INOVIO, a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, announced the publication of peer-reviewed Phase 1 clinical data from the first cohort of 40 participants for its COVID-19 DNA vaccine candidate, INO-4800, in EClinicalMedicine, an open access clinical journal published by The Lancet.
The paper, titled "Safety and immunogenicity of INO-4800 DNA vaccine against SARS-CoV-2: a preliminary report of an open-label, Phase 1 clinical trial," found that INO-4800 was immunogenic in all vaccinated subjects, effectively generating an immune response of humoral (including neutralizing antibodies) and/or cellular responses (both CD4 and CD8 T cells).
Additionally, Phase 1 clinical data found INO-4800 to have a favorable safety and tolerability profile with no serious adverse events reported; only six Grade 1 adverse events (AEs) were observed, primarily minor injection site reactions. Notably, these only occurred on the day of the first or second dosing, and the AEs did not increase in frequency with the second administration.
INO-4800, beyond being safe and tolerable, is stable at room temperature for more than a year, at 37o C (98.6o F) for more than a month, has a five-year projected shelf life at normal refrigeration temperature [i.e., at 2-8o C / 35.6 – 46.4o F] and does not need to be frozen during transport or storage – all critical factors for timely global distribution in the fight against COVID-19.
Dr. J. Joseph Kim, President and CEO of INOVIO, said, "We are very pleased to share peer-reviewed Phase 1 clinical data for INO-4800 published in The Lancet's EClinicalMedicine, and are grateful for the support of all participants and investigator staff involved in the clinical trial."
Dr. Stanley Plotkin, Professor Emeritus at The Wistar Institute, said, "INOVIO's DNA vaccine appeared to be quite safe with few significant reactions but yet induced both antibody and T cell responses to SARS-CoV-2."
Findings from the Phase 1 Clinical Trial
The Phase 1 clinical trial of INO-4800 initially enrolled 40 healthy adult volunteers, ages 18 to 50, at two U.S. sites with funding from the Coalition for Epidemic Preparedness Innovations (CEPI).
The participants were enrolled into 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 proprietary smart device CELLECTRA®.
Thirty-nine subjects completed both doses. One subject in the 2.0 mg group discontinued trial participation prior to receiving the second dose due to lack of transportation to the clinical site; discontinuation was unrelated to the study or the dosing. One subject was deemed to be seropositive at trial entry.
The 1.0 mg and 2.0 mg dose group both demonstrated seroconversion in 95% of the subjects, respectively, with 78% demonstrating neutralizing antibodies in the 1.0 mg dose group and 84% demonstrating neutralizing antibodies in the 2.0 mg dose group.
Cellular (T cell) response were observed to multiple regions of the spike protein including the RBD region. 74% had measurable cellular responses at the 1.0 mg dose group and 100% of the subjects in the 2.0 mg dose group demonstrated cellular responses.
Through week 8, no serious adverse events were reported. Only 6 related Grade 1 adverse events in 5 subjects were observed, primarily mild injection site reactions (e.g., redness); none of these increased in frequency with the second administration.
All 38 subjects who were evaluable for immunogenicity had balanced cellular and humoral immune responses following the second dose of INO-4800.
ClinicalTrials.gov identifier: NCT04336410.
INOVIO is currently conducting the Phase 2 segment of its planned Phase 2/3 clinical trial for INO-4800, called INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy). INNOVATE is a randomized, blinded, placebo-controlled safety and efficacy trial of I...
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