Sanofi's CD40L Monoclonal Antibody Frexalimab Meets Primary Endpoint in Phase II Study for Relapsing Multiple Sclerosis

On May 31, Sanofi presented positive data on the CD40L antibody frexalimab for the treatment of relapsing multiple sclerosis (MS) at the 2023 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting. The results showed that after 12 weeks of treatment, compared with placebo, the number of new gadolinium-enhancing (GdE) T1 lesions was reduced by 89% in the high-dose group and by 79% in the low-dose group, achieving the primary endpoint of the study.

MS still has a large number of unmet needs, requiring efficient and well-tolerated treatment options to sustainably control disease activity and disability progression while minimizing risks. Frexalimab is the first second-generation anti-CD40L antibody to demonstrate efficacy in MS, blocking the co-stimulatory CD40/CD40L cellular pathway essential for the activation and function of adaptive (T cells and B cells) and innate (macrophages and dendritic cells) immune cells without depleting lymphocytes.

In 2017, Sanofi and ImmuNext entered into a global exclusive licensing agreement, granting Sanofi the development rights for INX-021 (SAR441344, frexalimab) in a range of autoimmune diseases including lupus and multiple sclerosis. Under this agreement, the potential milestone payments from Sanofi to ImmuNext could reach up to $500 million, along with tiered royalties on product sales in the double-digit range.

Sanofi Plans to Launch Key Trial for Frexalimab in MS Indication in 2024.

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