Adagene Announces Clinical Advancement for ADG116

-NEObody product candidate ADG116 has been well tolerated in ongoing Phase 1 clinical trial- 
-Promising pharmacodynamic biomarker signals demonstrate clinical proof of mechanism-
-Poised for global expansion-

SAN FRANCISCO and SUZHOU, China, March 29, 2021 (GLOBE NEWSWIRE) -- Adagene Inc. (Nasdaq: ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, today announced the interim dose-escalation data up to 0.3 mg/kg in its ongoing Phase 1 clinical trial in Australia evaluating the safety and tolerability of ADG116 in patients with advanced/metastatic solid tumors. ADG116 is a fully human, anti-CTLA-4 monoclonal antibody (mAb), designed to target a unique conserved epitope of CTLA-4 and utilizes Adagene’s proprietary NEObody platform technology. ADG116 is designed to balance safety and efficacy through a novel mechanism of action; ADG116 maintains its original physiological function via partial blocking of CTLA-4 ligand binding, and in conjunction, depletes T_reg in the tumor microenvironment via strong antibody-dependent cellular cytotoxicity (ADCC).

Interim data for the ongoing Phase 1 clinical trial:

• Safety: Analysis of all safety data generated to date demonstrates that ADG116 has been well-tolerated in more than 10 patients with no dose-limiting toxicities or unexpected safety signals. No drug related Grade 3 and Grade 4 toxicities have been observed.
• Notable findings in pharmacodynamics: A dose-dependent change in CD8⁺ and CD4⁺ T_EM / T_reg ratios, important pharmacodynamic (PD) biomarkers indicating immune activation, was observed for patients dosed by ADG116. In particular, a patient, refractory to prior pembrolizumab therapy (> 25 cycles), demonstrated striking increases in T and NK cells, and CD8⁺ and CD4⁺ T_EM / T_reg ratios. The Grade 1 treatment-related pruritus of this patient is a clinical symptom consistent with immune-mediated action of ADG116 treatment.
• Pharmacokinetics: The terminal half-life of ADG116 was within the normal range of IgG1 based antibodies.
• Clinical proof of mechanism: The Phase 1 dose escalation data demonstrates the clinical proof of mechanism for ADG116 in targeting CTLA-4, consistent with preclinical observations for the potency of ADG116 starting from 0.03 to 0.3 mg/kg.

“We are encouraged by the positive PD marker signals and safety data,” said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. “It is particularly striking to observe immune activation biomarkers at 0.03 mg/kg, especially in the patient refractory to prior pembrolizumab therapies. We believe ADG116 has the potential to overcome the limitations of anti-CTLA-4 checkpoint inhibitors, extending the market potential beyond current anti-CTLA-4 inhibitors in both monotherapy and combination settings. Our highly differentiated anti-CTLA-4 therapeutics hold the potential to improve the clinical benefits by expanding clonal diversity, infiltrating into cold tumors, and treating patients resistant/refractory to current immuno-therapies.”