Sirnaomics Oncology IND Receives Approval from FDA

Sirnaomics announces the U.S. Food and Drug Administration (FDA) has approved the company's first oncology IND application. The IND approval will allow for the study of the company's lead product candidate, STP705, in patients with advanced cholangiocarcinoma (CCA).

Sirnaomics' lead product candidate, STP705, is an anti-cancer/anti-fibrosis siRNA (small interfering RNA) therapeutic. It takes advantage of a dual-targeted inhibitory property and a proprietary polypeptide nanoparticle (PNP)-enhanced delivery system to target cells in the liver. It acts by directly inhibiting tumorigenesis through down regulation of Cancer Associated Fibroblast (CAF) activity and cell proliferation by silencing both TGF-β1 and COX-2 gene expression within the tumor micro-environment. In 2017, STP705 was granted Orphan Drug Designation from the FDA Office of Orphan Products Development (OOPD) for treatment of Cholangiocarcinoma (CCA) and Primary Sclerosing Cholangitis (PSC). The product has also received both US FDA and Chinese FDA IND approval for Hypertrophic Scar Reduction. The dual-targeted approach of STP705 is expected to have efficacy across many diseases in multiple therapeutic areas.

"The green light from the US FDA for Sirnaomics' first oncology IND represents another major milestone for the company's mission in discovery and development of novel siRNA therapeutics for unmet clinical needs. Building on our company's anti-fibrosis therapeutic approach, Sirnaomics' drug target selection and tumor targeting delivery should support a high rate of success for novel anticancer siRNA therapeutics," said the Founder and CEO of the company, Dr. Patrick Y. Lu. "The latest success of Alnylam's Patisiran drug validates the RNAi class of therapeutics and it is our belief that the industry will see great enthusiasm and expanded discovery and development of novel RNAi therapeutics for many disease applications. Sirnaomics is currently in a strong position to lead the RNAi community in the development of novel Oncology and Fibrosis therapeutics."

"Cholangiocarcinoma is a devastating form of liver cancer with very high mortality and no effective therapy. Based on our preclinical data, we are very hopeful that STP705 will have a positive impact on this disease. This IND approval is in line with our mission to target critical diseases with high unmet clinical need," stated Chief Medical Officer, Michael Molyneaux M.D. "We expect that our rigorous clinical study design will enable us to gain great insights into the impact of STP705 on CCA. STP705 is able to achieve excellent uptake by the liver with a very good safety profile and it is expected this study will give us insight into other forms of liver cancer and fibrosis to support further indications in both oncology and fibrosis."

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