Sanofi has agreed to invest up to $25m in Adagene, which will enable the latter to fund its research and development (R&D) efforts, including the clinical development of muzastotug (ADG126).

The anti-CTLA-4 SAFEbody will be developed through a randomised Phase II study for the treatment of microsatellite stable colorectal cancer (MSS CRC).

Adagene chairman, CEO and president of R&D Peter Luo stated: “Expanding our partnership with Sanofi highlights the potential of our SAFEbody platform and the clinical proof of concept for ADG126, our masked anti-CTLA-4 programme and the most advanced of its kind.

“This strategic partnership reinforces our shared vision of ADG126’s promise in advanced solid tumours, including MSS CRC, where dose-limiting challenges have hindered anti-CTLA-4 therapies.”

As part of the ongoing partnership, Adagene will provide Sanofi with muzastotug for assessment of its efficacy, safety, pharmacokinetics and biomarker data along with other anticancer therapies in more than 100 subjects in a Phase I/II trial targeting advanced solid tumours.

Adagene retains global commercial rights to muzastotug.

Expanding on their existing agreement from 2022, Sanofi has exercised an option within the partnership that allows it to select a third SAFEbody discovery programme.

This programme uses Adagene’s technology and expertise in antibody engineering to develop a bispecific therapeutic aimed at undisclosed targets.

As of December 2024, the company reported cash reserves of $85.2m. With the additional funds from Sanofi's investment and current assets on hand, it anticipates sufficient funds to sustain its planned operations in 2027.

After the equity investment and strategic partnerships, a representative from Sanofi will become a member of Adagene’s Scientific Advisory Board, which offers guidance on the clinical dimensions of the company’s operations.