CMG1A46

GSK has announced that it will be expanding its immunology pipeline by acquiring a clinical-stage T cell-engager from Chimagen Biosciences in a deal worth $850m. GSK said it plans to develop and commercialise CMG1A46 with a focus on B cell-driven autoimmune diseases such as systemic lupus erythematosus (SLE) and lupus nephritis, adding that the drug could be expanded into related autoimmune diseases. The candidate is currently in early-stage clinical trials in leukaemia and lymphoma, with GSK aiming to begin a phase 1 lupus trial in 2025. The agreement will see GSK pay $300m upfront to acquire full global rights to CMG1A46, and Chimagen will be eligible to receive success-based development and commercial milestone payments totalling $550m. Affecting approximately five million people worldwide, lupus occurs when the immune system attacks healthy tissue, resulting in symptoms such as inflammation, pain, extreme fatigue and hair loss. There are four main types of the disease and SLE accounts for around 70% of all cases. CMG1A46 is directed at CD20, an established target in the treatment of autoimmune diseases, as well as CD19, which has shown promise as a differentiated therapeutic approach given its presence on more B cell types. In preclinical studies, CMG1A46 has already demonstrated “rapid” and “deep” B cell depletion both in the bloodstream and in tissues, GSK outlined, noting that this could lead to more durable responses in patients. GSK’s chief scientific officer, Tony Wood, said: “Through our work in SLE and LN, we increasingly understand the underlying drivers of B cell-driven diseases. “As a novel therapeutic option directed at deep B cell depletion, CMG1A46 offers exciting potential which we are pleased to take forward to address unmet need in lupus and related autoimmune conditions.” Zhenhao Zhou, chief executive officer of Chimagen, added: “We are excited by the potential of CMG1A46 to improve the lives of patients suffering from autoimmune conditions and grateful to have GSK accelerate that vision.” The acquisition is part of a series of deals GSK has made this year. In July, the company entered into a new licensing agreement worth over €1.4bn with CureVac, restructuring their current collaboration to develop mRNA vaccines for infectious diseases. It also announced in June that it had acquired US-based Elsie Biotechnologies and its oligonucleotide discovery platform for $50m, and completed its $1.4bn acquisition of Aiolos Bio in February.

LONDON, UK I October 29, 2024 I GSK plc (LSE/NYSE: GSK) and Chimagen Biosciences (Chimagen), a privately held biotechnology company, today announced an agreement for GSK to acquire CMG1A46, a clinical-stage dual CD19 and CD20-targeted T cell-engager (TCE), from Chimagen for $300 million upfront. GSK plans to develop and commercialise CMG1A46 with a focus on B cell-driven autoimmune diseases, such as systemic lupus erythematosus (SLE) and lupus nephritis (LN), with potential to expand into related autoimmune diseases. For over a decade, GSK has been a pioneer in the treatment of lupus. This agreement underscores the importance of novel therapeutic approaches to address the heterogeneity of lupus manifestations and the continued burden, particularly in patients who suffer from severe disease and are refractory to current standard of care. 1 Tony Wood, Chief Scientific Officer, GSK, said: “Through our work in systemic lupus erythematosus and lupus nephritis, we increasingly understand the underlying drivers of B cell-driven diseases. As a novel therapeutic option directed at deep B cell depletion, CMG1A46 offers exciting potential which we are pleased to take forward to address unmet need in lupus and related autoimmune conditions.” CD20 is an established target in the treatment of autoimmune diseases and there is growing clinical evidence that CD19 shows promise as a differentiated therapeutic approach given its presence on more B cell types. 2 In preclinical studies, CMG1A46, designed to target both CD19 and CD20, has shown rapid, deep B cell depletion both in the bloodstream and in tissues which could lead to more durable responses in patients. Zhenhao Zhou, Chief Executive Officer, Chimagen, said: “We are excited by the potential of CMG1A46 to improve the lives of patients suffering from autoimmune conditions and grateful to have GSK accelerate that vision. This agreement provides further validation of our proprietary T cell-engager platform, and we are eager to continue our mission of developing novel multi-specific antibody therapeutics.” CMG1A46 is currently in phase I clinical trials in leukaemia and lymphoma in both the US and China. GSK aims to begin a phase I trial in lupus in 2025. Terms of the agreement Under the terms of this agreement, GSK will pay $300 million upfront to acquire full global rights to CMG1A46. In addition, Chimagen will be eligible to receive success-based development and commercial milestone payments for CMG1A46 totalling $550 million. This agreement is subject to customary conditions, including applicable regulatory agency clearances under the Hart-Scott-Rodino Act in the US. About CMG1A46 CMG1A46, a dual CD19 and CD20-targeted T cell-engager (TCE), is an IgG-like molecule with high affinity for CD19 and CD20 positive B cells and low affinity for CD3, which could lower toxicities typically associated with TCEs. About Chimagen Biosciences Chimagen Biosciences is a clinical-stage biotechnology company focused on the discovery and development of novel multi-specific T cell-engagers and NK cell-engagers generated by proprietary antibody engineering platforms. Its mission is to advance breakthrough therapies that improve the lives of patients with cancer and autoimmune diseases. For more information, please visit www.chimagen.com. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. References SOURCE: GlaxoSmithKline