Sirnaomics Ltd., a cutting-edge biopharmaceutical company in the discovery and development of RNAi therapeutics, is thrilled to announce that it is making strides in the clinical development of STP705 for the treatment of two highly prevalent non-melanoma skin cancers: Squamous Cell Carcinoma in situ (isSCC) and Basal Cell Carcinoma (BCC). Following positive readouts from both a Phase IIb study for isSCC and a Phase II study for BCC, the Company is now preparing a communication package for the U.S. Food and Drug Administration (FDA) to seek guidance in conducting a late-stage clinical development for the treatment of isSCC and BCC. Simultaneously, the Company has created a commercialization plan to ensure a successful launch of STP705 when the upcoming clinical studies meet their primary endpoints.
The Phase IIb study of STP705 for the treatment of isSCC yielded remarkable results in December 2022, with 78% of 32 patients achieving histological clearance – the primary endpoint of the study. Of the three treatment cohorts, one achieved an outstanding 89% histological clearance. This success further validates STP705 as a revolutionary siRNA therapeutic, which uses a dual-targeted inhibitory property and a polypeptide nanoparticle (PNP)-enhanced delivery method to knock down TGF-β1 and COX-2 gene expressions directly.
In August 2022, STP705 – a potential treatment for non-melanoma conditions – showed promising results in a Phase II clinical study of five patients with BCC. All five patients achieved a 100% histological clearance and complete response (CR), with improved or stable cosmetic results and no significant cutaneous skin reactions. The optimal clinical dosage was established as 180µg, with an excellent safety profile. This success further validated the efficacy of STP705 in BCC treatment and its potential as a viable treatment for non-melanoma conditions.
At Sirnaomics, we are excited about the potential of our therapeutic candidate STP705. Our clinical studies so far have demonstrated significant efficacy and a strong safety profile for the treatment of isSCC, SCC, and BCC- three non-melanoma skin cancers that affect millions of people around the world. While surgical treatments are currently the only approved approach to treating these conditions, our injectable treatment has the potential to provide much-needed relief from the shortfalls of surgery. With a marketing and launch strategy in place, we are confident that STP705 can make a real difference in the lives of those affected by non-melanoma skin cancers.
Sirnaomics is thrilled to announce the success of Phase IIb study of isSCC and Phase II study of BCC, which have revealed the efficacy of STP705 without any drug-related Adverse Events (AEs) or Serious Adverse Events (SAEs). This milestone validates the potential of this lead drug candidate to be used for non-melanoma skin cancer treatment. With the FDA’s expert guidance, the company is confident to move STP705 into its next phase of clinical development to further investigate its immense potential in the said field. Dr. Patrick Lu, Founder, Chairman of the Board, Executive Director, President and CEO of Sirnaomics expressed his enthusiasm for the breakthrough.
About Non-Melanoma Skin Cancers
Non-melanoma skin cancers (NMSC) are the most common types of human neoplasia, with an estimated 5 million new cases diagnosed each year in the United States alone. In addition, the market size of the NMSC treatment market in the United States is set to skyrocket to US$22 billion in 2030, while China’s market size is expected to reach US$149 million the same year. Squamous cell carcinoma (SCC) and basal cell carcinoma (BCC) are the two major subtypes of NMSC, and together account for the vast majority of cases. Other types of NMSC include Extramammary Paget’s Disease (EMPD), Merkel cell carcinoma (MCC), and skin adnexal carcinomas.
In 2018, the World Health Organization’s International Agency for Research on Cancer revealed a staggering 65,155 deaths globally due to Non-Melanoma Skin Cancer (NMSC). Surprisingly, 41.9% of these fatalities occurred in Asian populations, making it the most affected group. This is a significant increase compared to other populations.
Surgery is currently the most common treatment option for the treatment of NMSC, yet it can carry significant risks such as cutaneous adverse events, scarring, infection, and bleeding. This has left a need for an FDA-approved local injection therapy that is both safe and effective.
Sirnaomics is a pioneering biopharmaceutical company that is revolutionizing the way we treat diseases! With innovative product candidates in preclinical and clinical stages of development, they are focused on discovering and developing new drugs to address medical needs and large market opportunities. As the first clinical-stage RNA therapeutics company to have a strong presence in both China and the United States, Sirnaomics achieved positive Phase IIa clinical outcomes in oncology with their core product, STP705, making them a true leader in the industry.