Masked Anti-CTLA-4 SAFEbody® Shows Strong Safety, Antitumor Activity, and Pharmacokinetics in Advanced Tumor Patients
SAN DIEGO and SUZHOU, China, Sept. 10, 2022 (GLOBE NEWSWIRE) — Adagene Inc. (Nasdaq: ADAG) revealed interim data on ADG126, a masked anti-CTLA-4 SAFEbody®, at the ESMO Congress 2022. The data from an ongoing Phase 1b/2 trial demonstrated impressive safety and antitumor activity in patients with advanced solid tumors. ADG126 has been administered in dose-escalation and expansion phases, showing favorable safety with no significant toxicities across dose levels up to 20 mg/kg.
Key findings include antitumor activity in heavily pretreated patients, particularly in cold tumors. An ovarian cancer patient exhibited a 90% reduction in a cancer biomarker (CA125) and a 22% tumor reduction after 16 cycles. ADG126 also showed strong pharmacokinetics, with a steady accumulation in the tumor microenvironment, potentially increasing its therapeutic efficacy.
ADG126 is being evaluated as monotherapy and in combination with anti-PD-1 agents, with ongoing trials across the US, China, and the Asia-Pacific region. The therapy is designed to address safety and efficacy concerns of existing CTLA-4 therapies through precision-masking technology, providing enhanced tumor-targeted killing effects.