Full Press Release Details
Adagene Announces Publication at ASCO of Interim
Monotherapy Dose Escalation Data Showing Compelling Safety Profile of Anti-CTLA-4 SAFEbody ADG126, with
Repeat Dosing Across Dose Levels
- First clinical data demonstrating
potential of SAFEbody technology platform to create best-in-class therapeutics -
- Additional data from ongoing ADG126
clinical program to be presented in second half of 2022, including safety in combination with anti-PD-1 therapies -
SAN DIEGO and SUZHOU, China, May 26, 2022 - Adagene Inc.
("Adagene") (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today
announced the publication of data showing the potential best-in-class safety profile of its anti-CTLA-4 monoclonal antibody (mAb), ADG126.
Interim results from the Phase 1 dose escalation portion of an ongoing Phase 1b/2 trial of ADG126 are published in an abstract on the
American Society of Clinical Oncology (ASCO) meeting website in conjunction with the 2022 Annual Meeting taking place in Chicago from
Key data in the abstract, titled "Phase 1 study of ADG126, a
novel masked anti-CTLA-4 SAFEbody, that combines tumor-localized activation with strong Treg depletion and soft ligand blocking in patients
with advanced solid tumors," include the following:
Commenting on the findings, Dr. Gary Richardson, OAM,
MBBS, FRACP, Group Director at Cabrini Health Research,
Neil Beauglehall Endowed Chair, Medical Oncology Research, and Professor of Medicine at Monash
University, Australia, said, "With the emerging clinical data
evaluating this novel immunotherapy candidate ADG126, a masked anti-CTLA-4 SAFEbody, we have the opportunity to detangle safety from efficacy,
and deeply understand the benefits of Treg depletion while we optimize anti-CTLA-4 therapy as a cornerstone of future therapy. Another
exciting and surprising aspect of these interim findings is that we see early signals of efficacy in certain cold' tumors
with SAFEbody ADG126, which further builds on prior clinical evidence with its parental
antibody ADG116, targeting a unique epitope of CTLA-4 to enable not only a safer but potentially better therapy than the options we have
ADG126 SAFEbody applies precision-masking technology to the parental
anti-CTLA-4 antibody, ADG116, for conditional activation in the TME to expand the therapeutic index and further address safety concerns
with existing CTLA-4 therapies. Binding to the same unique epitope as ADG116, the masked ADG126 is designed to provide enhanced safety
and efficacy profiles due to the combination of the potent Treg depletion in the TME and soft ligand blocking.
"Following these monotherapy dose escalation results, we look
forward to releasing further data in coming months to confirm if the strong safety profile of ADG126 is preserved in combination with
anti-PD-1 therapy, consistent with our preclinical observations," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and
Chairman of Adagene.
Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biopharmaceutical
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
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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 certain clinical results of ADG126, the potential implications of clinical results of the product candidate,
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.
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