Coronavirus Vaccine Candidate Found 94% Effective
A Pennsylvania based biotechnology company announced positive interim clinical data of INO-4800, its vaccine candidate against the SARS-CoV-2 virus, from the first two Phase 1 clinical trial cohorts.
INOVIO stated 94 percent of Phase 1 trial participants demonstrated overall immune responses at Week #6, after 2-doses of INO-4800, in a preliminary analysis.
In addition, INO-4800 has been selected to participate in a non-human primate (NHP) challenge study as part of the U.S. government's Operation Warp Speed.
Furthermore, INOVIO has expanded its Phase 1 trial to add older participants in additional cohorts and plans to initiate a Phase 2/3 efficacy trial this summer upon regulatory concurrence.
Dr. J. Joseph Kim, President and CEO of INOVIO, said in a press statement, "We look forward to urgently advancing INO-4800, as it is the only nucleic-acid based vaccine that is stable at room temperature for more than a year and does not require to be frozen in transport or for years of storage, which are important factors when implementing mass immunizations to battle the current pandemic."
The Phase 1 clinical trial of INO-4800 initially enrolled 40 healthy adult volunteers 18 to 50 years of age at two U.S. sites. The participants were enrolled in 1.0 mg and 2.0 mg dose cohorts; each participant received two doses of INO-4800 four weeks apart.
Each dose was administered by intradermal injection using INOVIO's CELLECTRA® 2000 device.
An independent Data Safety Monitoring Board reviewed the safety data.
INO-4800 was generally safe and well-tolerated in all participants in both cohorts through week 8; all ten reported adverse events were grade 1 in severity, and most were local injection site redness.
And, there were no reported serious adverse events.
Multiple immunology assays including those for humoral and cellular immune responses are being conducted for both 1.0 mg and 2.0 mg dose cohorts after two doses at week #6.
Analyses to date have shown that 34 out of 36 total trial participants (94%) demonstrated overall immunological response rates based on preliminary data assessing humoral (binding and neutralizing) and T cell immune responses.
INOVIO plans to publish the full data set in a peer-reviewed medical journal.
One key feature of INOVIO's DNA vaccines is the ability to generate balanced antibody and T cell immune responses, which in the case of SARS-CoV-2 infection could be important in the development of potential COVID-19 vaccines.
In this regard, recent scientific reports have highlighted that SARS-CoV-2-specific T cells found in convalescent patients have been positively implicated in controlling the severity of their COVID-19 disease while other studies have shown that a significant proportion (33% to 40%) of convalescent individuals in their reports had neutralizing antibody below detectable levels.
In addition to positive interim Phase 1 data, INO-4800 has been shown to protect mice in SARS-CoV-2 viral challenge studies, where vaccination with INO-4800 prevented viral replication in the lungs of animals challenged with SARS-CoV-2.
Moreover, INO-4800 is currently being tested in a ferret challenge model as well as in NHP challenge studies as part of Operation Warp Speed.
"While the pathophysiologic profile of SARS-CoV-2 is not completely understood, research and clinical studies suggest that both T cell and antibody immune responses will be important for protection in both mild and serious infections," said Dr. Kate Broderick, Senior Vice President of R&D at INOVIO.
“Leveraging our previous expertise in MERS with INO-4700, where we demonstrated significant antibody and cellular responses, the breadth and profile of the responses observed to date with INO-4800 targeting SARS-CoV-2 provide a promising read towards further development and addressing the existing public health threat.”
For more information, visit INOVIO.
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