FDA Lifts Clinical Holds on CARsgen® U.S. Trials

In Shanghai on October 31, 2024, CARsgen Therapeutics Holdings Limited, a company recognized by the stock code 2171.HK, announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical holds on several of its clinical trials. These trials involve the autologous CAR-T products targeting specific antigens related to cancer treatments, including zevorcabtagene autoleucel (zevor-cel, CT053) targeting BCMA, satricabtagene autoleucel (satri-cel, CT041) targeting Claudin18.2, and CT071 targeting GPRC5D. This significant regulatory decision allows CARsgen to resume its clinical research and development activities in the United States.

CARsgen Therapeutics Holdings Limited is a biopharmaceutical company with a strong presence in both China and the U.S. The company specializes in the development of innovative CAR T-cell therapies aimed at treating both hematologic malignancies and solid tumors. CARsgen has developed a comprehensive research and development platform that encompasses the entire process from target discovery, through innovative CAR T-cell development, clinical trials, and commercial-scale production.

The company has established itself as a leader in the field by creating novel technologies and a product pipeline with global rights. These innovations are designed to address key challenges that current CAR T-cell therapies face, such as improving the safety profile, enhancing the effectiveness in treating solid tumors, and reducing the costs of treatment. CARsgen's ambition is to become a leading global biopharmaceutical company that offers innovative and distinct cell therapies to cancer patients worldwide, striving towards making cancer a curable disease.

The lifting of the clinical holds by the FDA is a substantial milestone for CARsgen, as it provides an opportunity to advance their pioneering therapies through the clinical trial phases. The company's focus on CAR T-cell therapy represents a cutting-edge approach within oncology, aiming to harness the power of the immune system to fight cancer more effectively. By utilizing autologous CAR-T cells, CARsgen's therapies involve modifying a patient’s own T-cells to better recognize and attack cancer cells. This personalized approach is at the forefront of modern cancer treatment, offering hope for more effective and tailored therapies for individuals battling cancer.

CARsgen’s headquarters in both China and the U.S. facilitate a robust collaborative environment that leverages scientific expertise and technological advancements from both regions. This strategic positioning enables the company to pursue its ambitious research and development goals while keeping a firm focus on addressing unmet medical needs in oncology.

By committing to innovation and excellence in CAR T-cell therapy, CARsgen Therapeutics Holdings Limited is poised to make significant contributions to the field of cancer treatment. The company’s efforts to improve therapeutic options for patients represent a crucial step forward in the global fight against cancer. Through ongoing research, clinical trials, and eventual commercialization of its CAR T-cell products, CARsgen aims to provide new hope and improved outcomes for cancer patients around the world.