Sirnaomics advances isSCC candidate into late-stage clinical development

James Spargo | June 20, 2023 | News story | Research and Development FDA, Oncology, Sirnaomics, clinical trial, isSCC 

Global RNA therapeutics biopharmaceutical company Sirnaomics has announced that it has advanced its Squamous Cell Carcinoma in situ (isSCC) candidate STP705 into late-stage clinical development after promising phase 2a and 2b results were shared with the US Food and Drug Administration (FDA).

STP705 is a small interfering RNA (siRNA) therapeutic that uses a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expression. It has been studied in 100 patients with either isSCC and Basal Cell Carcinoma (BCC), and data from the studies showed STP705 was safe without any grade 3 or higher adverse effects.

Sirnaomics will now move STP705 into phase 3 clinical trials, with a focus on treating Squamous Cell Carcinoma (SCC) lesions within the programme. Pending FDA approval, BCC trials could me moved into late-stage development in 2023.

Dr Patrick Lu, founder, chairman of the Board, executive director, president and CEO of Sirnaomics, stated: “Moving STP705 for the treatment of isSCC into late-stage clinical development is a major milestone for our clinical programme 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.”

Dr Michael Molyneaux MD, executive director and chief medical officer at Sirnaomics, commented: “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 programme to late-stage development.”

James Spargo

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