Sirnaomics Advances Clinical Development of STP705 for Non-Melanoma Skin Cancers with Positive Phase II Data in isSCC and BCC

Hong Kong, Germantown, Maryland, and Suzhou, ChinaFebruary 1, 2023/PR Newswire/ --Sirnaomics Ltd.（"Company"，"Sirnaomics"Stock Code: 2257.HK) is a leading biopharmaceutical company focused on the discovery and development of RNAi therapeutics. Sirnaomics announced today that the company is advancing the clinical development of STP705 for the treatment of two types of non-melanoma skin cancers (in situ squamous cell carcinoma (isSCC) and basal cell carcinoma (BCC)). Based on positive results from the Phase IIb study for isSCC and the Phase II study for BCC, the company is preparing a plan to communicate with the U.S. FDA to seek guidance for conducting late-stage clinical development for the treatment of isSCC and BCC. Additionally, the company has developed a commercialization strategy to position STP705 effectively in the market upon achieving primary endpoints in upcoming clinical trials.

Interim Report Results from the Phase IIb Study of STP705 in the Treatment of isSCC in December 2022 Showed that the Majority (78%) of the 32 Patients Treated with STP705 Achieved Histological Clearance, as the Primary Endpoint of the Study. The Optimal Dose Group Among the Three Treatment Groups Achieved a Histological Clearance Rate of 89%. The Positive Results of This Study Further Validate STP705 as a Novel Small Interfering Nucleic Acid (siRNA) Therapy, Utilizing Dual-Target Inhibition Properties and an Enhanced Peptide Nanoparticle (PNP) Delivery Method to Directly Knock Down TGF-β1 and COX-2 Gene Expression.

In August 2022, the company reported the Phase II clinical study of STP705 in BCC patients, showing that all five patients achieved 100% histological clearance at the optimal clinical dose of 180μg, achieving complete clearance (CR), indicating the potential feasibility of the therapy. In addition to achieving 100% complete clearance (CR), the group data also showed stable or better cosmetic outcomes, with excellent safety and no significant cutaneous adverse reactions. The results of STP705 in treating BCC further validate the great potential of STP705 in treating non-melanoma skin cancers.

"So far, in multiple clinical studies of STP705, we have achieved significant efficacy and robust safety data," said Dr. Michael Molyneaux, Executive Director and Chief Medical Officer of Sirnaomics. "As we continue to research this promising therapeutic candidate, we will further confirm the most effective dosage and treatment efficacy for isSCC, SCC, and BCC. Non-melanoma skin cancer is affecting millions of people in the United States and globally. Currently, there are only a few non-surgical treatments approved. We have developed market entry and commercialization launch strategies to leverage our injectable treatment to address the limitations of surgical treatments."

Dr. Yang Lu, Founder, Chairman of the Board, Executive Director, President and CEO of Sirnaomics, stated: "The latest results from the Phase IIb study for isSCC and Phase II study for BCC have demonstrated the efficacy of STP705, with no drug-related adverse events (AEs) or serious adverse events (SAEs). This clearly validates the broad potential of STP705 in treating non-melanoma skin cancers. Under the guidance of U.S. FDA regulations and supervision, we are confident in advancing this lead candidate into later-stage clinical development to further explore and evaluate the significant potential of STP705 in treating non-melanoma skin cancers."

About Non-Melanoma Skin Cancer

Non-Melanoma Skin Cancer (NMSC) is one of the most common forms of human tumors. NMSC includes various types of non-melanoma skin cancers, such as Squamous Cell Carcinoma (SCC), Basal Cell Carcinoma (BCC), Extramammary Paget's Disease (EMPD), Merkel Cell Carcinoma (MCC), and cutaneous adnexal tumors. Among these, BCC and SCC account for a higher proportion in NMSC, with an estimated over 5 million new cases annually in the United States. BCC and SCC are the two main subcategories of NMSC. The market size for NMSC treatment in the U.S. is projected to increase from $6.5 billion in 2020 to $22 billion by 2030. In China, the market size of NMSC was $38 million in 2020 and is expected to grow rapidly in the coming years, reaching $149 million by 2030.

The report by the "International Agency for Research on Cancer" authorized by the World Health Organization (2019) showed that the number of men and women worldwide who died from NMSC in 2018 was 65,155, of which the mortality rate of NMSC patients in Asia accounted for 41.9% of the global total, significantly higher than any other single region.

Surgical operation is currently the most common treatment for NMSC, but various forms of surgical procedures can lead to significant skin adverse reactions, scars, infections, and bleeding risks. In view of this, there remains a substantial medical need for safe and effective local injection therapies approved by the US Food and Drug Administration.

AboutSirnaomics

Sirnaomics is an RNA therapeutics biopharmaceutical company with its candidate products in preclinical and clinical stages, focusing on exploring and developing innovative drugs for the treatment of indications with unmet medical needs and significant market opportunities. Sirnaomics is the first clinical-stage RNA therapeutics biopharmaceutical company to hold a strong market position in both China and the United States, and it is also the first company to achieve positive Phase IIa clinical results with its core product STP705, an RNAi therapy in the field of oncology. For more information about the company, please visit:www.sirnaomics.com。