Adagene declares FDA clearance to proceed with Phase 1b/2 clinical trial

KUALA LUMPUR, March 17 -- Adagene Inc (Adagene) has announced 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.

According to a statement, the global trial (ADG126-P001 / KEYNOTE-C98) will evaluate patients with advanced/metastatic solid tumours at multiple sites in the U.S. and Asia Pacific (APAC).

ADG126 SAFEbody is designed for conditional activation in the tumour 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 programme,” said Co-founder, Chief Executive Officer and Chairman of Adagene, Peter Luo, Ph.D.

“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.

“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 tumour-specific targeting of antibodies, while minimising on-target off-tumour 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 determine the recommended Phase 2 dose for ADG126 in combination with pembrolizumab.

Adagene Inc is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies.

More details at https://investor.adagene.com.

-- BERNAMA