Oncovir — Department of Health and Human Services SBIR Phase I: DESCRIPTION (provided by applicant): Hiltonol (poly-ICLC) is a stabilized dsRNA therapeut
Oncovir — SBIR Phase I award from Department of Health and Human Services.
- Amount
- $225,000
- Agency
- Department of Health and Human Services · National Institutes of Health
- Program / Phase
- SBIR · Phase I
- Solicitation
- PA13-234
- NAICS
- —
- Place of performance
- DC
- Period
- —
Description
DESCRIPTION (provided by applicant): Hiltonol (poly-ICLC) is a stabilized dsRNA therapeutic viral mimic or 'danger signal' that activates multiple elements of innate and adaptive immunity. It is a standalone immunomodulator, but when properly combined with antigen it generates a comprehensive Th-1 weighted immune response best suited for antiviral and antitumor action. This project will combine Hiltonol with cancer patients' own tumor antigens in-situ to generate a comprehensive systemic immune response against the tumor and its metastases. Objectives: 1) To determine the safety of intratumoral (IT) Poly-ICLC. 2) To explore efficacy as manifested by irRC defined disease control and progression-free survival at 26 weeks. Secondary objectives are overall survival and immunologic response in blood and tumor biopsy, including immunoscore. Indications/Tumor groups: 1) Unresectable stage 3b, 3c or IV, M1a or M1b melanomas that are accessible to IT injections 2) Unresectable head and neck cancers that are ac