Inovio Pharma (INO) Announces Online Preprint Publication of Homologous Boosting Data for its COVID-19 DNA Vaccine Candidate, INO-4800

October 12, 2021 8:12 AM EDT

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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, cancer, and HPV-associated diseases, today announced the online preprint publication in MedRxiv of Phase 1 clinical data on homologous boosting of its COVID-19 DNA vaccine candidate, INO-4800.

The paper, titled "SARS-CoV-2 DNA Vaccine INO-4800 Induces Durable Immune Responses Capable of Being Boosted in a Phase 1 Open-Label Trial," found that among the full Phase 1 cohort of 120 participants – of which 82.5%, or 99 participants, received a booster (or third) dose – INO-4800 produced robust immune responses and was well-tolerated as both a two-dose series and as a homologous booster dose in all adults, including participants 65 years of age and older. Of note, a durable antibody response was observed six months following the second dose, and a homologous booster dose administered 6 to 10.5 months following the second dose also significantly increased antibody and T cell responses. INO-4800 was well-tolerated, with no treatment-related serious adverse events reported. Most adverse events were mild in severity and did not increase in frequency with age and subsequent dosing.

Dr. J. Joseph Kim, President and CEO of INOVIO, said, "We are pleased to share the clinical data on the homologous boosting of INO-4800, as well as for our full Phase 1 cohort. As much of the world's population remains unvaccinated and susceptible to COVID-19, there remains an urgent need for additional safe and effective vaccines that are affordable, scalable and can be distributed to countries where the infrastructure may not be supportive of ultra-cold chain transport and storage. We believe that INO-4800, if approved, will be well suited to support the continued fight against COVID-19 – both as a primary vaccination and as a booster. We look forward to contributing to the international public health knowledge base via our global Phase 3 clinical trial."

The detailed trial write-up can be found at: - the preprint server for Health Sciences.

The newly reported results are consistent with previously shared data from the Phase 2 segment of INOVIO's INNOVATE clinical trial. Advancing in its efforts in the fight against COVID-19, INOVIO, with partner Advaccine, recently announced that it has received regulatory authorization from Mexico, Brazil, Colombia, and the Philippines to proceed with the global Phase 3 segment of INNOVATE.

INOVIO also announced in August that it had received the authorization from China to proceed with two Advaccine-sponsored clinical trials investigating the safety, tolerability, and immunogenicity of heterologous boost combinations with INO-4800 and an inactivated COVID vaccine.

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