Expanded partnership includes new clinical trial and third SAFEbody discovery program

Adagene has announced an expanded strategic partnership with Sanofi, including a potential investment of up to $25 million, further development of its masked anti-CTLA-4 antibody, and the initiation of a third antibody discovery program using its SAFEbody technology.

The collaboration will support the clinical development of muzastotug (ADG126), a tumour-activated, anti-CTLA-4 SAFEbody currently in phase 1b/2 studies for microsatellite stable colorectal cancer (MSS CRC). Adagene will also supply the antibody for use in a Sanofi-sponsored combination trial evaluating safety, efficacy, pharmacokinetics and biomarkers in over 100 patients with advanced solid tumours.

Sanofi has additionally exercised an option to initiate a third SAFEbody discovery program under its existing partnership agreement with Adagene. The new bispecific antibody, which targets undisclosed antigens, will be engineered by Adagene, triggering an option fee and enabling downstream milestones and royalties.

Adagene retains full commercial rights to muzastotug and expects the Sanofi investment to extend its cash runway into 2027. The company reported $85.2 million in cash and equivalents as of the end of 2024.

A representative from Sanofi will join Adagene’s Scientific Advisory Board to support strategic guidance on clinical and scientific matters.

Adagene’s SAFEbody platform is designed to enhance the safety profile of antibody-based therapies by shielding the active domain until it reaches the tumour microenvironment. Muzastotug is one of the most advanced CTLA-4 antibodies using this approach and is being studied both as monotherapy and in combination with PD-1 blockade.