Leman Biotech, co-founded by XtalPi Inc. (2228.HK) and Professor Li Tang’s team from the Swiss Federal Institute of Technology in Lausanne (EPFL), announced that its metabolic-enhanced CD19 CAR-T cell therapy product (Meta10-19 injection) has successfully completed dosing in the first systemic lupus erythematosus (SLE) subject in an investigator-initiated clinical trial (IIT) at the First Affiliated Hospital of Zhejiang University School of Medicine. This marks the therapy’s first expansion into autoimmune disease treatment following breakthrough progress in hematological malignancies.
Systemic lupus erythematosus is a severe systemic autoimmune disease characterized by multi-organ involvement, recurrent flares and remissions, and the presence of autoantibodies, primarily affecting women aged 15 to 40. When conventional treatments fail, the disease often relapses, causing irreversible organ damage and potentially leading to death. Currently, there is no effective cure. Epidemiological data indicate over 1 million SLE patients in China, with approximately 60% experiencing irreversible multi-organ damage due to disease progression, highlighting a significant unmet clinical need.
Among Leman Biotech’s pipeline, the metabolic-enhanced CD19 CAR-T therapy (Meta10-19 injection) is the most advanced, showing promising clinical results in leukemia and lymphoma treatment. In IITs, the therapy achieved complete tumor clearance at ultra-low doses (as low as 1% of standard CAR-T doses), enabling complete remission (CR) and successful discharge for over 20 patients with relapsed/refractory leukemia or lymphoma. Notably, the IITs have included pediatric patients. The first enrolled child, diagnosed with relapsed/refractory high-risk acute B-cell lymphoblastic leukemia with central nervous system involvement and unresponsive to four lines of therapy, showed significant improvement shortly after receiving an ultra-low dose (1% of standard) of Meta10-19. Tumor cells were effectively cleared, achieving complete remission (CR).
In the latest IIT, experts further reduced the metabolic-enhanced CAR-T dose to 0.1% of standard levels, successfully aiding several patients to CR and significantly shortening hospital stays.
About Leman Biotech
Shenzhen Leman Biotech Co., Ltd. is a clinical-stage company developing innovative immunometabolic therapies, co-founded by Professor Li Tang’s team from EPFL and XtalPi. Leveraging immunometabolic reprogramming (Meta 10) and cutting-edge artificial intelligence (AI), the company focuses on metabolic-enhanced tumor immunotherapies. Its core Meta 10 technology shows immense potential for curing solid tumors, with results published in Nature, Nature Biotechnology, and Nature Immunology, and multiple PCT and Chinese patents filed. With rapid growth, 70% of its high-caliber R&D team hails from top global universities with extensive industrialization experience. Multiple pipelines are advancing smoothly, including metabolic-enhanced CAR-T therapies in IITs (NCT05715606, NCT05747157, NCT06120166), with over 20 patients achieving complete remission and discharge.
