Inovio Pharmaceuticals, Inc.
INO announced today the peer-reviewed publication of results from
two phase I trials (HVTN 070 and HVTN 080) of its PENNVAX^®-B preventive HIV
DNA vaccine delivered with a DNA adjuvant and with or without Inovio's
proprietary CELLECTRA^® electroporation delivery device. The studies were
conducted by the HIV Vaccine Trials Network (HVTN). Inovio's HIV DNA vaccine
together with the CELLECTRA device significantly increased the number of
responders producing robust and durable CD4 and CD8 T-cell responses in
humans. The observation of robust T-cell responses against distinct targeted
diseases generated by different Inovio SynCon® DNA vaccines delivered using
CELLECTRA electroporation technology have now been published in two respected
peer-reviewed journals. These results are compelling because T-cells are
considered critical to fighting cancers and chronic infectious diseases.
While Inovio previously released preliminary data from these two trials, this
comparison and durability data was published in the peer-reviewed Journal of
Infectious Diseases in the article, "Safety and comparative immunogenicity of
an HIV-1 DNA vaccine in combination with plasmid IL-12 and impact of
intramuscular electroporation for delivery." The lead author was Dr. Spyros
Kalams, who is Associate Professor of Medicine, Vanderbilt University Medical
Center and principal investigator of Vanderbilt's HIV Vaccine Trials Unit for
both clinical studies.
Robust T-cell responses were generated in 89% of the subjects that received
three vaccinations of PENNVAX-B, which consists of 1 mg of each of three DNA
plasmids (encoding for HIV gag, pol, and env proteins) along with 1 mg of
IL-12 DNA plasmid, followed by intramuscular electroporation with Inovio's
CELLECTRA device. Three or four vaccinations with a 2 mg dose of each
PENNVAX-B plasmid plus 1.5 mg of IL-12 DNA generated fewer responses when
delivered without electroporation.
Comparative T-Cell Response Rates:
PENNVAX-B Plus DNA IL-12 With and Without CELLECTRA Electroporation (EP)
Regimen CD4 CD8
Half dose, 3 vaccinations, with EP 80.8% (21/26) 51.9% (14/27)
Full dose, 3 vaccinations, without EP 19.2% (5/26) 6.9% (2/29)
Full dose, 4 vaccinations, without EP 40.7% (11/27) 3.6% (1/28)
Notably, using only half the vaccine dose, and only three doses as compared to
four, CELLECTRA electroporation generated a 45% point increase (7% to 52%) in
the generation of CD8 T-cells compared to the subjects that received a full
dose without electroporation. In the three-vaccination regimen with
electroporation, 88.9% (24/27) of subjects developed a robust CD4 or CD8
response. Six months after vaccination, T-cell response rates remained strong
and persistent in the subjects that received only three doses delivered by
CELLECTRA EP. Of 24 positive CD4 or CD8 T-cell responders following the third
and last vaccination in month 3, 79% (19/24) showed persistent CD4 or CD8
T-cell responses at month 9. There were no safety issues observed when
Inovio's DNA vaccine for HIV was co-administered with IL-12 DNA and delivered
using electroporation with CELLECTRA.
CD4 and CD8 T-cells are both important in cellular immunity, however, CD8
T-cells are considered especially integral to fighting cancers and chronic
infectious diseases. Achieving a robust CD8 T-cell response in a significant
number of patients, i.e. a significant response rate, has been a particular
challenge for HIV researchers. In this study, PENNVAX-B generated CD8 T-cell
responses with significant magnitude (as measured by the validated HVTN
assay).
In other study arms that did not achieve statistical significance, the use of
IL-12 DNA appeared to positively impact T-cell response rates. The increased
response rate only occurred when IL-12 DNA was delivered with electroporation.
This effect may be further investigated in future studies of Inovio DNA
vaccines delivered with electroporation.
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