Leman Biotech Co., Ltd. (hereinafter referred to as "Leman Biotech"), a clinical-stage biotechnology company committed to the research, development, production, and commercialization of innovative metabolic immunotherapies, has recently made significant progress in its investigator-initiated trial (IIT) of metabolically armored CD19 CAR-T cell therapy (Meta10-19 infusion). In this IIT study, several patients who had lost mobility or experienced paralysis due to advanced cancer achieved complete response (CR) and successfully regained their ability to walk.
The patients, aged between 50 and 70, were diagnosed with relapsed and refractory diffuse large B-cell lymphoma (DLBCL) and had previously failed three or more lines of therapy. Disease progression had severely impaired their motor function and self-care abilities, with some patients bedridden for up to six months. This situation imposed significant hardship on the patients and their families. Remarkably, after receiving treatment with ultra-low doses (as low as 1% or less of conventional doses) of the metabolically armored CAR-T cells, these patients all achieved CR and gradually regained mobility within 2 to 3 months.
About Relapsed and Refractory Diffuse Large B-cell Lymphoma (DLBCL)
DLBCL is a malignant tumor arising from the lympho-hematopoietic system, often originating in the lymph nodes, spleen, thymus, or other lymphatic tissues. As the disease progresses, cancer cells can invade other tissues and organs, leading to more severe symptoms. For instance, DLBCL can spread to the spinal cord or central nervous system, causing paralysis, weakness in the legs, difficulty walking, and progressive loss of functional independence.
Traditional treatment options for DLBCL include chemotherapy, radiotherapy, targeted therapy, monoclonal antibodies, and stem cell transplantation, all of which are considered based on the patient’s overall health. Unfortunately, about 30% to 40% of patients experience relapse within two years of first-line therapy, with 10% developing relapsed and refractory lymphoma. The prognosis for these patients is extremely poor, and there is an urgent clinical need for more effective treatment strategies. CAR-T cell immunotherapy, a novel treatment that has shown tremendous promise in the field of hematological malignancies, significantly boosts the immune system's ability to attack cancer cells, improving the chances of successful treatment.
Despite its promise, current CAR-T cell therapies are associated with several side effects, including cytokine release syndrome (CRS) and neurotoxicity. CRS can lead to fever, hypotension, pulmonary symptoms, and organ dysfunction, while neurotoxicity may result in headaches, intracranial hypertension, and altered consciousness. For these reasons, CAR-T cell immunotherapies are generally used as second- or third-line treatments and require intensive monitoring. Patients with an ECOG score of ≥ 2, meaning they cannot walk independently or perform daily activities, are often excluded from clinical studies due to the associated risks.
Leman Biotech's Novel Meta10-19 CAR-T therapy: A Safer and More Effective Option
Leman Biotech’s novel CAR-T therapy, Meta10-19, has shown relatively mild side effects due to the ultra-low dose. In the IIT clinical studies, the dose used was as low as 1% or less of the conventional dose, and no severe side effects, such as CRS, were observed. To date, over 20 patients treated with Meta10-19 have achieved CR (a CR rate of 100%) and have been successfully discharged from the hospital. These preliminary clinical results demonstrate the excellent efficacy and safety of Meta10-19. After an extensive assessment of safety and efficacy by clinical experts, several patients over 50 years old who were suffering from lower limb weakness caused by DLBCL were enrolled in the study. All of these patients achieved CR and regained mobility after receiving Leman Biotech’s novel Meta10-19 CAR-T cell therapy.
The IIT clinical study of Meta10-19 has also recently begun enrolling pediatric patients. The first child enrolled in the study was diagnosed with high-risk relapsed and refractory acute B-lymphoblastic leukemia, which had metastasized to the central nervous system. Despite undergoing four prior lines of therapy, the disease remained uncontrolled. After receiving an ultra-low dose (1% of the conventional dose) of Meta10-19, the child's condition improved significantly, with tumor cells eradicated, ultimately leading to a CR.
About Leman Biotech
Leman Biotech is a clinical-stage cancer immunotherapy company co-founded by Professor Li Tang from the Swiss Federal Institute of Technology in Lausanne (EPFL) and XtalPi, a leader in AI-driven drug discovery. The company integrates innovative metabolic reprogramming technology with a state-of-the-art AI drug discovery platform to develop next-generation cancer immunotherapies. Its core technology, Meta10, has demonstrated the potential to cure solid tumors, as evidenced by research published in top-tier academic journals such as Nature, Nature Immunology, and Nature Biotechnology. Furthermore, Leman Biotech holds PCT patents covering major global economies. The company's metabolically enhanced CAR-T cell therapy is currently undergoing investigator-initiated clinical trials (NCT05715606, NCT05747157, NCT06120166). To date, over 20 patients have achieved complete remission and have been discharged from the hospital following this therapy. Leman Biotech recently completed a successful angel-plus round of financing, raising more then $18 million, with plans for further financing underway. Leman Biotech is committed to addressing the major bottlenecks in cancer immunotherapy, improving response rates and efficacy, and making continuous efforts to achieve the ultimate goal of curing cancer.
