Full Press Release Details
Progress and Expansion of Clinical Collaboration Program for Masked, Anti-CTLA-4 SAFEbody ADG126 (muzastotug) in Combination
with KEYTRUDA (pembrolizumab) to Demonstrate Further Efficacy in Patients with Metastatic Microsatellite-stable
(MSS) Colorectal Cancer (CRC)
- Interim data from additional MSS CRC patients
dosed at 10 mg/kg every three weeks (Q3W) in combination with pembrolizumab anticipated in 2024 at a medical conference -
Initiated evaluation of 20 mg/kg loading doses of ADG126 in combination with pembrolizumab to explore enhanced efficacy
given superior therapeutic index of ADG126 -
- Received clearance from China's Center
for Drug Evaluation (CDE) to evaluate ADG126 in combination with pembrolizumab -
SAN DIEGO and SUZHOU, China, February 9,
2024 - Adagene Inc. ("Adagene") (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based
therapies, today announced progress and expansion of the clinical collaboration development program for its masked, anti-CTLA-4 SAFEbody,
ADG126 in combination with Merck & Co., Inc., Rahway, NJ, USA's anti-PD-1 therapy, KEYTRUDA (pembrolizumab),
in patients with metastatic microsatellite-stable (MSS) colorectal cancer (CRC).
"Following completion of enrollment
of 12 additional patients at the end of last year, together with our ongoing expansion plans, we are on track to deliver data in 2024
that support the findings released at the recent ASCO-GI Symposium demonstrating the safety and efficacy profile of ADG126 in combination
with pembrolizumab in MSS CRC," said Peter Luo, Ph.D., Chairman, CEO
and President of R&D at Adagene.
He continued, "To address the requirements for Project Optimus
by FDA, we have initiated evaluation of ADG126 20 mg/kg loading doses in combination with pembrolizumab, which we believe can unlock even
greater efficacy for MSS CRC in planned cohort expansion, while still maintaining a robust safety profile. Additionally, we are now cleared
to evaluate ADG126 in combination with pembrolizumab in China, strengthening our efficacy evaluation with additional patients enrolled
at unprecedented dosing regimens for anti-CTLA-4 therapy."
The updates, which increase the ongoing phase 2 dose expansion in MSS
CRC to over 50 patients, include the following:
Data from the ongoing phase 1b/2 clinical trial of ADG126 in combination
with pembrolizumab, including dose expansion cohorts, are anticipated throughout 2024:
| Follow up of Part 1 evaluable patients at 10 mg/kg Q3W (n=12) and 10 mg/kg Q6W (n=10) | ||
| Data from Part 2 patients at 10 mg/kg Q3W (n=12) | ||
| Evaluation of 20 mg/kg loading doses for Project Optimus requirements: |
| o | Safety data with repeat doses | |
| o | Dose expansion in MSS CRC (n~10) |
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
more information, please visit: https://investor.adagene.com. Follow Adagene on WeChat, LinkedIn and Twitter.
a registered trademark in the United States, China, Australia, Japan, Singapore, and the European Union.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme
LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Safe Harbor Statement
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
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
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