Merck has secured a deal to acquire global rights to a promising bispecific antibody, CN201, from Curon Biopharmaceutical for an upfront payment of $700 million. This early-stage clinical development drug also has potential milestones that could total an additional $600 million, based on its development and regulatory advancements. The agreement highlights the potential of CN201 in the fields of oncology and immunology, providing Merck an opportunity to diversify and expand its treatment pipeline.

CN201 is designed to target CD3 on T cells and CD19 on B cells. CD19 is an immune cell implicated in some cancers and autoimmune disorders. Binding these two proteins together prompts T cells to eliminate problematic B cells. This mechanism was first utilized in the Amgen drug Blincyto, which is approved for treating specific leukemias and shows promise for autoimmune diseases as well. However, Blincyto has been associated with significant safety risks, including cytokine release syndrome (CRS), a potentially severe immune reaction.

Curon’s CN201 aims to offer a similar therapeutic benefit but with improved safety, specifically by reducing the severity of CRS while maintaining the drug’s ability to enable T-cells to eliminate target cells effectively. Preliminary data presented by Curon at the American Society of Clinical Oncology showed promising results, including lower incidences and severities of CRS and no observed neurotoxicity, alongside high response rates in relapsed or refractory B cell non-Hodgkin lymphoma patients.

Merck’s acquisition is part of a broader industry trend focusing on bispecific antibodies for treating not just cancers but also autoimmune diseases. Other companies like Roche and Cullinan Therapeutics (formerly Cullinan Oncology) are also advancing bispecific antibodies in this therapeutic area. Roche’s Lunsumio, approved for follicular lymphoma, is now being tested for lupus, while Cullinan’s CLN-978 targets lupus and expects to file a new drug application soon. Additionally, startup Zenas Biopharma is developing a bifunctional monoclonal antibody, obexelimab, for diseases like lupus and multiple sclerosis and has recently raised significant funding to support its clinical trials.

An important aspect of CN201’s ongoing development will be its method of administration. Currently designed as a once-weekly intravenous infusion, challenges may lie in adapting this format to suit chronic autoimmune conditions typically requiring less cumbersome treatment regimens. Analysts suggest the potential for a subcutaneous formulation which would be less burdensome for patients but also note skepticism regarding the reduction of CRS in clinical settings, referencing similar therapies that show comparable rates of serious CRS incidents.

Merck’s strategy with CN201 appears multi-pronged, aiming to harness its potential both in oncology and the expanding field of autoimmune treatments. The move is part of Merck’s broader acquisition strategy, evidenced by its earlier purchase of Harpoon Therapeutics, which is focused on developing tri-specific engagers for cancer treatments showing a strategic pattern of investing in next-generation multipurpose biologic therapies.

The acquisition of Curon’s CN201, expected to complete in the third quarter of the year, marks a significant step for Merck as it seeks to broaden its portfolio into more innovative and potentially transformative therapeutic areas.
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