PLYMOUTH MEETING, Pa.—Inovio Pharmaceuticals Inc. revealed today that its Ebola vaccine INO-4201 has been found safe and tolerable, and has generated strong T cell and antibody responses. This Phase 1 data was recently published in The Journal of Infectious Diseases, and further supports the advancement of the intradermal delivery platform for emerging infectious diseases. The article, entitled, “Intradermal SynCon Ebola GP DNA Vaccine is Temperature Stable and Safely Demonstrates Cellular and Humoral Immunogenicity Advantages in Healthy Volunteers,” was authored by Inovio and its collaborators.
The study demonstrated that intradermal administration with Inovio’s CELLECTRA delivery device resulted in 100% of evaluable subjects generating antigen-specific antibody responses that persisted for more than one year in most subjects, and generated T cell responses equivalent to or better than the group that received intramuscular delivery. The published data further validates the safety, potency and product stability advantages of Inovio’s vaccine and immunotherapy platform.
“INO-4201 has already demonstrated protection in 100% of non-human primates following a challenge with a lethal dose of the Ebola virus. With strong preclinical and human data, Inovio is executing on our overall development strategy in advancing INO-4201 as a viable stockpile vaccine,” said Dr. J. Joseph Kim, Inovio’s president and CEO. “Because Inovio’s Ebola vaccine can be used to protect against Ebola infection and can be boosted multiple times without any anti-vector response, it could be employed to boost viral vector vaccines that cannot be effectively re-administered. We now look to secure partner funding to further advance our Ebola vaccine as a stand-alone vaccine as well as a boost for those previously immunized with viral vector vaccines.”
Unlike viral vector vaccines, which must be kept frozen, INO-4201 is stable at room temperature for more than one year. Non-live vaccine approaches that are simple to deliver and stable at room temperature are desirable in controlling Ebola virus outbreaks.
Inovio’s Ebola vaccine was evaluated in five groups of healthy subjects. Of 70 evaluated subjects, 67 (96%) seroconverted and mounted a strong antibody response to the Ebola glycoprotein antigen following the three dose immunization regimen; 52 subjects (76%) seroconverted after only two doses. Significantly, in the study arm using intradermal administration, all 13 evaluable subjects generated antigen-specific antibody responses after only two doses, and all remained seropositive after three immunizations.
To date INO-4201 has been well-tolerated, and has not demonstrated systemic serious adverse effects such as fever, joint pain and low white blood cell counts, which have been reported in association with some viral vector-based Ebola vaccines currently in development.