6MW5311 is developed based on Mabwell’s T Cell Engager (TCE) technology platform, utilizing a “2+1” asymmetric molecular structure that simultaneously targets LILRB4 and CD3. It forms immune synapses by bridging tumor cells and T cells, activating T cells to efficiently kill tumors. The molecule incorporates a unique steric hindrance structural design, significantly reducing the binding activity of CD3 antibodies to T cells in the absence of tumor cells, and specifically activating T cells only in the presence of tumor cells, thereby greatly enhancing safety while improving anti-tumor efficacy.
In vitro study results show that 6MW5311 exhibits potent killing activity against multiple tumor cell lines and patient-derived samples. In vivo pharmacodynamic studies demonstrate that in AML tumor models with both high and low LILRB4 expression, 6MW5311 shows clear tumor inhibition, achieving complete tumor clearance particularly in high-expression models. Additionally, in cynomolgus monkey safety evaluation models, 6MW5311 displays a favorable safety profile.
As a key technical approach to directly mobilize T cells for efficient tumor killing, TCE has demonstrated significant clinical value in various lymphoma indications, with multiple products successfully launched. However, current treatments for AML and CMML primarily include chemotherapy, hematopoietic stem cell transplantation, and targeted drugs for specific mutations, with no TCE products approved to date.
About Acute Myeloid Leukemia (AML)
AML is a group of malignant clonal diseases originating from myeloid stem cells, characterized by high heterogeneity and mortality. According to Frost & Sullivan data, the global number of new AML cases was approximately 172,400 in 2022, projected to grow to 221,400 by 2035, with a compound annual growth rate (CAGR) of 1.94%. In 2022, new AML cases in China were approximately 30,800, accounting for about 17.9% of the global total. The number is expected to reach 36,700 by 2035, representing about 16.6% of global new cases, with a CAGR of 1.36%.
About Chronic Myelomonocytic Leukemia (CMML)
CMML is a clonal hematopoietic stem cell disorder with overlapping features of myelodysplastic syndromes (MDS) and myeloproliferative neoplasms (MPN), primarily characterized by significant peripheral blood monocytosis and an inherent risk of transformation to AML (approximately 15-20% within 3-5 years). CMML is a rare disease with an annual incidence of (3-4)/100,000 and lacks effective therapeutic drugs.
About Multiple Myeloma (MM)
MM is a clonal plasma cell malignancy characterized by uncontrolled proliferation of monoclonal plasma cells in the bone marrow, leading to excessive production of abnormal immunoglobulins and causing end-organ damage, manifested as hypercalcemia, renal dysfunction, anemia, and bone lesions (i.e., CRAB features). Globally, MM accounts for approximately 1%-2% of all cancers and about 10% of hematologic malignancies, with a median age at diagnosis of around 69 years and higher incidence in males and individuals of African descent. Over the past two decades, patient survival has significantly improved due to the use of proteasome inhibitors, immunomodulatory drugs, and monoclonal antibodies, but MM remains largely incurable, with most patients experiencing multiple relapses during the disease course.
About Mabwell
Mabwell (688062.SH, 02493.HK) is an innovative biopharmaceutical company with a full industry chain layout, always adhering to the vision of “Turning Innovation into Reality” and the mission of “Exploring Life, Benefiting Health,” committed to providing patients with better and more accessible innovative biologics through original innovation to meet unmet global clinical needs. Since its establishment in 2017, Mabwell has built an innovation system covering the entire drug R&D cycle, starting from antibody drug target discovery and molecular discovery, including druggability research, preclinical research, clinical research, and production transformation, achieving a full industry chain layout integrating R&D, production, and marketing. We focus on oncology and age-related diseases, covering therapeutic areas such as oncology, autoimmune diseases, bone diseases, ophthalmology, hematology, and cardiovascular diseases. Leveraging multi-field distinctive technology platforms and R&D innovation capabilities, we have established a rich and competitive pipeline. Currently, we have 16 key candidates in preclinical, clinical, or marketing stages, including 4 marketed products, 1 under marketing review, and 2 in Phase III pivotal registration clinical trials. We independently undertake 1 National “Major New Drug Creation” Major Science and Technology Project, 2 National Key R&D Programs, and multiple provincial and municipal science and technology innovation projects. Mabwell is innovation-oriented and focuses on industrial transformation. Our antibody and recombinant protein drug industrialization base, compliant with China NMPA, US FDA, and EU EMA GMP standards, has been put into operation in Taizhou, Jiangsu, and has passed EU QP audit. Large-scale commercial production bases in Jinshan, Shanghai, and Taizhou, Jiangsu, are under construction. For more information, please visit: www.mabwell.com.
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