Sirnaomics gets FDA approval for tumor treatment t

Daily Record Staff//July 6, 2021//

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Sirnaomics Inc., the Gaithersburg biopharmaceutical company in discovery and development of RNAi therapeutics, announced Tuesday that its IND application for a systemic siRNA (small interfering RNA) drug candidate, STP707, received the U.S. Food and Drug Administration (FDA) acknowledgment “Study May Proceed” in patients with advanced solid tumors.

This “Phase 1 Multicenter, Open-Label, Dose Escalation Study and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of STP707 Administered Intravenously in Subjects with Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy” is expected to begin enrolling in coming months.

Sirnaomics’ lead product candidate, STP707, is an anti-cancer siRNA (small interfering RNA) therapeutic. It takes advantage of a dual-targeted inhibitory property and a proprietary polypeptide nanoparticle (PNP)-enhanced targeted delivery to solid tumors and metastatic tumors via systemic administration. Initial preclinical study has demonstrated that knocking down TGF-β1 and COX-2 gene expression simultaneously in tumor microenvironment increases active T cell infiltration. A further combination study demonstrated a synergistic antitumor activity between STP707 and PD-L1 antibody using a mouse orthotopic liver cancer model.