Thursday, September 28, 2023
Adcentrx Therapeutics, a biotechnology company focused on advancing Antibody-Drug Conjugate (ADC) therapies for cancer and other life-threatening diseases, has announced a significant milestone with the initiation of patient dosing in the Phase 1a/b clinical study of ADRX-0706 for the treatment of advanced solid tumors.
Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx, expressed enthusiasm about the potential of ADRX-0706 to address the unmet needs of patients with cancers that express Nectin-4. This development marks a pivotal moment for Adcentrx as it transitions from the research and development phase to becoming a clinical-stage company.
The Phase 1a/b clinical trial of ADRX-0706 represents a first-in-human study, characterized as an open-label, multicenter dose escalation and dose expansion trial. It is currently enrolling patients with specific advanced solid tumors. The primary objectives of this trial encompass evaluating the safety and tolerability of ADRX-0706 and determining the optimal dosage. The company anticipates releasing initial data from the trial around mid-2024.
ADRX-0706, a product candidate discovered by Adcentrx, targets Nectin-4, a cell surface adhesion protein frequently overexpressed in various human cancers and associated with unfavorable disease outcomes. This ADC is developed using Adcentrx's proprietary i-Conjugation™ technology and incorporates a novel tubulin inhibitor payload known as AP052, resulting in an ADC with a drug-antibody ratio of eight (DAR 8). Preclinical models have demonstrated that ADRX-0706 possesses a favorable pharmacokinetic profile, safety, and significant efficacy across various tumor types.