Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that its
synthetic HIV vaccine PENNVAX®-GP delivered via intradermal route
demonstrated durable and robust antibody and T cell immune
responses measured throughout the duration of the Phase 1 clinical
study. In this reported study, PENNVAX-GP plasmids were delivered
intradermally or intramuscularly with CELLECTRA® device in healthy
volunteers. More specifically, the study results demonstrated that
PENNVAX-GP delivered intradermally (ID) with CELLECTRA generated
equivalent or superior immune responses compared to the delivery
via intramuscular (IM) route using the same delivery device, with
ID delivery using only one-fifth of the dose compared to IM
delivery. 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. The clinical and
scientific data were reported at the Research for Prevention
(HIVR4P) Conference held in Madrid, Spain by Protocol Chair of the
HVTN 098 study, Dr. Srilatha Edupuganti, MD, MPH, Associate
Professor of Medicine, Division of Infectious Disease, Department
of Medicine at Emory University.
Dr. Edupuganti said, “These are exciting results
for an early-phase HIV vaccine; the immunogenicity of the
PENNVAX-GP vaccine is robust when given via the intradermal or
intramuscular delivery methods but the intradermal was superior
with respect to antibody responses. Intradermal vaccination may
prove to be an important method of DNA vaccine delivery in the
future.”
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 other vaccine 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.”
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). 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.
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 tested by the HVTN. In particular, 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.
Moreover, the samples 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 vaccine-induced 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.
About HIV Infection
As 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
Immunotherapies
Inovio 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 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 a late-stage biotechnology company
focused on the discovery, development, and commercialization of DNA
immunotherapies that transform the treatment of cancer and
infectious diseases. Inovio’s proprietary platform technology
applies next-generation antigen sequencing and DNA delivery to
activate potent immune responses to targeted diseases. The
technology functions exclusively in vivo, and has been demonstrated
to consistently activate robust and fully functional T cell and
antibody responses against targeted cancers and pathogens. Inovio
is the only immunotherapy company that has reported generating T
cells whose killing capacity correlates with relevant clinical
outcomes. 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 Bill & Melinda
Gates Foundation, The Wistar Institute, University of Pennsylvania,
Parker Institute for Cancer Immunotherapy, CEPI, 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, and our plans and expectations regarding
partnerships. 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 June 30, 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, 484-362-0076, ben.matone@inovio.comMedia:
Jeff Richardson, Inovio, 267-440-4211, jrichardson@inovio.com
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