The FDA advised the biopharmaceutical firm to proceed with late-stage clinical development based on the efficacious data and the high prevalence of squamous cell carcinoma lesions
STP705 is a small interfering RNA therapeutic. (Credit: THAVIS 3D on Unsplash)
Biopharmaceutical company Sirnaomics has advanced its STP705 into Phase 3 trial for the treatment of squamous cell carcinoma in situ (isSCC).
The move comes after Sirnaomics shared the Phase 2a and Phase 2b clinical results with the US Food and Drug Administration (FDA) during an End of Phase-2 meeting.
The FDA advised the biopharmaceutical firm to proceed with late-stage clinical development based on the efficacious data and the high prevalence of squamous cell carcinoma lesions.
STP705 is a small interfering RNA (siRNA) therapeutic that leverages a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly target both TGF-β1 and COX-2 gene expression.
According to Sirnaomics, the company is currently well-positioned to take STP705 into a confirmatory clinical trial for isSCC treatment.
The firm is proceeding with a single dosage study to assess a sub-group of subjects in a large Phase 3 clinical study in 2023. The positive outcomes will serve as the foundation to complete this registration Phase 3 trial.
Additionally, Sirnaomics is evaluating STP705 for basal cell carcinoma (BCC). It will move the drug candidate into the Phase 3 trial for this indication, pending the review of the FDA.
The siRNA therapeutic has been studied in isSCC and BCC in more than 100 participants.
As per the safety data from earlier clinical studies for both forms of cancer, STP705 was safe and did not cause any adverse events of grade 3 or higher, the biopharmaceutical company claimed.
The majority of the treatment groups showed preliminary efficacy data with complete histological clearance of cancer cells.
Sirnaomics president and CEO Patrick Lu said: “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.
“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.”
STP705 has secured multiple investigational new drug application (IND) approvals from the US Food and Drug Administration (FDA) as well as the Chinese National Medical Products Administration (NMPA).