INOVIO Completes Enrollment of Phase 1B Clinical Trial for its DNA Vaccine Candidate Against Lassa Fever, INO-4500, in West Africa
PLYMOUTH MEETING, Pa., Oct. 26, 2021 /PRNewswire/ -- INOVIO announced its Phase 1B clinical trial for INO-4500, its DNA vaccine candidate for Lassa fever, completed full enrollment of 220 participants. This trial (LSV-002 - NCT04093076) is ongoing at the Noguchi Memorial Institute for Medical Research in Accra, Ghana, and is the first vaccine clinical trial for Lassa fever conducted in West Africa, where the viral illness is endemic.
INOVIO is advancing INO-4500 with full funding from CEPI, a global partnership between public, private, philanthropic, and civil society organizations to stimulate and accelerate the development of vaccines against emerging infectious diseases and enable access to these vaccines for people in need during outbreaks. The company was awarded up to US $56 million from CEPI in 2018 under which INOVIO is advancing vaccine candidates against Lassa fever and MERS. INOVIO and CEPI plan to establish a stockpile of these vaccines for emergency use after P2 testing, if successful. As part of CEPI's $3.5B plan to reduce, or even eradicate, the risk of epidemics and pandemics, CEPI's goal is to get a licensed Lassa vaccine for use in endemic countries. The forward-looking strategy also includes the aim to advance clinical trial capacity, infrastructure, and expertise in low- and middle-income countries.
Dr. Laurent Humeau, INOVIO's Chief Scientific Officer, said, "Completing enrollment of LSV-002 is an important milestone for the clinical development of INO-4500, our DNA vaccine candidate against Lassa fever. INOVIO and our partners are committed to addressing this significant unmet public health need, considering the prevalence of the Lassa virus, the potential severity of Lassa fever, and the lack of any licensed vaccines or other treatments for this disease.
We are grateful to CEPI for their support as we work with our partners to advance INO-4500."
Dr. Humeau added, "This milestone represents another example of the progress we are making across INOVIO's infectious disease portfolio, including our late-stage development efforts with INO-4800 against COVID-19 as well as advancements with INO-4700 against MERS."
Dr. Melanie Saville, Director of Vaccine R&D at CEPI, said, "I am delighted to see the rapid progress in enrollment for this pivotal trial to assess the safety and immunogenicity of INOVIO's promising Lassa vaccine candidate in Ghana. At a time when much scientific attention is drawn towards COVID-19, it is critical that we continue to progress research against this potentially fatal disease which affects many countries across the West African region. Data provided by this study will be critical for assessing potential of the candidate to advance into late-stage clinical trials and towards our goal, at CEPI, Lassa vaccine for use in endemic countries."
Professor Dorothy Yeboah-Manu, Director of the Noguchi Memorial Institute for Medical Research (NMIMR) in Ghana, said, "This achievement is another feather in our cap that goes to demonstrate the expertise and dedication of the NMIMR in the global fight against infectious diseases. As a leading biomedical institute in the West African sub region and considering the public health importance of Lassa fever in West Africa, we are happy to be part of INO-4500 development, indeed the fight against these emerging infections requires us to work together and we look forward to such further collaborations."
Professor Kwadwo Koran, the PI for the Noguchi Memorial Institute for Medical Research site in Ghana, said, "It has been exciting working on this trial, a great achievement for the Institute and the country as whole. Personally, I see this as NMIMR continuing in the noble ideals of contributing to solutions for public health problems.
in the sub region. With the successful enrollment, even under the trying conditions engendered by the COVID-19 pandemic for nearly two years now, the Institute and indeed the country as a whole has demonstrated the capacity to be able to conduct early-stage trials in support of product development for emerging and re-emerging diseases such as Lassa Fever. It is my sincere hope that this will be built upon not only for Lassa Fever but other important infections that plague us."
