Sirnaomics has dosed the first subject in Phase I clinical trial of its drug candidate, STP705, for the treatment of liver cancer in the US.
A small interfering ribonucleic acid drug, STP705 leverages a dual-targeted inhibitory property and polypeptide nanoparticle-boosted delivery to target gene expression of TGF-β1 and COX-2.
Increased expressions of TGF-β1 and COX-2 are known to play major regulatory roles in tumour development.
The multi-centre, open-label, dose-escalation and dose-expansion Phase I trial will assess the safety, tolerability, pharmacokinetics and anti-tumour activity of intratumoral doses of STP705.
This ‘basket study’ will enrol up to 50 participants with cholangiocarcinoma, hepatocellular carcinoma, or liver metastases from colorectal cancer.
It will have subjects with advanced/metastatic or surgically unresectable solid tumours and those who are refractory to standard treatment.
Sirnaomics intends to report preliminary results from the Phase I trial in the second half of this year.
Sirnaomics founder, president and CEO Patrick Lu said: “Advancing STP705 from skin cancer to liver cancer is a major milestone for Sirnaomics’ clinical programmes, especially with a basket study design that consists of multiple tumour types.
“We are particularly interested in learning whether the mechanism of action validated in the skin cancer clinical study can be further verified in this liver cancer study.”
The US Food and Drug Administration granted orphan drug status to STP705 for the treatment of hepatocellular carcinoma and cholangiocarcinoma.
In prior pre-clinical and clinical studies, STP705 demonstrated the ability to enhance the infiltration of active T cells into the tumour microenvironment.
Eradicating TGF-β1 and COX-2 gene expressions in animal fibrosis tissue can induce fibroblast apoptosis with substantial antifibrotic effectiveness, the company added.
In April this year, Sirnaomics commenced a Phase IIb study to evaluate the safety and efficacy of STP705 to treat patients with squamous cell skin cancer.