Adagene Inc. announced that the U.S. Food and Drug Administration has granted Fast Track designation to its lead antibody‑based therapy, muzastotug (ADG126), in combination with Merck’s KEYTRUDA® (pembrolizumab) for adult patients with microsatellite stable metastatic colorectal cancer (MSS mCRC) who do not have active liver metastases.
The Fast Track status is a regulatory endorsement that can accelerate the development and review of the combination therapy. It allows for more frequent FDA interactions and the possibility of a rolling review of future marketing applications, potentially shortening the time to market. The designation also validates Adagene’s proprietary SAFEbody® technology, a precision‑masking platform that shields antibody binding domains until the drug reaches the tumor microenvironment, thereby improving safety and tolerability.
Phase 1b/2 data that underpinned the designation showed an overall response rate of 33% in a heavily pre‑treated MSS mCRC cohort, with durable responses and a favorable safety profile. The data demonstrated deep, durable tumor shrinkage and a manageable adverse event profile, supporting the FDA’s view that the therapy addresses an unmet medical need in a population with limited options.
The Fast Track designation is expected to accelerate Adagene’s clinical program. The company plans to launch a registration trial in 2027, with the FDA already aligning on Phase 2 and Phase 3 trial designs and endpoints. The Phase 2 study will randomize patients to receive either 10 mg/kg or 20 mg/kg of muzastotug with pembrolizumab, while the Phase 3 trial will use overall survival as its primary endpoint. The combination targets the challenge of MSS mCRC, a disease that has historically shown limited response to immunotherapy alone.
Adagene’s stock surged 16.3% in pre‑market trading on the day of the announcement, reflecting investor confidence in the regulatory milestone and the potential of the SAFEbody platform. CEO Peter Luo said, “Receiving Fast Track Designation marks an important milestone for Adagene and further validates the promise of our SAFEbody® technology to unlock CTLA‑4 biology in a fundamentally safer and more effective way.” The market reaction underscores the perceived value of the combination and the strategic advantage of partnering with a well‑established immunotherapy like KEYTRUDA.
The Fast Track designation positions Adagene to move more quickly through the regulatory pathway, potentially bringing a new treatment option to patients with MSS mCRC sooner. It also strengthens the company’s pipeline and supports the broader adoption of its SAFEbody technology across other antibody‑based therapies.
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