Otsuka Pharmaceutical Co., Ltd. has secured exclusive global development and commercialization rights to HBM7020, a novel BCMAxCD3 bispecific T-cell engager developed by Harbour BioMed for treating autoimmune diseases. The licensing agreement covers all territories worldwide except Greater China, marking a significant expansion of Otsuka's autoimmune disease pipeline.
Strategic Partnership Details
Under the terms of the agreement, Otsuka will pay Harbour BioMed a total of $47 million in upfront and near-term milestones. The collaboration includes additional contingent payments of up to $623 million upon achievement of specified development and commercial milestones, along with tiered royalties based on future net sales. Otsuka will assume responsibility for funding all future development activities.
"Otsuka is expanding our development pipeline in the autoimmune disease field by leveraging the antibody drug platform of our subsidiary Visterra, and the small molecule drug discovery platform of our subsidiary Jnana," said Makoto Inoue, president and representative director of Otsuka Pharmaceutical. "HBM7020 is expected to demonstrate efficacy in a broad range of autoimmune diseases in which B cells play a major role in disease pathogenesis, and we hope to contribute further to the field of specialized autoimmune diseases and thereby benefit patients."
Mechanism of Action and Therapeutic Potential
HBM7020 has been confirmed in preclinical studies to activate T cells and bring them into close proximity with antibody-producing B cells and plasma cells to induce cell destruction. The bispecific antibody is designed to crosslink target cells and T cells by binding to BCMA and CD3 on the cell surface, leading to potent T cell activation and targeted cell elimination.
Since many autoimmune diseases involve B cells and plasma cells that produce autoantibodies, HBM7020 is expected to have broad efficacy against these diseases. The therapeutic approach represents a novel strategy for addressing the underlying pathophysiology of autoimmune conditions by targeting the cellular sources of pathogenic antibodies.
Advanced Technology Platform
HBM7020 is generated using Harbour BioMed's proprietary fully human HBICE® bispecific technology and Harbour Mice® platform. The antibody incorporates dual anti-BCMA binding sites for enhanced cell targeting and monovalent-optimized CD3 activity to minimize cytokine release syndrome (CRS), a potentially serious side effect associated with T-cell engaging therapies.
This design optimization has enabled HBM7020 to demonstrate potent cytotoxicity with broad therapeutic potential in both immunological and oncological diseases. In August 2023, HBM7020 obtained IND clearance from the National Medical Products Administration (NMPA) to commence a Phase I trial for cancer in China.
Industry Impact
Dr. Jingsong Wang, founder, chairman, and CEO of Harbour BioMed, emphasized the significance of the collaboration: "We are delighted to collaborate with Otsuka, a global healthcare leader renowned for its innovative approach to addressing unmet medical needs. This collaboration underscores the strength of Harbour BioMed's proprietary Harbour Mice® and HBICE® technology platforms, which enable the rapid development of fully human bispecific antibodies with optimized safety and efficacy profiles."
The strategic collaboration establishes a foundation for potential future partnerships between the two companies in the T-cell engager area, suggesting broader implications for the development of next-generation immunotherapies targeting autoimmune diseases.
