zevor-cel in China.

CT041 is an autologous humanized CAR T-cell product candidate against Claudin18.2. Based on our information, CT041 is the world's first CAR T-cell candidate for the treatment of solid tumors that has entered a confirmatory Phase II clinical trial. In April 2023, CT041 has achieved IND clearance from the NMPA for the postoperative adjuvant therapy of Claudin18.2 positive pancreatic cancer (PC) (CT041-ST-05, NCT05911217). In May 2023, a Phase 2 clinical trial of CT041 in the U.S. has been 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. Active CT041 trials include a Phase 1b/2 clinical trial for advanced gastric cancer (GC) and PC in the United States and Canada (CT041-ST-02, NCT04404595), a Phase Ib clinical trial for advanced gastric cancer/gastroesophageal junction cancer (GC/GEJ) and PC (CT041-ST-01, NCT04581473), a confirmatory Phase II clinical trial for advanced GC/GEJ in China (CT041-ST-01, NCT04581473), and an investigator-initiated trial (NCT03874897). On August 21, 2023, CARsgen announced that CARsgen and Moderna, Inc. (Nasdaq: MRNA) have initiated a collaboration agreement to investigate CT041 in combination with Moderna's investigational Claudin18.2 mRNA cancer vaccine.

On top of these existing clinical programs, CARsgen will actively explore the treatment with innovative CAR T-cell products for the earlier lines of therapies. CARsgen has also been taking efforts to develop innovative technologies and product candidates that will better address the challenges with existing cell therapy products. As of June 30, 2023, we had more than 300 patents of which 101 patents had been issued globally including China, the United States, Europe, and Japan. This status is an increase of 9 issued patents and 24 patent applications from the end of 2022. Our R&D activities would continue to generate substantial intellectual property in our areas of expertise.

We have established in-house, vertically integrated manufacturing capabilities for the three key stages of CAR T manufacturing, including the production of plasmids, lentiviral vectors, and CAR T cells. We have been expanding our global manufacturing capacity in China and the U.S. to support both clinical trials and the subsequent commercialization of our pipeline products. With the clinical manufacturing facility in Xuhui, Shanghai and commercial GMP manufacturing facility in Jinshan, Shanghai, we manufacture CAR T-cell products in-house to support clinical trials in China and manufacture the lentiviral vectors in-house to support clinical trials globally. Our Research Triangle Park (RTP) CGMP manufacturing facility in Durham, North Carolina, has commenced operations of GMP production of autologous CAR T-cell products. The RTP Manufacturing Facility will provide CARsgen additional manufacturing capacity of autologous CAR T-cell products for 700 patients annually to support clinical studies and early commercial launch in the United States, Canada, and Europe.

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.

Contact CARsgen

For more information, please visit https://www.carsgen.com/
Contact CARsgen PR: pr@carsgen.com

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SOURCE CARsgen Therapeutics