Adcentrx's ADRX-0706 Receives Fast Track Status for Advanced Cervical Cancer Treatment

Adcentrx Therapeutics, a biotechnology firm at the forefront of developing innovative Antibody-Drug Conjugate (ADC) therapies, has recently achieved a significant milestone. The company's leading program, ADRX-0706, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients suffering from locally advanced or metastatic squamous cell cervical cancer. This FDA status highlights the potential of ADRX-0706 to meet the pressing needs of patients with advanced cervical cancer.

ADRX-0706 is a Nectin-4 ADC currently undergoing evaluation in an ongoing Phase 1a/b clinical trial (NCT06036121) aimed at treating various advanced solid tumors, including cervical cancer. The company plans to showcase interim data from the completed Phase 1a dose escalation at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Preliminary results have indicated a unique safety and pharmacokinetic profile, with a particularly lower incidence of adverse effects such as peripheral neuropathy. Additionally, preliminary efficacy signals have been observed across multiple types of tumors.

Cervical cancer remains a challenging condition, especially for patients whose disease has progressed after initial treatments. The high expression of Nectin-4 in cervical cancer makes it a suitable candidate for treatment using a Nectin-4 ADC like ADRX-0706. Hui Li, Ph.D., Founder and CEO of Adcentrx, pointed out that the FDA’s Fast Track designation emphasizes the significant unmet need in advanced cervical cancer management. This recognition, coupled with early clinical observations for ADRX-0706, bolsters the view of its best-in-class potential. Additionally, it facilitates enhanced regulatory dialogue, aiding the advancement of this crucial program through clinical development stages.

The FDA’s Fast Track program is specifically designed to expedite the development and review process of therapies aimed at addressing serious conditions with unmet medical needs. The program's goal is to ensure that essential new treatments reach patients more swiftly. The designation enables earlier and more frequent communication with the FDA throughout the developmental process. It may also provide regulatory advantages, such as eligibility for Accelerated Approval, Priority Review, and Rolling Review options, which can lead to earlier sections of a New Drug Application (NDA) or Biologic License Application (BLA) being reviewed as they are completed, rather than waiting for the entire application to be finalized.

ADRX-0706 is a proprietary ADC product candidate developed by Adcentrx. It features a novel fully human IgG1 antibody targeting Nectin-4, a cell surface adhesion protein that is highly expressed in various solid tumors. Nectin-4 is associated with poor disease prognosis and is a validated target for ADCs. The ADC is coupled with a proprietary tubulin inhibitor payload, AP052, through Adcentrx's innovative i-Conjugation® technology platform. This platform, a core component in the company’s ADC design, utilizes a cleavable linker and stable conjugation chemistry to optimize payload delivery. This technology leads to a highly stable ADC with a drug-antibody ratio of eight (DAR 8) and a significantly expanded therapeutic window, as demonstrated in preclinical studies.

In preclinical models, ADRX-0706 has shown a favorable pharmacokinetic and safety profile, along with significant efficacy across various tumor types examined both in vitro and in vivo. Adcentrx Therapeutics is dedicated to driving innovation in protein conjugate therapeutic development for cancer and other life-threatening diseases. The company has developed a comprehensive pipeline that includes two clinical-stage ADCs and multiple preclinical ADCs, all with the potential to be first-in-class and best-in-class therapies.