- Inovio Pharmaceuticals Inc (NASDAQ: INO) has announced positive data from the Phase 2 segment of its Phase 2/3 INNOVATE trial in the U.S., evaluating INO-4800, its DNA vaccine candidate for COVID-19.
- The Phase 2 segment of the trial enrolled approximately 400 participants, 18 years of age or older.
- Preliminary results show that INO-4800 was generally safe, well-tolerated, and immunogenic in all studied age groups in a larger population.
- Safety endpoints included systemic and local administration site reactions through 8 weeks post-dose one (or 4 weeks post-dose 2).
- Immunology endpoints included antigen-specific binding antibody titers, neutralization titers, and antigen-specific interferon-gamma (IFN-γ) cellular immune responses after two doses of the vaccine.
- Vaccine administration was generally safe and well-tolerated. The majority of adverse events were mild and moderate in severity and did not appear to increase in frequency with the second dose.
- The geometric mean fold rise (GMFR) of binding and neutralizing antibody levels were statistically significantly greater in the 2.0 mg dose group versus the 1.0 mg dose group.
- The T cell immune responses measured by the ELISpot assay were also higher in the 2.0 mg dose group compared to the 1.0 mg dose group.
- "The expanded data set enabled a clear dose selection to be made with 2.0 mg as the dose for the global Phase 3 efficacy trial," said Dr. Laurent M. Humeau, INO's Chief Scientific Officer.
- Price Action: INO shares are down 2.04% at $6.70 on the last check Monday.
Inovio's DNA COVID-19 Vaccine Candidate Triggers Immune Response In Pivotal Study