Adcentrx Therapeutics, a biotechnology company dedicated to advancing Antibody-Drug Conjugate (ADC) therapeutics for cancer and other serious diseases, has announced the clearance of its Investigational New Drug (IND) application for ADRX-0706 by the U.S. Food and Drug Administration (FDA). ADRX-0706 is designed to target Nectin-4, a biomolecule that shows high expression in multiple solid tumors and limited expression in normal tissues.
Nectin-4 plays a crucial role in tumor progression and has been associated with poor prognosis and resistance to conventional therapies. ADRX-0706 is aimed at specifically targeting Nectin-4 to achieve potent anti-cancer activity while minimizing toxicity, offering a promising alternative to current treatment approaches.
Preclinical studies have shown ADRX-0706 to have a remarkable efficacy and safety profile. The next step is a first-in-human Phase 1a/1b clinical trial, which will be an open-label, multicenter study involving dose escalation and dose expansion. The trial will enroll patients with select advanced solid tumors and aims to characterize safety and tolerability while determining the optimal dosage of ADRX-0706.
The company plans to enroll the first patient in the second half of 2023, with initial data expected in mid-2024. ADRX-0706 is an ADC product candidate discovered by Adcentrx, utilizing a proprietary conjugation technology and a novel tubulin inhibitor payload, resulting in a drug-antibody ratio of eight (DAR 8). The preclinical models have demonstrated favorable pharmacokinetic and safety profiles, as well as significant efficacy across various tumor indications, making ADRX-0706 a promising potential treatment option for advanced solid tumors.