Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) announced the first subject systemic dosing in a Phase I/II clinical study for its therapeutic candidate STP705 in facial squamous cell carcinoma in situ (isSCC). The study is expected to be completed during Q1 2023.
Study Design and Objectives
The open-label, dosage escalation study (clinicaltrials.gov: NCT05421013) is designed to assess the safety, tolerability, and efficacy of different doses of STP705 via intralesional injection. The trial aims to determine the recommended dose of STP705 and analyze biomarkers associated with isSCC formation pathways, including TGF-β1 and COX-2. The primary endpoint is to determine the number of patients with histological clearance (HC) of facial isSCC lesions after STP705 treatment. A total of 30 subjects are included in the trial, divided into three groups receiving a fixed weekly dose (30 μg, 60 μg, or 90 μg) for six weeks.
Product Overview
STP705 is a siRNA (small interfering RNA) therapeutic that leverages a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expression. The product has been awarded orphan drug designations (ODDs) for use in cholangiocarcinoma and primary sclerosing cholangitis and is currently undergoing clinical trials in cholangiocarcinoma, non-melanoma skin cancer, isSCC, and hypertrophic scarring.-Fineline Info & Tech
