Inovioが2人目の患者のHPV関連頭頸部がんからの完全寛解を報告

AsiaNet 77212 （0135）

Inovioが2人目の患者のHPV関連頭頸部がんからの完全寛解を報告

【プリマスミーティング（米ペンシルベニア州）2019年1月24日PR Newswire＝共同通信JBN】

＊合成DNAワクチンとPD-1チェックポイント阻害剤による治療で

Inovio Pharmaceuticals, Inc.（NASDAQ: INO）は24日、第1相試験でINO-3112（現在はMEDI0457と呼ばれる）で治療を受けたHPV（ヒトパピローマウイルス）関連頭頸部がんの2人目の患者が、PD-1チェックポイント阻害剤による後続治療の後、持続的な完全奏効（完全寛解）を達成した、と発表した。これは、合成DNAワクチンとそれに続くPD-1チェックポイント阻害剤による治療の後、完全寛解（完全奏効）が観察された2番目の転移性がん患者（https://c212.net/c/link/?t=0&l=en&o=2355306-1&h=2399539705&u=http%3A%2F%2Fir.inovio.com%2Fnews-and-media%2Fnews%2Fpress-release-details%2F2018%2FMajor-Cancer-Journal-Highlights-Data-From-An-Inovio-Sponsored-Trial-In-Which-A-Patient-Achieved-Full-Remission-After-Dosing-With-DNA-Immunotherapy-and-Checkpoint-Inhibitor%2Fdefault.aspx&a=second+patient ）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「転移性がん患者の免疫療法で持続的な完全寛解を達成することは、新規のがん治療で望まれていることである。このHPV関連がん患者集団において、2つの異なるPD-1阻害剤を併用した当社の合成DNAワクチンによる治療が4人のがん発症者のうち2人で完全奏効を示したという事実は、転移性頭頸部がんの単剤療法の完全奏効率が約4%であることを鑑みると、PD-1阻害剤による最高の完全奏効率として非常に有望である。第2相臨床試験からの追加データは合成DNAワクチンの力に関する多くの知見を提供する一方で、この新しく報告されたデータは、さまざまなチェックポイント阻害剤を提供している製薬会社のパートナーとともに、多くのがんに対してT細胞活性剤とチェックポイント阻害剤を組み合わせて使用するというInovioの全体的ながん併用戦略の追加的検証を提供する。Inovioは、HPV関連がんをめぐるパートナーシップに加え、F. Hoffman-La Roche Ltd./GenentechおよびRegeneronと共同で、InovioのINO-5401と、転移性膀胱がんおよびGBMのそれぞれの奏効率を高めるように設計されたチェックポイント阻害剤を組み合わせた有効性試験も行っている。有効性に関する暫定データは年内に出る見込みだ」と語った。

完全寛解を達成した患者はいずれも、HPV関連頭頸部扁平上皮がんを有する22人の患者を対象とした第1相単剤療法試験の1部として合成DNAワクチンを4回投与された。このうち91%（20/22）では血液中ないし細胞組織中におけるT細胞活動が示された。これは、合成DNAワクチンが末梢血中で強力なHPV16/18型CD8+T細胞反応を引き起こし、切除された腫瘍組織試料においてCD8+T細胞浸潤を増大させることを実証している。

進行性疾患を発症し、その後、PD-1チェックポイント阻害剤の投与を受けた4人の患者のうち、2人は急速に完全奏効を示した。データが昨日提出された最新の患者は、ペムブロリズマブ（キイトルーダ（R））の投与を受けた。一方、以前に報告された完全奏効の患者はニボルマブ（オプジーボ（R））で治療された。患者は転移性頭頸部がんから「疾患徴候なし」まで移行し、治療2年後の現在も生存している。ニボルマブを投与された最初の頭頸部がん患者の詳細な結果はClinical Cancer Research10月号に掲載された。

これらの結果は1月23日、カナダ・バンクーバーで開催中のKeystone Symposia Conference/Cancer Vaccinesで、ウィスター研究所執行副所長兼同ワクチン・センター所長でがん研究のW・W・スミス慈善信託寄附講座教授でもあるデービッド・B・ウェイナー医学博士によって発表された。

キイトルーダ（R）はメルク・アンド・カンパニー（MRK）の登録商標で、オプジーボ（R）はブリストル・マイヤーズスクイブ株式会社（BMY）の登録商標である。

▽HPV関連頭頸部がんについて

ヒトパピローマウイルス（HPV）は米国で最も一般的な性感染症で、現在約7900万人の米国人が感染している。HPVは、口腔がん、中咽頭がん、鼻／鼻腔がん、喉頭がんを含む頭頸部がんの発症において主要な役割を果たすことが知られている。2019年には、米国で推定5万3000人が口腔がんないし口腔咽頭がんにかかる見通し。頭頸部がんの新しい症例は、男性の場合には女性の3倍近く発生する。頭頸部がん、中でも男性のHPV関連口腔咽頭がんの発生率は上昇しており、今後も拡大すると予想される。

▽Inovio Pharmaceuticals, Inc.について

Inovioは、がんと感染症の治療を変革するDNA免疫療法の発見、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独自のプラットフォーム技術は、次世代の抗原シークエンシングとDNAデリバリーを応用し、標的疾患に対する強力な免疫反応を活性化する。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は、殺能力が関連する臨床転帰と相関するT細胞の生成を報告している唯一の免疫療法企業である。Inovioの最先端臨床プログラムであるVGX-3100は、HPV関連子宮頸がんの治療薬として第3相試験に入っている。また、頭頸部がん、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、MedImmune、Regeneron、Roche/Genentech、ApolloBio Corporation、ビル&メリンダ・ゲイツ財団、ウィスター研究所、ペンシルベニア大学、パーカーがん免疫療法研究所、CEPI、国防高等研究計画局（DARPA）、GeneOne Life Science、Plumbline Life Sciences、ドレクセル大学、国立衛生研究所（NIH）、HIV Vaccines Trial Network、国立がん研究所、米軍のHIV研究プログラム、ラバル大学が含まれている。詳しい情報はhttp://www.inovio.com を参照。

▽問い合わせ先

投資家：

Ben Matone

Inovio

+1 484-362-0076

ben.matone@inovio.com

メディア：

Jeff Richardson

Inovio

+1 267-440-4211

jrichardson@inovio.com

ソース：Inovio Pharmaceuticals, Inc.

Inovio Reports 2nd Patient Achieving Full Remission from HPV-Related Head & Neck Cancer after Treatment with Synthetic DNA Vaccine and a PD-1 Checkpoint Inhibitor

PR77212

PLYMOUTH MEETING, Pennsylvania, Jan. 24, 2019 /PRNewswire=KYODO JBN/ --

Inovio Pharmaceuticals, Inc. (NASDAQ: INO) today announced that a second

patient with HPV-related head and neck cancer treated with INO-3112 (now called

MEDI0457) in a Phase 1 trial achieved a sustained complete response (full

remission) after subsequent treatment with a PD-1 checkpoint inhibitor. This

marks the second patient (https://c212.net/c/link/?t=0&l=en&o=2355306-1&h=2399539705&u=http%3A%2F%2Fir.inovio.com%2Fnews-and-media%2Fnews%2Fpress-release-details%2F2018%2FMajor-Cancer-Journal-Highlights-Data-From-An-Inovio-Sponsored-Trial-In-Which-A-Patient-Achieved-Full-Remission-After-Dosing-With-DNA-Immunotherapy-and-Checkpoint-Inhibitor%2Fdefault.aspx&a=second+patient )

with metastatic cancer observed in full remission (complete response)

after treatment with synthetic DNA vaccine followed by a PD-1 checkpoint inhibitor.

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Dr. J. Joseph Kim, Inovio's President and CEO, said, "Achieving sustained

complete responses with immunotherapy in metastatic cancer patients is what you

hope for with novel cancer treatments. The fact that the treatment with our

synthetic DNA vaccine followed with two different PD-1 inhibitors in this

HPV-related cancer patient population showed a complete response in 2 out of 4

progressors is very encouraging as the best complete response rate by PD-1

inhibitors as a monotherapy in metastatic head and neck cancer is approximately

4%. While additional data from Phase 2 clinical studies will provide more

insights to the power of synthetic DNA vaccine, this newly reported data

provides additional validation for Inovio's overall cancer combination strategy

using a T cell activator combined with a checkpoint inhibitor against an array

of cancers with big pharma partners providing various checkpoint inhibitors. In

addition to our partnership around HPV-related cancers, Inovio is also

collaborating with F. Hoffman-La Roche Ltd./Genentech and Regeneron in efficacy

trials coupling Inovio's INO-5401 with their checkpoint inhibitors designed to

increase response rates in metastatic bladder and GBM, respectively, with

interim efficacy data expected later this year."

Both patients who achieved full cancer remission were treated with four doses

of synthetic DNA vaccine as part of a Phase 1 monotherapy trial of 22 patients

with HPV-related head and neck squamous cell carcinoma in which 91% of patients

(20/22) showed T cell activity in the blood or tissue. This demonstrates that

synthetic DNA vaccine generated robust HPV16/18 specific CD8+ T cell responses

in peripheral blood and increased CD8+ T cell infiltration in resected tumor

tissue samples.

Of the four patients who developed progressive disease and were subsequently

administered a PD-1 checkpoint inhibitor, two patients rapidly exhibited a

complete response. The most recent patient for which data was presented

yesterday received pembrolizumab (KEYTRUDA(R)); while the previously reported

complete responder was treated with nivolumab (OPDIVO(R)). The patients moved

from metastatic head and neck cancer to no evidence of disease and they remain

alive two years after treatment. Detailed results of the first patient with

head and neck cancer who received nivolumab were published in the October issue

of Clinical Cancer Research.

These results were presented on January 23 at the Keystone Symposia

Conference/Cancer Vaccines being held in Vancouver, Canada by Dr. David B.

Weiner, Executive Vice President of The Wistar Institute, Director of its

Vaccine Center, and the W. W. Smith Charitable Trust Endowed Professorship in

Cancer Research.

KEYTRUDA(R) is a registered trademark of Merck & Co. (MRK); OPDIVO(R) is a

registered trademark of Bristol-Myers Squibb Company (BMY).

About HPV-Related Head & Neck Cancer

Human papillomavirus (HPV) is the most common sexually transmitted disease in

the United States, currently infecting about 79 million Americans. HPV is known

to play a major role in the development of head and neck cancers, which include

cancers of the oral cavity, oropharynx, nose/nasal passages and larynx. In 2019

an estimated 53,000 persons will get oral cavity or oropharyngeal cancer in the

U.S. New cases of head and neck cancer occur nearly three times more often in

men as in women. Incidence rates of head and neck cancers have been on the

rise, especially HPV-related oropharyngeal cancer in men, and are expected to

continue growing.

About Inovio Pharmaceuticals, Inc.

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

development, and commercialization of DNA immunotherapies that transform the

treatment of cancer and infectious diseases. Inovio's proprietary platform

technology applies next-generation 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 is the only immunotherapy company that has reported

generating T cells whose killing capacity correlates with relevant clinical

outcomes. 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 head and neck cancer, bladder cancer, and

glioblastoma, as well as platform development programs in hepatitis B, Zika,

Ebola, MERS, and HIV. Partners and collaborators include MedImmune, Regeneron,

Roche/Genentech, ApolloBio Corporation, The Bill and Melinda Gates Foundation,

The Wistar Institute, the University of Pennsylvania, Parker Institute for

Cancer Immunotherapy, CEPI, DARPA, GeneOne Life Science, Plumbline Life

Sciences, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer

Institute, U.S. Military HIV Research Program, 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

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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, 2017,

our Quarterly Report on Form 10-Q for the quarter ended September 30, 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, +1 484-362-0076, ben.matone@inovio.com

Media:      Jeff Richardson, Inovio, +1 267-440-4211, jrichardson@inovio.com

SOURCE  Inovio Pharmaceuticals, Inc.