Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) announced the peer-reviewed publication of Phase IIa clinical study results of its lead therapeutic candidate, STP705, for the treatment of skin cancer, in the May 2022 issue of the Journal of Drugs in Dermatology (the “JDD”).
Clinical Trial Results
The single-center, open-label, dose-escalation cohort study evaluated the safety and efficacy of various doses of intralesional injections of STP705 in patients with cutaneous squamous cell carcinoma. The primary endpoint was the proportion of patients achieving complete histological clearance. Among the 25 patients who received STP705, 19 (76%) achieved histological clearance. Specifically, 80% and 100% of patients in the 30 µg/treatment and 60 µg/treatment groups, respectively, achieved histological clearance. These results indicate that STP705 is non-invasive, safe, and effective in treating cutaneous in situ squamous cell carcinoma.
Product Profile and Mechanism
STP705 is a siRNA 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 received multiple Investigational New Drug (IND) approvals from both the US FDA and China’s National Medical Products Administration for various indications, including cholangiocarcinoma, non-melanoma skin cancer, and hypertrophic scarring. It has also been granted Orphan Drug Designation for the treatment of cholangiocarcinoma and primary sclerosing cholangitis.
Clinical Development
Currently, STP705 is being evaluated in five clinical trials for different indications: a Phase IIa trial for in situ squamous cell carcinoma (isSCC), a Phase II trial for basal cell carcinoma (BCC), Phase I/II trials for keloid scarring and hypertrophic scar, and a Phase I trial for liver cancer (basket).-Fineline Info & Tech
