Leman Biotech Co., Ltd. (hereinafter referred to as "Leman Biotech"), a clinical-stage biotechnology company dedicated to the research, development, production, and commercialization of innovative metabolic immunotherapies, recently announced the successful treatment of the first pediatric patient enrolled in its investigator-initiated clinical trial (IIT). The patient, treated with an extremely low dose (1% of the conventional dose), achieved complete remission (CR) and was discharged without complications.
The first pediatric patient to receive Leman Biotech's metabolically armored CD19 CAR-T cell therapy (Meta10-19 infusion) was treated at the Children's Hospital Affiliated with Zhejiang University School of Medicine (referred to as "Zhejiang University Children's Hospital").
The child had been diagnosed with high-risk relapsed and refractory acute B-lymphocytic leukemia with central nervous system metastasis. Despite four prior lines of therapy, the disease remained uncontrolled and relapsed. In March 2024, Zhejiang University Children's Hospital initiated the Meta10-19 CAR T cell IIT clinical study for pediatric patients, with Dr. Xu Xiaojun, Director of the Hematological Oncology Center, serving as the principal investigator (PI). After aan extensive screening and evaluation, the child met the eligibility criteria for the Meta10-19 infusion and became the first pediatric patient to be successfully enrolled in the study.
Given the urgency of the patient’s condition, the medical team at Zhejiang University Children's Hospital collaborated closely with Leman Biotech's clinical team. Following careful preparation and coordination, the patient received an infusion of Meta10-19 CAR T cells at an extremely low dose (1% of the conventional dose) in the shortest possible time. Post-infusion of Meta10-19 CAR T cells, the patient showed significant clinical improvement, with effective clearance of tumor cells and achievement of complete remission (CR). Throughout the treatment, the patient remained physiologically stable, with no severe side effects such as cytokine release syndrome observed.
About Meta10-19 infusion
Meta10-19 infusion is Leman Biotech's first therapeutic candidate to advance to clinical research. This therapy uses Leman Biotech's metabolic reprogramming technology, enhancing CAR-T cells resistance to exhaustion by promoting oxidative phosphorylation. Additionally, CAR-T cells in Meta10-19 infusion acquire a stem cell-like memory phenotype, leading to a more durable and effective anti-tumor response in vivo. In preclinical studies, metabolically armored CAR-T cells demonstrated a cure rate of up to 100% in models of hematological malignancies and various solid tumors. In the ongoing investigator-initiated clinical trial (IIT), over 20 adult patients have been treated, all achieving complete remission (CR) and being discharged.
The successful treatment of first pediatric patients marks significant progress in the clinical research of pediatric malignant hematologic diseases at Leman Biotech, offering new treatment options and hope for affected children. Notably, the dose of metabolically armored CD19 CAR-T cell therapy is only 1% dose of the conventional CD19 CAR-T, significantly reducing the risk of severe side effects such as cytokine release syndrome. The low dose offers great potential to shorten production time and enable rapid manufacturing using small automated equipment, thereby lowering production costs and enhancing the therapy's accessibility.
About Acute B-Lymphocytic Leukemia in Pediatric Patients
Relapsed and Refractory Acute B-lymphocytic leukemia (ALL) is a severe form of leukemia that affects a subset of pediatric patients who do not respond adequately to initial treatment or experience a relapse after achieving remission. In the United States, approximately 3,000 new cases of ALL are diagnosed in children each year, with about 15-20% classified as high-risk. Of these, around 10-20% will experience a relapse, and a significant portion of these cases will become refractory to standard treatments. In the European Union, the incidence is similar, with roughly 3,500 new pediatric cases annually, and similar percentages of relapse and refractory disease. This high-risk group is particularly challenging to treat due to the aggressive nature of the disease and the limited efficacy of traditional therapies.
When central nervous system (CNS) metastasis occurs, the prognosis for children with high-risk relapsed and refractory ALL becomes even more concerning. CNS involvement is seen in approximately 3-5% of pediatric ALL cases at diagnosis, and it can occur in up to 30% of relapsed cases. The presence of CNS disease complicates treatment due to the difficulty of delivering effective therapies across the blood-brain barrier. In both the U.S. and the EU, the survival rates for children with CNS-involved relapsed/refractory ALL are significantly lower than for those without CNS involvement, underscoring the urgent need for new, more effective treatment strategies that can address both systemic and CNS disease.
About Leman Biotech
Leman Biotech is a clinical-stage cancer immunotherapy company co-founded by Professor Li Tang of the Swiss Federal Institute of Technology in Lausanne (EPFL) and AI-driven drug R&D leader XtalPi. The company combines innovative metabolic reprogramming technology with a cutting-edge AI drug discovery platform to develop next-generation cancer immunotherapies. The core technology, Meta 10, has the potential to cure solid tumors, as demonstrated in published research in top academic journals such as Nature Immunology and Nature Biotechnology. Additionally, it holds PCT patents covering major economies worldwide. Leman Biotech completed a successful angel plus round of financing, raising nearly $18 million in total, with plans for further financing underway. The company is committed to finding solutions to tackling the bottlenecks in cancer immunotherapy, improving response rates and efficacy, and making unremitting efforts to achieve the ultimate goal of curing cancer.
