Adcentrx Therapeutics announces FDA clearance of Investigational New Drug Application for ADRX-0405, a potential first-in-class ADC targeting STEAP1 for the treatment of advanced solid tumors

CAR-T Digest - August 2020

Weekly Digest - October 2024

21 Oct 2024: Adcentrx Therapeutics announces FDA clearance of Investigational New Drug Application for ADRX-0405, a potential first-in-class ADC targeting STEAP1 for the treatment of advanced solid tumors

Adcentrx Therapeutics has received FDA clearance for its Investigational New Drug (IND) application for ADRX-0405, aimed at treating advanced solid tumors
This next-generation ADC targets the STEAP1 protein, which is upregulated in prostate cancer and other malignancies but has limited expression in healthy tissue
ADRX-0405 utilizes Adcentrx’s proprietary i-Conjugation technology, featuring protease-cleavable linkers and stable conjugation chemistry, resulting in a highly stable ADC with a drug-to-antibody ratio of eight
The company expects to enroll the first patient in the trial in the fourth quarter of 2024, with an initial data readout anticipated in the fourth quarter of 2025

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