Recently, Leman Biotech, an enterprise incubated by XTALPI (02228), delivered a presentation at the 44th J.P. Morgan Healthcare Conference, showcasing the latest results from its investigator-initiated trial (IIT) for an ultra-low-dose CAR-T therapy to global investors. With R&D support from XTALPI, Leman Biotech has developed multiple R&D pipelines based on its AI + immune metabolic reprogramming platform. Notably, its metabolically enhanced CD19 CAR-T therapy, administered at an extremely low dose of just one-thousandth (1‰) of the conventional CAR-T therapeutic dose, has achieved complete remission and hospital discharge (100% CR) in multiple patients with systemic lupus erythematosus, demonstrating the future potential for "outpatient-style" CAR-T treatment. Concurrently, this therapy has helped dozens of patients with relapsed/refractory leukemia/lymphoma achieve CR, and several IIT clinical trials in the solid tumor field are either underway or set to commence. This series of advancements further validates the exceptional capability of XTALPI's R&D platform in empowering disruptive technologies and accelerating clinical translation. With XTALPI's investment incubation and R&D empowerment, Leman Biotech focuses on developing innovative tumor immunotherapy drug pipelines, creating and continuously upgrading its unique META 10 metabolic reprogramming technology platform. The two companies have also collaborated to develop the META 10-AI platform, which integrates XTALPI's AI algorithms with high-throughput screening experiments to optimize the design of core metabolic enhancement factors used in metabolically enhanced CAR-T therapy, resulting in a several-hundred-fold improvement in affinity. The team has also developed an AI-trained "ultra-high-definition microscope" that precisely identifies antibodies targeting subtle feature differences—as minute as a single amino acid—between tumor markers and healthy markers, significantly enhancing the affinity, specificity, and immunological activity of CAR-T therapy binding to receptors. This approach aims for "efficient target elimination" while avoiding collateral damage, minimizing toxic side effects, and delivering superior efficacy and safety. The relevant results have been submitted for Chinese patent applications and are being applied in the R&D of metabolically enhanced CAR-T pipelines for solid tumor targets, substantially improving the anti-exhaustion capability of CAR-T cells within the solid tumor immune microenvironment.
AI + Immune Metabolic Reprogramming: Overcoming CAR-T Therapy Bottlenecks According to estimates by Grand View Research, the global CAR-T therapy market size was USD 4.65 billion in 2024 and is projected to reach USD 15.97 billion by 2030, with a compound annual growth rate of 22.2%. While current CAR-T therapies have achieved some success in hematological malignancies, they still face three major challenges: high relapse rates, limited response in solid tumors, and high costs. The root cause lies in T cells easily entering a state of "terminal exhaustion" during sustained anti-tumor activity, losing their proliferative and cytotoxic capabilities, and becoming unresponsive to immune checkpoint inhibitors like PD-1/PD-L1. Leman Biotech, an innovative company incubated and invested in by XTALPI in 2022, has a founding team originating from the globally top-ranked Swiss Federal Institute of Technology Lausanne (EPFL). Through deep R&D collaboration with XTALPI, Leman Biotech has developed its two unique AI + metabolic reprogramming technology platforms, META 10 and META 10-AI, enabling precise regulation of the metabolism of exhausted T cells. This significantly enhances their proliferative capacity, cytotoxic activity, and immune memory function. The approach aims to achieve higher clinical response rates and superior safety with lower doses and a cheaper, faster preparation process, promoting complete remission in patients and offering a more ideal cell therapy option.
Dual Clinical Breakthroughs in Hematologic Malignancies and Autoimmune Diseases With support from XTALPI, the metabolically enhanced CD19 CAR-T therapy developed by Leman Biotech has demonstrated breakthrough therapeutic potential in both autoimmune diseases and hematologic malignancies. In 2025, Leman Biotech initiated an IIT clinical study for Systemic Lupus Erythematosus (SLE), achieving significant progress. Using an extremely low dose of just one-thousandth (1‰) of the conventional CAR-T therapeutic dose, and without the need for lymphodepletion preconditioning, interruption of original immunosuppressive drugs, and with significantly shortened hospital stays, the therapy successfully achieved drug-free complete remission (100% CR) in multiple patients with moderate to severe SLE. Based on favorable safety data, the metabolically enhanced CD19 CAR-T therapy holds promise for supporting an outpatient administration model, offering a new, more convenient and safer paradigm of "immune reset" therapy for autoimmune diseases. In IIT clinical studies for malignant hematologic malignancies, the metabolically enhanced CD19 CAR-T therapy has also shown impressive results. All of the first cohort of over 20 patients with relapsed/refractory leukemia/lymphoma achieved complete remission (100% CR) and were successfully discharged from the hospital. Furthermore, the study successfully included pediatric patients and chronic lymphoma patients who had responded poorly to traditional CAR-T therapy, with the first enrolled pediatric patient and chronic lymphoma patient both achieving CR. Regarding safety, patient vital signs remained stable and controllable during treatment, with no observed serious side effects commonly associated with CAR-T therapy, such as severe cytokine release syndrome or significant neurotoxicity.
Platform Technology Reshaping the Economics and Accessibility of Cell Therapy Leman Biotech's related clinical research won the highest award, the "Honor Award," at the 2025 National Disruptive Technology Innovation Competition and received funding from the National Key R&D Program for Disruptive Technology Innovation. This progress has the potential to change the current landscape of CAR-T therapy, often characterized by high costs ("millions per injection"), low response rates, and significant toxic side effects. By utilizing small-scale automated equipment to enable rapid production and further reduce costs, it lays the foundation for the launch of a safe, efficient, and new generation of "affordable" CAR-T therapy, potentially even inclusion in medical insurance schemes. This drives an important leap for cell therapy from "treatment" towards "cure," and from "centralized production" to "point-of-care preparation." Beyond hematologic malignancies and autoimmune diseases, Leman Biotech is expanding its META 10 platform into areas such as solid tumors. Metabolically enhanced cell therapies for solid tumor indications like cervical cancer, liver cancer, and cholangiocarcinoma have entered the IIT clinical research stage, with patient recruitment and enrollment currently underway. IL-10 CAR-T therapies targeting EGFR vIII-positive glioblastoma and GPC3-positive hepatocellular carcinoma are in the preparatory stage for IIT clinical studies, expected to commence in the first quarter of 2026. It is noteworthy that Leman Biotech's META 10 technology platform is highly compatible, applicable not only to autologous CAR-T but also extendable to various cell therapy modalities such as in vivo CAR-T, TCR-T, and TILs, possessing the potential to provide partners with "plug-and-play" solutions. This flexibility and scalability make it a "universal engine" in the field of cell therapy, capable of rapidly advancing the upgrade and expansion of treatment pipelines.
The rapid development of Leman Biotech and its series of breakthrough achievements in CAR-T therapy serve as another strong testament to the successful incubation capabilities of XTALPI's "AI + Robotics" empowerment platform. XTALPI has not only provided crucial financial support to Leman Biotech but has also deeply participated in the development and continuous optimization and upgrading of Leman's core platforms (META 10, META 10-AI) through its industry-leading AI drug R&D platform capabilities, accelerating its pipeline development process. Leman Biotech's groundbreaking clinical results in hematologic malignancies and autoimmune diseases, coupled with its rapid advancement in the solid tumor field, demonstrate its immense clinical value and commercial potential. XTALPI will continue to empower frontier enterprises like Leman Biotech, incubate more disruptive therapies, and lead innovation at the source in biopharmaceuticals.
About Leman Biotech Shenzhen Leman Biotech Co., Ltd. is a clinical-stage innovative drug R&D company focused on immune metabolism, co-founded by Professor Li Tang's team from the Swiss Federal Institute of Technology Lausanne (EPFL) and XTALPI. Leveraging innovative technology based on immune metabolic reprogramming (META 10) and cutting-edge artificial intelligence (AI), the company specializes in developing metabolically enhanced tumor immunotherapeutics. The company's core META 10 technology demonstrates significant potential for curing solid tumors, with related results published in top-tier international academic journals such as Nature, Nature Biotechnology, Nature Immunology, and The Lancet Haematology, and with multiple PCT patents and Chinese invention patents filed. The company is developing rapidly, with 70% of its high-level R&D personnel graduating from prestigious domestic and international universities and possessing rich industrial experience. Multiple R&D pipelines are progressing smoothly. Among them, metabolically enhanced CAR-T cell therapy is undergoing IIT clinical studies (NCT05715606, NCT05747157, NCT06120166), with over 20 patients achieving complete remission and being discharged. Since 2022, the company has cumulatively received over RMB 400 million in venture capital and project funding, won more than 20 national or provincial/municipal awards in the biopharmaceutical field, and been selected for late-breaking progress oral presentations at the American Society of Gene & Cell Therapy (ASGCT 2024) and the American Association for Cancer Research (AACR 2024) (the only one in China). Originating from Switzerland, Leman Biotech is committed to breaking through the bottlenecks of immunotherapy, improving the response rate and efficacy of immunotherapy, and striving tirelessly towards the ultimate goal of curing cancer!
About XTALPI XTALPI ("XtalPi Holdings Limited", stock abbreviation: XTALPI, stock code: 02228) was founded in 2015 by three MIT physicists and is an innovative R&D platform powered by quantum physics, artificial intelligence, and robotics. The company integrates first-principles calculations based on quantum physics, artificial intelligence, high-performance cloud computing, and scalable, standardized robotic automation to provide drug and materials science R&D solutions and services for global and domestic companies in industries including pharmaceuticals and materials science (encompassing agricultural technology, energy, new chemicals, and cosmetics).
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