On June 19, 2023 Sirnaomics Ltd. (the "Company"; stock code: 2257, together with its subsidiaries, the "Group" or "Sirnaomics"), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, reported the advancement of STP705 for the treatment of Squamous Cell Carcinoma in situ (isSCC) into late-stage clinical development after encouraging Phase IIa and Phase IIb clinical results were shared with the U.S. Food and Drug Administration (FDA) in an End of Phase-2 meeting (Press release, Sirnaomics, JUN 19, 2023, View Source [SID1234632777]). 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.

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Sirnaomics is well-positioned currently to advance STP705 into a confirmatory clinical study for treatment of Squamous Cell Carcinoma in situ (isSCC). We are preparing to move forward in 2023 with a well-designed single dosage study as a sub-group of subjects in a large Phase III clinical study. Positive results will provide the basis for completion of this large registration Phase III trial. 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," said Dr. Patrick Lu, Founder, Chairman of the Board, Executive Director, President and Chief Executive Officer of Sirnaomics. "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," said Dr. Michael Molyneaux, M.D., Executive Director and Chief Medical Officer of Sirnaomics.

About STP705
Sirnaomics’ leading product candidate, 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. The product candidate has received multiple IND approvals from both the U.S. Food and Drug Administration (FDA) and the Chinese National Medical Products Administration (NMPA), including treatments of cholangiocarcinoma, non-melanoma skin cancer and hypertrophic scar. There are currently three product pipeline programs prioritized by STP705: a late-stage clinical development for Squamous Cell Carcinoma in situ (isSCC), completion of a Phase II for Basal Cell Carcinoma (BCC) and a Phase I for the fat remodeling. For other indications, STP705 has received Orphan Drug Designation for the treatment of cholangiocarcinoma (CCA) and primary sclerosing cholangitis (PSC).