– Best-in-class profile demonstrated with repeated dosing across all dose levels –

– Antitumor activity observed in cold tumors with steady accumulation of activated ADG126 –

On track in 2022 to report results of ADG126 dose escalation in combination with anti-PD-1 therapy and establish a dose regimen for Phase 2a dose expansion cohorts –

SAN DIEGO and SUZHOU, China, September 10, 2022 (GLOBE NEWSWIRE) – Adagene Inc. (“Adagene”) ADAG, a company advancing the discovery and development of novel antibody-based therapies, today announced the publication of data demonstrating the first-in-class potential of ADG126, a masked anti-CTLA-4 SAFEbody®. Interim results from the Phase 1 portion of an ongoing Phase 1b/2 study of ADG126 will be presented at the European Society for Medical Oncology (ESMO) 2022 Congress, September 9-13, 2022 in Paris.

The poster entitled “Phase 1 results show highly differentiated safety and PK profile of ADG126, a masked anti-CTLA-4 SAFEbody® in patients with advanced solid tumors,” reviewed data from the first open-label Phase 1 human dose escalation and dose expansion. The poster reports data from 26 patients with advanced metastatic solid tumors, a majority (58%) of whom received three or more lines of prior therapies and nearly half (42%) of whom progressed after prior immuno-oncology (IO) therapy exhibited

Key findings include:

• Security: ADG126 monotherapy demonstrated an unprecedented clinical safety profile at doses up to 20 mg/kg when administered once every three weeks to this heavily pretreated patient population. ADG126 was well tolerated, with no grade 3 or greater dose-limiting toxicities or treatment-emergent adverse events observed. The most common treatment-emergent adverse events (TRAEs) (≥10%) were fatigue (12%), pruritus (12%), rash (12%), and diarrhea (12%). Dose escalation is complete at 20 mg/kg and dose escalation continues at 10 mg/kg.
• Antitumor activity in cold tumors: With 18 courses of treatment at 1 mg/kg, one ovary…