Mabwell (688062.SH), an innovation-focused biopharmaceutical company with an integrated value chain, has announced that the National Medical Products Administration (NMPA) has accepted the Investigational New Drug (IND) application for its novel LILRB4/CD3 T cell engager (TCE) bispecific antibody, 6MW5311. This candidate is being developed to treat hematologic cancers, including Acute Myeloid Leukemia (AML), Chronic Myelomonocytic Leukemia (CMML), and Multiple Myeloma (MM).
6MW5311 is the first LILRB4/CD3 TCE bispecific antibody worldwide to reach the clinical trial application stage, highlighting its strong development potential and promising commercial outlook. In the United States, the IND process is currently at the pre-IND stage, with a formal submission to the FDA planned for the second quarter of 2026.
Built on a T cell engager platform, 6MW5311 features a “2+1” asymmetric design that enables it to bind simultaneously to LILRB4 on tumor cells and CD3 on T cells. This dual targeting facilitates the formation of an immune synapse, activating T cells to effectively attack cancer cells.
The molecule also incorporates a distinctive steric hindrance mechanism that limits CD3 binding in the absence of tumor cells. As a result, T cells are primarily activated only when tumor cells are present, which enhances safety while maintaining strong anti-tumor activity.
Preclinical in vitro studies have shown that 6MW5311 demonstrates robust cytotoxic effects across various tumor cell lines and patient-derived samples. In vivo studies further indicate significant tumor suppression in both high and low LILRB4-expressing AML models, with complete tumor elimination observed in high-expression cases. Additionally, safety evaluations in cynomolgus monkeys suggest a favorable safety profile.
T cell engager therapies represent an important strategy for directing immune cells to target cancer, and they have already shown meaningful clinical success in several lymphoma indications, with multiple approved products. However, treatment options for AML and CMML are still largely limited to chemotherapy, stem cell transplantation, and mutation-specific targeted therapies. To date, no TCE therapies have been approved for these diseases.
6MW5311 is the first LILRB4/CD3 TCE bispecific antibody worldwide to reach the clinical trial application stage, highlighting its strong development potential and promising commercial outlook. In the United States, the IND process is currently at the pre-IND stage, with a formal submission to the FDA planned for the second quarter of 2026.
Built on a T cell engager platform, 6MW5311 features a “2+1” asymmetric design that enables it to bind simultaneously to LILRB4 on tumor cells and CD3 on T cells. This dual targeting facilitates the formation of an immune synapse, activating T cells to effectively attack cancer cells.
The molecule also incorporates a distinctive steric hindrance mechanism that limits CD3 binding in the absence of tumor cells. As a result, T cells are primarily activated only when tumor cells are present, which enhances safety while maintaining strong anti-tumor activity.
Preclinical in vitro studies have shown that 6MW5311 demonstrates robust cytotoxic effects across various tumor cell lines and patient-derived samples. In vivo studies further indicate significant tumor suppression in both high and low LILRB4-expressing AML models, with complete tumor elimination observed in high-expression cases. Additionally, safety evaluations in cynomolgus monkeys suggest a favorable safety profile.
T cell engager therapies represent an important strategy for directing immune cells to target cancer, and they have already shown meaningful clinical success in several lymphoma indications, with multiple approved products. However, treatment options for AML and CMML are still largely limited to chemotherapy, stem cell transplantation, and mutation-specific targeted therapies. To date, no TCE therapies have been approved for these diseases.
]]>
