China-based biotech Adagene Inc. (NASDAQ: ADAG), which also operates out of San Diego, California, has announced the initiation of a randomized, international, multi-center clinical study to assess the effects of its anti-CTLA-4 monoclonal antibody (mAb) ADG126, combined with Roche’s Tecentriq (atezolizumab) and Avastin (bevacizumab), in first-line advanced hepatocellular carcinoma (HCC). The study will utilize Roche’s MORPHEUS-LIVER platform to accelerate joint development.
Study Design and Objectives
The Phase Ib/II study, financed by Roche and expected to enroll 60 patients initially, is designed to compare the efficacy, safety, and pharmacokinetics of the ADG126 combination against the standard treatment of atezolizumab/bevacizumab. Adagene will retain the global development and commercialization rights to ADG126. No other financial details were disclosed.
ADG126: Innovative Monoclonal Antibody
Adagene’s ADG126 was designed on the firm’s SAFEbody platform, which aims to reduce issues of on-target off-tumor toxicity that affect antibody therapeutics. The platform incorporates a masking peptide that covers the binding domain of the biologic therapy, triggering the drug to bind to the target only under specific conditions within the tumor environment. The combination of PD-L1 mAb Tecentriq and VEGF mAb bevacizumab is approved by the US FDA for liver cancer and won approval for the same indication in China in October 2020.-Fineline Info & Tech
