Full Press Release Details
Presents Clinical Data for Anti-CTLA-4 SAFEbody ADG126 Reinforcing Best-in-Class Safety
Profile at Repeat Doses and Showing Early Efficacy Profile in Advanced/Metastatic Solid Tumors
- Results of dose escalation portion from phase
1b/2 trials of ADG126 in combination with anti-PD-1 therapies, including confirmed clinical responses, pave way for dose expansion in
- Tumor shrinkage and prolonged stable disease
observed in cold' tumors such as MSS CRC -
- Robust safety profile allows repeat dosing,
sustained target engagement and Treg depletion to maximize long-term clinical benefit -
SAN DIEGO and SUZHOU, China, April 18, 2023-- Adagene Inc. ("Adagene")
(Nasdaq: ADAG), a company transforming the discovery and development of antibody-based therapies, today announced interim results from
its combination dose escalation studies of the masked, anti-CTLA-4 SAFEbody, ADG126, presented at the AACR Annual Meeting in Orlando,
Florida, April 14-19, 2023.
Two poster presentations on ADG126 SAFEbody reported
results of ongoing phase 1b/2 trials at multiple dosing regimens (6 mg/kg and 10 mg/kg) in combination with either
pembrolizumab or toripalimab, as well as updated data for ADG126 monotherapy in heavily pre-treated
Both posters, "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" and "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,"
may be viewed on the company's website here.
Key findings include:
31 patients in combination dose escalation cohorts of ADG126, a total of seven (22.6%) Grade 3 TRAEs were reported, suggesting a safety
profile comparable to anti-PD-1 monotherapy and a best-in-class safety profile in combination
with anti-PD-1, even at much higher doses. This has been achieved without aggressive safety management for
immune-mediated diarrhea/colitis, such as infliximab infusion.
Further, the strong safety profile of
ADG126 has enabled a randomized clinical trial that is being initiated in collaboration with Roche to evaluate ADG126 in combination with
atezolizumab and bevacizumab as a first-line treatment for patients with advanced/metastatic HCC.
The trial is being sponsored and conducted by Roche.
Potential Shown for ADG153, a masked, anti-CD47 IgG1 SAFEbody
poster, "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," reported preclinical data for
ADG153. The data demonstrated strong in vivo anti-tumor activities in solid tumor models and a robust safety profile due to
preferential CD47 target engagement in the tumor microenvironment.
are available on the company's website at www.adagene.com/pipeline/publications in
accordance with the AACR embargo policy.
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.
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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 ADG126 and ADG153, the potential implications of clinical and preclinical 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.
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