Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today that
three recent published studies of its DNA-Encoded monoclonal
antibody (dMAb™) technology showed impressive results in treating
cardiovascular disease and in preventing infection from the Ebola
virus and Lyme disease-causing bacteria in preclinical models.
Leveraging several recent published positive preclinical data,
Inovio plans to initiate a first clinical study of an infectious
disease treatment dMAb product early next year with full external
funding.
Traditional monoclonal antibodies represent the
largest segment of pharmaceutical markets today, accounting for
more than $50 billion in pharmaceutical sales each year, with
treatments spanning from cancer and infectious diseases to
inflammation and cardiovascular diseases. With its synthetic design
and in-patient production, Inovio’s dMAb products could provide
new, disruptive entrants to this important class of drugs. When
delivered directly into the body, the genetic instructions provided
by the DNA plasmid enables the patient’s own cells to become the
factory which manufactures the therapeutic antibody products.
Inovio has received over $60 million in non-dilutive grant funding
to advance its dMAb platform in the last few years. Additional
support for Inovio’s dMAb platform recently came from the Bill
& Melinda Gates Foundation which invested $2.2 million to
advance Inovio’s dMAb platform and to support the development of
next-generation clinical delivery devices for dMAbs. In this
regard, there is a significant interest in Inovio dMAbs’ high
applicability for rapidly responding to emerging global infectious
disease threats and addressing critical vaccine limitations.
In the first of the three published studies,
Inovio applied its dMAb technology against cardiovascular disease
in a preclinical study directed against PCSK9, a protein key to
regulating cholesterol levels in the bloodstream. Elevated,
low-density lipoprotein cholesterol (LDL-C) is a major risk factor
for cardiovascular disease, the leading cause of death in the U.S.
and worldwide. Statins are effective and widely used
cholesterol-lowering medications, but have been associated with a
number of side effects that have prompted development of
alternative treatment strategies, including monoclonal antibodies
targeting the PSCK9 protein that result in reduced degradation of
LDL-C receptors on liver cells and increased cholesterol clearance
from blood circulation. Several PCSK9 inhibitors in the form of
monoclonal antibodies have already been approved for use, including
Repatha® (evolocumab) by Amgen and PRALUENT® (alirocumab) by
Regeneron/Sanofi. Both of these products are dosed as injections
every 2 weeks or 4 weeks. They target and inactivate PCSK9,
dramatically reducing the amount of harmful LDL cholesterol
circulating in the bloodstream.
Impressively, a single intramuscular
administration of Inovio’s dMAb drove robust anti-PCSK9 antibody
expression within days and for up to two months, resulting in a
substantial increase in the presence of LDL-C receptors on liver
cells. This in turn resulted in a significant decrease in total
cholesterol and non-high-density lipoprotein cholesterol
(non-HDL-C), two important parameter for evaluating cardiovascular
risk, opening the door for further development of this approach as
a simple, less frequent and cost-effective therapy. These results
were reported in a paper published in Molecular Therapy, by Inovio
researchers and their academic collaborators.
The second study, published in the journal Cell
Reports, demonstrated that Inovio’s anti-Ebola dMAb product
protected all animals from a lethal Ebola virus challenge. In fact,
results showed that dMAbs were expressed over a wide window of time
and offered complete and long-term protection against this lethal
virus challenge. These studies were funded by a $45 million grant
from DARPA to Inovio and collaborators to develop both dMAb-based
therapy and DNA vaccines against Ebola.
The third dMAb study showed it can block
transmission of the bacteria that causes Lyme disease in
mice. These results, published on-line in the Journal of
Infectious Diseases, represent the first demonstration using dMAbs
that block transmission of the Lyme disease-causing bacteria
(Borrelia) in animal models. In the study, plasmid DNA-encoded
anti-OspA monoclonal antibodies inoculated in mice achieved a very
high serum antibody concentration of >6 μg/mL. Among mice
injected with the wildtype dMAb or the protein control wildtype
MAb, about 75% in each group were protected against an acute
challenge by Borrelia-infected ticks. Interestingly, when the dMAb
was further optimized with SynCon sequence engineering, the
protection level increased even further to 92%, fully demonstrating
the power of Inovio’s dMAb approach. These results are also
important because there is no marketed vaccine against Lyme
disease.
In the arena of global infectious diseases,
Inovio’s dMAb platform has many advantages over a conventional
vaccine approach, including immediate protection with an antibody
of known specificity and concentration, and independence from the
age-dependent responses to active immunization. While a traditional
protein antibody delivery is an attractive approach for
intervention against pathogens, the expense of bioprocessing and
cold chain requirements limit this approach for dissemination to
global populations.
Dr. Laurent Humeau, Inovio’s Chief Scientific
Officer, said, “We are truly excited about these findings that
support the flexibility and versatility of our dMAb platform as a
next generation approach that can be optimized for a wide host of
applications. Just in the past 18 months Inovio has published 10
impactful papers consistently demonstrating potent preclinical data
from its dMAb platform, with therapeutic displays spanning
protection against deadly infections to eliminating cancers and
lowering life-threatening levels of cholesterol. Inovio’s dMAbs
offer unique features that could remove the difficult and costly
issues surrounding the manufacture of monoclonal antibody drugs. In
addition, we also published the first of our own dMAb checkpoint
inhibitors with anti-cancer effects; and the U.S. patent office
just granted the first two patents covering our dMAb technology
last quarter. Inovio plans to develop a pipeline of multiple dMAb
products through corporate partnerships, external funding and
collaborations, starting with advancing our first dMAb product into
clinical testing early next year.”
Inovio’s recently published dMAb results can be
found in the peer-reviewed journals below:
- Molecular Therapy -- “Development of Novel DNA-encoded PCSK9
Monoclonal Antibodies as Lipid-lowering Therapeutics.”
- Cell Reports -- “In Vivo-delivered Synthetic Human dMAbs
Protect Against Ebola Virus Infection in a Mouse Model.”
- The Journal of Infectious Diseases – “Anti-OspA DNA-Encoded
Monoclonal Antibody Prevents Transmission of Spirochetes in Tick
Challenge Providing Sterilizing Immunity in Mice.”
About Inovio’s DNA-based Monoclonal
Antibody Platform
Traditional monoclonal antibodies are
manufactured outside the body in bioreactors, typically requiring
costly large-scale manufacturing facility development and laborious
production. Inovio’s disruptive dMAb technology has the potential
to overcome these limitations by virtue of their simplified design,
rapidity of development, product stability, ease of manufacturing
and deployability, and cost effectiveness, thereby providing
potential new avenues for treating a range of diseases. Another
significant advancement seen in Inovio dMAb technologies is that
the optimized genes for a desired monoclonal antibody is encoded in
a DNA plasmid, which is produced using very cost effective and
highly scalable fermentation techniques. These plasmids are
delivered directly into cells of the body using electroporation and
the encoded monoclonal antibody is then directly produced by these
cells. Previously published studies show that a single
administration of a highly optimized DNA-based monoclonal antibody
targeting HIV virus produced a high level of expression of the
antibody in the bloodstream of mice; Inovio similarly reported data
showing that dMAb products against flu, Ebola, chikungunya and
dengue protected animals against lethal challenge.
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. 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 September 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, 484-362-0076, ben.matone@inovio.comMedia:
Jeff Richardson, 267-440-4211, jrichardson@inovio.com
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