Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that its
HIV vaccine, PENNVAX®-GP, maintained durable and robust immune
responses at month 12, a full six months after the last dose in a
Phase 1 clinical study. Inovio previously reported that
PENNVAX-GP elicited the highest overall levels of immune response
rates (cellular and humoral) ever demonstrated in a human study by
an HIV vaccine. To potentially prevent and treat HIV, PENNVAX-GP
consists of a combination of four HIV antigens designed to generate
both antibody and T-cell responses and cover multiple global HIV
strains.
This breakthrough data was presented at a
plenary session at the 2018 HVTN Full Group Meeting on May 14 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 is 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 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).
More comprehensive immune analyses demonstrated
that PENNVAX-GP (plus IL-12) generated HIV-specific CD4+ T cell and
binding antibody response rates close to 100% when delivered with
either CELLECTRA® intramuscular or intradermal devices. For
instance, 96% (26 of 27) of participants receiving PENNVAX-GP and
IL-12 via the IM route demonstrated a CD4+ T cell response while
the same percentage (96% or 27 of 28) of participants receiving the
vaccine formulation via ID administration also displayed anti-HIV
CD4+ T cell responses -- even though those vaccinated via
intradermal administration received 1/5th the total dose compared
to those vaccinated via the intramuscular device.
The new data from subjects followed for a full
one year of the study showed that the immune responses were
maintained in most subjects at month 12 (or six months after the
last dose) as evidenced by the durability of activated T cells as
well as the magnitude of responder rates. Notably, the percentage
of patients who had CD8+ T cell responses immediately after the
last dose stayed the same or even increased slightly over the 6
month follow up period, clearly demonstrating durable
vaccine-generated memory responses.
These 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.
Dr. De Rosa, said, “Nearly all the
immunogenicity assays for HVTN 098 have been completed, and the
results collectively and consistently show nearly all participants
had detectable CD4+ T cell and antibody responses to envelope and
over 50% had CD8+ T cell responses. Not only were these high
response rates exceptional, we further observed that high T cell
response rates, especially for those of very difficult to
generate CD8+ T cells, were maintained at month 12 time point or a
full six months after the last dose. 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, “We are truly pleased to see these robust and durable immune
response data, which 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 a 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 further advancing PENNVAX-GP into later-stage clinical
development with our partners and
collaborators.”
Development of Inovio’s PENNVAX-GP vaccine,
which widely targets multiple major clades of HIV — providing
global coverage — has been funded through a five-year $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 InfectionAs of the
end of year 2016 worldwide, nearly 35 million people had died from
HIV-related causes and over 36 million were living with HIV then
[UNAIDS (2018); WHO (2018)]. 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 HIV-1 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-1 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
ImmunotherapiesInovio completed initial clinical studies
of its HIV vaccine PENNVAX-B, targeting clade B viruses, to achieve
proof of principle in generating potent immune responses using its
SynCon® 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 HVTNThe 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 a late-stage biotechnology company focused
on the discovery, development, and commercialization of DNA
immunotherapies that transform the treatment of cancer and
infectious diseases. The ASPIRE (Antigen Specific Immune Responses)
technology platform is designed to activate an individual’s immune
system to generate a robust, targeted T cell and antibody response
against targeted diseases. We are the only immunotherapy company
that has reported generating T cells entirely in vivo in high
quantity that are fully functional and whose killing capacity
correlates with relevant clinical outcomes with a favorable safety
profile. Inovio’s most advanced clinical program, VGX-3100, is in
Phase 3 for the treatment of HPV-related cervical pre-cancer. Also
in development are Phase 2 immuno-oncology programs targeting head
and neck cancer, bladder cancer, and glioblastoma, as well as
platform development programs in hepatitis B, Zika, Ebola, MERS,
and HIV. Partners and collaborators include MedImmune, Regeneron,
Roche/Genentech, ApolloBio Corporation, The Wistar Institute,
University of Pennsylvania, the Parker Institute for Cancer
Immunotherapy, DARPA, GeneOne Life Science, Plumbline Life
Sciences, 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, including the planned initiation
and conduct of clinical trials and the availability and timing of
data from those trials, our plans and expectations regarding
partnerships and the plans of GENEOS Therapeutics, Inc. to raise
capital. 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, 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 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 us or our collaborators, including
alternatives that may be more efficacious or cost effective than
any therapy or treatment that we and our collaborators hope to
develop, issues involving product liability, issues involving
patents and whether they or licenses to them will provide us 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 we can finance or devote other
significant resources that may be necessary to prosecute, protect
or defend them, the level of corporate expenditures, assessments of
our 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, 2017, our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2018
and other regulatory filings we make from time to time. There can
be no assurance that any product candidate in our pipeline will be
successfully developed, manufactured or commercialized, that final
results of clinical trials 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. Forward-looking statements speak only as of the date of
this release, and we undertake no obligation to update or revise
these statements, except as may be required by law.
CONTACTS:
Investors:
Ben Matone, Inovio Pharmaceuticals, 484-362-0076,
ben.matone@inovio.comMedia:
Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211,
jrichardson@inovio.com
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