FDA Clears Adcentrx's Investigational New Drug Application for ADRX-0405, an ADC Targeting STEAP1 for Advanced Tumors

SAN DIEGO, CA, USA, October 21, 2024 – Adcentrx Therapeutics, a clinical-stage biotechnology company committed to advancing innovative protein conjugates for cancer and other serious diseases, recently announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for ADRX-0405. This investigational treatment is intended for patients with select advanced solid tumors.

ADRX-0405 is a sophisticated antibody-drug conjugate (ADC) that includes a humanized IgG1 antibody targeting STEAP1, a prostate cancer-associated cell surface protein. STEAP1 shows increased expression in prostate cancer and some other malignancies but is minimally present in normal tissues.

This IND approval by the FDA represents a significant achievement for Adcentrx, marking the company's second IND clearance. The design of ADRX-0405 relies heavily on Adcentrx’s proprietary i-Conjugation® technology platform. This technology employs protease-cleavable linkers and stable conjugation chemistry to improve payload delivery. Consequently, ADRX-0405 features a highly stable ADC with a topoisomerase inhibitor payload at a drug-to-antibody ratio of eight (DAR 8). Preclinical trials of ADRX-0405 have shown promising results, including favorable pharmacokinetics, a good safety profile, and notable efficacy across various tumor models.

Hui Li, Ph.D., President and CEO of Adcentrx, expressed enthusiasm over this development, stating, "The FDA’s clearance of our second IND marks another major advancement for Adcentrx. We are excited about the first-in-class potential for ADRX-0405 and the opportunity to make a meaningful difference for patients battling advanced cancers, including those with metastatic castration-resistant prostate cancer, who are in dire need of new targeted therapies."

The forthcoming first-in-human Phase 1a/b clinical trial for ADRX-0405 is designed as an open-label, multicenter, non-randomized study involving dose escalation and dose expansion. This trial aims to enroll patients suffering from select advanced solid tumors, including metastatic castration-resistant prostate cancer. The primary goals are to assess the safety and tolerability of ADRX-0405 and to determine its optimal dosing. Adcentrx plans to begin enrolling the first patient by the fourth quarter of 2024, with initial data expected to be available by the fourth quarter of 2025.

Adcentrx Therapeutics is a biotechnology company that focuses on accelerating the development of protein conjugate therapeutics for cancer and other critical diseases. Utilizing its innovative i-Conjugation® technology, the company addresses crucial aspects of protein conjugate design, aiming to overcome common challenges associated with ADCs. In addition to ADRX-0405, Adcentrx is developing a comprehensive pipeline of ADCs with both first-in-class and best-in-class potential, including ADRX-0706, which targets Nectin-4 and is currently undergoing a Phase 1a/b clinical trial.

Adcentrx remains dedicated to pushing the boundaries of medical research and providing new hope for patients with life-threatening conditions through its groundbreaking ADC technologies.