PLYMOUTH MEETING, Pa. and
GERMANTOWN, Md. and HILDEN,
Germany, May 16, 2019 /PRNewswire/ -- Inovio
Pharmaceuticals Inc. (NASDAQ: INO) and QIAGEN N.V. (NYSE: QGEN;
Frankfurt Prime Standard: QIA) today announced a collaboration to
co-develop a diagnostic test to identify patients most likely to
respond to VGX-3100, Inovio's immunotherapy to treat advanced
cervical dysplasia associated with the human papillomavirus virus
(HPV). This precision medicine partnership focuses on Inovio's
VGX-3100, a late-stage product candidate currently in two pivotal
Phase 3 clinical trials (REVEAL 1 and 2) with potential to become
the first treatment for HPV infection of the cervix and the first
non-surgical treatment for precancerous cervical lesions associated
with the virus. Financial arrangements were not disclosed.
Dr. J. Joseph Kim, Inovio's
President & CEO, said, "As we advance our Synthetic Nucleics
platform we are always looking for ways to drive innovation within
our own technology or via a creative partner like QIAGEN. QIAGEN is
bringing their extensive track record of commercially developing
and marketing novel diagnostic tests to this important
collaboration. Inovio is developing VGX-3100 as a non-surgical
treatment for women with cervical pre-cancer and pre-treatment
biomarkers we have discovered could provide a targeted way to
identify patients most likely to respond to treatment with
VGX-3100, increasing absolute efficacy of the product."
"We are pleased to support Inovio by developing a liquid
biopsy-based companion diagnostic to identify patients who would
benefit from VGX-3100, which has potential to make a dramatic
difference in the treatment of HPV infections and precancerous
disease. Our Sample to Insight workflows and experience in
developing diagnostic solutions for Precision Medicine in
immuno-oncology are well-suited to help Inovio address this large
unmet medical need," said Peer M.
Schatz, Chief Executive Officer of QIAGEN. "Our team has
deep experience in HPV-related molecular testing and cervical
cancer and is looking forward to applying this expertise in
partnership with Inovio, This project is also a case study of a
collaboration that started in the discovery phase, when Inovio
selected QIAGEN Genomic Services to work on the discovery of novel
microRNA biomarkers that now contribute to the power of this unique
molecular assay. The project progressed into development and Inovio
now aims to make regulatory submissions for VGX-3100 in 2021."
HPV is the most common viral infection of the reproductive tract
and the major cause of cervical cancer, the fourth most common
cancer among women. The World Health Organization (WHO) reported an
estimated 570,000 new cases of cervical cancer and 311,000 deaths
in 2018. Almost 300 million women globally are estimated to be
infected with HPV, and about 30 million additional cases have
progressed to the precancerous stage. The high-risk HPV 16 and HPV
18 genotypes are estimated to cause at least 70% of cervical
cancers.
Inovio's VGX-3100 is a novel immunotherapy under clinical
investigation for the treatment of infection with HPV 16 and HPV 18
and advanced cervical dysplasia (Phase 3), and the vulva and anus
(Phase 2). VGX-3100 propels the patient's own immune system to
clear the HPV 16 and HPV 18 infections and precancerous lesions
without the increased risks associated with surgery.
About Inovio Pharmaceuticals Inc.
Inovio is an
innovative biotechnology company focused on the discovery,
development, and commercialization of its synthetic nucleic
technology targeted against cancers and infectious diseases.
Inovio's proprietary technology platform applies antigen sequencing
and 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'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
HPV-related cancers, bladder cancer, and glioblastoma, as well as
platform development programs in hepatitis B, Zika, Ebola, MERS,
and HIV. Partners and collaborators include AstraZeneca, Regeneron,
Roche/Genentech, ApolloBio Corporation, GeneOne Life Science, The
Bill & Melinda Gates Foundation, Coalition for Epidemic
Preparedness Innovations, Defense Advanced Research Projects
Agency, National Institutes of Health, National Institute of
Allergy and Infectious Diseases, National Cancer Institute, HIV
Vaccines Trial Network, Walter Reed Army Institute of Research, The
Wistar Institute, and the University of
Pennsylvania. For more information, visit
www.inovio.com.
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the
leading global provider of Sample to Insight solutions that enable
customers to gain valuable molecular insights from samples
containing the building blocks of life. Our sample technologies
isolate and process DNA, RNA and proteins from blood, tissue and
other materials. Assay technologies make these biomolecules visible
and ready for analysis. Bioinformatics software and knowledge bases
interpret data to report relevant, actionable insights. Automation
solutions tie these together in seamless and cost-effective
workflows. QIAGEN provides solutions to more than 500,000 customers
around the world in Molecular Diagnostics (human healthcare),
Applied Testing (primarily forensics), Pharma (pharma and biotech
companies) and Academia (life sciences research). As of
March 31, 2019, QIAGEN employed
approximately 5,100 people in over 35 locations worldwide.
Inovio Forward-Looking Statement:
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, 2018, our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2019, 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.
QIAGEN Forward-Looking Statement:
Certain
statements contained in this press release may be considered
forward-looking statements within the meaning of Section 27A of the
U.S. Securities Act of 1933, as amended, and Section 21E of the
U.S. Securities Exchange Act of 1934, as amended. To the extent
that any of the statements contained herein relating to QIAGEN's
products, launches, regulatory submissions, collaborations,
markets, strategy, taxes or operating results, including without
limitation its expected sales, adjusted net sales and adjusted
diluted earnings per share results, are forward-looking, such
statements are based on current expectations and assumptions that
involve a number of uncertainties and risks. Such uncertainties and
risks include, but are not limited to, risks associated with
management of growth and international operations (including the
effects of currency fluctuations, regulatory processes and
dependence on logistics); variability of operating results and
allocations between customer classes; the commercial development of
markets for our products to customers in academia, pharma, applied
testing and molecular diagnostics; changing relationships with
customers, suppliers and strategic partners; competition; rapid or
unexpected changes in technologies; fluctuations in demand for
QIAGEN's products (including fluctuations due to general economic
conditions, the level and timing of customers' funding, budgets and
other factors); our ability to obtain regulatory approval of our
products; difficulties in successfully adapting QIAGEN's products
to integrated solutions and producing such products; the ability of
QIAGEN to identify and develop new products and to differentiate
and protect our products from competitors' products; market
acceptance of QIAGEN's new products and the integration of acquired
technologies and businesses; and the other factors discussed under
the heading "Risk Factors" contained in Item 3 of our most recent
Annual Report on Form 20-F. For further information, please refer
to the discussions in reports that QIAGEN has filed with, or
furnished to, the U.S. Securities and Exchange Commission
(SEC).
Contacts:
QIAGEN
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Investors
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Media
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John
Gilardi
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Dr. Thomas
Theuringer
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+49 2103 29
11711
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+49 2103 29
11826
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ir@QIAGEN.com
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pr@QIAGEN.com
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Inovio
Pharmaceuticals Inc.
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Investors
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Media
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Ben Matone
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Jeffrey C.
Richardson
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1-484-362-0076
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1-267-440-4211
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ben.matone@inovio.com
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jrichardson@inovio.com
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SOURCE Inovio Pharmaceuticals, Inc.