Leman Biotech, Powered by XtalPi, Achieves Major Breakthrough with Ultra-Low-Dose (1‰) CD19 CAR-T Therapy, Inducing Complete Remission in Multiple Systemic Lupus Erythematosus Patients

Recently, XtalPi (2228.HK) Incubated company Leman Biotech Co., Ltd. delivered a speech at the 44th J.P. Morgan Healthcare Conference and presented the latest results of its investigator-initiated clinical trial (IIT) for ultra-low-dose CAR-T therapy to global investors.With the R&D support from XtalPi,Leman Biotech Co., Ltd has developed multiple R&D pipelines based on its AI + Immune Metabolism Reprogramming platform. Among them is the metabolism-enhanced CD19 CAR-T therapy.At an ultra-low dose of only one-thousandth (1‰) of the conventional CAR-T treatment dose, complete remission (100% CR) was achieved in multiple systemic lupus erythematosus patients, demonstrating a new possibility for future "outpatient" CAR-T therapy.At the same time，This therapy has helpedDozens of patients with relapsed/refractory leukemia/lymphoma achieved CR,And hasMoreClinical trials in the field of solid tumors are currently being conducted or are about to be launched. These advancements once again demonstrate the exceptional capabilities of XtalPi's R&D platform in empowering disruptive technologies and accelerating clinical translation.

Under the investment incubation and R&D empowerment of XtalPi, Leman Biotech focuses on innovative tumor immunotherapy.Development of therapeutic drug pipelines, continuously upgrading its uniqueMETA 10Metabolic Reprogramming Technology Platform. The two companies have also collaborated to developMETA 10-AI The platform, combining XtalPi's AI algorithms with high-throughput screening experiments, optimized the design of core metabolic enhancers used in metabolism-enhanced CAR-T therapy.Achieving Hundreds of Times Increase in Affinity; The team also developed an "ultra-high-definition microscope" for AI training,Antibodies that precisely identify subtle characteristic differences of only one amino acid between tumor markers and healthy markers significantly enhance the affinity, specificity, and immunological activity of CAR-T therapy in receptor binding., while "efficiently killing enemies," avoid collateral damage, minimize toxic side effects as much as possible, and deliver superior efficacy and safety. The relevant results have currently been patented in China and applied to the development of metabolic-enhanced CAR-T pipelines for solid tumor targets, significantly improving the anti-exhaustion capability of CAR-T cells in the immunosuppressive microenvironment of solid tumors.

AI + Immune Metabolic Reprogramming,

Breaking the Bottleneck of CAR-T Therapy

According to estimates by Grand View Research, the global CAR-T therapy market size was $4.65 billion in 2024 and is expected to reach $15.97 billion by 2030, with a compound annual growth rate (CAGR) of 22.2%. Although CAR-T therapy has achieved some success in the field of hematologic tumors, it still faces three major challenges: high recurrence rates, limited response in solid tumors, and high costs. The root cause lies in T cells' tendency to enter a state of "terminal exhaustion" during continuous anti-tumor processes, losing their ability to proliferate and kill, and showing no response to immune checkpoint inhibitors such as PD-1/PD-L1.

Leman Biotech is an innovative company incubated and invested in by XtalPi in 2022. Its founding team comes from the globally renowned engineering university, École Polytechnique Fédérale de Lausanne (EPFL) in Switzerland. Through in-depth research and development cooperation with XtalPi, Leman Biotech has developed its unique...META 10 withMETA 10-AI Two Major AI+Metabolic Reprogramming Technology Platform, achieving precise regulation of exhausted T cell metabolism, thereby significantly enhancing their proliferation capacity, cytotoxic activity, and immune memory function,Achieve higher clinical response rates and better safety with a lower dose, lower cost, and faster preparation process.To drive patients to achieve complete remission and provide them with a more ideal choice for cell therapy.

Hematological Tumors and Autoimmune Diseases

Clinical Dual Breakthrough

With the support of XtalPi, the metabolism-enhanced CD19 CAR-T therapy developed by Leman Biotech has demonstrated breakthrough treatment potential in autoimmune diseases and hematological tumors. In 2025, Leman Biotech initiated an IIT clinical study targeting Systemic Lupus Erythematosus (SLE), achieving significant progress. This therapy, with only...ForA very low dose of one-thousandth (1‰) of the conventional CAR-T treatment dose，Successfully Achieved Complete Remission Without Drug Dependence in Multiple Patients with Moderate to Severe SLE, Under Conditions of No Lymphodepletion Pre-treatment, No Interruption of Original Immunosuppressive Drugs, and Significantly Shortened Hospital Stay（100% CR）。Based on favorable safety data, the metabolism-enhanced CD19 CAR-T therapy is expected to support an outpatient administration model, providing a more convenient and safer "immune reset" treatment paradigm for autoimmune diseases.

In the IIT clinical trials in the field of malignant hematological tumors，Metabolism-enhanced CD19 CAR-T therapy also showed impressive results.The first group of over 20 patients with relapsed/refractory leukemia/lymphoma also all achieved complete remission (100% CR) and were successfully discharged.In addition, this study successfully covered pediatric patients and patients with chronic lymphoma who had a poor response to traditional CAR-T therapy. The first enrolled child patient and the first chronic lymphoma patient both achieved CR. In terms of safety, the patients' vital signs were stable and controllable during the treatment process, and no serious side effects commonly associated with CAR-T treatment, such as severe cytokine storms or severe neurotoxicity, were observed.

Platform Technology,

Reshaping the Economics and Accessibility of Cell Therapy

Leman Biotech Co., Ltd.'s Relevant Clinical Research Awarded the Highest Prize of "Honorary Award" in the 2025 China Disruptive Technology Innovation Competition, and Received Funding from the Key Special Project for Disruptive Technology Innovation under China's National Key R&D Program. This advancement is expected to transform the current state of CAR-T therapy, which is characterized by its "million-yuan-per-dose" cost, low response rates, and significant toxic side effects. Leveraging compact automated equipment, it will enable rapid production and further cost reduction, laying the foundation for the launch of a new generation of safe, efficient, and "affordable" CAR-T therapies, potentially paving the way for their inclusion in health insurance.Promote Cell Therapy: From "Treatment" to "Cure," and from "Centralized Production" to "Outpatient Preparation"

In addition to hematologic tumors and autoimmune diseases, Leman Biotech is expanding the META 10 platform to areas such as solid tumors.Metabolism-enhanced cell therapy for solid tumor indications such as cervical cancer, liver cancer, and cholangiocarcinoma has entered the IIT clinical research stage.Patient recruitment and treatment enrollment are currently underway. The IL-10 CAR-T therapy targeting EGFR vIII-positive glioblastoma and GPC3-positive hepatocellular carcinoma has entered the IIT clinical preparation stage, with the IIT clinical study expected to commence in the first quarter of 2026.

Notably, 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. It has the potential to provide partners with "plug-and-play" solutions. The flexibility and scalability of this technology make it a "universal engine" in the field of cell therapy, capable of rapidly advancing the upgrade and expansion of therapeutic pipelines.

The rapid development of Leman Biotech and its series of breakthrough achievements in CAR-T therapy serve as another compelling testament to the successful incubation capabilities of XtalPi's “AI + Robotics” empowerment platform. XtalPi not only provided crucial financial support to Leman Biotech but also deeply participated in the development and continuous optimization of Leman’s core platforms (META 10, META 10-AI) through its industry-leading AI drug discovery platform, accelerating the progress of its pipeline development. Leman Biotech’s groundbreaking clinical outcomes in hematological tumors and autoimmune diseases, along with its rapid advancements in solid tumors, demonstrate its tremendous clinical value and commercial potential.XtalPi will continue to empower frontier companies like Leman, incubate more disruptive therapies, and lead the source innovation in the biopharmaceutical industry.

● CloseLeman Biotech Co., Ltd●

Leman Biotech Co., Ltd, a clinical-stage immunometabolism innovation drug development company, was co-founded by Professor Li Tang's team from EPFL (École Polytechnique Fédérale de Lausanne), Switzerland, and XtalPi. Based on the innovative technology of immunometabolic reprogramming (META 10) + cutting-edge artificial intelligence (AI), the company focuses on developing metabolism-enhanced cancer immunotherapy.Therapeutic drugs. The company's core technology META 10 has demonstrated great potential in curing solid tumors, with related results published inNature、Nature Biotechnology、Nature Immunology、Lancet Haematology in international top-tier academic journals, and has applied for multiple PCT patents and Chinese invention patents.

Currently, the company is developing rapidly, with 70% of its high-level R&D personnel coming from top universities both in China and abroad, and possessing extensive industrialization experience. Multiple R&D pipelines are underway.The pipeline is proceeding smoothly. Among them, the metabolism-enhanced CAR-T cell therapy is currently undergoing IIT clinical research (NCT05715606, NCT05747157, NCT06120166), with over 20 patients achieving complete remission and being discharged. Since 2022, the company has cumulatively received over 400 million yuan in venture capital and project funding, won more than 20 national or provincial-level awards in the biopharmaceutical field, and gained recognition from the American Society of Gene and Cell Therapy (ASGCT 2024) and the American Association for Cancer Research (AACR 20).24) The Latest Late-Breaking Progress Oral Report (the only one in China). Leman Biotech Co., Ltd, originating from Switzerland, is committed to breakthroughs in immunotherapy.The bottleneck problem of treatment, improve the response rate and efficacy of immunotherapy, and strive unremittingly for the ultimate goal of curing tumors!