Full Press Release Details
Adagene announces up to $25 million strategic
investment from Sanofi
Sanofi to exercise option on third SAFEbody discovery program
and sponsor combination clinical trial with
- Company expects proceeds to extend cash runway
SAN DIEGO and SUZHOU, China, July 1, 2025
(GLOBE NEWSWIRE) -- Adagene Inc. ("Adagene or the Company") (Nasdaq: ADAG), a company transforming the discovery and development
of novel antibody-based therapies, today announced strategic investment and option exercise by Sanofi (Euronext: SAN FP).
Sanofi has agreed to make strategic investment
of up to US$25 million in Adagene. The Company plans to use the proceeds to fund its research and development activities, including clinical
development of muzastotug (ADG126), an anti-CTLA-4 SAFEbody, through a randomized phase 2 trial in microsatellite stable colorectal cancer
To further explore the clinical potential of muzastotug,
Adagene will supply Sanofi with muzastotug to evaluate the safety, efficacy, pharmacokinetics and biomarker data in combination with other
anticancer therapies in over 100 patients in a phase 1/2 clinical trial in advanced solid tumors. Adagene continues to own worldwide commercial
rights to muzastotug.
Sanofi has also exercised its option to select
a third SAFEbody discovery program, utilizing Adagene's proprietary masking technology and antibody engineering expertise. The bispecific
therapeutic, with undisclosed targets, will be engineered by Adagene and induces an option exercise fee, as well as milestones and royalties
as per the 2022 partnership agreement with Adagene.
"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. We value our trusted relationship with Sanofi."
As of December 31, 2024, the Company had
audited cash and cash equivalents of US$85.2 million. The proceeds from the investment of Sanofi, together with the current cash
and cash equivalents, are expected to be sufficient to fund planned operations into 2027.
Following the equity investment and strategic
collaborations, a Sanofi representative will join Adagene's Scientific Advisory Board (SAB), which provides strategic advice on
the scientific and clinical aspects of the Company's activities.
Adagene Inc. (Nasdaq: ADAG) is a platform-driven,
clinical-stage biotechnology company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies.
Adagene combines computational biology and artificial intelligence to design novel antibodies that address globally unmet patient
needs. The company has forged strategic collaborations with reputable global partners that leverage its SAFEbody precision
masking technology in multiple approaches at the vanguard of science.
Powered by its proprietary Dynamic Precision
Library (DPL) platform, composed of NEObody , SAFEbody, and POWERbody technologies, Adagene's highly differentiated
pipeline features novel immunotherapy programs. The company's SAFEbody technology is designed to address safety and tolerability
challenges associated with many antibody therapeutics by using precision masking technology to shield the binding domain of the biologic
therapy. Through activation in the tumor microenvironment, this allows for tumor-specific targeting of antibodies in tumor microenvironment,
while minimizing on-target off-tumor toxicity in healthy tissues.
Adagene's 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) in the tumor microenvironment.
ADG126 is currently in phase 1b/2 clinical studies in combination with anti-PD-1 therapy, particularly focused on Metastatic Microsatellite-stable
(MSS) Colorectal Cancer (CRC). Validated by ongoing clinical research, the SAFEbody platform can be applied to a wide variety of antibody-based
therapeutic modalities, including Fc empowered antibodies, antibody-drug conjugates, and bi/multi-specific T-cell engagers.
more information, please visit: https://investor.adagene.com.
Adagene on WeChat, LinkedIn and X.
SAFEbody is a registered trademark in the United
States, China, Australia, Japan, Singapore, and the European Union.
Safe Harbor Statement
This press release contains forward-looking statements,
including statements regarding the impact of Sanofi's strategic investment and Adagene's relationship with Sanofi; the
expected timeframe for funding Adagene's operating plan with current cash and cash equivalents and the proceeds from Sanofi's
investment; certain clinical results of ADG126, the potential implications of clinical data for patients, and Adagene's advancement
of, and anticipated preclinical activities, clinical development, regulatory milestones, and commercialization of its product candidates.
Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors,
including but not limited to Adagene's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results
for its drug candidates, which may not support further development or regulatory approval; the content and timing of decisions made by
the relevant regulatory authorities regarding regulatory approval of Adagene's drug candidates; Adagene's ability to achieve
commercial success for its drug candidates, if approved; Adagene's ability to obtain and maintain protection of intellectual property
for its technology and drugs; Adagene's reliance on third parties to conduct drug development, manufacturing and other services;
Adagene's limited operating history and Adagene's ability to obtain additional funding for operations and to complete the
development and commercialization of its drug candidates; Adagene's ability to enter into additional collaboration agreements beyond
its existing strategic partnerships or collaborations, as well as those risks more fully discussed in the "Risk Factors" section
in Adagene's filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information
currently available to Adagene, and Adagene undertakes no obligation to publicly update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise, except as may be required by law.
Elixir Health Public Relations