Full Press Release Details
Interim Results Reinforcing Best-in-Class Profile of Masked anti-CTLA-4 SAFEbody
ADG126 (muzastotug) in Combination with Pembrolizumab in Metastatic Microsatellite-stable (MSS) Colorectal Cancer (CRC)
from first tranche of MSS CRC patients treated with ADG126 10 mg/kg every three weeks (Q3W) in dose expansion showed clinical benefit
including confirmed responses at higher, more frequent and repeat doses of the anti-CTLA-4 therapy -
survival analysis of ADG126 10 mg/kg dosing regimens in patients without liver and peritoneal metastases indicates best-in-class median
progression-free survival (PFS) of seven months -
from additional patients at 10 mg/kg Q3W dosing regimen expected throughout 2024 -
SAN DIEGO and SUZHOU, China, January
16, 2024 - Adagene Inc. ("Adagene") (Nasdaq: ADAG), a company transforming the discovery and development of novel
antibody-based therapies, today announced data from its presentation at the American Society of Clinical Oncology (ASCO) 2024 Gastrointestinal
(GI) Cancers Symposium, taking place January 18-20 in San Francisco.
expanded therapeutic index for the masked ADG126 allows us to dose with a higher and more frequent effective dose of anti-CTLA-4 therapy
than today's options," said Daneng Li, MD and Associate Professor Department of Medical Oncology
& Therapeutics Research at the City of Hope Comprehensive Cancer Center. "These promising data support further evaluation
of this potential best-in-class anti-CTLA-4 antibody, ADG126, in combination with pembrolizumab for MSS CRC patients, including battling
new liver lesions in those patients initially without detectable liver metastasis. We also see a tremendous opportunity to help
patients in other tumor types where there is a significant need for safe and potent anti-CTLA-4 therapy."
Key highlights from the poster (November
30, 2023 data cutoff) include:
Commenting on the results, Heinz Josef-Lenz,
MD, FACP, Associate Director for Clinical Research and Co-leader of the Translational Science Program at the USC Norris Comprehensive
Cancer Center (NCCC) said, "I believe that CTLA-4 is an essential part of an effective immunotherapy for MSS CRC, yet physicians
have been limited by the safety challenges from first generation options. The clinical profile of ADG126 in combination with pembrolizumab
presents a great opportunity for MSS CRC patients that otherwise have limited immunotherapy options available."
ASCO-GI Poster Presentation Details
Results of a phase 1b/2 study of ADG126 (a masked anti-CTLA-4 SAFEbody) in combo with pembrolizumab (Pembro)
in patients (Pts) with metastatic microsatellite-stable (MSS) colorectal cancer (CRC)
Consistent with the ASCO-GI embargo
policy, the data are being released today in conjunction with the abstract publication.
KEYTRUDA is a registered
trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
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.
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Safe Harbor Statement
press release contains forward-looking statements, including statements regarding 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
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efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or regulatory
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