GSK Acquires China-Originated First-in-Class Trispecific Antibody CMG1A46 for Lupus with $850M Deal

Oct 30, 2024 17:04 CST Updated 17:04

GSK

Pharmaceutical R&D Manufacturer

On October 29, GSK announced that$850 millionAcquisition of Chimagen BiosciencesTri-specific Antibody CMG1A46, according to the terms of this agreement:

GSK will pay$300 millionThe upfront payment to acquire global rights to CMG1A46.
In addition, Chimagen Biosciences will be eligible to receive a total of$550 millionCMG1A46 Development and Commercial Milestone Payments.

According to the press release, GSK plans to develop and commercialize CMG1A46, focusing on the drug's potential in the field of B-cell-driven autoimmune diseases, such as systemic lupus erythematosus (SLE) and lupus nephritis (LN), with the possibility of expanding to other autoimmune diseases.

Public information shows that CMG1A46 is a first-in-class T cell Engager trispecific antibody targeting CD3, CD19, and CD20. It can simultaneously target CD3 on the surface of T cells and two different biomarkers, CD20 and CD19, on tumor cells. By narrowing the spatial distance between tumor cells and T cells, it activates T cells to kill tumor B cells expressing CD19 and/or CD20, for the treatment of various drug-resistant and relapsed B-cell hematologic malignancies.

December 2021CMG1A46, a clinical trial application for the treatment of refractory and relapsed B-cell malignant hematological tumors, has been officially approved by the FDA. In October 2022, the world's first T-cell mediated tri-specific antibody CMG1A46 targeting malignant B-cell hematological tumors completed the first dosing of a subject in the United States during its Phase I clinical trial.

December 2021Bioray Biotechnology and Chimagen Biosciences announced a strategic partnership. Bioray Biotechnology, as the exclusive partner, received approval from the National Medical Products Administration (NMPA) for the IND application of CMG1A46, marking it as the world's first approved clinical anti-CD3/CD19/CD20 trispecific antibody product. Bioray Biotechnology has obtained the rights for clinical development, manufacturing, and commercialization in China.

GSK has more than ten years of experience in the field of treating lupus erythematosus,Tony Wood, Chief Scientific Officer of GSKStated: "Through our work in the development of new drugs for systemic lupus erythematosus and lupus nephritis, we are gaining a deeper understanding of the underlying drivers of B-cell-driven diseases. As a novel therapeutic option targeting deep B-cell depletion, CMG1A46 offers exciting potential, and we are pleased to further address the unmet needs in lupus and related autoimmune diseases."

The agreement emphasized the importance of novel therapeutic approaches in addressing the heterogeneity and persistent burden of lupus manifestations, especially under the current standard of care, which is difficult to treat.SevereIn patients.Currently,CMG1A46 is currently in Phase I clinical trials for leukemia and lymphoma in the United States and China. GSK aims to initiate a Phase I trial for lupus erythematosus in 2025.

Chimagen Biosciences CEO Zhou Zhenhao"We are excited about the potential of CMG1A46 to improve the lives of patients with autoimmune diseases and are grateful to GSK for accelerating this vision. This agreement further validates our proprietary T-cell engager platform, and we are eager to continue our mission of developing novel multispecific antibody therapeutics."

According to Qichacha information, Chimagen Biosciences, headquartered in Chengdu, Sichuan, was established in 2016. It focuses on discovering and developing novel multispecific T-cell engagers and NK-cell engagers generated by its proprietary antibody engineering platform, aiming to improve the lives of patients with cancer and autoimmune diseases.Since its establishment in 2016, Chimagen Biosciences has only raised approximately 100 million RMB.

Currently, there are no tri-specific antibody products available on the global market. According to data from PharmaCube, as of June this year, there are 136 tri-specific antibody drugs in development globally, with 41 having entered clinical research. The development of tri-specific antibody drugs is still in its early stages globally, with the most advanced being in Phase II clinical trials (3 drugs).

According to the data from the Drug Hunter Club, there are currently over 70 institutions or pharmaceutical companies globally involved in the development of trispecific antibody drugs. Multinational corporations (MNCs) such as Merck (14 candidates), Sanofi (9 candidates), BMS (5 candidates), Pfizer (2 candidates), and Roche (3 candidates) have a total of 44 candidates under development, accounting for one-third of all trispecific antibody drugs in research. Notably, more than half of the companies developing trispecific antibodies are Chinese domestic enterprises, including Chimagen Biosciences, Simcere Pharma, BeiGene, Promab, Mabworks, H&H Medicines, Tavotek Biotherapeutics, Genor Biopharma, and Innovent Biologics, among others.

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