Country for PR: United States
Contributor: PR Newswire New York
Wednesday, February 24 2021 - 17:45
AsiaNet
INOVIO and QIAGEN expand collaboration to develop next generation sequencing (NGS) companion diagnostic for INOVIO's VGX-3100 for advanced cervical dysplasia
PLYMOUTH MEETING, Pa. and GERMANTOWN, Md. and HILDEN, Germany, Feb. 24, 2021 /PRNewswire-

  -- Liquid biopsy-based precision test guides patient selection and 
     offers potential for cost-effective, non-invasive alternative to 
     surgical removal of cervical lesions
  -- QIAGEN's bioinformatic expertise raises predictive biomarker 
     power in INOVIO's patient selection
  -- First-in-class next generation sequencing (NGS) assay designed 
     for use on Illumina NextSeq(TM) 550Dx

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(TM) 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			
			
QIAGEN			
			
Investor Relations			
John Gilardi	
+49 2103 29 11711
	
Phoebe Loh	
+49 2103 29 11457

e-mail: ir@QIAGEN.com 

Public Relations
Thomas Theuringer	
+49 2103 29 11826

Robert Reitze	
+49 2103 29 11676

e-mail: pr@QIAGEN.com
			
INOVIO 			
			
Investors
Ben Matone
484-362-0076		
ben.matone@inovio.com 
	
Media
Jeffrey C. Richardson
267-440-4211
jeff.richardson@inovio.com

Source - INOVIO Pharmaceuticals, Inc.
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