INOVIO Announces First Subject Dosed in Phase 1B Clinical Trial for its DNA Vaccine Against Lassa Fever, INO-4500, in West Africa - Yahoo Finance

Phase 1B clinical trial is first study for Lassa fever conducted in Africa.

23, 2021 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, today announced the first participant was dosed in a Phase 1B clinical trial for INO-4500, its DNA vaccine candidate for Lassa fever, in Ghana.

The Phase 1B clinical trial (LSV-002), ongoing at the Noguchi Memorial Institute for Medical Research in Accra, Ghana, is the first vaccine clinical trial for Lassa fever to be conducted in West Africa, where the infection is endemic.

INO-4500 is also the first vaccine candidate for Lassa fever to enter human trials.

INOVIO previously received a $56 million grant from CEPI in 2018, under which the company is developing vaccine candidates for Lassa fever and Middle East Respiratory Syndrome (MERS).

Joseph Kim, President and CEO of INOVIO, said, "We have observed that INO-4500 vaccination generates robust antibody and T cell immune responses in a Phase 1 clinical trial conducted in the U.S., and this continued advancement of INO-4500 into Phase 1B trial is another important step in a fight against Lassa fever.

Kim added, "This is the same device being used to deliver our DNA vaccine candidate, INO-4800, in the Phase 2 segment of our INNOVATE Phase 2/3 COVID-19 trial.

We are grateful to CEPI for the continued support and confidence in our vaccine programs – and we look forward to advancing INO-4500 as a vaccine candidate against Lassa fever.".

Dr Melanie Saville, Director of Vaccine R&D at CEPI, said, "We are delighted to see our partner INOVIO launch the first-ever Lassa vaccine trial on the African continent, with today's announcement marking an important milestone in the fight against this deadly hemorrhagic fever.

With the emerging infectious disease remaining a serious public health threat across West Africa, including Ghana, it is crucial that populations can participate in vaccine trials to ensure sufficient data is generated so that they can be confidently rolled out in outbreak-prone areas in the future, dependent on safety and immunogenicity testing.

About INOVIO's Phase 1B Clinical Trial for INO-4500.

Specifically, INOVIO's lead candidate VGX-3100, currently in Phase 3 trials for precancerous cervical dysplasia, destroyed and cleared high-risk HPV 16 and 18 in a Phase 2b clinical trial.

Also in development are programs targeting HPV-related cancers and a rare HPV-related disease, recurrent respiratory papillomatosis (RRP); non-HPV-related cancers glioblastoma multiforme (GBM) and prostate cancer; as well as externally funded infectious disease DNA vaccine development programs in Zika, Lassa fever, Ebola, HIV, and coronaviruses associated with MERS and COVID-19 diseases.

Partners and collaborators include Advaccine, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations (CEPI), Defense Advanced Research Projects Agency (DARPA)/Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND)/Department of Defense (DoD), HIV Vaccines Trial Network, International Vaccine Institute (IVI), Kaneka Eurogentec, Medical CBRN Defense Consortium (MCDC), National Cancer Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Ology Bioservices, the Parker Institute for Cancer Immunotherapy, Plumbline Life Sciences, Regeneron, Richter-Helm BioLogics, Thermo Fisher Scientific, University of Pennsylvania, Walter Reed Army Institute of Research, and The Wistar Institute.

The aim is to advance COVID-19 vaccine candidates into clinical testing as quickly as possible.