Sirnaomics Ltd (HKG: 2257) is advancing the clinical development of STP705 following positive results from a Phase IIb study in cutaneous squamous cell carcinoma in situ (isSCC) and a Phase II study in basal cell carcinoma (BCC). The company is actively engaging with the US FDA to finalize the protocol, according to a recent press release. Additionally, Sirnaomics has outlined a commercialization plan for the drug, highlighting its commitment to bringing the therapy to market.
STP705: Mechanism and Development
STP705 is a small interfering RNA (siRNA) therapeutic that leverages a dual-targeted inhibitory mechanism and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down the expression of both TGF-β1 and COX-2 genes. This innovative approach has garnered multiple Investigational New Drug (IND) approvals from the US FDA and China’s National Medical Products Administration (NMPA) for indications including cholangiocarcinoma, non-melanoma skin cancer, and hypertrophic scarring. The drug has also received orphan drug designations (ODDs) for use in cholangiocarcinoma and primary sclerosing cholangitis.
Clinical Trial Results
Positive results from the Phase II and Phase IIb studies were published in August and December of last year, respectively. These findings demonstrated the therapeutic potential of STP705 in treating cutaneous cancers, positioning it as a promising candidate for further clinical development and eventual commercialization.-Fineline Info & Tech
