Sirnaomics Doses First Patient in Phase 2b Study of STP705 for Treatment of Squamous Cell Skin Cancer
Company Expects to Report Interim Clinical Data of the Phase 2 in Second Half of 2021
GAITHERSBURG, Md. and SUZHOU BIOBAY, China, June 30, 2021 /PRNewswire/ -- Sirnaomics, Inc. a biopharmaceutical company engaged in the discovery and development of RNAi therapeutics against cancer and fibrotic diseases, today announced dose administration for the first patient in a Phase 2b study of the company's drug candidate, STP705, for the treatment of squamous cell skin cancer in situ (isSCC). 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 randomized, double-blind, placebo-controlled Phase 2b study is evaluating the safety and efficacy of intralesional injection of STP705 in up to 100 adult patients with isSCC. This portion of the trial will further evaluate the two most efficacious dosing regimens of 30 ug and 60 ug. The primary endpoint of this trial is the proportion of participants with histological clearance of treated isSCC lesion at the end of treatment. Histological clearance will be defined as the absence of detectable evidence of isSCC tumor cell nests as determined by central pathology review.
"For many patients with isSCC, surgery is still considered the only viable treatment option, so with our first patient dosed in this Phase 2b study, we'll be able to observe the efficacy of STP705, which has to the potential to be a non-surgical, non-invasive alternative," said Michael Molyneaux M.D., Chief Medical Officer. "Our interim readout later this year will guide our clinical development for this indication."
"After a high rate of patients achieved histological clearance in the Phase 2a study of STP705 for isSCC, we're looking forward to seeing the results of our Phase 2b study as we begin patient dosing," said Patrick Lu, Ph.D., founder, President and CEO of Sirnaomics. "The anticipated clinical readout in the second half of 2021 will provide more insights into the potential of STP705 for the treatment of non-melanoma skin cancer and the impact of RNAi therapeutics in oncology."
Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT04844983.
About Non-melanoma Skin Cancer and Squamous Cell Carcinoma In Situ
Squamous cell carcinoma in situ, also called Bowen disease, is the earliest form of squamous cell skin cancer (SCC). Along with basal cell carcinoma, SCC is one of two major subtypes of NMSC. The key driver for development of SCC is ultraviolet rays from the sun. It is believed that development of SCC is linked closely to genomic perturbations, genetic mutations, and altered expression of key molecules (e.g., overexpression of TGF-β1 and COX-2) that impacts squamous cell lineage commitment and terminal differentiation.
Surgery is the currently the most common treatment option for the treatment of NMSC. The various forms of surgical modalities carry significant cutaneous adverse events, risk of scar, infection and bleeding. Surgery can also have a significant recurrence rate. As a result, there is a high unmet need for an FDA approved local injection therapy that is safe and effective.
About Sirnaomics, Inc.
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SOURCE Sirnaomics, Inc.