GeoVax Labs receives favorable European regulatory guidance supporting GEO-MVA

GeoVax Labs (GOVX) announced that it has received positive Scientific Advice, SA, from the European Medicines Agency, EMA, for GEO-MVA, a Modified Vaccinia Ankara, MVA,-based vaccine for the prevention of Mpox and smallpox. The SA supports the suitability of GeoVax’s clinical and nonclinical development strategy. The EMA’s Committee for Medicinal Products for Human Use, CHMP, confirmed the adequacy of GeoVax’s proposed non-clinical immuno-bridging and toxicity studies to support progression to a Phase 3 study and MAA, assuming no unexpected findings occur. They also confirmed Phase 1 and Phase 2 trials could be omitted and that a single, robustly designed Phase 3 immuno-bridging trial against the approved MVA vaccine, if successful, would be sufficient to support an MAA for GEO-MVA via the centralized procedure. The CHMP also agreed with the Company’s proposed immunogenicity endpoints in order to demonstrate non-inferiority. eoVax believes this guidance represents a potentially significant acceleration in the regulatory approval timeline.