On March 16, 2022 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, reported FDA clearance to proceed with a Phase 1b/2 clinical trial of its anti-CTLA-4 monoclonal antibody (mAb), ADG126, in combination with the anti-PD-1 antibody pembrolizumab (Press release, Adagene, MAR 16, 2022, View Source [SID1234610161]). The global trial (ADG126-P001 / KEYNOTE-C98) will evaluate patients with advanced/metastatic solid tumors at multiple sites in the U.S. and Asia Pacific (APAC).
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ADG126 SAFEbody is designed for conditional activation in the tumor microenvironment (TME), as well as to enhance the efficacy profile by potent Treg depletion and to maintain its physiological function by soft ligand blocking in order to expand the therapeutic index and further address safety concerns with existing CTLA-4 therapies.
"The FDA clearance of this trial represents a major step forward in our wholly-owned CTLA-4 program. It builds on a strong safety profile for ADG126 SAFEbody and its parental antibody ADG116, respectively, as a single agent and the ability to achieve doses that may unlock the full potential of CTLA-4 as a proven target for strong ADCC-mediated Treg depletion in the TME. Our goal is to establish the CTLA-4 pathway as the cornerstone of cancer treatment in both single-agent and combination regimens," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "We are excited to initiate our clinical trial evaluating combination therapy with ADG126, which leverages SAFEbody precision masking technology to address toxicity limitations. This multi-regional trial of ADG126 with pembrolizumab also reflects our commitment to bringing highly differentiated therapies to cancer patients globally."
SAFEbody technology is designed to address safety and tolerability challenges associated with many antibody therapeutics by using precision masking technology to shield the binding domain of the biologic therapy. Through activation in the TME, this allows for tumor-specific targeting of antibodies, while minimizing on-target off-tumor toxicity in healthy tissues.
The ADG126-P001 trial is expected to dose the first patients soon. The trial is designed to evaluate safety and tolerability, and to determine the recommended Phase 2 dose for ADG126 in combination with pembrolizumab. The trial will begin with dose-escalation (ADG126 at 6 mg/kg) followed by dose expansion at the recommended dose for early efficacy evaluation. A combination cohort of ADG126 with the anti-PD-1 therapy, toripalimab is also being initiated in Australia.