Adagene (NASDAQ: ADAG) has announced that the FDA has designated muzastotug, in combination with Merck’s (NYSE: MRK) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), as a fast track product for adult patients with microsatellite stable metastatic colorectal cancer (MSS mCRC) without current or active liver metastases.
Muzastotug is a next-generation masked anti-CTLA-4 SAFEbody engineered to overcome CTLA-4–mediated Treg resistance in tumors with enhanced safety and efficacy, delivering a therapeutic index beyond the reach of existing CTLA-4 therapies.
In a statement, Peter Luo, PhD, CEO and president of R&D at Adagene, commented, “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. We are deeply encouraged by the responses we are seeing with muzastotug in combination with pembrolizumab and believe this therapy has the potential to reshape the treatment paradigm by offering patients an opportunity for extended survival with an improved quality of life. We look forward to sharing updated topline Phase 1b/2 clinical data over the next few months as we continue advancing this program with urgency and purpose.”
