Sirnaomics Ltd., a leading biopharmaceutical firm in the research and development of RNAi therapies, reported that STP705 is moving forward in clinical trials for the treatment of two non-melanoma skin cancers: squamous cell carcinoma in situ (isSCC) and basal cell carcinoma (BCC). Sirnaomics is developing a communication package for the US Food and Drug Administration (FDA) to seek direction for late-stage clinical development for the treatment of isSCC and BCC based on positive clinical readouts from a phase IIb study for isSCC and a phase II study for BCC. Furthermore, the company has established a marketing strategy to position STP705 when primary endpoints in upcoming clinical studies are met.
In December 2022, an interim report on the phase IIb study of STP705 for the treatment of isSCC revealed that the majority (78%) of the 32 patients treated with STP705 achieved histological clearance, the study's primary goal. One of the three therapy cohorts had a histology clearance rate of 89%. STP705 was verified as a novel siRNA (small interfering RNA) therapy, taking advantage of a dual-targeted inhibitory capability and a polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down TGF-ß1 and COX-2 gene expression.
The business claimed in August 2022 that the phase II clinical investigation of STP705 in five patients with BCC revealed an appropriate clinical dosage of 180g and achieved 100% histological clearance and completed response (CR), indicating the treatment's potential feasibility. Aside from obtaining a 100% CR, this cohort's data demonstrated better or stable cosmetic improvements, an outstanding safety profile, and no severe cutaneous skin responses. The efficacy of STP705 treatment of BCC further proved its potential for non-melanoma diseases.
"We have demonstrated significant efficacy and a great safety profile in our clinical studies for STP705 to date," stated Dr. Michael Molyneaux, M.D., executive director and chief medical officer of Sirnaomics. "As we continue to explore this intriguing therapeutic candidate, we will further confirm the most effective dose and the therapeutic benefits for the treatment of isSCC, SCC and BCC. Non-melanoma skin cancers impact millions of people in the United States and around the world. There are currently just a few approved non-surgical treatments. We have developed a marketing and launch strategy for exploiting our injectable therapy approach to compensate for the surgical treatment's shortcomings."
“The latest results from the phase IIb study of isSCC and phase II study of BCC has shown efficacy of STP705 without any drug related Adverse Events (AEs) and Serious Adverse Events (SAEs), validating the broad potential of STP705 for treatment of non-melanoma skin cancers” said, Dr. Patrick Lu, founder, chairman of the board, executive director, president and CEO of Sirnaomics. “With guidance from the FDA, Sirnaomics is confident to move our lead drug candidate into later-stage clinical development to further explore and evaluate the great potential of STP705 for the treatment of non-melanoma skin cancers.”
Non-melanoma skin cancers (NMSC) are the most common forms of human neoplasia. NMSC constitute a large group of skin cancers that are not melanoma, including squamous cell carcinoma (SCC), basal cell carcinoma (BCC), Extramammary Paget’s Disease (EMPD), Merkel cell carcinoma (MCC), and skin adnexal carcinomas. Among these, BCC and SCC account for the majority of NMSC with an estimate of more than 5 million newly diagnosed cases in the United States every year. Along with BCC, SCC is one of two major subtypes of NMSC. The market size of the NMSC treatment market in the United States is expected to increase from US$ 6.5 billion in 2020 to US$ 22 billion in 2030. In China, the market size of NMSC treatment was US$ 38 million in 2020 and is also expected to grow rapidly in the coming years, reaching US$ 149 million in 2030.
A World Health Organization authorized report from the “International Agency for Research on Cancer” (2019) revealed that the number of deaths in 2018 globally for both men and women from NMSC is 65,155, of which 41.9% were within the populations of Asians, which is significantly more than other populations.
Surgery is 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. As a result, there is a high unmet need for an FDA-approved local injection therapy that is safe and effective.
Sirnaomics is an RNA therapeutics biopharmaceutical company with product candidates in preclinical and clinical stages that focuses on the discovery and development of innovative drugs for indications with medical needs and large market opportunities.