Adagene has dosed the first patient in its randomized, open‑label Phase 2 study of muzastotug (ADG126) combined with Merck’s KEYTRUDA® in microsatellite stable colorectal cancer (MSS CRC) patients without liver metastases.
The study will enroll up to 30 patients per arm at 10 mg/kg or 20 mg/kg and is designed to confirm the preferred dose for a future Phase 3 trial under the Project Optimus framework. The company expects the trial to complete in early 2027, with interim data releases anticipated in 2026.
In a prior Phase 1b/2 study, Adagene reported a 29 % overall response rate at 20 mg/kg and a 19.4‑month median overall survival at 10 mg/kg. The new Phase 2 trial will randomize patients to the two dose levels and collect additional safety and efficacy data.
Adagene’s CEO, Dr. X, said the dose‑confirmation milestone is critical for advancing to a Phase 3 design that aligns with FDA guidance received in July following a Type B meeting. The company also highlighted that the collaboration with Merck leverages KEYTRUDA’s established immunotherapy platform.
The MSS CRC market is estimated at $19.4 billion, but KEYTRUDA has shown limited efficacy in this setting, underscoring the unmet need. Adagene’s approach aims to overcome this challenge by combining its novel agent with KEYTRUDA.
Financially, Adagene reported full‑year 2024 net revenue of $0.1 million, down from $18.1 million in 2023, and a net loss of $33.4 million versus $18.9 million in 2023. The company has secured up to $25 million in strategic investment from Sanofi, extending its cash runway into 2027.
Management noted that the company remains focused on advancing its pipeline while managing costs, and that the Phase 2 milestone positions Adagene to pursue regulatory submission for muzastotug in MSS CRC.
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