Adagene presents clinical data for anti-CTLA-4 SAFEbody ADG126

Adagene announced interim results from its combination dose escalation studies of the masked, anti-CTLA-4 SAFEbody, ADG126, presented at the AACR Annual Meeting in Orlando, Florida, April 14-19, 2023. Two poster presentations on ADG126 SAFEbody reported results of ongoing phase 1b/2 trials at multiple dosing regimens in combination with either pembrolizumab or toripalimab, as well as updated data for ADG126 monotherapy in heavily pre-treated patients. Key findings include: Best-in-class Safety Profile Reinforced in Combination with Anti-PD-1: In dose escalation studies of ADG126 in combination with anti-PD-1 treatments, ADG126 continues to demonstrate a best-in-class safety profile at doses from 6 mg/kg up to 10 mg/kg. The combination was well tolerated with no dose-limiting toxicities observed with repeat cycles, including in patients who received four or more cycles in the combination cohort with toripalimab. Confirmed Clinical Responses & Tumor Shrinkage in Combination with Anti-PD-1: In the heavily pre-treated patient groups, clinical responses and tumor shrinkage were observed during combination dose escalation. Compelling Monotherapy Safety Profile with Prolonged Stable Disease Supports ADG126 Mechanism: An additional cohort of 30 patients who received ADG126 monotherapy showed a compelling safety profile for ADG126, with no Grade 3 or higher TRAEs reported at repeat doses up to 20 mg/kg. Across all dose levels, the disease control rate was 37% among 27 evaluable patients. Prolonged stable disease was observed in five patients, with notable tumor shrinkage observed in an ovarian cancer patient who received 25 cycles at 1 mg/kg and a non-small cell lung cancer patient who received 14 cycles at 20 mg/kg. Analysis of a clinical sample from a hepatocellular carcinoma patient previously treated with atezolizumab and bevacizumab demonstrated Treg depletion, supporting the mechanism of action for ADG126. Combination Dose Expansion Ongoing in MSS CRC: Dose expansion cohorts are currently underway evaluating ADG126 in combination with anti-PD-1 therapy with an update planned later in 2023. The cohorts evaluate disease control rate, progression free survival, overall survival and objective response rate. Multiple dosing schedules are being evaluated, including ADG126 10 mg/kg every three and six weeks.