InovioとQIAGENが新しい免疫療法VGX-3100の診断検査開発で協業

AsiaNet 78771 （0860）

【プリマスミーティング（米ペンシルベニア州）、ジャーマンタウン（米メリーランド州）、ヒルデン（ドイツ）2019年5月17日PR Newswire＝共同通信JBN】

＊進行性子宮頸部前がんを標的としたInovioのVGX-3100の患者選択につながる液体生検ベースの精密医療試験

Inovio Pharmaceuticals Inc.（NASDAQ: INO）とQIAGEN N.V.（NYSE: QGEN; Frankfurt Prime Standard: QIA）は20日、Inovioのヒトパピローマウイルス（HPV）関連の進行性子宮頸部異形成治療用の免疫療法であるVGX-3100に反応する可能性が最も高い患者を特定するための診断試験を共同開発事業を発表した。この精密医療パートナーシップは、子宮頸部へのHPV感染に対する初の承認済み治療法と、同ウイルス関連の前がん性子宮頸部病変に対する初の非外科的治療法となる可能性があり、現在、2つの重要な第3相臨床試験（REVEAL 1および2）が行われている後期製品候補であるInovioのVGX-3100に焦点を当てたものである。金銭的取り決めは明らかにされていない。

Inovioの社長兼最高経営責任者（CEO）であるJ・ジョゼフ・キム博士は「当社の合成核プラットフォームを進歩させるため、われわれは常に自社の技術あるいはQIAGENのような創造的パートナーを通じてイノベーションを推進する方法を模索している。QIAGENは、同社の新規診断試験の商業開発とマーケティングの豊富な実績を、この重要な協業にもたらしてくれる。Inovioは、子宮頸部前がんを有する女性のための非外科的治療法としてVGX-3100を開発しており、われわれが発見した治療前のバイオマーカーは、VGX-3100による治療に反応する可能性が最も高い患者を特定するための的を絞った方法を提供し、製品の絶対的有効性を高められる可能性がある」と語った。

QIAGENのピアー・M・シャーツ最高経営責任者（CEO）は「HPV感染症や前がん性疾患の治療に劇的な変化をもたらす可能性のあるVGX-3100の恩恵を受けられる患者を特定するための液体生検ベースのコンパニオン診断薬を開発することで、Inovioをサポートできるのをうれしく思う。当社のサンプルから解析に至るワークフローと、免疫腫瘍の精密医療向け診断ソリューションの開発経験は、この満たされていない大きな医療ニーズにInovioが応える手助けとして非常に適している。当社のチームはHPV関連の分子試験と子宮頸がんに関して豊富な経験を有しており、Inovioと共同でこの専門知識を生かせることを楽しみにしている。このプロジェクトは、Inovioがこのユニークな分子アッセイの力に現在貢献している新しいマイクロRNAバイオマーカーの発見に取り組むためにQIAGEN Genomic Servicesを選択した発見段階に始まった協業のケーススタディでもある。プロジェクトは開発に進み、Inovioは現在、VGX-3100の規制当局への申請を2021年に行うことを目指している」と述べた。

HPVは生殖管の最も一般的なウイルス感染症で、子宮頸がんの主な原因であり、女性の間で4番目に一般的ながんである。世界保健機関（WHO）は2018年、推定57万件の子宮頸がんの新規症例と31万1000人の死亡を報告した。世界中で3億人近い女性がHPVに感染していると推定され、前がん段階に進行している症例がさらに約3000万件もある。子宮頸がんの原因の少なくとも70％が、リスクの高いHPV 16およびHPV 18の遺伝子型と推定されている。

InovioのVGX-3100は、HPV 16とHPV 18の感染症と進行性子宮頸部異形成（第3相）、ならびに外陰部と肛門の異形成（第2相）の治療に向けた臨床試験中の新規免疫療法である。VGX-3100は患者自身の免疫システムを活性化させ、手術に伴うリスクの増加なしに、HPV 16とHPV 18の感染と前がん性病変を除去する。

▽Inovio Pharmaceuticals, Inc.について

Inovioは、がんと感染症を標的とした合成核技術の発見、開発、商品化に重点的に取り組む革新的バイオテクノロジー企業である。Inovioは独自の技術プラットフォームを抗原シーケシングとDNA送達に応用し、標的疾患に対する強力な免疫反応を活性化させている。この技術は生体内でのみ機能し、標的のがんや病原体に対する強力で完全に機能するT細胞と抗体反応を、絶え間なく活性化することが実証されている。Inovioの最先端臨床プログラムであるVGX-3100は、HPV関連子宮頸部前がんの治療薬として第3相試験に入っている。また、HPV関連がん、膀胱がん、膠芽細胞腫を標的とした免疫腫瘍プログラム開発が第2相試験中で、B型肝炎、ジカ、エボラ、MERS（中東呼吸器症候群）、HIV用のプラットフォーム開発プログラムもある。パートナーおよび共同研究者には、アストラゼネカ、Regeneron（リジェネロン）、Roche/Genentech（ロシュ/ジェネンテック）、ApolloBio Corporation、GeneOne Life Science、ビル&メリンダ・ゲイツ財団、Coalition for Epidemic Preparedness Innovations、米国防高等研究計画局（DARPA）、国立衛生研究所（NIH）、国立アレルギー・感染症研究所、国立がん研究所、HIV Vaccines Trial Network、ウォルター・リード陸軍研究所、ウィスター研究所、ペンシルベニア大学が含まれている。詳細は、www.inovio.com を参照。

▽QIAGENについて

オランダに本拠を置く持株会社QIAGEN N.V.は、顧客が生命の構成要素を含むサンプルから貴重な分子解析を得ることを可能にする「サンプルから解析まで」ソリューションの世界的大手プロバイダーである。当社のサンプル技術は、血液、組織、その他の材料からDNA、RNA、タンパク質を分離し、処理する。アッセイ技術がこれらの生体分子を可視化し、分析の準備を整える。バイオインフォマティクス・ソフトウエアと知識ベースは、データを読み取り、関連があり、すぐ実施可能な解析を報告する。自動化ソリューションは、シームレスで費用対効果の高いワークフローでこれらを結び付ける。QIAGENは、分子診断学（ヒューマンヘルスケア）、応用検査（主に法医学）、医薬品（製薬およびバイオテクノロジー企業）、学術（ライフサイエンス研究）で、世界中の50万以上の顧客にソリューションを提供している。2019年3月31日現在、QIAGENは世界の35を超す場所で約5100人を雇用している。

▽問い合わせ先

QIAGEN

投資家向け

John Gilardi

+49 2103 29 11711

ir@QIAGEN.com

メディア向け

Dr. Thomas Theuringer

+49 2103 29 11826

pr@QIAGEN.com

Inovio Pharmaceuticals Inc.

投資家向け

Ben Matone

1-484-362-0076

ben.matone@inovio.com

メディア向け

Jeffrey C. Richardson

1-267-440-4211

jrichardson@inovio.com

ソース：Inovio Pharmaceuticals, Inc.

Inovio and QIAGEN Establish Collaboration to Develop Diagnostic Test for VGX-3100, Inovio's Novel Immunotherapy Targeting Advanced Cervical Pre-Cancer

PR78771

PLYMOUTH MEETING, Pa., GERMANTOWN, Md., HILDEN, Germany, May 17, 2019 /PRNewswire=KYODO JBN/

--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.