Inovio Biomedical Therapeutic Cervical Cancer Vaccine Demonstrates Safety and Immunogenicity in Clinical Trial

* Reuters is not responsible for the content in this press release.

Mon Oct 5, 2009 2:00am EDT

Preliminary Data Shows Electroporation-Delivered DNA Vaccine Induces Significant
Antigen-Specific T-cell and Antibody Responses in First, Low Dose Cohort
SAN DIEGO--(Business Wire)--
Inovio Biomedical Corporation (NYSE Amex: INO), a leader in DNA vaccine design,
development and delivery, announced today interim safety and immunogenicity data
from its therapeutic cervical cancer vaccine (VGX-3100) trial. VGX-3100 is a DNA
vaccine targeting the E6 and E7 proteins of human papillomavirus (HPV) types 16
and 18 and is delivered via in vivo electroporation. The vaccine was found to be
generally safe and well tolerated, and achieved significant cellular and humoral
immune responses at the lowest dose administered. Dr. David B. Weiner,
Professor, University of Pennsylvania and Chairman of Inovio`s Scientific
Advisory Board, presented the data at the Vaccine 3rd Global Congress in
Singapore in a presentation entitled, "Delivering on the Promise of DNA Vaccines
for HIV and Cancer: From Bench to Clinical Data." 

This phase I clinical trial was designed to test the safety and immunogenicity
of VGX-3100 in women with a previous history of cervical intraepithelial
neoplasia (CIN) 2/3, a precursor lesion prior to the development of cancer. This
dose escalation study is enrolling patients in three cohorts of six subjects
each with DNA vaccine doses at 0.6 mg (0.3 mg each of two DNA plasmids), 2.0 mg,
and 6.0 mg. The immunization regimen consists of each subject receiving three
immunizations at the indicated dose. The vaccine is delivered using Inovio`s
proprietary CELLECTRA intramuscular electroporation delivery device. 

Inovio has completed immunizations of the lowest dose cohort. The interim safety
analysis indicated that all six subjects tolerated the vaccine administration
and electroporation procedure well over each of the three vaccinations. In
general, reported adverse events and injection site reactions were mild to
moderate and required no treatment. 

The preliminary immunological analysis of blood samples collected before and
after vaccine administration indicated the induction of vaccine-specific immune
responses against the target antigens produced by the vaccine. Antigen-specific
cytotoxic T-lymphocyte (CTL) responses were observed against all four antigens,
i.e. E6 and E7 proteins for HPV types 16 and 18. The subjects were considered as
responders if antigen-specific CTL responses greater than 50 spot forming units
(SFU) per million white blood cells were observed (50 being a benchmark
significantly beyond the normally existing background presence of CTL). By this
measure, 3 of 6 vaccinated subjects (50%) were deemed to be responders and
yielded CTL responses ranging from 250 - 450 SFU per million cells after three
immunizations. Inovio`s scientists also tested the samples for antibody
responses against the target antigens and observed strong antibody responses in
5 of 6 subjects (83%). Antibodies were generated to all three antigen components
tested. Specific antibody responses to tumor antigens can function as an
important surrogate potency marker for determining the immunogenicity of a
vaccine. Furthermore, Inovio believes they generally underscore the potential
usefulness of the Inovio DNA vaccine platform in the vaccine arena. 

Speaking at the Vaccine Congress, Dr. Weiner said, "We are pleased with the
safety and tolerability profile of the VGX-3100 DNA vaccine delivered via in
vivo electroporation. Significantly, although still preliminary, the immune
analysis of the vaccinated subjects indicates that this vaccine is immunogenic
and led to the induction of antigen-specific T-cell and antibody responses. We
are excited by the demonstration in humans of a single, non-live vaccine
inducing antibody and cellular immune responses from a single formulation. The
induction of antigen-specific CTL responses, considered critical for cancer
immunotherapy, has been difficult to achieve in vaccine trials. It is impressive
to get clear cellular immunity with this approach at such a low DNA vaccine
dose." 

Dr. J. Joseph Kim, Inovio`s CEO, said, "Cervical cancer is the second leading
cause of cancer-related deaths in women worldwide. While preventive vaccines
have demonstrated efficacy in preventing HPV infection, they have shown no
benefit in controlling cervical cancer in women already infected with HPV. A
therapeutic vaccine capable of mobilizing the immune system to kill
pre-cancerous and cancerous cervical cells would be a significant accomplishment
and of great importance to the millions of individuals already infected with
HPV. Inovio selected this important disease as its lead cancer target for its
novel synthetic consensus SynCon DNA vaccines. We are excited by this
preliminary data and the prospect of advancing a potential new cancer
immunotherapy." 

The VGX-3100 clinical trial is now enrolling the second cohort of patients.
Inovio expects full enrollment of all three cohorts in the first half of 2010
and full analysis of immunogenicity and safety data by 3Q 2010. 

About HPV, Cervical Cancer and Inovio`s Therapeutic DNA Vaccine

Human papillomavirus (HPV) is the causative agent responsible for most cases of
cervical cancer. Almost all HPV affecting the cervix is spread by sexual
contact. There are over 100 distinct HPV types, but HPV types 16 and 18 are
responsible for about 70% of cervical cancer incidences. 

The world prevalence of HPV infection is estimated at 9 - 13% of the population.
Globally, over 253,500 women die of cervical cancer each year, a majority of
those deaths occurring in the developing world. The US Centers for Disease
Control and Prevention estimated there would be 11,270 new cases of cervical
cancer and 4,070 related deaths in the US in 2009 alone. 

Preventive vaccines such as GARDASIL and CERVARIX have begun to play a role in
limiting the contraction of HPV. However, the huge prevalence of patients
already infected with HPV cannot be addressed by preventive vaccines - and there
is no viable therapeutic vaccine or drug to fight HPV and cervical cancer. 

Inovio`s HPV DNA vaccine (VGX-3100) is intended to treat HPV as well as cervical
pre-cancerous cell abnormalities and cancer. Cells transformed by HPV into
cancer cells continue to express E6 and E7 proteins. Unfortunately, since this
cell transformation can occur over 10 years or longer, the relatively slow
proliferation of the HPV virus and these antigenic proteins could allow the
immune system to become tolerant of their presence. VGX-3100 is designed to
express the E6 and E7 genes from both HPV types 16 and 18. Using Inovio`s
proprietary electroporation technology, the vaccine is delivered into muscle
cells of the patient. The principle of this mechanism is to enable these cells
to produce these antigenic proteins in sufficient quantity that the immune
system may recognize them, induce a robust T-cell response targeting the E6 and
E7 proteins on HPV-infected cells, and cause those cells to be rejected from the
body. 

About Inovio Biomedical Corporation

Inovio Biomedical is focused on the design, development, and delivery of a new
generation of vaccines, called DNA vaccines, to prevent and treat cancers and
infectious diseases. The company`s SynCon technology enables the design of
DNA-based vaccines capable of protecting against both known and new, unknown
strains of pathogens such as influenza. Inovio`s proprietary
electroporation-based DNA vaccine delivery technology has been shown by initial
human data to safely and significantly increase gene expression and immune
responses. Inovio`s clinical programs include HPV/cervical cancer (therapeutic)
and HIV vaccines. An IND has been filed for an avian influenza vaccine. Inovio
is developing its universal and avian influenza vaccines in collaboration with
scientists from the University of Pennsylvania, the National Microbiology
Laboratory of the Public Health Agency of Canada, and the NIH`s Vaccine Research
Center. Other partners and collaborators include Merck, Tripep, University of
Southampton, National Cancer Institute, and HIV Vaccines Trial Network. More
information is available at www.inovio.com. 

This press release contains certain forward-looking statements relating to our
plans to develop electroporation-based drug and gene delivery technologies and
DNA vaccines. Actual events or results may differ from the expectations set
forth herein as a result of a number of factors, including uncertainties
inherent in 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 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 ability to manufacture vaccine
candidates, 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, evaluation of potential
opportunities, issues involving patents and whether they or licenses to them
will provide the parties 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 combined 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
companies` combined 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, 2008, our Form 10-Q for the three months ended June 30, 2009, 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.

Inovio Biomedical
Bernie Hertel, 858-410-3101 (Investors)
or
Richardson & Associates
Jeff Richardson, 805-491-8313 (Media) 



Copyright Business Wire 2009

Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.