Adagene Receives FDA Approval for Phase 2 Trial of Muzastotug in MSS CRC

Adagene has received positive feedback from the FDA for its clinical development plan for muzastotug in combination with Merck's KEYTRUDA for MSS CRC. The Phase 2 trial will enroll approximately 60 patients and focus on late-line MSS CRC patients without liver metastases. The trial will assess overall response rate, duration of response, progression-free survival, and overall survival as endpoints. Enrollment is expected to commence in the second half of 2025.

Adagene Inc. (Nasdaq: ADAG) has received positive feedback from the FDA for its clinical development plan to evaluate muzastotug (ADG126) in combination with Merck’s KEYTRUDA® (pembrolizumab) for microsatellite stable colorectal cancer (MSS CRC). The Phase 2 trial will enroll approximately 60 patients, focusing on late-line MSS CRC patients without liver metastases. The trial will assess overall response rate, duration of response, progression-free survival, and overall survival as endpoints. Enrollment is expected to commence in the second half of 2025 [1].

Adagene has completed patient enrollment for the MSS CRC dose expansion cohorts of the ADG126 + pembrolizumab combination (NCT05405595). The Phase 2 trial aims to identify the optimal dose of ADG126 for use in the Phase 3 trial. The FDA has agreed with Adagene’s proposed standard-of-care (SOC) control arm for the Phase 3 clinical trial and confirmed that an ADG126 monotherapy arm is not required [2].

Dr. Marwan Fakih, Professor of Medical Oncology and Therapeutics Research at City of Hope, noted that the FDA's endorsement allows for a nearly two-fold increase in overall response rate (ORR) from 17% at 10 mg/kg to 29% at 20 mg/kg, while maintaining a favorable safety profile [1]. Peter Luo, Ph.D., CEO and President of R&D at Adagene, expressed gratitude to Merck for supplying pembrolizumab to support the Phase 2 trial [1].

Adagene's lead clinical program, ADG126, is a masked, anti-CTLA-4 SAFEbody that targets a unique epitope of CTLA-4 in regulatory T cells (Tregs) in the tumor microenvironment. The SAFEbody platform aims to address safety and tolerability challenges associated with many antibody therapeutics by using precision masking technology to shield the binding domain of the biologic therapy [1].

References:
[1] https://investor.adagene.com/news-releases/news-release-details/adagene-announces-regulatory-update-clinical-development-plan
[2] https://www.biospace.com/press-releases/adagene-announces-regulatory-update-on-clinical-development-plan-for-muzastotug-in-microsatellite-stable-colorectal-cancer-following-productive-type-b-end-of-phase-1-meeting-with-fda