GeoVax targets Q4 phase 3 trial for MVA mpox vaccine with EMA expedited pathway

GeoVax Labs (NASDAQ:GOVX) CEO David Dodd tells Proactive that the company is on track to initiate a pivotal phase 3 trial of its GEO-MVA mpox and smallpox vaccine candidate before the end of 2024. The CRO has been hired, trial sites have been identified, and the product has already been manufactured, packaged and released, ready to be administered to humans. Dodd explains that the European Medicines Agency granted GeoVax an expedited regulatory pathway, waiving the requirement for phase 1 and phase 2 clinical trials. Instead, the company only needs to conduct an immunobridging study comparing GEO-MVA against Bavarian Nordic's MVA-BN vaccine in healthy adults, measuring neutralising antibodies and conversion rate. The EMA justified this approach because GeoVax's MVA and Bavarian Nordic's MVA were derived from the same parental cell line, making them equivalent at origin, and because of a critical global supply shortage. Dodd describes a market gap of approximately 15 million doses in annual MVA demand versus what was supplied last year, noting that Bavarian Nordic is at manufacturing capacity with no apparent plans to expand. He says GeoVax aims to be the first additional supplier of MVA vaccine globally. The commercial route to market is through government procurement agencies and national stockpiles rather than a traditional drug launch. Dodd identifies stockpile buyers including the US Strategic National Stockpile, the UK biosecurity entity, Israel, Saudi Arabia, the EU through HERA, and Unicef via the Gavi Vaccine Alliance. He notes the vaccine is relevant not only for mpox but also as a defence against the potential weaponisation of smallpox. Read Proactive's Editorial Policy here: https://www.proactiveinvestors.co.uk/pages/editorialPolicy #GeoVax #GOVX #biotechnology #mpox #smallpox #infectiousdisease #clinicalstage #vaccinestock #biotech #investing