Adagene's Posts Early Safety, Efficacy Data From Cold Tumors Trial

Adagene Inc ADAG announced clinical data on ADG116, and ADG106, in two poster presentations at the European Society for Medical Oncology Immuno-Oncology (ESMO-IO) Congress 2021.

• ADG116 monotherapy in Phase 1 study was well-tolerated up to 6 mg/kg with only mild or moderate treatment-related adverse events (TRAEs) observed; rash (20%) and pruritus (20%) were the most common.
• In the ongoing 10 mg/kg cohort, a rash (Grade 3) and dose-limiting toxicity event (Grade 4 hyperglycemia) occurred in a patient with renal cell carcinoma who relapsed on nivolumab. 
• A significant increase in the patient's CD8 T cells after one treatment cycle showed that ADG116 is highly active for triggering T cell activation.
• ADG116 treatment resulted in dose-dependent increases in peripheral CD8 and CD4 T cells, indicating immune activation, starting at a dose as low as 0.03 mg/kg and becoming more striking at the 6 mg/kg and 10 mg/kg dose levels.
• In the dose-escalation portion of the trial, four prolonged stable diseases were observed amongst these heavily pre-treated patients.
• A 22% tumor reduction was observed in target lesions following two cycles of ADG116 for a pancreatic cancer patient treated at 10 mg/kg. 
• Additionally, an ovarian cancer patient treated at 6mg/kg showed stable disease for more than 116 days with increased CD8 and CD4 T cells. The patient continues on treatment.
• The presentation included a separate poster of pharmacodynamic (PD) biomarker analyses of ADG106 in combination with the anti-PD-1 antibody toripalimab.
• The ADG106/toripalimab combo resulted in a 2-fold greater immune activation versus ADG106 alone. 
• Additional analyses demonstrate that the addition of toripalimab did not alter the pharmacokinetic profile of ADG106.
• Price Action: ADAG shares are up 7.01% at $8.85 during the premarket session on the last check Tuesday.