Sirnaomics, a biopharmaceutical company focused on discovering and developing innovative drugs for indications with medical needs and large market opportunities, has announced the advancement of STP705 into late-stage clinical development for the treatment of Squamous Cell Carcinoma in situ (isSCC). The decision follows encouraging Phase IIa and Phase IIb clinical results that were shared with the U.S. Food and Drug Administration (FDA) in an End of Phase-2 meeting. The FDA provided guidance to move forward with late-stage clinical development due to the efficacious data provided as well as the widespread prevalence of SCC lesions. STP705 has been studied in isSCC and Basal Cell Carcinoma (BCC) in over 100 participants, showing excellent safety and efficacy for the treatment of isSCC. Sirnaomics' leading product candidate, STP705, uses a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expression.
The next step will be advancing STP705 into a confirmatory clinical study for treatment of isSCC.