DARPA’s investments look well spent as expanded clinical trial results are confirmed.
Inovio’s Vice President of Clinical Development, Dr. Scott White, presented favorable data on expanded Phase 1 clinical study results for EBOV-001, at the Vaccine World Vaccine Congress in Washington, D.C. on April 11.
The expanded study, said Inovio, examined different regimens of its Ebola DNA vaccine INO-4201 using intradermal (skin) administration. The results across both stages of the trial, including both intramuscular and intradermal delivery, demonstrated that 95% (170/179) of evaluable subjects generated an Ebola-specific antibody immune response, with the mean antibody titer comparable or superior to those reported from viral vector-based Ebola vaccines.
Dr. J. Joseph Kim, Inovio’s president & CEO explained “This response rate mirrors the high response rates we recently reported from our MERS and Zika clinical studies, reinforcing Inovio’s ability to rapidly design and construct vaccines against emerging global infectious diseases.” With strong results from 200 subjects and positive preliminary preclinical data from several animal species said Kim, “We plan to meet with regulators this year regarding a path forward for the licensure of our Ebola product.”
According to Inovio, its expanded Phase 1 study showed its DNA-based Ebola vaccine was well-tolerated with a favorable safety profile compared to viral vector-based Ebola vaccines, including some associated with serious side effects including myalgia, arthralgia, fever, and rash. The company said their faster construct design, ability to continue to boost immune responses, protection with additional administrations, easier scalability of manufacturing and better product thermal stability make DNA vaccines an attractive platform to rapidly respond to emerging global infectious diseases.
Inovio’s Ebola vaccine program is being funded by a $45 million contract with DARPA (Defense Advanced Research Projects Agency) to develop an Ebola vaccine and a DNA-based monoclonal antibody therapy. Inovio said a more detailed data set and analysis from this study is being prepared for publishing in a peer-reviewed journal.