• Clinical posters detail results of dose escalation portion of phase 1b/2 trials of ADG126 in combination with anti-PD-1 therapies, demonstrating benefits of SAFEbody precision masking technology 
  
• Additional poster reports preclinical profile for ADG153, a novel masked anti-CD47 IgG1 SAFEbody demonstrating strong in vivo anti-tumor activities in solid tumor models and preferential CD47 target engagement in the tumor microenvironment 

SAN DIEGO and SUZHOU, China, March 14, 2023 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of antibody-based therapies, today announced poster presentations at the upcoming AACR Annual Meeting in Orlando, Florida from April 14-19, 2023.

Two poster presentations on ADG126 SAFEbody will report results of ongoing phase 1b/2 trials of this masked, anti-CTLA-4 therapy in combination with two different anti-PD-1 treatments at multiple dosing regimens (6 mg/kg and 10 mg/kg). Following an interim update in January reporting compelling safety and confirmed clinical responses for ADG126 combo with toripalimab, detailed results will be presented along with updated data for ADG126 monotherapy in heavily pre-treated patients. Notably, the results of ADG126 in combination with pembrolizumab after repeated dosing to assess late-onset toxicity will also be presented for the first time.

The third poster will review the differentiated preclinical profile of ADG153, an anti-CD47 SAFEbody^® in IgG1 isotype, currently in the IND-enabling stage. As expected, IgG1 isotype of masked anti-CD47, ADG153, enables monotherapy efficacy for solid tumors due to strong antibody-dependent cellular cytotoxicity (ADCC) and enhanced antibody-dependent cellular phagocytosis (ADCP) effects, while masking anti-CD47 in IgG1 can overcome the safety challenges of CD47- therapies, particularly for potent IgG1-mediated tumor killing proven for both solid and liquid tumors. The poster will also include results demonstrating preferential CD47 target engagement by ADG153 in the tumor microenvironment.

Details for the poster presentations include:

• Title: Initial results of a phase 1b/2 study of ADG126 (a masked anti-CTLA-4 SAFEbody^®) in combination with pembrolizumab (an anti-PD-1 antibody) in patients with advanced/metastatic solid tumors

Session Date: Tuesday, Apr 18, 2023 (abstract publication on April 14)
Session Time: 9:00 AM - 12:30 PM (Eastern time)
Location: Poster Section 47
Poster Board Number: 23
Abstract Number: CT233

• Title: Interim results of a phase 1b/2 study of ADG126 (a masked anti-CTLA-4 SAFEbody^®) monotherapy and in combination with toripalimab (an anti-PD-1 antibody) in patients (pts) with advanced / metastatic solid tumors

Session Date: Tuesday, Apr 18, 2023 (abstract publication on April 14)
Session Time: 9:00 AM - 12:30 PM (Eastern time)
Location: Poster Section 47
Poster Board Number: 17
Abstract Number: CT227

• Title: ADG153, a novel masked anti-CD47 IgG1 SAFEbody, demonstrates strong in vivo anti-tumor activities in preclinical solid tumor models and preferential CD47 target engagement in the tumor microenvironment

Session Date: Monday, Apr 17, 2023 (abstract publication on March 14)
Session Time: 1:30 PM - 5:00 PM (Eastern time)
Location: Poster Section 23
Poster Board Number: 8
Abstract Number: 2930

The posters will be published on the company’s website at www.adagene.com/pipeline/publications in accordance with the AACR embargo policy.

About Adagene
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 unmet patient needs. 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. Adagene has forged strategic collaborations with reputable global partners that leverage its technology in multiple approaches at the vanguard of science.

For more information, please visit: https://investor.adagene.com. Follow Adagene on WeChat, LinkedIn and Twitter.

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 ADG126 and ADG153, the potential implications of preclinical and clinical findings of these product candidates, and Adagene’s advancement of, and anticipated clinical development, regulatory milestones and commercialization of Adagene pipeline 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, and the impact of the COVID-19 pandemic on Adagene’s clinical development, commercial and other operations, 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.