PR88222

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=KYODO JBN/

  -- 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.