Adagene Inc. announced data for its masked anti-CTLA-4 SAFEbody, ADG126, in combination with anti-PD-1 therapy in patients with advanced/metastatic solid tumors. The results (as of January 6, 2023) in 14 heavily pre-treated patients demonstrate the safety and initial efficacy profiles of ADG126 in combination with anti-PD-1 treatment. Adagene plans to present the detailed dose escalation data at an upcoming medical conference in the first half of 2023.

Key findings include: Compelling Safety Profile in Combination with Anti-PD-1: ADG126 has been administered at escalating doses up to 10 mg/kg every three weeks in combination with a fixed dose of anti-PD-1 therapy (toripalimab = 240 mg), including repeat dosing cycles. The combination was well tolerated, with no dose-limiting toxicities observed, or maximum tolerated dose yet reached. As of January 6, 2023, an additional 10 patients are being evaluated with the combination of ADG126 and pembrolizumab in a separate clinical trial.

Dose Optimization following FDA Project Optimus1 Initiative: Following completion of the dose escalation cohorts, two separate doses of ADG126 (6 mg/kg and 10 mg/kg evaluated every three or six weeks) are proceeding in expansion cohorts to address different tumor types and follow the goal of the Food and Drug Administration's ‘Project Optimus' initiative to reform the dose optimization and dose selection paradigm in oncology drug development. Confirmed Clinical Responses & Antitumor Activity: Adagene also confirmed several partial responses were observed in multiple tumor types during combination dose escalation. Furthermore, continuous tumor shrinkage has been observed in cold tumors (e.g., MSS CRC) and immune-oncology-resistant patients with difficult-to-treat tumor types, consistent with the depletion of T regulatory cells (Treg) by ADG126 and its parental antibody, ADG116, as well as other next-generation anti-CTLA-4 therapies with strong Treg depletion.