Adcentrx Therapeutics, a clinical-stage biotechnology company involved in Antibody-Drug Conjugate (ADC) therapies for cancer treatment and other life-threatening diseases, announced on Tuesday that the US Food and Drug Administration (FDA) has granted Fast Track designation to its lead programme, ADRX-0706, for the treatment of patients with locally advanced or metastatic squamous cell cervical cancer.

ADRX-0706 is a Nectin-4 ADC being evaluated in the Phase 1b portion of an ongoing Phase 1a/b clinical trial for the treatment of selected advanced solid tumours, including cervical cancer. The company says that it will present interim data from the completed Phase 1a dose escalation portion at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Early findings demonstrated a differentiated safety and pharmacokinetic profile, including a notably lower incidence of adverse events such as peripheral neuropathy, along with preliminary efficacy signals across multiple tumour types.

ADRX-0706 is a fully proprietary ADC product candidate discovered by Adcentrx. The antibody component is a novel fully human IgG1 targeting Nectin-4, a cell surface adhesion protein with high expression in multiple solid tumours and limited expression in normal tissues. Nectin-4 is associated with poor disease prognosis and is a validated target for ADCs.