Adagene reports 29% ORR in MSS colorectal cancer, secures $74.5M cash runway
Adagene’s 20 mg/kg cohort of muzastotug plus pembrolizumab achieved 29% ORR in 21 MSS colorectal cancer patients, with 10 mg/kg cohorts showing median OS of 19.4 months after 17.8 months follow-up and no Grade 4/5 TRAEs. Cash reserves of $74.5M plus 2026 ATM proceeds extend runway into early 2028.
1. Clinical Efficacy and Safety
Adagene’s Phase 1b/2 study of muzastotug plus pembrolizumab in MSS CRC showed a 29% confirmed overall response rate in 21 patients at 20 mg/kg. Across 67 patients in all dose cohorts, there was a 4% discontinuation rate, no dose limiting toxicities, no Grade 4/5 TRAEs and manageable Grade 3 events in 15% and 27% of the 10 mg/kg and 20 mg/kg cohorts, respectively.
2. Phase 2 and Registrational Outlook
Enrollment in the randomized Phase 2 dose‐optimization trial is ahead of schedule, with data updates expected later in 2026 and top-line results due in 1H 2027. Upon selection of the optimal combination dose, a registrational MSS colorectal cancer trial is planned under FDA Project Optimus and Fast Track designation.
3. Financial Position and Runway
As of December 31, 2025, Adagene held $74.5 million in cash and cash equivalents. Proceeds from the 2026 ATM offering bolster this balance, providing funding for ongoing clinical programs and extending the cash runway into early 2028.
4. 2026 Milestones and Collaborations
Key objectives include presenting triplet regimen data at AACR 2026, completing neoadjuvant and combination cohort enrollment, sharing initial results from the Roche triplet in first-line HCC, and advancing collaborations with Sanofi and Exelixis to support further development of muzastotug and next-generation SAFEbody candidates.