PLYMOUTH MEETING, Pa.,
Nov. 15, 2021 /PRNewswire/
-- INOVIO (NASDAQ:INO), a biotechnology company focused on
bringing to market precisely designed DNA medicines to help protect
people from infectious diseases, and help treat cancer, and
HPV-associated diseases, announced today that eight
company-sponsored presentations will be given this week at the 34th
International Papillomavirus Conference (IPVC) , which is being
held virtually from today, November
15 through Friday, November
19.
"The IPVC meeting provides INOVIO with an exciting opportunity
to showcase our work to develop treatments for HPV-driven diseases,
as well as to advance the understanding of the epidemiology and
standard of care in these disease states," said Jeffrey Skolnik, M.D., SVP, Clinical Development
at INOVIO. "These data highlight our continued commitment to
developing medicines, technologies and solutions to help address
the unmet needs of patients across the spectrum of HPV
diseases."
INOVIO will give two oral presentations and one featured
e-poster presentation from its VGX-3100 clinical trials. VGX-3100
is in Phase 3 clinical trials to study the immunotherapy candidate
for the treatment of cervical high-grade squamous intraepithelial
lesions (HSIL) and in Phase 2 clinical trials to study the
immunotherapy candidate for the treatment of anal and vulvar
HSIL.
INOVIO also will present a poster on its INO-3107 Phase 1/2
clinical trial protocol to assess the safety, immunogenicity and
efficacy of its use for the potential treatment of recurrent
respiratory papillomatosis (RRP) in adults.
In partnership with Optum Life Sciences, another oral
presentation will detail the U.S. epidemiology burden of cervical
HSIL and a comprehensive assessment of the effectiveness and safety
of the cervical HSIL standard of care in the United States. Additional oral and poster
presentations given jointly with Optum Life Sciences will address
the U.S. epidemiology burden of anal and vulvar HSIL and RRP.
The following INOVIO-sponsored data will be presented at IPVC
2021:
- VGX-3100 for the Treatment of HPV16/18 Related Cervical HSIL:
Results from a Phase 3 Study (Abstract #233)
- Results of VGX-3100 for the Treatment of HPV16/18 Associated
Vulvar HSIL: Phase 2 Open-Label Trial Efficacy and Safety Results
(Abstract #164)
- VGX-3100 for the Treatment of HPV16/18 Attributable Anal HSIL:
Results of a Phase 2 Study (Abstract #235)
- Evaluation of INO-3107 – A Novel DNA Immunotherapy for the
Treatment of HPV6/11 Associated Recurrent Respiratory
Papillomatosis (Abstract #247)
- Cervical HSIL – U.S. Burden and Comprehensive Assessment of
Standard of Care Effectiveness and Safety, 2008-2018: The
EACH-WOMAN Project (Abstract #244)
- Vulvar High-Grade Squamous Intraepithelial Lesion (HSIL): U.S.
Epidemiology burden in the Post-HPV Vaccine Introduction Era,
2015-2019 (Abstract #156)
- Anal High-Grade Squamous Intraepithelial Lesion (HSIL): U.S.
Epidemiology Burden in the Post-HPV Vaccine Introduction Era,
2015-2019 (Abstract #161)
- Recurrent Respiratory Papillomatosis (RRP) – All-Ages U.S.
Prevalence in 2018 (Abstract #173)
About INOVIO's DNA Medicines Platform
INOVIO currently has 15 clinical development programs focused on
HPV-associated diseases, cancer, and infectious diseases, including
coronaviruses associated with COVID-19 and MERS. "DNA medicines"
are composed of optimized DNA plasmids, which are small circles of
double-stranded DNA that are synthesized or reorganized by a
computer sequencing technology and designed to produce a specific
immune response in the body.
INOVIO's vaccine and immunotherapy candidates deliver optimized
plasmids directly into cells intramuscularly or intradermally using
INOVIO's proprietary hand-held smart device called CELLECTRA®. The
CELLECTRA® device uses a brief electrical pulse to reversibly open
small pores in the cell to allow the plasmids to enter, which is
designed to overcome a key limitation of other DNA and other
nucleic acid approaches, such as mRNA. Once inside the cell, the
DNA plasmids enable the cell to produce the targeted antigen. The
antigen is processed naturally in the cell and triggers the desired
T cell and antibody-mediated immune responses. Administration with
the CELLECTRA® device is designed to ensure that the vaccine is
efficiently delivered directly into the body's cells, where it can
go to work to drive an immune response. INOVIO's vaccine candidates
do not interfere with or change in any way an individual's own DNA.
The potential advantages of INOVIO's vaccine platform include how
quickly DNA vaccine candidates can be designed and manufactured;
the stability of the vaccine candidates, which do not require
freezing in storage and transport; and the immune response and
tolerability that have been observed in clinical trials.
With more than 3,900 patients receiving INOVIO investigational
vaccine candidates in more than 12,000 applications across a range
of clinical trials, INOVIO has a strong track record of rapidly
generating vaccine candidates with potential to meet urgent global
health needs.
About INOVIO
INOVIO is a biotechnology company with a goal focused on rapidly
bringing to market precisely designed DNA medicines to treat and
protect people from infectious diseases, cancer, and diseases
associated with HPV. INOVIO is the first company to have clinically
demonstrated that a DNA vaccine candidate can be delivered directly
into cells in the body via a proprietary smart device to produce a
robust and tolerable immune response. Specifically, INOVIO's lead
therapeutic vaccine candidate VGX-3100 met primary and secondary
endpoints for all evaluable subjects in REVEAL 1, the first of two,
Phase 3 trials for precancerous cervical dysplasia, demonstrating
ability to destroy and clear both high-grade cervical lesions and
the underlying high-risk HPV-16/18. INOVIO is also evaluating
INO-4800, a DNA vaccine candidate against COVID-19, in a Phase 2/3
clinical trial; the Phase 3 segment of which has received
regulatory approvals to begin in Colombia, Mexico, Brazil, Philippines, India, Thailand and the
United States. INOVIO's partners, Advaccine
Biopharmaceuticals and International Vaccine Institute, are also
evaluating INO-4800 in ongoing clinical trials in China and South
Korea, respectively.
Partners and collaborators include Advaccine, ApolloBio
Corporation, AstraZeneca, The Bill & Melinda Gates Foundation,
Coalition for Epidemic Preparedness Innovations, Defense Advanced
Research Projects Agency/Joint Program Executive Office for
Chemical, Biological, Radiological and Nuclear Defense/Department
of Defense, HIV Vaccines Trial Network, International Vaccine
Institute, Kaneka Eurogentec, Medical CBRN Defense Consortium,
National Cancer Institute, National Institutes of Health, National
Institute of Allergy and Infectious Diseases, Ology Bioservices,
the Parker Institute for Cancer Immunotherapy, Plumbline Life
Sciences, Regeneron, Richter-Helm BioLogics, Thermo Fisher
Scientific, University of Pennsylvania,
Walter Reed Army Institute of Research, and The Wistar Institute.
For more information, visit www.inovio.com.
CONTACTS:
Media: Jeff Richardson,
267-440-4211, jrichardson@inovio.com
Investors: Ben Matone, 484-362-0076,
ben.matone@inovio.com
This press release contains certain forward-looking
statements relating to our business, including our plans to develop
and commercialize DNA medicines, our expectations regarding our
research and development programs, including the planned initiation
and conduct of pre-clinical studies and clinical trials and the
availability and timing of data from those studies and trials, our
ability to successfully manufacture and produce large quantities of
our product candidates if they receive regulatory approval and
planned collaborations with third parties. 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, product development programs and
commercialization activities and outcomes, our ability to secure
sufficient manufacturing capacity to mass produce our product
candidates, 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 medicines, our ability to support our pipeline of DNA
medicine 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 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, 2020 , our Quarterly Report on Form
10-Q for the quarter ended September 30,
2021 and other filings we make from time to time with the
Securities and Exchange Commission. There can be no assurance that
any product candidate in our pipeline will be successfully
developed, manufactured, or commercialized, that results of
clinical trials will be supportive of regulatory approvals required
to market 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.
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SOURCE INOVIO Pharmaceuticals, Inc.