AB-011

SHANGHAI, March 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 2022 Annual Results. Business Highlights Zevor-cel (CT053) NDA was accepted by the NMPA (Oct 2022) with priority review granted. CT041 entered confirmatory Phase II clinical trial in China. AB011 completed the enrollment for Phase I monotherapy and combination with chemotherapy. Multiple data disclosure in academic journals and conferences, including Nature Medicine, Haematologica, Frontiers in Immunology, ASCO 2022, 7th CAR-TCR summit, ASH 2022, ASCO GI 2023. Collaboration agreement for zevor-cel commercialization in mainland China with Huadong Medicine. Collaboration agreement for the evaluation of AB011 with Roche. CARsgen's RTP Manufacturing Facility in the U.S. started GMP production of autologous CAR T cell products and released the first GMP batch. Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics Holdings Limited, said, "In 2022, we have achieved important milestones in the clinical and regulatory advancements of our pipeline products, development of innovative technologies, expansion of global manufacturing capacities, business development, etc. Looking forward, we are embarking on an even more exciting journey. We are confident that CARsgen is well positioned to strengthen the leadership in CAR T-cell therapies globally, powered by our differentiated pipeline product candidates, dedicated team efforts, and the high operational efficiencies." Zevor-cel is an upgraded fully human, autologous BCMA CAR T-cell product candidate for the treatment of R/R MM. China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) and has granted the priority review in October 2022. Updates from the Phase 2 study in the U.S. (NCT03915184) were presented orally at the 7th Annual CAR-TCR Summit and the updates from the pivotal Phase II study in China (NCT03975907) were provided in poster presentations at the 64th American Society of Hematology (ASH) Annual Meeting in December 2022. An update from China investigator-initiated trials was published in Haematologica in August 2022. CARsgen plans to submit a Biologics License Application (BLA) to the U.S. FDA in 2024. For CT041, the first-in-class CAR T-cell product candidate against CLDN18.2, a confirmatory Phase II clinical trial for advanced GC/GEJ in China is ongoing. A Phase 2 clinical trial in the U.S. is expected to initiate in the first half of 2023. Updates from the Phase 1b study in the U.S. (NCT04404595) and the Phase Ib/II study in China (NCT03975907) were provided in poster presentations at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in June 2022. An update from a China IIT was published in Nature Medicine in May 2022. CARsgen plans to submit an NDA to the NMPA in China in the first half of 2024 and plans to submit the BLA to the U.S. FDA in 2025. AB011 is a humanized monoclonal antibody product candidate that targets CLDN18.2. CARsgen has completed the enrollment for the Phase I monotherapy and combination with chemo therapies. Updates from Phase I study (AB011-ST-01; NCT04400383) were provided in poster presentations at the 2023 ASCO Gastrointestinal (GI) Cancers Symposium in January 2023. 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. 2022 is an important year for CARsgen for the expansion of manufacturing capacities outside of China. CARsgen's state-of-the-art GMP Manufacturing Facility in Research Triangle Park (RTP), Durham, has started GMP production of autologous CAR T cell products and successfully released the first GMP batch for the clinical trials in September 2022. The RTP Manufacturing Facility will continue to support CARsgen's ongoing clinical studies and the early commercial launch overseas. For business development, CARsgen entered into a collaboration agreement Huadong Medicine Co., Ltd. (SZ. 000963) for the commercialization of zevor-cel in mainland China. CARsgen will continue to be responsible for the development, regulatory approval, and manufacturing of zevor-cel in mainland China. In January 2023, CARsgen announced a collaboration agreement with F. Hoffmann-La Roche Ltd ("Roche") to evaluate CARsgen's investigational drug AB011 in combination with atezolizumab, Roche's PD-L1 checkpoint inhibitor, along with standard-of-care chemotherapy in patients with GC/GEJ. CARsgen looks forward to establishing more collaborations with industry partners and academic institutes to develop and advance innovative cell therapies and technologies, benefiting cancer patients worldwide. 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 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. 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. Contact Us For more information, please visit Company Codes: HongKong:2171

SHANGHAI, Jan. 31, 2023 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative therapies for the treatment of hematologic malignancies and solid tumors, has announced CARsgen's execution of a collaboration agreement with F. Hoffmann-La Roche Ltd ("Roche") to evaluate CARsgen's investigational drug AB011, the first humanized monoclonal antibody against Claudin18.2 (CLDN18.2) that received IND clearance globally, in combination with atezolizumab, Roche's PD-L1 checkpoint inhibitor, along with standard-of-care chemotherapy in patients with gastric or gastroesophageal junction carcinoma . Under the terms of the agreement, Roche will be responsible for operation and conduct of the trial while both companies co-share the costs of the AB011 treatment arms in the study. As part of the clinical collaboration, CARsgen's proprietary CLDN18.2 IHC test kit, which has showed excellent specificity and sensitivity pro will be applied to evaluate CLDN18.2 expression in the gastric cancer patients. The co-funded study of AB011 in combination with atezolizumab will be conducted as part of Roche's Morpheus Platform. The Morpheus Platform is a collection of Phase Ib/II clinical trials in multiple cancers with high unmet clinical needs including gastrointestinal cancer, designed to assess the safety and early efficacy to enable more rapid and efficient development of novel cancer treatment combinations. "We are glad to work with Roche, a global leader in oncology, to explore the potential of AB011 in combination with atezolizumab and chemotherapy for the treatment of gastric cancer," said Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen, "Gastric cancer is one of the most common cancer types worldwide and the treatment options for gastric cancer patients are still very limited. CLDN18.2 is a promising therapeutic target for the treatment of CLDN18.2 positive solid tumors, including gastric cancer, pancreatic cancer, etc. Since 2014, CARsgen team has developed several innovative medicines against CLDN18.2 in the pipeline including CAR T-cell therapies and AB011. AB011 is an important asset in the CLDN18.2 franchise of CARsgen and is the first monoclonal antibody against CLDN18.2 that received IND clearance in China. Through this collaboration, we are excited to evaluate the combination of AB011 and atezolizumab which can potentially bring greater clinical benefits to gastric cancer patients." About AB011 AB011 is a humanized Claudin18.2 monoclonal antibody (mAb) product that has received an investigational new drug (IND) approval from the National Medical Products Administration (NMPA) for the treatment of Claudin18.2 positive solid tumors. CARsgen is conducting a Phase I clinical trial of AB011 for the treatment of Claudin18.2 positive solid tumors in China to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of AB011 infusion. About CARsgen 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 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. 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. Contact Us For more information, please visit Company Codes: HongKong:2171