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

Second asset utilizing Adcentrx’s ADC platform to receive IND clearance
Dosing of first patient in a Phase 1a/b clinical trial anticipated by 4Q 2024

SAN DIEGO, Oct. 21, 2024 /PRNewswire/ — Adcentrx Therapeutics (“Adcentrx”), a clinical-stage biotechnology company advancing innovative protein conjugates for cancer and other life-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application of ADRX-0405 for the treatment of select advanced solid tumors.

ADRX-0405 is a next-generation antibody-drug conjugate (ADC) composed of a humanized IgG1 antibody targeting six-transmembrane epithelial antigen of the prostate 1 (STEAP1), a cell surface protein that is upregulated in prostate cancer and certain other cancers, yet has limited expression in healthy tissue.

Adcentrx’s proprietary i-Conjugation® technology platform is an important component in the design of ADRX-0405. The platform utilizes protease-cleavable linkers and stable conjugation chemistry to enhance payload delivery. This advanced technology ensures a highly stable ADC with a topoisomerase inhibitor payload conjugated at a drug-to-antibody ratio of eight (DAR 8). ADRX-0405 preclinical studies have demonstrated its favorable pharmacokinetics, safety profile, and significant efficacy across multiple tumor models.

“The FDA’s clearance of our second IND marks another major advancement for Adcentrx,” said Hui Li, Ph.D., President and CEO of 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 patients with metastatic castration resistant prostate cancer, who have a significant need for new targeted therapies.”

The planned first-in-human Phase 1a/b clinical trial of ADRX-0405 is an open-label, multicenter, non-randomized dose escalation and dose expansion study. The study will enroll patients with select advanced solid tumors, including metastatic castration resistant prostate cancer. The primary objectives of the study will be to characterize the safety and tolerability and to determine the optimal dose of ADRX-0405. The company anticipates the first patient to be enrolled in 4Q 2024, with an estimated initial data readout in 4Q 2025.

About Adcentrx Therapeutics

Adcentrx is a biotechnology company focused on accelerating breakthroughs in protein conjugate therapeutic development for cancer and other life-threatening diseases. Adcentrx has pioneered the development of i-Conjugation®, an ADC technology platform addressing key components of protein conjugate design to solve challenges typically seen in ADCs. In addition to ADRX-0405, Adcentrx is developing a robust pipeline of ADCs with first-in-class and best-in-class potential, including ADRX-0706, a Nectin-4 targeting ADC currently in a Phase 1a/b clinical trial (Study ID NCT06036121 on ClinicalTrials.gov).

For more information about Adcentrx and its innovative ADC technologies, please visit https://adcentrx.com.

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SOURCE Adcentrx Therapeutics