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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 is advancing INO-4500 with full funding from the Coalition for Epidemic Preparedness Innovations (CEPI), a global partnership that leverages funding from public, private, philanthropic, and civil society organizations to support research projects to develop vaccines against emerging infectious diseases. 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). INOVIO and CEPI are committed to making a vaccine available as soon as possible for emergency use as a stockpile product post-Phase 2 testing.

Dr. J. 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. This trial also represents a significant advancement within INOVIO's infectious disease portfolio and further validates the company's DNA medicines platform and proprietary CELLECTRA® delivery device."

Dr. 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. Together, this work plays into broader research efforts led by CEPI to minimize the threat of the disease, including the launch of the largest-ever Lassa fever epidemiology research program launched in West Africa late last year."

Professor Kwadwo A. Koram, Principal Investigator of the clinical trial and head of Noguchi Medical Center, said, "I see this as a great opportunity to use the resources of the Institute for the benefit not only of the country but the sub-region at large. We are grateful to the sponsor, INOVIO Pharmaceuticals, and hope that this will be only the beginning of a long and fruitful collaboration in the fight against infectious diseases."



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