Adcentrx Therapeutics Announces FDA Fast Track Designation for ADRX-0706, a Nectin-4 Targeting ADC, in Advanced Cervical Cancer

Adcentrx Therapeutics (hereinafter referred to as “Adcentrx”), a biotechnology company focused on developing breakthrough protein-conjugated drug therapies for cancer and other serious diseases, announced today that its core investigational product, ADRX-0706, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with locally advanced or metastatic squamous cell cervical cancer.

ADRX-0706 is an Nectin-4-targeting antibody-drug conjugate (ADC) currently being evaluated in the dose expansion phase (Phase 1b) of a Phase 1a/1b clinical study (NCT06036121) for the treatment of specific advanced solid tumors, including cervical cancer. The Company will present interim data from the completed Phase 1a dose-escalation stage at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Preliminary results for ADRX-0706 have demonstrated a differentiated safety and pharmacokinetic profile, including a significantly reduced incidence of adverse events (AEs) such as peripheral neuropathy, and preliminary signals of efficacy have been observed across multiple cancer types.

Cervical cancer represents a significant unmet medical need, particularly for patients whose disease progresses despite initial treatment. Nectin-4 is highly expressed in cervical cancer, making it an attractive tumor type for treatment with Nectin-4-targeting antibody-drug conjugates (ADCs).

Dr. Hui Li, Founder and CEO of Adcentrx Therapeutics, stated, “The FDA’s granting of Fast Track designation not only highlights the significant unmet clinical need in advanced cervical cancer but also marks another important milestone in Adcentrx’s development journey. This recognition, together with the positive early clinical signals observed for ADRX-0706, further validates the best-in-class potential of our Nectin-4-targeting antibody-drug conjugate (ADC). As clinical development of this program continues to advance, we will have additional opportunities for in-depth discussions with regulatory authorities.”

The FDA’s Fast Track program is designed to accelerate the development and review of therapies for serious conditions with unmet medical needs, with the goal of making important new treatments available to patients more quickly. This designation facilitates earlier and more frequent communication with the FDA throughout the development process and may confer regulatory advantages, such as eligibility for Accelerated Approval, Priority Review, and Rolling Review, which allows the agency to review completed sections of a New Drug Application (NDA) or Biologics License Application (BLA) without waiting for the entire application to be submitted.

ADRX-0706 is a fully patented ADC candidate independently developed by Adcentrx. The antibody component of this product targets Nectin-4, a cell surface adhesion protein overexpressed in various human tumors and associated with poor disease prognosis, which is a validated effective target for ADCs.

ADRX-0706 antibody utilizes the company’s newly developed conjugation technology, i-Conjugation.^®, stably linked via a cleavable linker to the company’s proprietary tubulin inhibitor toxin molecule (AP052). This novel platform technology enables the ADC to achieve a highly stable drug-to-antibody ratio (DAR of 8) and has demonstrated a significantly widened therapeutic window in preclinical studies.

ADRX-0706 demonstrates favorable pharmacokinetics and safety in preclinical models, and has shown significant efficacy against multiple tumor indications in both in vitro and in vivo studies. ADRX-0706 is currently being evaluated in Phase Ia/Ib clinical trials.

For more information on the Phase Ia/Ib clinical study of ADRX-0706, please refer toClinicalTrials.govInformation on the website (ID NCT06036121).

Adcentrx is a biotechnology company dedicated to accelerating the development of breakthrough protein-conjugated therapies for cancer and other serious diseases. Adcentrx pioneered an ADC technology platform that effectively addresses common challenges in ADC drug development through groundbreaking optimization of key components in protein-conjugated drug design. The company has established a robust pipeline comprising two clinical-stage ADC candidates and multiple preclinical programs, all of which demonstrate significant potential to become first-in-class or best-in-class therapies.

For more information about Adcentrx and its innovative ADC technology, please visit: https://adcentrx.com。