Inovioの第3相製品VGX-3100の品質・非臨床データに欧州医薬品庁が認証

AsiaNet 78572 （0761）

【プリマスミーティング（米ペンシルベニア州）2019年5月7日PR Newswire＝共同通信JBN】Inovio Pharmaceuticals, Inc.（NASDAQ: INO）は7日、主要な第3相製品候補であるVGX-3100が、その品質および非臨床データに対し先端医療医薬品認証（Advanced Therapy Medicinal Product Certificate）を得たとを発表した。品質および非臨床データの認証手続きには、将来の登録や関連する欧州科学データ要件を考慮した利用可能なデータの評価が含まれるが、臨床データあるいはベネフィットリスク評価は含まれない。付与された欧州医薬品庁（EMA）認証は、これまでに入手可能なInovioの化学・製造・管理（CMC）データおよび非臨床結果が、EU医薬品販売認可の評価のための科学的、技術的基準に全体として準拠していることを確認するものである。

Inovioの規制関連業務担当上級副社長であるアミ・シャー・ブラウン博士は「当社の主力製品であるVGX-3100を支える非臨床データに加え、現在のCMCが、厳しいEMA要件を満たしていることを非常にうれしく思う。この認証は、VGX-3100に応用されたInovioの技術的卓越性、機能横断的開発の専門知識、高品質規格、さらに間接的にはInovioの技術力の証しだ」と語った。

VGX-3100は現在、極めて重要なグローバル第3相試験を実施中で、これは子宮頸がんの直接の前駆体である子宮頸部HSIL（高悪性度扁平上皮内病変）の退縮や、これらの病変を引き起こすヒトパピローマウイルス（HPV）感染の排除に関するVGX-3100の有効性を評価するものである。並行して、最終的な商用製造プロセスが検証され、EU提出時までに追加の品質データが得られる予定。

▽VGX-3100について

VGX-3100は、現在研究が進められているHPV-16とHPV-18感染症と子宮頸部（第3相）、外陰部、肛門（第2相）の前がん病変の治療用のDNAベースの免疫療法である。VGX-3100は、子宮頸部へのHPV感染に対する初の承認済み治療法と、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る。VGX-3100は、感染を標的とし、前がん細胞の破壊を引き起こすHPV-16とHPV-18に対する特異的免疫反応を刺激することで機能する。組織学的に記録されたHPV-16/18子宮頸部HSIL（CIN2/3）を有する167人の成人女性を対象とした無作為化二重盲検プラセボ対照第2b相試験で、VGX-3100による治療は、統計的に有意に大きな子宮頸部HSILの減少と、対プラセボでHPV感染のクリアランスをもたらした。最も一般的な副作用は注射部位の痛みで、重大な有害事象は報告されていない。VGX-3100は患者自身の免疫系を利用し、リプロダクティブヘルスの喪失や心理社会的悪影響といった手術に伴うリスクの増加なしに、HPV-16とHPV-18の感染と前がん病変を除去する。

▽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、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

投資家向け

Ben Matone

+1-484-362-0076

ben.matone@inovio.com;

メディア向け

Jeff Richardson

+1-267-440-4211

jrichardson@inovio.com

ソース：Inovio Pharmaceuticals, Inc.

Inovio Receives European Medicines Agency Certification For Quality and Non-Clinical Data for Its Phase 3 Product, VGX-3100

PR78572

PLYMOUTH MEETING, PA., May 7, 2019 /PRNewswire=KYODO JBN/--

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

3 product candidate, VGX-3100, has been granted an Advanced Therapy Medicinal

Product Certificate for quality and non-clinical data. The procedure of

certification of quality and non-clinical data involves an assessment of the

available data in view of future registration and the related European

Scientific Data Requirements, not including any clinical data or benefit-risk

assessment. The granted EMA's certificate confirms that Inovio's chemistry,

manufacturing and controls (CMC) data and nonclinical results available to date

overall comply with the scientific and technical standards for evaluating an EU

Marketing Authorization.

Dr. Ami Shah Brown, Inovio's Senior Vice President of Regulatory Affairs, said,

"We are extremely pleased that the current CMC, coupled with the nonclinical

data supporting our lead product, VGX-3100, meets stringent EMA requirements.

This certification is a testament to Inovio's technical excellence,

cross-functional development expertise, and high quality standards as applied

for VGX-3100 and indirectly for Inovio's technology."

VGX-3100 is currently being tested in a pivotal, global Phase 3 program, which

is assessing the efficacy of VGX-3100 to regress cervical HSIL (high-grade

squamous intraepithelial lesions), a direct precursor to cervical cancer, and

to eliminate the HPV infection that causes these lesions. In parallel, the

final commercial manufacturing process will be validated yielding additional

quality data by time of the EU filing.

About VGX-3100

VGX-3100 is a DNA-based immunotherapy under investigation for the treatment of

HPV 16 and HPV 18 infection and precancerous lesions of the cervix (Phase 3)

and vulva and anus (Phase 2). VGX-3100 has the potential to be the first

approved treatment for HPV infection of the cervix and the first non-surgical

treatment for precancerous cervical lesions. VGX-3100 works by stimulating a

specific immune response to HPV-16 and HPV-18, which targets the infection and

causes destruction of precancerous cells. In a randomized, double-blind,

placebo-controlled Phase 2b study in 167 adult women with histologically

documented HPV 16/18 cervical HSIL (CIN2/3), treatment with VGX-3100 resulted

in a statistically significantly greater decrease in cervical HSIL and

clearance of HPV infection vs. placebo. The most common side effect was

injection site pain, and no serious adverse events were reported. VGX-3100

utilizes the patient's own immune system to clear HPV 16 and HPV 18 infection

and precancerous lesions without the increased risks associated with surgery,

such as loss of reproductive health and negative psychosocial impacts.

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

+1-484-362-0076

ben.matone@inovio.com;

Media:

Jeff Richardson

+1-267-440-4211

jrichardson@inovio.com

SOURCE: Inovio Pharmaceuticals, Inc.