Sirnaomics Receives IND Clearance from the Taiwan Ministry of Health and Welfare
for Phase I Clinical Study of RNAi Therapeutic STP705 for Liver Cancer Treatment
Gaithersburg, MD, USA and Suzhou BioBay, China, July 26, 2022 — Sirnaomics Ltd. (the “Company” or “Sirnaomics”, stock code: 2257.HK), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, announced today that the Company has received regulatory clearance from the Taiwan Ministry of Health and Welfare (TMHW) of its Investigational New Drug (IND) application to commence a Phase I trial of STP705, siRNA (small interfering RNA) drug candidate, for the treatment of patients with advanced liver tumors.
The Phase I multicenter, open-Label, dose escalation study in Taiwan is part of a global study of STP705 designed to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity. STP705 is administered intratumorally for cholangiocarcinoma, hepatocellular carcinoma, or liver metastases in subjects with advanced/metastatic or surgically unresectable solid tumors who are refractory to standard therapy. The study was started in the United States in March 2021, and the study in Taiwan is expected to begin enrolling in the coming months.
“The IND green light in Taiwan for STP705 represents a major milestone for the Company’s expansion of its clinical studies into Asia,” said Dr. Patrick Lu, founder, chairman of the Board, Executive Director, President and CEO of Sirnaomics. “We believe that the study results in Taiwan will strengthen the body of data in a multicenter global trial, which will also include a future study in the mainland China. Sirnaomics is currently in a strong position to lead the way in RNAi therapeutics for the development of novel oncology therapies.”
“This IND approval will allow more opportunities to manage critical diseases such as liver cancer with high unmet clinical need in Taiwan and the region,” stated Steven Long, Ph.D. Sirnaomics Chief Development Officer. “Taiwan’s regulatory bodies and clinical testing hospitals are well known for meeting international standards. We expect to conduct more oncology clinical studies in Asia-Pacific regions in the coming years.”
STP705 is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA respectively, formulated in nanoparticles with a Histidine-Lysine Co-Polymer (HKP) peptide as the carrier. Each individual siRNA was demonstrated to inhibit the expression of the target mRNA, and combining the two siRNA’s produces a synergistic effect that diminishes pro-inflammatory factors. Over-expressions of TGF-β1 and COX-2 have been well-characterized in playing key regulatory roles in tumorigenesis.
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. Sirnaomics is the first clinical-stage RNA therapeutics company to have a strong presence in both China and the United States, and also the first company to achieve positive Phase IIa clinical outcomes in oncology for an RNAi therapeutic for its core product, STP705. Learn more atwww.sirnaomics.com.
Michael Molyneaux, MD, MBA
Executive Director and Chief Medical Officer, Sirnaomics
Chief Financial Officer, China, Sirnaomics
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