Adcentrx Therapeutics Announces China NMPA’s IND Grant for ADRX-0706

Adcentrx Therapeutics Announces China NMPA’s IND Grant for ADRX-0706

By, Admin 7 May 2024

Adcentrx Therapeutics Announces China NMPA Grants IND Clearance for ADRX-0706, a Novel Nectin-4 ADC for the Treatment of Advanced Solid Tumors

Overview

Follows initiation of Phase 1a/1b study in the U.S.

Company plans to include clinical centers in China to broaden geographic representation and accelerate patient enrollment into the Phase 1a/1b study  Adcentrx Therapeutics (""Adcentrx""), a biotechnology company revolutionizing Antibody-Drug Conjugate (ADC) therapeutics for cancer and other life-threatening diseases, announced today that China National Medical Products Administration (NMPA) has cleared Adcentrx's Investigational New Drug (IND) application for ADRX-0706 which enables the company to include China-based clinical centers in the ongoing Phase 1a/1b study for the treatment of select advanced solid tumors.

ADRX-0706

  • ADRX-0706 is an ADC comprised of a novel fully human IgG1 antibody targeting human Nectin-4 linked to a proprietary tubulin inhibitor payload, AP052, through Adcentrx's innovative i-Conjugation™ technology using a cleavable linker and stable conjugation chemistry. 
  • This novel platform technology enables a highly stable ADC with a drug-antibody ratio of eight (DAR 8) with a substantially expanded therapeutic window as demonstrated in preclinical studies.
  • Nectin-4 is a validated target for ADCs with 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.

Words from CEO: Adcentrx

  • "NMPA's clearance of the ADRX-0706 IND is an important milestone for Adcentrx,"" said Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx. 
  • "We now have the ability to recruit patients in both the U.S. and China to generate valuable data in different patient populations, and the data will enable us to further explore ADRX-0706 in treating patients with high unmet needs across multiple tumor types.""

First-In-Human Phase 1a/b Trial

  • The first-in-human Phase 1a/b clinical trial of ADRX-0706 is an open-label, multicenter dose escalation and dose expansion study. 
  • The study is enrolling patients with select advanced solid tumors. 
  • The primary objectives of the study are to characterize the safety and tolerability and to determine the optimal dose of ADRX-0706. 
  • The company expects an initial data readout in mid-2024.

About ADRX-0706

  • ADRX-0706 is a fully proprietary 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. 
  • ADRX-0706 has a favorable pharmacokinetic and safety profile in preclinical models and has demonstrated significant efficacy across a variety of tumor indications in vitro and in vivo. 
  • ADRX-0706 is currently being evaluated in a Phase 1a/b clinical trial.

For more information about the ADRX-0706 Phase 1a/b clinical trial, please refer to the Study ID NCT06036121 on ClinicalTrials.gov.

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-0706, Adcentrx is developing a robust pipeline of ADCs with first-in-class potential.

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