Pharma Focus Europe

Adcentrx Therapeutics Receives FDA Clearance for Investigational New Drug Application of ADRX-0706, an Innovative ADC Targeting Nectin-4 to Treat Advanced Solid Tumors

Tuesday, July 18, 2023

Adcentrx Therapeutics is a pioneering biotechnology company dedicated to revolutionizing Antibody-Drug Conjugate (ADC) therapies for cancer and other life-threatening diseases. Recently, the U.S. Food and Drug Administration (FDA) granted clearance to Adcentrx's Investigational New Drug (IND) application for ADRX-0706, an exciting development for the company. This milestone marks the first program to receive FDA clearance, bringing the novel ADC technology one step closer to helping patients in need across the oncology landscape.

The primary target for ADRX-0706 is Nectin-4, a protein known for its high expression in various solid tumors and limited expression in normal tissues. By specifically targeting Nectin-4, ADRX-0706 demonstrates potent anti-cancer activity with a lower toxicity profile, offering a promising alternative to existing therapeutic approaches. Preclinical studies have shown impressive efficacy and safety profiles for ADRX-0706, further supporting its potential as a game-changing treatment.

The company's Chief Executive Officer, Dr. Hui Li, expressed enthusiasm about the FDA's acceptance of the IND application, stating that it is a significant milestone for Adcentrx. Additionally, Dr. Pia Challita-Eid, the Chief Scientific Officer, highlighted their excitement to progress the first program into the clinical trial phase while building a robust and differentiated product pipeline using their optimized ADC platform.

The Phase 1a/1b clinical trial of ADRX-0706 will be an open-label, multicenter, non-randomized dose escalation and dose expansion study. The trial will involve patients with select advanced solid tumors, and its primary objectives are to assess safety, tolerability, and determine the optimal dosage for ADRX-0706. Patient enrollment is expected to commence in the latter half of 2023, with the initial data readout anticipated in mid-2024.

ADRX-0706 is a promising ADC product candidate discovered by Adcentrx. It comprises an antibody component targeting Nectin-4, a cell surface adhesion protein known to be over-expressed in multiple human cancers and associated with poor disease prognosis. The ADC is manufactured using a proprietary conjugation technology and a novel tubulin inhibitor payload, resulting in a drug-antibody ratio of eight (DAR 8). Preclinical studies have shown that ADRX-0706 exhibits favorable pharmacokinetics and safety profiles, along with significant efficacy across a variety of tumor indications.

This clearance from the FDA represents a major leap forward for Adcentrx in their mission to transform ADC therapies, offering hope to patients facing cancer and other life-threatening conditions.

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