Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that its
HIV vaccine, PENNVAX®-GP, produced amongst the highest overall
levels of immune response rates (cellular and humoral) ever
demonstrated in a human study by an HIV vaccine. The vaccine
candidate, PENNVAX-GP, consists of a combination of four HIV
antigens designed to cover multiple global HIV strains and generate
both an antibody (humoral) immune response as well as a T cell
(cellular) immune response to both potentially prevent and treat
HIV.
These preliminary results are from a study
supported by the HIV Vaccine Trials Network (HVTN) and the National
Institute of Allergy and Infectious Diseases (NIAID), part of the
National Institutes of Health (NIH) in collaboration with Inovio.
The study evaluated a four-dose regimen of PENNVAX-GP DNA vaccine
administered by intradermal (ID) or intramuscular (IM)
administration in combination with a DNA encoded immune activator,
IL-12 (INO-9012). Overall, 71 of 76 (93%) evaluable vaccinated
participants showed a CD4+ or CD8+ cellular immune response to at
least one of the vaccine antigens (env A, env C, gag, or pol).
Similarly, 62 of 66 (94%) evaluated participants demonstrated an
env specific antibody response. None of the placebo recipients (0
of 9; 0%) demonstrated either a cellular or an antibody response in
the study. Notably, amongst the participants receiving PENNVAX-GP
vaccine and IL-12 with intradermal immunization, 27 of 28 (96%)
participants demonstrated a cellular response and 27 of 28 (96%)
demonstrated an HIV env specific antibody response.
Amongst the evaluated participants receiving
PENNVAX-GP and IL-12 via IM vaccination, 27 of 27 (100%)
demonstrated a cellular response and 19 of 21 (90%) demonstrated an
env specific antibody response. Similar immune responses and
response rates were achieved via both ID and IM administration of
the vaccine although participants vaccinated via intradermal
vaccine administration received 1/5th the dose of vaccine compared
to those vaccinated via intramuscular administration.
This breakthrough data was presented at a
plenary session at the 2017 HVTN Spring Full Group Meeting on May
23 in Washington, D.C. by the Protocol Co-Chair of the HVTN 098
study, Dr. Stephen De Rosa, Research Associate Professor,
Laboratory Medicine at the University of Washington and Fred
Hutchinson Cancer Research Center. The HVTN 098 trial was the first
clinical study of PENNVAX-GP. The randomized, placebo-controlled
multi-center study enrolled 94 subjects (85 vaccine and 9 placebo)
to characterize and optimize PENNVAX-GP immunization regimens
delivered through vaccinations using either intramuscular or
intradermal delivery.
Dr. De Rosa, said, “The preliminary results of
HVTN 098 are remarkable for a number of reasons. In HVTN 098,
nearly all individuals vaccinated with the regimens including IL-12
had detectable CD4 responses and over half had CD8 T cell
responses. Similarly, the antibody response rate was 100% or close
to 100% for several of the env antigens tested in the assay. Thus,
these high response rates are exceptional. Further studies will be
needed to determine if this vaccine candidate can safely and
effectively prevent HIV infection.”
Dr. J. Joseph Kim, Inovio’s President & CEO,
said, “These results are among the highest ever responses
we’ve seen with an HIV vaccine, and they are remarkably consistent
with our recent data reported from our Ebola, Zika and MERS
clinical trials in terms of demonstrating nearly 100% vaccine
response rates with very favorable safety profile. Furthermore, our
newer and more tolerable intradermal vaccine delivery device showed
that we can elicit very high immune responses at a much lower dose.
We look forward to advancing PENNVAX-GP into later-stage clinical
development with our partners and collaborators.”
Development of Inovio’s PENNVAX-GP
immunotherapy, which widely targets multiple major clades of HIV —
providing global coverage — has been funded through a $25 million
NIAID contract previously awarded in 2009 to Inovio and its
collaborators. In addition, Inovio and its collaborators were
awarded an additional five-year $16 million Integrated
Preclinical/Clinical AIDS Vaccine Development (IPCAVD) grant in
2015 from NIAID.
About HIV Infection
Nearly 35 million people have died from
HIV-related causes and over 36 million are living with HIV. HIV is
a retrovirus that causes acquired immunodeficiency syndrome (AIDS),
a condition in which progressive failure of the immune system
allows life-threatening opportunistic infections and cancers to
thrive. HIV is classified into clades, sub-types within which the
virus has genetic similarities. The most prevalent clades are B
(found mainly in North America and Europe), A and D (found mainly
in Africa), and C (found mainly in Africa and Asia).
HIV clade C accounts for 48% of worldwide and
51% of African-HIV type 1 cases. It is the most rapidly spreading
subtype of HIV. Although highly active antiretroviral therapy
regimens have dramatically transformed the treatment of the disease
in developed countries, safe and effective HIV vaccines are needed
to stop the spread of disease.
About Inovio's PENNVAX® HIV Vaccines and
Immunotherapies
Inovio completed initial clinical studies of its
HIV immunotherapy PENNVAX-B, targeting clade B viruses, to achieve
proof of principle in generating potent immune responses using its
SynCon® immunotherapy technology. In two published phase 1 studies,
PENNVAX-B immunization via IM injection generated high levels of
activated and antigen-specific CD8+ killer T cells. This ability
uniquely positions PENNVAX as an important product candidate for
both preventing and treating HIV infections.
Using a $25 million contract from the NIH,
Inovio designed its universal, multi-clade, multi-antigen
PENNVAX-GP immunotherapy targeting the env, gag and pol antigens to
provide coverage against all major HIV-1 clades. Inovio’s HIV
development focus for both preventive and therapeutic purposes is
on PENNVAX-GP.
About the HVTN
The HIV Vaccine Trials Network (HVTN),
headquartered at Fred Hutchinson Cancer Research Center in Seattle,
Wash., is an international collaboration of scientists and
educators searching for an effective and safe HIV vaccine. The
HVTN's mission is to facilitate the process of testing preventive
vaccines against HIV/AIDS. The HVTN conducts all phases of clinical
trials, from evaluating experimental vaccines for safety and the
ability to stimulate immune responses, to testing vaccine efficacy.
Support for the HVTN comes from the National Institute of Allergy
and Infectious Diseases (NIAID) of the U.S. National Institutes of
Health (NIH). The Network's HIV Vaccine Trial Units are located at
leading research institutions in 27 cities on four continents.
Internationally renowned HIV vaccine and prevention researchers
lead the units.
About Inovio Pharmaceuticals,
Inc.
Inovio is taking immunotherapy to the next level
in the fight against cancer and infectious diseases. We are the
only immunotherapy company that has reported generating T cells in
vivo in high quantity that are fully functional and whose killing
capacity correlates with relevant clinical outcomes with a
favorable safety profile. With an expanding portfolio of immune
therapies, the company is advancing a growing preclinical and
clinical stage product pipeline. Partners and collaborators include
MedImmune, Regeneron Pharmaceuticals, The Wistar Institute,
University of Pennsylvania, DARPA, GeneOne Life Science, Plumbline
Life Sciences, ApolloBio Corporation, Drexel University, NIH, HIV
Vaccines Trial Network, National Cancer Institute, U.S. Military
HIV Research Program, and Laval University. For more information,
visit www.inovio.com.
This press release contains certain
forward-looking statements relating to our business, including our
plans to develop electroporation-based drug and gene delivery
technologies and DNA vaccines, our expectations regarding our
research and development programs and our capital resources. Actual
events or results may differ from the expectations set forth herein
as a result of a number of factors, including uncertainties
inherent in pre-clinical studies, clinical trials and product
development programs, including PENNVAX®-GP, the availability of
funding to support continuing research and studies in an effort to
prove safety and efficacy of electroporation technology as a
delivery mechanism or develop viable DNA vaccines, our ability to
support our broad pipeline of SynCon® active immunotherapy and
vaccine products, the ability of our collaborators to attain
development and commercial milestones for products we license and
product sales that will enable us to receive future payments and
royalties, the adequacy of our capital resources, the availability
or potential availability of alternative therapies or treatments
for the conditions targeted by the company or its collaborators,
including alternatives that may be more efficacious or cost
effective than any therapy or treatment that the company and its
collaborators hope to develop, issues involving product liability,
issues involving patents and whether they or licenses to them will
provide the company with meaningful protection from others using
the covered technologies, whether such proprietary rights are
enforceable or defensible or infringe or allegedly infringe on
rights of others or can withstand claims of invalidity and whether
the company can finance or devote other significant resources that
may be necessary to prosecute, protect or defend them, the level of
corporate expenditures, assessments of the company's technology by
potential corporate or other partners or collaborators, capital
market conditions, the impact of government healthcare proposals
and other factors set forth in our Annual Report on Form 10-K for
the year ended December 31, 2016, Form 10Q for the quarter ended
March 31, 2017, and other regulatory filings from time to time.
There can be no assurance that any product in Inovio's pipeline
will be successfully developed or manufactured, that final results
of clinical studies will be supportive of regulatory approvals
required to market licensed products, or that any of the
forward-looking information provided herein will be proven
accurate.
CONTACTS:
Investors: Bernie Hertel, Inovio Pharmaceuticals, 858-410-3101, bhertel@inovio.com
Media: Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211, jrichardson@inovio.com
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