Sirnaomics Ltd., a leading biopharmaceutical company in discovery and development of RNAi therapeutics, 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”). The study, titled “Safety and Efficacy of TGF-β1/COX-2 Silencing Therapeutic in Adults with Cutaneous Squamous Cell Carcinoma In Situ,” showed that STP705 was safe and well-tolerated in patients with Cutaneous Squamous Cell Carcinoma In Situ (isSCC).
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The key results from the publication indicate that this single-center, open label, dose escalation cohort study evaluated the safety and efficacy of various doses of intralesional injections of STP705, a therapeutic of TGF-β1/COX-2 combined with histidine-lysine polypeptide (siRNA/HKP) nanoparticle silencing, in patients with cutaneous cell carcinoma. The primary endpoint was the proportion of patients with complete histological clearance. Twenty-five patients received STP705 where nineteen of them (76%) achieved histological clearance. In the 30 µg/treatment group and 60 µg/treatment group, 80% and 100% of them achieved histological clearance, respectively. As a result of the study, STP705 appears to be noninvasive, safe and efficacious in treating cutaneous in situ squamous cell carcinoma. The recommended doses for future study of the investigational product are 30 µg/treatment and 60 µg/treatment.
At last fall’s Clinical Dermatology Conference 2021, Brian Berman, MD, PhD, Professor of Dermatology at The University of Miami Miller School of Medicine, a member of the Board of Directors of the American Academy of Dermatology, and the principal investigator of the clinical study of STP705 for treatment of isSCC, gave a presentation on the details of the clinical development and study results. Following his presentation, an audience survey was conducted among 2000+ clinical dermatologists, with questions about whether STP705 fulfilled a need for clinical practices for the treatment of isSCC. The survey results provided a strong favorable opinion regarding the clinical application potential of STP705. Through the Gore Range Capital Skin Health Innovation Competition during the conference, Sirnaomics STP705 was selected as one of the top three finalists.
“A limited number of approved, non-surgical treatments for isSCC currently exist. Our results suggest that STP705 has the potential to be a viable option for patients with skin lesions due to this form of non-melanoma skin cancer, and publication and survey results further validated the clinical application potential of this novel siRNA therapeutic,” said Michael Molyneaux M.D., Executive Director and Chief Medical Officer at Sirnaomics and lead author of the study. “The overexpression of TGF-β1 and COX-2 genes are strongly associated with SCC development, with TGF-β1 having a prominent role in tumor progression. By using RNAi based therapeutics such as STP705 that silence these genes, we have the potential to block the proliferation of isSCC through non-invasive means. This study supports this thesis, and we plan to continue to evaluate 30 µg and 60 µg doses in future studies.”