Inovio Expects Late-Stage COVID-19 Vaccine Trial Data by Second Quarter
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In a fourth quarter 2020 financial results announcement made on Monday, Inovio Pharmaceuticals said it has completed enrollment of 400 participants in its Phase II segment of the INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy) Phase II/III trial, which is investigating the company’s COVID-19 DNA vaccine candidate INO-4800.
According to Inovio, the U.S. Department of Defense (DoD) made the commitment to provide funding for the Phase II and Phase III segments of the INNOVATE trial. This doesn’t include the $71.1 million the DoD said it will provide for the large-scale manufacture of Inovio’s proprietary device CELLECTRA® 3PSP.
"INOVIO recognizes and applauds the incredible work to address the global COVID-19 pandemic across the industry, while also acknowledging the need for continued collaboration and coordination in vaccine development, manufacturing, and distribution, said INOVIO's President and Chief Executive Officer Dr. J. Joseph Kim. “I am also extremely proud of the dedication and efforts of our INOVIO team in contributing to this global endeavor, grateful for the continued support of our partners, and thankful for all Phase 2 participants in our INNOVATE clinical trial for their help in the ongoing fight against the pandemic. We look forward to successfully completing our Phase 2 segment in the second quarter and seeking to advance to the Phase 3 portion of the trial."
Inovio said in their fourth quarter 2020 announcement that it is currently investigating its COVID-19 vaccine’s effects on new and emerging variants of SARS-CoV-2, the novel coronavirus responsible for COVID-19. Additionally, the company said it is currently working on the development of next-generation COVID-19 vaccine candidates that may be tailored to both known and unknown variants of SARS-CoV-2.
Despite the news of the vaccine and its trial enrollment, Inovio shares did not increase following the announcement. Instead, shares in the company were down 3% in extended trading.
Inovio started on the development of INO-4800 in 2020, but not after other companies like Pfizer and Moderna received U.S. authorization for their COVID-19 vaccines. Additionally, the U.S. Food and Drug Administration previously placed a U.S. portion of the study for INO-4800 on hold to examine the vaccine delivery device, further delaying study and development of the COVID-19 vaccine candidate.
Late-stage vaccine trial data is expected by early next quarter, the company said.
Also, Inovio is currently testing IN0-4800’s utility as a seasonal booster shot. According to results from an open-label, Phase I vaccine trial, a total of 93 out of 120 patients have received a third booster shot of the vaccine. The company expects to share immune response data in the second quarter of 2021.
In addition to the COVID-19 vaccine trial news, Inovio also announced that its cervical dysplasia treatment VGX-3100 met primary and secondary goals of regression of abnormal cell growth and clearance of underlying disease-causing virus in the Phase III trial REVEAL 1 trial. No treatment-related serious adverse events (AEs) were reported, and most AEs resolved on their own.
The overall financial results from the company reveal revenue was $5.6 million for the quarter and $7.4 million at the 2020-year end. This was compared to $279,000 and $4.1 million for the same time periods in 2019. Additionally, the company said its total operating expenses were $34.9 million for the quarter and $131.5 million for the year ending on December 31, 2020. In comparison to 2019, the costs were $30.7 million and $115.2 million, respectively.