Sino-US small interfering RNA (siRNA) specialist Sirnaomics (HKG: 2257) has revealed that its lead pipeline candidate STP707 has produced strong early safety and efficacy data in a Phase I clinical trial. STP707, which is comprised of two siRNA oligonucleotides targeting TGF-β1 and COX-2 mRNA and formulated in a peptide nanoparticle carrier, is under assessment as a treatment for various metastatic solid tumor types.
Phase I Trial Design and Results
In the Phase I multi-center, open-label, dose-escalation and dose-expansion study, 20 patients have so far been recruited in the dose-escalation stage, administered STP707 intravenously in 3 mg, 6 mg, 12 mg, 24 mg, and 48 mg dosing cohorts over a 28-week cycle. The interim analysis involves subjects from the 3 mg, 6 mg, and 12 mg dosing cohorts, producing ‘strong’ safety and efficacy data.
Preclinical Findings and Future Prospects
In preclinical studies, STP707 has demonstrated that simultaneously knocking down TGF-β1 and COX-2 gene expression in the tumor microenvironment increases active T cell infiltration. The molecule has also shown signs of producing synergistic effects in combination with a PD-L1 antibody. These promising results position Sirnaomics to further advance STP707 through clinical development, addressing significant unmet medical needs in the treatment of metastatic solid tumors.-Fineline Info & Tech
