InovioがINO-5401とRegeneronのPD-1阻害剤を併用した膠芽腫（GBM）の免疫腫瘍試験で登録を完了

AsiaNet 78093（0528）

【プリマスミーティング（米ペンシルベニア州）2019年4月1日PR Newswire＝共同通信JBN】Inovio Pharmaceuticals, Inc.（NASDAQ: INO）は1日、新たに診断された膠芽腫（GBM）患者に対する第1/2相免疫腫瘍試験が予定より3カ月早く登録を完了したと発表した。52人の患者を対象とする試験は、GBMで発現する複数の抗原をコードするInovioのINO-5401 T細胞活性化免疫療法と、IL-12をコードする免疫賦活剤INO-9012を、Regeneron Pharmaceuticals（リジェネロン・ファーマシューティカルズ）がSanofi（サノフィ）と共同で開発したPD-1阻害剤であるcemiplimab-rwlc（Libtayo（R）またはREGN2810としても知られる）と併用し、評価することが目的である。この試験情報は1日、アトランタで開催中の米国がん学会年次総会の第1－3相試験中セッションで発表される。

Inovioは、安全性、免疫学的影響、無増悪生存期間および全生存期間を評価する本試験の中間結果を今年末までに報告する予定（www.clinicaltrials.gov 、identifier NCT03491683を参照）。

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「当社の革新的な併用試験に参加してくれた患者とその医師に心から感謝する。これは、当社のT細胞生成療法をPD-1/PD-L1阻害剤と併用することで、GBMやその他複数のがんに対する免疫療法の全体的有効性を向上させる、Inovioのがん併用戦略にとって重要なステップだ。われわれは既に、頭頸部がん第1相臨床試験で、InovioのT細胞生成免疫療法MEDI0457とチェックポイント阻害剤の併用が、2年を過ぎてもがんのない完全奏効を得た患者2人を生んだことを明らかにしている。われわれは今回のGBM試験で、10年以上に渡って標準治療も臨床転帰も臨床的に有意な変化をしていない疾患に直面している患者の全生存期間を伸ばすことを目標としている」と語った。

InovioはMEDI0457（HPV関連がん用）でアストラゼネカと臨床パートナーシップを組み、INO-5401（膀胱がんとGBM用）でRoche/Genentech（ロシュ/ジェネンテック）およびRegeneronとの共同研究を行っており、それぞれチェックポイント阻害剤を併用したInovioの免疫療法の臨床評価を提供している。特に、INO-5401の共同研究は、抗原特異的キラーT細胞を生成するINO-5401とT細胞活性を増強するチェックポイント阻害剤という2つの免疫療法を併用する、強力な科学的根拠に基づいている。

▽膠芽腫について

膠芽腫（GBM）は、最も一般的かつ攻撃的なタイプの脳腫瘍であり、患者、介護者双方にとって依然として悲惨な疾患である。過去10年間に限られた数の新規治療法が承認されたものの、その予後は極めて悪い。標準治療を受けている患者の全生存期間の中央値は約15カ月で、平均5年生存率は5％未満である。

▽INO-5401について

INO-5401は、InovioのhTERT、WT1、PSMA用SynCon（R）抗原を含有しており、チェックポイント阻害剤との併用で強力ながん免疫療法となる可能性がある。国立がん研究所は既に、重要ながん抗原リストの中でhTERT、WT1、PSMAを強調、がん免疫療法開発にとって優先順位の高い抗原に指定している。これらの3つの抗原は、様々なヒトのがんにおいて過剰発現され、しばしば突然変異することが知られており、これらの抗原を標的とすることでがん患者の治療における有効性が証明される可能性がある。

▽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（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

484-362-0076

ben.matone@inovio.com

メディア向け

Jeff Richardson

267-440-4211

jrichardson@inovio.com

ソース：Inovio Pharmaceuticals, Inc.

Inovio Completes Enrollment Ahead of Schedule In Immuno-Oncology Study for Glioblastoma (GBM) with INO-5401 in Combination with Regeneron's PD-1 Inhibitor

PR78093

PLYMOUTH MEETING, Pa., April 1, 2019 /PRNewswire=KYODO JBN/ --

Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today that its Phase 1/2

immuno-oncology trial in patients with newly diagnosed glioblastoma (GBM) has

completed its enrollment three months ahead of schedule. The 52-patient trial

is designed to evaluate Inovio's INO-5401 T cell activating immunotherapy

encoding multiple antigens expressed by GBM and INO-9012, an immune activator

encoding IL-12, in combination with cemiplimab-rwlc (also known as Libtayo(R)

or REGN2810), a PD-1 inhibitor developed by Regeneron Pharmaceuticals in

collaboration with Sanofi. This trial information will be presented today at

Phase I-III Trials in Progress session at the Annual Meeting of the American

Association for Cancer Research being held in Atlanta.

Inovio expects to report interim results from this study before the end of this

year evaluating safety, immunological impact, progression-free survival and

overall survival (see www.clinicaltrials.gov, identifier NCT03491683).

Dr. J. Joseph Kim, Inovio's President and Chief Executive Officer, said, "We

sincerely thank the patients and their doctors for participating in our

innovative combination trial. This is an important step for Inovio's cancer

combination strategy using our T cell-generating therapies in combination with

PD-1/PD-L1 inhibitors for GBM and for multiple other cancers to improve overall

efficacy of immunotherapy. We have previously shown in a Phase 1 head and neck

cancer clinical study, combining Inovio's T cell-generating immunotherapy

MEDI0457 along with checkpoint inhibitors have resulted in two complete

responders who remain cancer free for over two years.  In this GBM trial, our

goal is to increase the overall survival of patients facing a disease where

neither the standard of care, nor clinical outcomes have changed in a

clinically significant way in more than a decade."

Inovio holds clinical partnerships with AstraZeneca for MEDI0457 (in

HPV-related cancers) and collaborations with Roche/Genentech and Regeneron for

INO-5401 (in bladder cancer and GBM), each providing for clinical evaluation of

Inovio immunotherapies combined with checkpoint inhibitors. In particular, the

INO-5401 collaborations are based on a strong scientific rationale to combine

two immunotherapies: INO-5401, which generates antigen-specific killer T cells,

and a checkpoint inhibitor, which augments T cell activity.

About Glioblastoma

Glioblastoma (GBM) is the most common and aggressive type of brain cancer and

remains a devastating disease for both patients and caregivers. Its prognosis

is extremely poor, despite a limited number of new therapies approved over the

last 10 years. The median overall survival for patients receiving standard of

care therapy is approximately 15 months and the average five-year survival rate

is less than five percent.

About INO-5401

INO-5401 includes Inovio's SynCon(R) antigens for hTERT, WT1, and PSMA, and has

the potential to be a powerful cancer immunotherapy in combination with

checkpoint inhibitors. The National Cancer Institute previously highlighted

hTERT, WT1, and PSMA among a list of important cancer antigens, designating

them as high priorities for cancer immunotherapy development. These three

antigens are known to be over-expressed, and often mutated, in a variety of

human cancers, and targeting these antigens may prove efficacious in the

treatment of patients with cancer.

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, Inovio, 484-362-0076, ben.matone@inovio.com

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

SOURCE: Inovio Pharmaceuticals, Inc.