Adcentrx Therapeutics Announces FDA Clearance of Investigational New Drug Application for ADRX-0706, a Novel ADC Targeting Nectin-4 for the Treatment of Advanced Solid Tumors

  • First asset utilizing Adcentrx’s ADC platform to receive IND clearance
  • Planned Phase 1a/1b clinical trial expected to begin in 2H 2023

San Diego, CA, July 17, 2023 /PR NEWSWIRE/ — Adcentrx Therapeutics (“Adcentrx”), a biotechnology company dedicated to revolutionizing Antibody-Drug Conjugate (ADC) therapeutics 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-0706 for the treatment of select advanced solid tumors.

“The FDA’s acceptance of our IND application is an exciting milestone for Adcentrx,” said Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx. “As our first program to receive FDA clearance, we are one step closer to bringing our novel ADC technology to patients in need across the oncology landscape.”

Nectin-4 is an attractive target for ADCs due to its high expression in multiple solid tumors and limited expression in normal tissues. It plays a crucial role in tumor progression and has been associated with poor prognosis and resistance to conventional therapies. By specifically targeting Nectin-4 with ADRX-0706, potent anti-cancer activity can be achieved with a lower toxicity profile, offering a promising alternative over current therapeutic approaches.

“ADRX-0706 demonstrated a remarkable efficacy and safety profile in preclinical studies,” added Pia Challita-Eid, Ph.D., Chief Scientific Officer of Adcentrx. “We are thrilled to be progressing our first program into the clinic as we continue to apply our optimized ADC platform on a robust and differentiated product pipeline.”

The first-in-human Phase 1a/1b clinical trial of ADRX-0706 will be an open-label, multicenter, non-randomized dose escalation and dose expansion study. The study will enroll patients with select advanced solid tumors. The primary objectives of the study will be to characterize the safety and tolerability and to determine the optimal dose of ADRX-0706. The company expects the first patient to be enrolled in the second half of 2023, with an initial data readout in the middle of 2024.

About ADRX-0706

ADRX-0706 is an ADC product candidate discovered by Adcentrx. The antibody component targets Nectin-4, a cell surface adhesion protein over-expressed in multiple human cancers and associated with poor disease prognosis. The ADC is manufactured using a proprietary conjugation technology and novel tubulin inhibitor payload to generate an ADC with a drug-antibody ratio of eight (DAR 8). ADRX-0706 has demonstrated a favorable pharmacokinetic and safety profile in preclinical models, in addition to demonstrating significant efficacy across a variety of tumor indications.