Pharma Focus Asia

Adcentrx Therapeutics Receives IND Clearance from China NMPA for ADRX-0706, a Novel Nectin-4 ADC Aimed at Advanced Solid Tumors

Tuesday, May 07, 2024

Adcentrx Therapeutics, a prominent biotechnology firm specializing in advancing Antibody-Drug Conjugate (ADC) therapies for cancer and other severe illnesses, has shared significant news. They announced that the China National Medical Products Administration (NMPA) has given clearance for Adcentrx’s Investigational New Drug (IND) application for ADRX-0706. This clearance allows for the inclusion of China-based clinical centers in the ongoing Phase 1a/1b study, aimed at treating specific advanced solid tumors.

ADRX-0706 is an ADC composed 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. This technology results in a highly stable ADC with a drug-antibody ratio of eight (DAR 8), widening the therapeutic window, as shown in preclinical studies. Nectin-4 is a known target for ADCs, highly expressed in multiple solid tumors while having limited expression in normal tissues, playing a crucial role in tumor progression.

Adcentrx, highlighted the significance of NMPA's clearance of the ADRX-0706 IND, marking a crucial milestone for the company. This clearance now allows patient recruitment in both the U.S. and China, facilitating the collection of valuable data across different patient populations. These data will further fuel the exploration of ADRX-0706 in addressing the needs of patients with various high unmet needs across multiple tumor types.

The Phase 1a/b clinical trial of ADRX-0706, the first of its kind in humans, is an open-label, multicenter study focusing on dose escalation and expansion. Patients with select advanced solid tumors are being enrolled in this trial. The primary objectives include characterizing safety and tolerability while determining the optimal dosage of ADRX-0706. The company anticipates an initial data readout by mid-2024.

ADRX-0706, a fully proprietary ADC product candidate developed by Adcentrx, targets Nectin-4, a cell surface adhesion protein excessively expressed in various human cancers and associated with poor disease prognosis. Demonstrating a favorable pharmacokinetic and safety profile in preclinical models, ADRX-0706 has exhibited significant efficacy across diverse tumor indications in both in vitro and in vivo settings. Presently, ADRX-0706 is undergoing evaluation in a Phase 1a/b clinical trial.



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