ヘルペスワクチン最前線 10: GenVec GV2207

さて、皆さん！ウダウダとしながらも、「ヘルペスワクチン最前線 第10弾！」を迎えることができました！( ｀ー´)ノ

いやぁ、なんとか10回まで持ちこたえることができました…。これも、皆様の熱いご支援のおかげでございます。これからも、是非、よろしくお願い申し上げます☆


さてさて、今回取り上げるヘルペスワクチンは、GenVac というバイオ製薬会社（アメリカ メインランド州）が研究・開発を進めている GV2207 というものであります。


（１）GenVac と GV2207 について

今やバイオ系の製薬会社は、遺伝子工学技術の進歩により、以前よりも安価で質のいい＆小型機器が手に入りやすくなったことから、GenVacのような小さな製薬会社がたくさん研究を進めているんです…。GenVacも調べてみると…、とっても「小さな・可愛らしい会社」のようで、アメリカでよく見る平屋・赤煉瓦のビジネス・コンプレックスみたいな感じのところにあるようです。

このピルの一角にGenVacがあるらしい…

その、「小さな・可愛らしい」GenVacですが…、ホームページは結構シッカリ作りこんでましたね☆

「ヘルペスワクチン最前線09」で取り上げた G103 の二の前にならないように（汗）、ちゃんと Pipeline Information も調べておきました！そうすると、

GV2207（HSV）が、ちゃんと一覧表の中に書いてありました！(^^♪

いやぁ、まずは、一安心ですね…。

それで、同社が開発している GV2207 について何ですが、ホームページを見ると…、何やら技術的なことが少しだけ説明してあるPDF文書がUPされておりまして…、それが以下の文書になります。

技術的な特徴としては、GV2207は、単純なアデノベクター構造体（a single adenovector construct）で、二つのHSVに最適化された抗体を表すことができるようなんですが…、ちょっとここの部分は専門的な知識がなくて分かりませんでした…。(´・ω・`)

なにやら、よく見ると…、

　　Gorilla adenovirus（ゴリラ・アデノウイルス）

と書いてあるので…、

を想像してしまったんですが…、正しいのかなぁ… (;・∀・)

自分の解釈がどのくらいあっているのか、ちょっと（というか、かなり）不安ですが、技術的なことに関しては、今回のGV2207に関してはほとんど太刀打ちできなかったですね…。

他にもいろいろと資料があれば、まだ何とか対応もできるのでしょうが、数時間かけて探してみても、先ほど示したPDFの資料だけしか出てこなかったので…、

　　ひょっとして、研究論文として出す程の結果を出せなかったとか… (;・∀・)

という一抹の不安を覚えてしまいました…。

一応、動物実験は行っているようでして、その結果を見てみると…、

• In a preclinical study, a single administration of GV2207 reduced HSV2 lesion scores in guinea pigs within 2weeks in an industry-standard recurrence model
  GV2207を一回ギニーピッグに投与した実験では、2週間以内に症状の度合いが小さくなった
• In a preclinical study, mice given a single vaccination of GV2207 and challenged with HSV2 7 days postvaccination showed a 50x to 100x reduction in viral load compared with unvaccinated mice
  GV2207を投与されたマウスにHSV2ウィルスを投与したところ、投与しなかったマウスと比べて、50倍から100倍、ウィルス濃度が少なくなっていた
• A robust, durable T cell response was seen in treated mice
  GV2207を投与されたマウスには、T細胞の活性化が見られた
• Repeat administration of GV2207 demonstrated an increased HSV-specific T cell response in treated mice
  繰り返しGV2207を投与したマウスにおいては、HSVに対応したT細胞の反応が見られた

という結果を得ているようです。動物実験の詳しい結果が手に入らなかったのは残念ですが…、ウィルス量が50倍～100倍小さくなった！というのはかなり魅力ですよね！

（２）では、今後はどうなりそうなの…？

というわけで、今後の見通しなんですが…、

これがまた…、

よく分からないんですねぇ… (;・∀・)

というのも、GenVac が 2017年6月3日にUPした Form 10-K（有価証券報告書）を見てみると（原本は以下のForm 10Kをクリック）…、

こんな文章が記されていたんです！

Herpes Simplex Virus.

We are seeking a partner to continue the development of our GV2207 vaccine for the treatment of HSV including HSV type 2 (“HSV-2”), the virus responsible for most cases of genital herpes. According to the World Health Organization (the “WHO”), an estimated 417 million people aged 14 – 49 (11%) worldwide have HSV-2 infections. According to the CDC, genital herpes is common in the United States — one of every six people aged 14 – 49 is infected. All HSV-2 infections are permanent and result in periodic virus shedding. The CDC notes that herpes infections are most contagious when symptoms are present, but can still be transmitted to others in the absence of symptoms. Of added concern, infection with HSV-2 increases the risk of acquiring and transmitting HIV infection. There is no approved vaccine for HSV-2 in the United States. Although antiviral regimens have become a standard of care, their inconvenience, cumulative cost and potential for drug resistance further underscore the need for safe, new approaches to reducing HSV-2 lesions, virus shedding, and transmission. Estimated costs of treating HSV in the United States alone are close to $1 billion, primarily for drugs and outpatient medical care.

Data on our HSV vaccine program has shown that a single administration of our genetic vaccine was effective against HSV-2 in two industry-accepted HSV disease models. Specifically, immunization was shown to reduce viral shedding, and the recurrence and severity of lesions.

We are not engaging in significant development for HSV while we seek to partner this program.

この部分は、いわゆる、株主やこれから株を買ってもらう人たちに自分たちの業績の説明をしているところなんですが…、それにも関わらず…！

We are not engaging in significant development for HSV while we seek to partner this program.

HSVワクチンの開発にはさほど力を入れていないが、このプログラムを一緒に進めていくパートナーを探しているところである

と、非常に後ろ向きな書き方をしているわけですね…！

普通、株主に説明をするとか、新しい株主を開拓するという場合には、もっとこうポジティブなことを書くはずじゃないですか！もちろん、ウソはつかずに＆正直にですが、現状に問題があったとしても、客観的に説明をすると思うんですね…。

ところが、こんな感じの「後ろ向き」な書き方だったので…、

　　これはウラに何かあるんじゃないか…？

と思ってしまったわけです…。

そうすると…、

　　ありましたよ、奥さん！家政婦はミタ！じゃないですが…

何と、

別の INTREXON というバイオ系の会社から2017年1月に買収の話しが来ており、今（2017年6月上旬）の段階で、株主からの同意書を集めている

という状況らしいのです…！

そうなると、気になるのが…、INTREXON がワクチン開発を継続するかどうか、という点になるわけですが…、どうやら、以下のプレスリリースを見る限り、INTREXON は GenVac が開発した AdenoVerse technology に興味があるようで、その他の事業については、おそらく削減ということになるかもしれません…。


今後も状況は思いますが…、ちょっと先行きは怪しいかもしれません… (;・∀・)


折角の「ヘルペスワクチン最前線 第10弾！」ということで、良い情報をお伝えできればよかったのですが…、ちょっと残念な見通しとなってしまいました…。


けど、「捨てる神あれば、拾う神あり」ということわざもありますし、また他の分野で活躍してくれるかもしれません！それに、今回、この研究に携わった人たちが、他の会社に行き、そこでまた違った方法で研究を再開する可能性も十分にあるかと思います☆(^^♪

まずは、これからの研究がうまく実を結んでいくように、祈りたいと思います。


これからも、これに懲りず、皆さんに情報を提供していきたいと思いますので、よろしくご支援くださいませ☆


では、また、次回の報告をお楽しみに ( ｀ー´)ノ


Gen Vac Press Releases

Intrexon to Acquire GenVec

Released January 24, 2017GenVec’s AdenoVerse™ to be Integrated into Intrexon's Proprietary Synthetic Biology Platform 

GERMANTOWN, MD, and GAITHERSBURG, MD, Jan. 24, 2017 -- Intrexon Corporation (NYSE: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, today announced that it has entered into a definitive agreement to acquire GenVec, Inc. (NASDAQ: GNVC), a clinical-stage company and pioneer in the development of AdenoVerse™ gene delivery technology.

Intrexon intends to integrate and expand upon GenVec’s expertise in adenoviral vectors and cGMP drug product manufacturing to enhance its broad gene transfer capabilities that encompass multiple viral and non-viral platforms. Notably, the combined technologies have the potential to yield the next generation of adenoviral (AdV) delivery through the creation of a scalable manufacturing platform utilizing helper-dependent adenovirus with significantly higher payload capacity of >30kb, as compared to current viral delivery methods ranging from 4.5kb – 9kb.

Thomas D. Reed, Ph.D., Intrexon’s chief science officer commented, “Our acquisition of GenVec will mark our continuing commitment to add gene delivery platforms that complement our multigenic control systems. Intrexon’s proficiency in using various viral as well as non-viral transfer techniques to integrate our gene programs affords us the capability to pursue an array of in vivo and ex vivo gene and cell therapy approaches, and the addition of a helper-dependent adenoviral system with a substantial payload capacity dramatically expands the types of in vivotherapeutic programs we can pursue.”

“GenVec has contributed significantly to advancements in gene therapy through its AdenoVerse technology, and over 3,000 clinical trial subjects have received their therapeutics and vaccines across the globe. We are enthusiastic to begin working alongside their highly accomplished research and drug development team,” added Dr. Reed.

“After a detailed and careful evaluation, our board of directors believes that this is the best alternative to maximize value for GenVec’s shareholders,” said Douglas Swirsky, GenVec’s president and CEO. “We expect that the strong scientific synergies, coupled with Intrexon’s extensive resources, will help unlock the true potential of the AdenoVerse platform.”

Through an AdV-based vector, Intrexon has already delivered the first clinically validated transcriptional gene switch utilizing the RheoSwitch Therapeutic System® to regulate the expression and concentration of a powerful cytokine, interleukin-12, to treat cancer. Intrexon’s gene control systems combined with the array of GenVec’s AdV-based technology is projected to accelerate its ability to develop cutting-edge gene therapies that regulate in vivo expression of multiple therapeutic effectors.

Additionally, GenVec's selection of vector origins and serotypes as well as know-how in specifying cellular and tissue targets is expected to expedite the design and production of vectors that complement Intrexon’s multigene programming and focus on safety with limited off-target effect.

Douglas E. Brough, Ph.D., GenVec’s chief scientific officer stated, “We are excited to be joining the talented team at Intrexon. Utilization of their advanced synthetic biology tools and expertise is expected to enable the development of a manufacturing approach that will greatly increase the capacity of our expression cassettes to over 30kb. This next-generation delivery platform is anticipated to vastly exceed other viral delivery methods and accommodate Intrexon’s advanced gene programming to target complex multi-gene disorders.”

Transaction Terms and Timing

Pursuant to the definitive agreement, upon the closing of the transaction GenVec stockholders will receive 0.297 of a share of Intrexon Common Stock in exchange for each share of GenVec common stock. This exchange ratio represents $7.00 per share of GenVec’s common stock based on Intrexon’s 5-day volume weighted average price as of January 23, 2017. GenVec stockholders will also receive a right to contingent consideration equal to 50% of any milestone or royalty payments received within 36 months after the closing of the transaction under GenVec’s Research Collaboration and License Agreement with Novartis. Consummation of the acquisition is subject to customary closing conditions, including GenVec stockholder approval, and is expected to occur in the second quarter of 2017.

Roth Capital Partners provided advisory services to the Board of Directors of GenVec in connection with the transaction, and Hogan Lovells is serving as legal counsel to GenVec. Thompson Hine is serving as legal counsel to Intrexon.

About Intrexon Corporation 

Intrexon Corporation (NYSE:XON) is Powering the Bioindustrial Revolution with Better DNA™ to create biologically-based products that improve the quality of life and the health of the planet. The Company’s integrated technology suite provides its partners across diverse markets with industrial-scale design and development of complex biological systems delivering unprecedented control, quality, function, and performance of living cells. We call our synthetic biology approach Better DNA®, and we invite you to discover more at www.dna.com or follow us on Twitter at @Intrexon, on Facebook, and LinkedIn.

About GenVec

GenVec is a clinical-stage gene delivery company focused on developing a pipeline of cutting-edge therapeutics and vaccines using its proprietary AdenoVerse platform. The company is a pioneer in the design, testing and manufacture of adenoviral-based product candidates that can deliver on the promise of gene-based medicine. GenVec's lead product candidate, CGF166, is licensed to Novartis and is currently in a Phase 1/2 clinical study for the treatment of hearing loss and balance disorders. In addition to its internal and partnered pipeline, the company is also focused on opportunities to license its proprietary technology platform, including vectors and production cell lines, for the development and manufacture of therapeutics and vaccines to the biopharmaceutical industry. Additional information about GenVec is available at www.genvec.com and in the company's various filings with the Securities and Exchange Commission.

Trademarks

Intrexon, Powering the Bioindustrial Revolution with Better DNA, and Better DNA are trademarks of Intrexon and/or its affiliates. AdenoVerse™ is a trademark of GenVec, Inc. Other names may be trademarks of their respective owners.

Safe Harbor Statement

This communication contains “forward-looking” statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, known as the PSLRA. These statements, as they relate to Intrexon Corporation (“Intrexon”) or GenVec, Inc (“GenVec”), the management of either such company, the proposed transaction between Intrexon and GenVec, or the future development of gene delivery technology and gene therapies as a result of the transaction, involve risks and uncertainties that may cause results to differ materially from those set forth in the statements. These statements are based on current plans, estimates and projections, and therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Intrexon and GenVec undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. Forward-looking statements are not historical facts, but rather are based on current expectations, estimates, assumptions and projections about the business and future financial results of the biotechnology industry, and other legal, regulatory and economic developments. We use words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe harbor provisions of the PSLRA. Actual results could differ materially from the results contemplated by these forward-looking statements due to a number of factors, including, but not limited to, those described in the documents Intrexon and GenVec have filed with the U.S. Securities and Exchange Commission (the “SEC”), risks related to the development of gene delivery technology and gene therapies, as well as the possibility that (1) Intrexon and GenVec may be unable to obtain stockholder or regulatory approvals required for the proposed transaction or may be required to accept conditions that could reduce the anticipated benefits of the merger as a condition to obtaining regulatory approvals; (2) the length of time necessary to consummate the proposed transaction may be longer than anticipated; (3) problems may arise in successfully integrating the business and technologies of Intrexon and GenVec; (4) the proposed transaction may involve unexpected costs; (5) the businesses may suffer as a result of uncertainty surrounding the proposed transaction, including difficulties in maintaining relationships with third parties or retaining key employees; (6) the parties may be unable to meet expectations regarding the timing, completion and accounting and tax treatments of the transaction; or (7) the industry may be subject to future risks that are described in the “Risk Factors” section of the Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents filed from time to time with the SEC by Intrexon and GenVec. Neither Intrexon nor GenVec gives any assurance that either Intrexon or GenVec will achieve its expectations.

The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties that affect the businesses of Intrexon and GenVec described in the “Risk Factors” section of their respective Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents filed by either of them from time to time with the SEC. All forward-looking statements included in this document are based upon information available to Intrexon and GenVec on the date hereof, and neither Intrexon nor GenVec assumes any obligation to update or revise any such forward-looking statements.

Additional Information and Where to Find It

This document relates to a proposed transaction between GenVec and Intrexon, which will become the subject of a registration statement and joint proxy statement/prospectus forming a part thereof to be filed with the SEC by Intrexon. This document is not a substitute for the registration statement and joint proxy statement/prospectus that Intrexon will file with the SEC or any other documents that GenVec or Intrexon may file with the SEC or send to stockholders in connection with the proposed transaction. Before making any voting decision, investors and security holders are urged to read the registration statement, joint proxy statement/prospectus and all other relevant documents filed or that will be filed with the SEC in connection with the proposed transaction as they become available because they will contain important information about the proposed transaction and related matters.

Investors and security holders will be able to obtain free copies of the registration statement, joint proxy statement/prospectus and all other relevant documents filed or that will be filed with the SEC by GenVec or Intrexon through the website maintained by the SEC at www.sec.gov.

In addition, investors and security holders will be able to obtain free copies of the joint proxy statement/prospectus, once it is filed, from GenVec by accessing GenVec’s website at ir.genvec.com/all-sec-filings or upon written request to ir@genvec.com.

Participants in Solicitation

Intrexon, GenVec and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from GenVec’s stockholders in connection with the proposed transaction. Information regarding GenVec’s directors and executive officers is contained in the proxy statement for GenVec’s 2016 Annual Meeting of Stockholders, which was filed with the SEC on September 12, 2016. You can obtain a free copy of this document at the SEC’s website at www.sec.gov or by accessing GenVec’s website at ir.genvec.com/all-sec-filings. Information regarding Intrexon’s executive officers and directors is contained in the proxy statement for Intrexon’s 2016 Annual Meeting of Stockholders filed with the SEC on April 29, 2016. You can obtain a free copy of this document at the SEC’s website at www.sec.gov or by accessing Intrexon’s website at www.dna.com. Additional information regarding the interests of those persons and other persons who may be deemed participants in the proposed transaction may be obtained by reading the joint proxy statement/prospectus regarding the proposed transaction when it becomes available. You may obtain free copies of this document as described in the preceding paragraph.

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