Business Context and Reporting Period
Company: Adagene Inc.
Filing Type: Form 6-K (Report of Foreign Private Issuer)
Date: April 2, 2026
Subject: Announcement of updated interim efficacy and safety results from the Phase 1b/2 study of muzastotug (ADG126) in combination with pembrolizumab (KEYTRUDA) for patients with advanced microsatellite stable colorectal cancer (MSS CRC) without liver metastases. The FDA has designated this combination as a Fast Track product.
Key Financial Metrics
This filing is a clinical update and does not contain financial statements. The text does not provide values for revenue, profit, cash flow, margins, debt, or liquidity.
Material Changes and Clinical Data
The filing presents updated data as of January 24, 2026, for 67 treated patients (65 efficacy-evaluable). Key clinical metrics include:
- Overall Response Rate (ORR):
- 10 mg/kg cohorts (N=39): 13% (0% in Q6W regimen; 17% in Q3W regimen).
- 20 mg/kg cohorts (N=26): 31% (25% in Q6W; 36% in loading dose cohort).
- Median Progression-Free Survival (mPFS):
- 10 mg/kg cohorts: 4.8 months.
- 20 mg/kg cohorts: 6.7 months (15.4 months in the 20 mg/kg loading dose sub-cohort).
- Overall Survival (OS):
- 10 mg/kg cohorts: Median OS 19.8 months; 1-year OS rate 70.1%.
- 20 mg/kg cohorts: Median OS not yet reached; 1-year OS rate 80.8%.
- Safety: Low 4% discontinuation rate; no dose-limiting toxicities; no Grade 4 or 5 treatment-related adverse events (TRAEs). Grade 3 TRAEs were 15% (10 mg/kg) and 38% (20 mg/kg). Most common TRAEs included pruritus, fatigue, hypothyroidism, and diarrhea.
Guidance, Outlook, and Risks
Outlook and Next Steps:
- Phase 2 Randomized Trial: Initiated in October 2025 (NCT05405595). Enrolling up to 60 patients randomized 1:1 into two arms (Arm A: 10 mg/kg induction; Arm B: 20 mg/kg induction). Results expected in the first half of 2027.
- Regulatory Strategy: The Company intends to leverage the FDA Fast Track designation to initiate a potential registrational study pending further FDA feedback on the optimal dose regimen.
- Collaboration: A new clinical collaboration with Incyte to evaluate muzastotug in combination with Incyte's TGFβR2xPD-1 bispecific antibody was announced (Exhibit 99.1).
Risks and Contingencies:
- Forward-looking statements regarding development timelines, regulatory approvals, and clinical outcomes are subject to risks and uncertainties.
- Actual data may differ materially from projections due to inherent risks in clinical development.
- The Company undertakes no obligation to update forward-looking statements.
Investor Verification Checklist
- Verify the specific dosing regimens (Arm A vs. Arm B) selected for the ongoing Phase 2 randomized trial and their alignment with the FDA's feedback.
- Monitor the timeline for Phase 2 results, currently expected in the first half of 2027.
- Review the terms and scope of the new clinical collaboration with Incyte regarding the TGFβR2xPD-1 bispecific antibody.
- Assess the long-term safety profile, specifically the incidence and management of Grade 3 TRAEs in the higher dose cohorts.
- Confirm the Company's cash runway and capital requirements, as this filing does not disclose financial liquidity.