The FDA provided Sirnaomics guidance to move forward with late-stage clinical development because of the efficacious data provided as well as the widespread prevalence of Squamous Cell Carcinoma (SCC) lesions.

Sirnaomics Ltd.’s STP705 for the treatment of Squamous Cell Carcinoma in situ (isSCC) is moving into late-stage clinical development after encouraging Phase IIa and Phase IIb clinical results.

These results were shared with the U.S. Food and Drug Administration (FDA) in an End of Phase-2 meeting. The FDA provided Sirnaomics guidance to move forward with late-stage clinical development because of the efficacious data provided as well as the widespread prevalence of Squamous Cell Carcinoma (SCC) lesions.

STP705 is a siRNA (small interfering RNA) therapeutic that takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expression. 

Sirnaomics is also studying STP705 for Basal Cell Carcinoma (BCC), which will be the next candidate to move into late-stage development pending the FDA's review.

STP705 has been studied in isSCC and BCC in more than 100 participants. The safety data generated from prior clinical studies for both types of cancers has shown that STP705 was safe without grade 3 or higher adverse events. The preliminary efficacy data with complete histological clearance of cancer cells was observed in majority of the treatment groups.

"Moving STP705 for the treatment of isSCC into late-stage clinical development is a major milestone for our clinical program and for a dermatology/oncology application," says Dr. Patrick Lu, Founder, Chairman of the Board, Executive Director, President and Chief Executive Officer of Sirnaomics, in a news release. "According to a 2020 research report from JAMA Dermatology, among patients with isSCC, the cumulative risk of developing an invasive SCC was 11.7% in men and 6.9% in women. Given the widespread prevalence of SCC lesions and a tremendous unmet need, Sirnaomics is dedicated to taking on the challenge for development of a novel therapeutic product with RNAi-based technology."

"Based on the guidance from the type B meeting with the FDA, we currently have a clear path moving forward for late-stage development for STP705 as an innovative drug for treatment of isSCC. Our data has demonstrated excellent safety and efficacy for the treatment of isSCC, and we look forward to advancing this program to late-stage development," adds Dr. Michael Molyneaux, M.D., Executive Director and Chief Medical Officer of Sirnaomics.