Adagene is a clinical-stage biotech developing antibody-based cancer immunotherapies. The core thesis is that existing immune checkpoint inhibitors — particularly anti-CTLA-4 drugs like ipilimumab — are limited by systemic toxicity, which caps dosing and therefore efficacy. Adagene's proprietary SAFEbody platform addresses this by engineering a "mask" onto antibodies that keeps them inactive in healthy tissue and only activates them in the tumor microenvironment, where tumor-specific proteases cleave the mask. This is designed to allow higher, more frequent dosing without the side effects that constrain existing therapies. The lead drug, ADG126, is a masked anti-CTLA-4 antibody in Phase 1b/2 and Phase 2 trials, primarily in combination with Merck's pembrolizumab in metastatic colorectal cancer — a tumor type historically unresponsive to immunotherapy. ADG126 has FDA Fast Track designation in this indication. Adagene's broader platform includes NEObody (synthetic antibody discovery) and POWERbody (bispecific and multispecific antibody engineering), and the pipeline includes earlier-stage candidates targeting CD137, HER2xCD3, CD47, and CD20xCD3. The company has no approved products and generates current revenue through technology licensing deals — notably with Sanofi and Exelixis — where Adagene receives upfront fees, milestones, and royalties in exchange for access to its masking platform. Manufacturing is fully outsourced to WuXi Biologics.
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