On Apr. 23, 2021, Inovio Pharma announced that it was planning for a predominantly ex-U.S. Phase 3 trial for its COVID-19 vaccine candidate, INO-4800. Given the increasing availability of vaccines authorized for emergency use, the Department of Defense announced that was discontinuing funding for the Phase 3 segment of the INNOVATE trial, while continuing to fund the completion of the ongoing Phase 2 segment.

This decision does not impact other work that INOVIO does with the US government and is neither a result of the partial clinical hold nor a reflection of the data generated to date for INO-4800 vaccine. With existing global collaborators such as INOVIO’s China partner, Advaccine, and the International Vaccine Institute (IVI,) the company is planning for a predominantly ex-US global Phase 3 trial based on upcoming evaluation of Phase 2 safety and immunogenicity data. INOVIO continues to evaluate its pan-COVID variant vaccine, INO-4802, to protect against current and future variants of concern, as well as assessing boosting capabilities for INO-4800. INOVIO remains well-positioned to support both pandemic and endemic vaccine needs with INO-4800 and INO-4802. INOVIO and its partners and collaborators look forward to being part of the global solution to prevent the spread of COVID-19 – including both current and future variants.

INO-4800 is INOVIO’s DNA vaccine candidate against SARS-CoV-2, the coronavirus that causes COVID-19. INOVIO has extensive experience working with coronaviruses and was the first company to initiate a Phase 2a trial for INO-4700, a DNA vaccine candidate for a related coronavirus that causes Middle East Respiratory Syndrome (MERS).

Composed of an optimized DNA plasmid, INO-4800 is delivered directly into cells in the body via a proprietary smart device to produce a robust and tolerable immune response. INO-4800 is the only nucleic-acid based vaccine that is stable at room temperature for more than a year, at 37°C for more than a month, has a five-year projected shelf life at normal refrigeration temperature and does not need to be frozen during transport or storage – all of which are important considerations when preparing for mass immunizations.

INOVIO has 15 DNA medicine clinical programs currently in development focused on HPV-associated diseases, cancer, and infectious diseases, including coronaviruses associated with MERS and COVID-19 diseases being developed under grants from the Coalition for Epidemic Preparedness Innovations (CEPI) and the U.S. Department of Defense. DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA that are synthesized or reorganized by a computer sequencing technology and designed to produce a specific immune response in the body.