Sirnaomics

Sirnaomics is a biopharmaceutical company engaged in the discovery and development of RNA therapeutics. The company focuses on innovative drugs for indications with unmet medical needs and large market opportunities. Sirnaomics utilizes two proprietary delivery platforms: the Polypeptide Nanoparticle Formulation (PNP) and the second generation of GalNAc conjugates called GalAhead.

Sirnaomics has established a robust pipeline of drug candidates, with several products in clinical and preclinical stages. The company's lead clinical product, STP705, has demonstrated positive results in Phase II clinical trials for the treatment of squamous cell carcinoma in situ (isSCC) and basal cell carcinoma (BCC). Additionally, STP705 is being explored for focal fat reduction in the medical aesthetics field. Another promising candidate, STP707, is a PNP formulation consisting of two siRNAs targeting TGF-β1 and COX-2 for intravenous treatment of solid tumors. STP707 has shown promising results in a Phase I basket clinical study, exhibiting stable disease response in 74% of evaluable patients.

Sirnaomics achieved a significant milestone by advancing STP122G, the first candidate utilizing the GalAhead technology, into clinical development. STP122G targets Factor XI for anticoagulation therapeutics and is currently undergoing Phase I clinical trials.

In March 2023, Sirnaomics' subsidiary, RNAimmune, received IND clearance from the FDA to initiate a Phase I clinical trial for RV-1770, an mRNA vaccine targeting respiratory syncytial virus (RSV). Additionally, RNAimmune obtained FDA clearance for a SARS-CoV-2 vaccine booster candidate, RV-1730.

Sirnaomics has established its manufacturing facility in China, enabling the transition from a biotech company to a biopharmaceutical corporation. The facility has successfully produced a full GMP batch of STP707 for human injection and is expected to support the company's clinical pipeline.

In July 2024, Sirnaomics announced the completion of IND-enabling studies for STP125G, an siRNA therapeutic targeting Apolipoprotein C3 (ApoC3) for the treatment of cardiovascular diseases. The positive results from non-human primate studies support the filing of an IND with the FDA.