Adcentrx Therapeutics Secures China NMPA IND Clearance for ADRX-0706, a New Nectin-4 ADC for Advanced Solid Tumors

Adcentrx Therapeutics, a biotech firm specializing in Antibody-Drug Conjugate (ADC) therapeutics for cancer and other severe diseases, has announced the clearance of its Investigational New Drug (IND) application for ADRX-0706 by the China National Medical Products Administration (NMPA). This approval enables the inclusion of clinical centers in China in the ongoing Phase 1a/1b study of ADRX-0706, aimed at treating select advanced solid tumors.

ADRX-0706 represents a novel ADC, combining a fully human IgG1 antibody that targets human Nectin-4 with a proprietary tubulin inhibitor payload, AP052. This combination is made possible through Adcentrx's innovative i-Conjugation™ technology, which uses a cleavable linker and stable conjugation chemistry. The resulting ADC has a drug-antibody ratio of eight (DAR 8), offering a significantly expanded therapeutic window, as demonstrated in preclinical studies. Nectin-4 is a validated target for ADCs due to its high expression in multiple solid tumors and limited expression in normal tissues. It is crucial in tumor progression and is often associated with poor prognosis and resistance to standard treatments.

Dr. Hui Li, Founder and CEO of Adcentrx, expressed that the NMPA clearance is a pivotal achievement for the company. The ability to recruit patients from both the U.S. and China will generate valuable data across different populations, aiding in the exploration of ADRX-0706's efficacy in treating various challenging tumor types.

The Phase 1a/1b clinical trial of ADRX-0706 is designed as an open-label, multicenter study focusing on dose escalation and dose expansion. This trial is currently enrolling patients with specific advanced solid tumors. The primary objectives are to assess the safety and tolerability of ADRX-0706 and to determine its optimal dosage. Initial data from the study is anticipated by mid-2024.

ADRX-0706 is Adcentrx's proprietary ADC product, with its antibody component targeting Nectin-4, a cell surface adhesion protein overexpressed in numerous human cancers and linked to poor disease outcomes. Preclinical models have shown ADRX-0706 to possess a favorable pharmacokinetic and safety profile, demonstrating significant efficacy across various tumor types both in vitro and in vivo. The Phase 1a/1b clinical trial is currently evaluating ADRX-0706's safety and effectiveness.

Adcentrx Therapeutics is dedicated to advancing protein conjugate therapeutic development for cancer and other serious diseases. The company has developed the i-Conjugation™ platform, addressing key aspects of protein conjugate design to overcome common challenges in ADC development. Besides ADRX-0706, Adcentrx is building a robust pipeline of ADCs with potential for groundbreaking treatments.

In summary, the NMPA's clearance of the ADRX-0706 IND marks a significant milestone for Adcentrx, enabling the company to expand its clinical trials to include centers in China. This expansion aims to accelerate patient enrollment and gather comprehensive data across diverse populations, ultimately advancing the development of ADRX-0706 for treating multiple high-need tumor types. The Phase 1a/1b study will continue to assess ADRX-0706's safety, tolerability, and optimal dosage, with initial results expected in 2024.