PLYMOUTH MEETING, Pa.
and GERMANTOWN, Md. and HILDEN, Germany, Feb. 24,
2021 /PRNewswire/ -- QIAGEN (NYSE: QGEN; Frankfurt Prime
Standard: QIA) and INOVIO Pharmaceuticals (NASDAQ: INO) today
announced an extension of their partnership with a new master
collaboration agreement to develop liquid biopsy-based companion*
diagnostic products based on next-generation sequencing (NGS)
technology to complement INOVIO's therapies. (*Complementary
when referring to the US regulatory pathway.)
The initial project in this expanded collaboration focuses on
the co-development of a diagnostic test that identifies women who
are most likely to benefit from clinical use of VGX-3100, INOVIO's
immunotherapy to treat advanced cervical dysplasia associated with
the human papillomavirus (HPV). QIAGEN's bioinformatic expertise
will further increase the predictive power of INOVIO's preliminary
biomarker signature – and the assay will now be developed for use
on the Illumina NextSeq™ 550Dx platform, the first
development based on a partnership QIAGEN and Illumina signed in
October 2019.
VGX-3100 is INOVIO's late-stage DNA immunotherapy candidate. It
is currently in two Phase 3 trials (REVEAL 1 and REVEAL 2), with
the potential to become the first non-surgical treatment for
advanced pre-cancerous cervical lesions associated with the virus
(HPV-16 and HPV-18).
"As we advance our DNA medicines platform, we are always
looking for ways to drive innovation with our own technology or
that of a creative and accomplished partner. QIAGEN is contributing
an extensive track record of developing and commercializing novel
diagnostic tests," said Dr. J. Joseph
Kim, INOVIO's President and CEO. "INOVIO is
developing VGX-3100 as a non-surgical treatment for cervical
pre-cancer and pre-treatment biomarkers we have discovered could be
a targeted way to identify patients most likely to respond to
treatment. The goal is to increase the absolute efficacy of the
immunotherapy."
QIAGEN and INOVIO in 2019 announced a collaboration to develop a
companion diagnostic to guide clinical decision-making for the use
of INOVIO's DNA-based immunotherapy to treat cervical dysplasia
caused by HPV. The new master collaboration agreement covers the
development of companion diagnostics for INOVIO's HPV therapies for
a range of sample types and technologies such as PCR and NGS.
QIAGEN pioneered HPV testing with the gold-standard digene
Hybrid Capture 2 High-Risk HPV DNA Test, which became a driving
force in HPV screening as a standard of care in cervical cancer
prevention.
"We are pleased to support INOVIO by developing companion
diagnostics to identify patients who would benefit from VGX-3100.
Our experience in developing liquid biopsy-based diagnostic
solutions for precision medicine in immuno-oncology will help
INOVIO address a larger unmet medical need," said Jean-Pascal Viola, Senior Vice President, Head
of the Molecular Diagnostics Business Area and Corporate Business
Development at QIAGEN. "We bring to this partnership our proven
leadership in PCR companion diagnostics, as well as long-standing
experience in developing innovative and custom NGS panels for our
customers. Our recognized bioinformatic capabilities will help
improve the efficacy of biomarker signatures. Our team is looking
forward to applying our expertise for HPV-related cervical
pre-cancer identification with INOVIO."
HPV is the most common viral infection of the reproductive tract
and 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.
At least 70% of cervical cancers are estimated to be the result of
the high-risk HPV 16 and HPV 18 – genotypes that VGX-3100 instructs
a suitable patient's immune system to reduce or fully
eliminate.
QIAGEN is a pioneer in precision medicine and the global leader
in collaborating with pharmaceutical and biotechnology companies to
develop companion diagnostics that can detect clinically relevant
genetic abnormalities to provide insights that guide clinical
decision-making about diseases like cancer. The company offers an
unmatched depth and breadth of technologies from polymerase chain
reaction (PCR) to next-generation sequencing (NGS) for companion
diagnostic development. The ability to tailor a CDx to partners'
needs, proven IVD development expertise, and a global
commercialization track record allow QIAGEN to develop novel and
innovative NGS products and other diagnostic solutions.
About VGX-3100
VGX-3100 is INOVIO's DNA medicine in clinical trials for
the treatment of three HPV-16/18 related disease states – anal
dysplasia, vulvar dysplasia, and cervical dysplasia. The cervical
dysplasia program is in late Phase 3 clinical trials (REVEAL 1 and
REVEAL 2). VGX-3100 is designed to utilize the patient's own immune
system to clear HPV-16/18-associated high-grade precancerous
lesions with the aim of reducing the risk of cancer.
About INOVIO
INOVIO is a biotechnology company 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 and only
company to have clinically demonstrated that a DNA medicine
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 candidate VGX-3100, currently
in Phase 3 trials for precancerous cervical dysplasia, destroyed
and cleared high-risk HPV 16 and 18 in a Phase 2b clinical
trial. High-risk HPV is responsible for 70% of
cervical cancer, 91% of anal cancer, and 69% of vulvar cancer. Also
in development are programs targeting HPV-related cancers and
a rare HPV-related disease, recurrent respiratory papillomatosis
(RRP); non-HPV-related cancers glioblastoma multiforme (GBM)
and prostate cancer; as well as externally funded infectious
disease DNA vaccine development programs in Zika, Lassa fever,
Ebola, HIV, and coronaviruses associated with MERS and COVID-19
diseases. Partners and collaborators include Advaccine, ApolloBio
Corporation, AstraZeneca, The Bill & Melinda Gates Foundation,
Coalition for Epidemic Preparedness
Innovations (CEPI), Defense Advanced Research Projects
Agency (DARPA)/Joint Program Executive Office for Chemical,
Biological, Radiological and Nuclear Defense
(JPEO-CBRND)/Department of Defense (DoD), HIV Vaccines Trial
Network, International Vaccine Institute (IVI), Kaneka Eurogentec,
Medical CBRN Defense Consortium (MCDC), 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. INOVIO also is a
proud recipient of 2020 Women on Boards "W" designation recognizing
companies with more than 20% women on their board of
directors. 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
December 31, 2020, QIAGEN employed
approximately 5,600 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, manufacture and commercialize DNA medicines, in particular
our candidate VGX-3100 and a companion diagnostic in collaboration
with QIAGEN, and our expectations regarding our research and
development programs. Actual events or results may differ from the
expectations set forth herein as a result of a number of factors,
including uncertainties inherent in preclinical 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 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, 2019, our
Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 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 final
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.
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, including those products used in the response to
the COVID-19 pandemic, timing for launch and development, marketing
and/or regulatory approvals, financial and operational outlook,
growth and expansion, collaborations markets, strategy or operating
results, including without limitation its expected adjusted net
sales and adjusted diluted earnings 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; actions of governments, global or regional economic
developments, weather or transportation delays, natural disasters,
political or public health crises, including the breadth and
duration of the COVID-19 pandemic and its impact on the demand for
our products and other aspects of our business, or other force
majeure events; as well as the possibility that expected benefits
related to recent or pending acquisitions may not materialize as
expected; 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.
CONTACTS
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QIAGEN
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Investor
Relations
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Public
Relations
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John
Gilardi
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+49 2103 29
11711
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Thomas
Theuringer
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+49 2103 29
11826
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Phoebe Loh
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+49 2103 29
11457
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Robert
Reitze
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+49 2103 29
11676
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e-mail:
ir@QIAGEN.com
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e-mail:
pr@QIAGEN.com
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INOVIO
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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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484-362-0076
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267-440-4211
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ben.matone@inovio.com
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jeff.richardson@inovio.com
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SOURCE INOVIO Pharmaceuticals, Inc.