皮内投与されたInovioのエボラワクチンが臨床研究で100％の免疫原性を示す

AsiaNet 77966 （0474）

【プリマスミーティング（米ペンシルベニア州）2019年3月21日PR Newswire＝共同通信JBN】

＊Journal of Infectious Diseasesに掲載

Inovio Pharmaceuticals, Inc.（NASDAQ: INO）は21日、同社のエボラワクチン、INO-4201は安全で耐容性があり、強力なT細胞および抗体反応を発現させると発表した。この第1相データはThe Journal of Infectious Diseases（https://c212.net/c/link/?t=0&l=en&o=2409747-1&h=3108008505&u=https%3A%2F%2Facademic.oup.com%2Fjid%2Fadvance-article-abstract%2Fdoi%2F10.1093%2Finfdis%2Fjiz132%2F5395966&a=The+Journal+of+Infectious+Diseases ）に掲載、新たな感染症向けの皮内送達プラットフォームの前進をさらに支持するものである。重要なのは、この研究が、InovioのCELLECTRA（R）送達装置を用いた皮内（皮膚）投与で、評価可能被験者の100％が抗原特異的抗体反応を発現、ほとんどの被験者で同反応が1年以上持続し、筋肉内送達を受けたグループと同等か、それ以上のT細胞反応の発現を示したことである。公表されたデータは、Inovioのワクチンおよび免疫療法プラットフォームの安全性、有効性、製品安定性における優位を一層、裏付けるものである。

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Inovioの社長兼最高経営責任者（CEO）であるJ・ジョセフ・キム博士は「INO-4201は既に、致死量のエボラウイルス投与を受けた非ヒト霊長類で100％の予防を実証している。Inovioは、説得力のある前臨床データとヒトデータを使用し、実行可能な備蓄ワクチンとしてINO-4201を推進することで、当社の全体的な開発戦略を遂行しつつある。Inovioのエボラワクチンはエボラ感染の予防に使用可能で、抗ベクター反応なしに何度も免疫強化できるので、事実上、再投与ができないウイルスベクターワクチンの増強用に使用することができる。われわれは今、当社のエボラワクチンをスタンドアロンワクチンとして、またウイルスベクターワクチンの予防接種を受けたことのある人々の免疫強化用ワクチンとしてさらに前に進めるべく、パートナーからの資金確保を検討している」と語った。

冷凍保存しなければならないウイルスベクターワクチンと異なり、INO-4201は室温で1年以上変化しない。エボラウイルスの大流行を抑制するには、送達が簡単で室温で品質の変わらない非生ワクチンアプローチが望ましい。

Inovioのエボラワクチンは、5つの健康な被験者グループで評価された。評価された70人の被験者のうち、67人（96％）が3回の免疫療法後に抗体陽転し、エボラ糖タンパク質抗原に対して強い抗体反応を示した。52人の被験者（76％）は、わずか2回の投与で抗体陽転した。

重要なのは、皮内（皮膚）投与を用いた研究群で、13人の評価可能被験者のうち13人（100％）がたった２回の投与後に抗原特異的抗体反応を発現し、3回の免疫療法後も抗体陽転したままだったことである。

現在まで、INO-4201は高い忍容性を示しており、現在開発中のいくつかのウイルスベクターベースのエボラワクチンに関して報告されている、発熱、関節痛、低白血球数などの全身性の重篤な副作用は現れていない。

米国防高等研究計画局（DARPA）が全面的に資金提供している、この研究に関するより詳しい情報は、Journal of Infectious Diseasesの最新号のInovioと共同研究者の共著記事「Intradermal SynCon(R) Ebola GP DNA Vaccine is Temperature Stable and Safely Demonstrates Cellular and Humoral Immunogenicity Advantages in Healthy Volunteers」を参照 。

▽Inovio Pharmaceuticals, Inc.について

Inovioは、がんと感染症の治療と予防を変革するDNAベースの免疫療法とワクチンの発見、開発、商品化に重点的に取り組む後期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クエンシングと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関連のがん、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、Roche/Genentech、ApolloBio Corporation、ウィスター研究所、ビル&メリンダ・ゲイツ財団、ペンシルベニア大学、パーカーがん免疫療法研究所、CEPI、米国防高等研究計画局（DARPA）、GeneOne Life Science、Plumbline Life Sciences、国立衛生研究所（NIH）、HIV Vaccines Trial Network、国立がん研究所、ウォルター・リード陸軍研究所、ドレクセル大学、ラバル大学が含まれている。詳細については、www.inovio.com  を参照。

▽問い合わせ先

投資家関係

Ben Matone

484-362-0076

ben.matone@inovio.com

メディア関係

Jeff Richardson

267-440-4211

jrichardson@inovio.com

ソース：Inovio Pharmaceuticals, Inc.

Inovio's Ebola Vaccine Delivered Intradermally Demonstrates 100% Immunogenicity in a Clinical Study Published in The Journal of Infectious Diseases

PR77966

PLYMOUTH MEETING, Pa., March 21, 2019 /PRNewswire=KYODO JBN/ --

Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today that its Ebola

vaccine, INO-4201, was safe, tolerable, and generated strong T cell and

antibody responses. This Phase 1 data was published in The Journal of

Infectious Diseases (https://c212.net/c/link/?t=0&l=en&o=2409747-1&h=3108008505&u=https%3A%2F%2Facademic.oup.com%2Fjid%2Fadvance-article-abstract%2Fdoi%2F10.1093%2Finfdis%2Fjiz132%2F5395966&a=The+Journal+of+Infectious+Diseases ) and further supports the advancement of the intradermal delivery platform for

emerging infectious diseases.  Significantly, the study demonstrated that

intradermal (skin) administration with Inovio's CELLECTRA(R) delivery device

resulted in 100% of evaluable subjects generating antigen-specific antibody

responses that persisted for more than one year in most subjects and generated

T cell responses equivalent to or better than the group that received

intramuscular delivery. The published data further validates the safety, potency,

and product stability advantages of Inovio's vaccine and immunotherapy platform.

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Dr. J. Joseph Kim, Inovio's President and CEO, said, "INO-4201 has already

demonstrated protection in 100% of non-human primates following a challenge

with a lethal dose of the Ebola virus. With strong preclinical and human data,

Inovio is executing on our overall development strategy in advancing INO-4201

as a viable stockpile vaccine. Because Inovio's Ebola vaccine can be used to

protect against Ebola infection and can be boosted multiple times without any

anti-vector response, it could be employed to boost viral vector vaccines that

cannot be effectively re-administered. We now look to secure partner funding to

further advance our Ebola vaccine as a stand-alone vaccine as well as a boost

for those previously immunized with viral vector vaccines."

Unlike viral vector vaccines which must be kept frozen, INO-4201 is stable at

room temperature for more than one year. Non-live vaccine approaches that are

simple to deliver and stable at room temperature are desirable in controlling

Ebola virus outbreaks.

Inovio's Ebola vaccine was evaluated in five groups of healthy subjects. Of 70

evaluated subjects, 67 (96%) seroconverted and mounted a strong antibody

response to the Ebola glycoprotein antigen following the three dose

immunization regimen; 52 subjects (76%) seroconverted after only two doses.

Significantly, in the study arm using intradermal (skin) administration, 13 of

13 evaluable subjects (100%) generated antigen-specific antibody responses

after only two doses and all remained seropositive after three immunizations.

To date INO-4201 has been well-tolerated and has not demonstrated systemic

serious adverse effects, such as fever, joint pain, and low white blood cell

counts, reported in association with some viral vector-based Ebola vaccines

currently in development.

More information on this study, fully funded by U.S. Defense Advanced Research

Projects Agency (DARPA), can be found in the most recent edition of The Journal

of Infectious Diseases in the article entitled, "Intradermal SynCon(R) Ebola GP

DNA Vaccine is Temperature Stable and Safely Demonstrates Cellular and Humoral

Immunogenicity Advantages in Healthy Volunteers," authored by Inovio and its

collaborators.

About Inovio Pharmaceuticals, Inc.

Inovio is a late-stage biotechnology company focused on the discovery,

development, and commercialization of DNA-based immunotherapies and vaccines

that transform the treatment and prevention of cancer and infectious disease.

Inovio's proprietary technology platform applies antigen sequencing and DNA

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, The Wistar Institute, The Bill & Melinda Gates Foundation, the

University of Pennsylvania, Parker Institute for Cancer Immunotherapy, CEPI,

DARPA, GeneOne Life Science, Plumbline Life Sciences, NIH, HIV Vaccines Trial

Network, National Cancer Institute, Walter Reed Army Institute of Research,

Drexel University, and Laval University. For more information, visit

www.inovio.com.

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

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.

CONTACTS:

Investors: Ben Matone, 484-362-0076, ben.matone@inovio.com

Media: Jeff Richardson, 267-440-4211, jrichardson@inovio.com

SOURCE Inovio Pharmaceuticals, Inc.