Sanofi has announced a strategic investment of up to $25 million in Adagene Inc., a clinical-stage biotechnology company developing novel antibody-based cancer immunotherapies using proprietary masking technology. The investment extends Adagene's operational runway into 2027 and deepens the partnership between the French pharmaceutical giant and the Chinese biotech.
The proceeds will fund Adagene's research and development activities, including clinical development of muzastotug (ADG126), an anti-CTLA-4 SAFEbody currently advancing through a randomized phase 2 trial in microsatellite stable colorectal cancer (MSS CRC). As of December 31, 2024, Adagene reported audited cash and cash equivalents of $85.2 million.
Expanded Clinical Collaboration
Under the expanded partnership, Sanofi will sponsor a phase 1/2 clinical trial evaluating muzastotug in combination with other anticancer therapies in over 100 patients with advanced solid tumors. The trial will assess safety, efficacy, pharmacokinetics and biomarker data, while Adagene retains worldwide commercial rights to muzastotug.
"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 program and the most advanced of its kind," said Peter Luo, Chairman, CEO and President of R&D at Adagene. "This strategic partnership reinforces our shared vision of ADG126's promise in advanced solid tumors, including MSS CRC, where dose-limiting challenges have hindered anti-CTLA-4 therapies."
SAFEbody Technology Platform
Adagene's SAFEbody technology addresses safety and tolerability challenges associated with many antibody therapeutics by using precision masking technology to shield the binding domain of biologic therapies. The technology enables activation specifically in the tumor microenvironment, allowing for tumor-specific targeting while minimizing on-target off-tumor toxicity in healthy tissues.
The lead clinical program, ADG126 (muzastotug), is a masked anti-CTLA-4 SAFEbody that targets a unique epitope of CTLA-4 in regulatory T cells (Tregs) within the tumor microenvironment. The candidate is currently in phase 1b/2 clinical studies in combination with anti-PD-1 therapy, with particular focus on metastatic microsatellite-stable colorectal cancer.
Third Discovery Program Option
Sanofi has exercised its option to select a third SAFEbody discovery program under their 2022 partnership agreement. The bispecific therapeutic, targeting undisclosed mechanisms, will be engineered by Adagene utilizing the company's proprietary masking technology and antibody engineering expertise. The option exercise triggers fees, milestones and royalties as outlined in the original partnership terms.
Strategic Governance Enhancement
Following the equity investment and strategic collaborations, a Sanofi representative will join Adagene's Scientific Advisory Board, which provides strategic guidance on scientific and clinical aspects of the company's activities. This governance structure reflects the deepening strategic relationship between the partners.
Sanofi's R&D Expansion Strategy
The Adagene investment represents another component of Sanofi's aggressive pipeline expansion strategy. The deal follows the company's $5.2 billion strategic alliance with UK artificial intelligence company Exscientia covering up to 15 development programs, as well as the $3.2 billion acquisition of mRNA specialist Translate Bio and immuno-oncology acquisitions including Amunix and Kadmon Pharma for $1 billion and $1.9 billion respectively.
Sanofi's immuno-oncology ambitions are currently anchored by Libtayo (cemiplimab), a PD-1 checkpoint inhibitor developed in partnership with Regeneron, though the company continues seeking assets with combination therapy potential to strengthen its position in the competitive oncology market.
