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Contributor: PR Newswire New York
Friday, May 17 2019 - 06:11
AsiaNet
Inovio and QIAGEN Establish Collaboration to Develop Diagnostic Test for VGX-3100, Inovio's Novel Immunotherapy Targeting Advanced Cervical Pre-Cancer
PLYMOUTH MEETING, Pa., GERMANTOWN, Md., HILDEN, Germany, May 17, 2019 /PRNewswire-AsiaNet/

--Liquid biopsy-based Precision Medicine test to guide patient selection for 
Inovio's VGX-3100 

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(R) 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 	
	
Investors	              Media
John Gilardi 	              Dr. Thomas Theuringer
+49 2103 29 11711	      +49 2103 29 11826
ir@QIAGEN.com                 pr@QIAGEN.com

	
Inovio Pharmaceuticals Inc.	
	
Investors 	              Media
Ben Matone 	              Jeffrey C. Richardson
1-484-362-0076 	              1-267-440-4211
ben.matone@inovio.com         jrichardson@inovio.com

 
SOURCE: Inovio Pharmaceuticals, Inc.
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