Two scientific journals publish data showing robust, sustained T-cell responses and protection generated by Inovio's DNA vaccine
BLUE BELL, Pa., July 5, 2011 // - Inovio Pharmaceuticals, Inc. (NYSE Amex: INO), a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that novel data from a preclinical study of its
SynCon T DNA vaccine against HIV were published in two separate
scientific journals. In vaccinated animals, the studies demonstrated Inovio's HIV vaccine's ability to harness the power of the immune
system, generating unique immune system responses, significant antigen-specific T-cell responses, and protection from the virus. The
results were published in two peer-reviewed journals in papers co-authored by researchers from Inovio and its academic
collaborators: Vaccine published a paper entitled "Immunogenicity of a novel engineered HIV-1 clade C synthetic
consensus-based envelope DNA vaccine"; PLoS One published the paper "Long-term programming of antigen-specific
immunity from gene expression signatures in the PBMC of rhesus macaques immunized with an SIV DNA vaccine."
In the first study, the investigators generated a synthetic, optimized DNA vaccine encoding for a novel HIV envelope clade
C protein utilizing Inovio's SynConT vaccine design process. Further optimization processes were conducted including codon/RNA
optimization, and addition of a Kozak sequence and IgE leader sequence to enhance the expression of the vaccine in humans.
Developing a vaccine for clade C is considered to be a very high priority since this clade or sub-type of HIV virus is
most prevalent in many parts of Africa, India, and China. When assessed in rigorous tests, this vaccine construct
generated robust and high levels of T cell responses that were up to three times greater than T cell responses
from other comparable DNA vaccine constructs targeting HIV envelope. Two phase I human studies will test the
immunogenicity of this vaccine in human volunteers in the U.S. and in Africa.
In the second study, the investigators assessed the protective effects of Inovio's PENNVAXT HIV DNA vaccines by examining
an equivalent vaccine for the corresponding monkey virus, called SIV (simian immunodeficiency virus). The vaccine was encoded for the three
major proteins (e.g. gag, pol, and env antigens) encoded within the retroviral genome and was delivered using Inovio's
proprietary electroporation (EP)
technology. Researchers evaluated the treatment using a novel gene microarray analysis along with standard immunological and
flow-based activation assays. They observed several gene sequences that were differentially regulated in vaccine-protected groups
compared to non-vaccinated animals. The novel microarray analysis used to test the vaccine effects of DNA vaccines demonstrated that
Inovio's PENNVAX vaccination led to the increased production of several gene sequences, including those involved in interferon signaling
as well as those involved in immune cell trafficking and cell cycle progression. These results are relevant to humans because understanding
these mechanisms could provide better insight into the ways immune responses could protect PENNVAX-immunized individuals from infection and virus
propagation and may aid in the further optimization of Inovio's HIV vaccine candidates currently in multiple Phase I clinical studies.
Significantly, this study included a virus challenge in rhesus monkeys. Vaccinated animals were protected from a subsequent
injection of the SIV (HIV-equivalent in non-human primates) virus (i.e. the vaccinated animals demonstrated strong control of viral
replication and had significantly lower viral load) while also displaying significantly enhanced antigen-specific killer T cell
responses, an outcome that Inovio has observed in multiple previous preclinical and clinical studies. By comparison, the
non-vaccinated animals failed to control SIV virus infection. Generation of CD8+ killer T cells are considered
instrumental in clearing cancerous or infected cells from the body and imperative to achieving sufficient
potency of new vaccines against cancers and chronic infectious diseases such as HIV and hepatitis C.
Dr. J. Joseph Kim, Inovio's president and CEO, said: "This new preclinical data further validates the ability of Inovio's
vaccines to induce powerful antigen-specific immune responses. In the past year, we have demonstrated best-in-class clinical
immunogenicity data from our DNA vaccines for cervical cancer and HIV in Phase I studies. Collectively, these clinical and
preclinical studies further substantiate our product development efforts in these important disease areas."
Late last year, Inovio announced interim immunogenicity and safety data in humans from its Phase I clinical study of
PENNVAXT-B, a DNA vaccine for the prevention of HIV clade B infection. PENNVAX-B achieved high vaccine-induced response rates and
strong magnitude of T cell immune responses in vaccinated subjects. Similar to reported results from a Phase I clinical study
of Inovio's therapeutic DNA vaccine for cervical cancer, the response rates and magnitude of responses achieved in this
study were significantly higher than those seen previously from other DNA vaccine trials. The complete immunogenicity
data and end-of-study safety data from PENNVAX-B study are expected in the third quarter of this year. In a separate
study, PENNVAX-B is also being tested as a therapeutic vaccine in HIV-positive volunteers, with immunogenicity and
safety data expected in the fourth quarter of 2011.
Two Phase I studies will test the optimized clade C DNA vaccine reported in the Vaccine paper. One study involves Inovio's
global HIV DNA vaccine candidate, PENNVAXT-G (clades A, C, and D), which is currently being tested in a 92-patient global Phase I clinical
study in the U.S. and Africa in a collaboration with the U.S. Military HIV Vaccine Research Program. Inovio plans to initiate another
Phase I study in mid-2012 with its PENNVAXT-GP vaccine (against HIV clades A and C; intradermal delivery), which is being developed
using a multi-year $25-plus million NIAID development contract awarded to Inovio.
About Inovio Pharmaceuticals, Inc.
Inovio is developing a new generation of vaccines, called DNA vaccines, to treat and prevent cancers and infectious diseases. Its SynConT
vaccines are designed to provide broad cross-strain protection against known as well as newly emergent strains of pathogens such as
influenza. These vaccines, in combination with Inovio's proprietary electroporation delivery devices, have been shown to be safe
and generate significant immune responses. Inovio clinical programs include three Phase II studies for vaccines treating
cervical dysplasia/cancer, hepatitis C virus, and leukemia. Other clinical programs target influenza (preventive)
and HIV (preventive and therapeutic). Inovio partners and collaborators include the University of Pennsylvania,
Merck, ChronTech, National Cancer Institute, U.S. Military HIV Research Program, NIH, HIV Vaccines Trial
Network, University of Southampton, and PATH Malaria Vaccine Initiative. More information is available
at 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 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, but not limited to, the fact that pre-clinical and clinical results
referenced in this release may not be indicative of results achievable in other trials or for other indications, that the
studies or trials may not be successful or achieve the results desired, that results from one study may not necessarily
be reflected or supported by the results of other similar studies and that results from an animal study may not be
indicative of results achievable in human studies), 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, 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, evaluation of potential opportunities,
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, our ability to successfully integrate Inovio and VGX Pharmaceuticals, 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, 2010, our Form 10-Q for the three months ended March 31, 2011, 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.
Investors: Bernie Hertel, Inovio Pharmaceuticals 858-410-3101 firstname.lastname@example.org
Media: Jeff Richardson, Richardson & Associates 805-491-8313 email@example.com
Source: Inovio Pharmaceuticals, Inc.
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