Adcentrx Therapeutics Receives FDA Clearance for ADRX-0405, a New ADC for Advanced Solid Tumours
Tuesday, October 22, 2024
Adcentrx Therapeutics has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for ADRX-0405.
ADRX-0405 is an advanced antibody-drug conjugate (ADC) designed using a humanized IgG1 antibody that targets six-transmembrane epithelial antigen of the prostate 1 (STEAP1), a cell surface protein found in prostate cancer and other cancers, with limited expression in healthy tissue.
This investigational treatment is aimed at specific advanced solid tumours, including metastatic castration-resistant prostate cancer.
The ADC is developed using Adcentrx's proprietary i-Conjugation® technology platform, which employs protease-cleavable linkers and stable conjugation chemistry to improve drug delivery.
This ensures a stable drug-to-antibody ratio of eight (DAR 8), with a topoisomerase inhibitor payload. Preclinical studies have shown promising results, including favourable pharmacokinetics, a good safety profile, and notable efficacy across various tumour models.
A first-in-human Phase 1a/b clinical trial is planned for ADRX-0405, which will involve an open-label, multicenter, non-randomised dose escalation and dose expansion study.
The trial will enrol patients with advanced solid tumours, including metastatic castration-resistant prostate cancer, aiming to evaluate the safety, tolerability, and optimal dosage of the drug.
The trial is expected to begin in the fourth quarter of 2024, with initial data anticipated by late 2025.
Source: adcentrx.com
