HerpVの研究開発を進めているAhenusですが、以前にも記事（「HerpV」）で説明したように、「あまり経営状態が芳しくないようで、少し心配…」なところがあります…。
今回の記事を見てみると、そのあたりについての情報も記載してあるようで…、特に関係のある部分というのが…、
The trial results were well received by George B. Zavoico, senior equity analyst at McNicoll, Lewis, Vlak, who wrote in a Sept. 27 update note: “We consider Agenus’ achievement of developing what we think is the first potential therapeutic vaccine for genital herpes capable of eliciting critical T cell responses to be a key milestone. In our view, demonstration of efficacy in the next Phase 2 trial could be a significant value driver for the company. We look forward to the initiation of the Phase 2 trial and are maintaining our BUY recommendation with a one year price target of $2.50.”
Zavoico also noted that if development of vaccine and adjuvant candidates in Agenus’ pipeline proceeds without any significant delays, unfavorable trial results, or other negative surprises, Agenus could become profitable in 2015. That is based on regulatory approvals and the launch of QS-21 for use in therapeutic cancer and chronic disease vaccines in the United States and the successful development of at least one Prophage Series of vaccines in the United States and European Union. He added that after a several year delay, he also expects a distribution partner for Oncophage to soon be identified in Russia, which will allow Agenus to start collecting revenue in 2014.
という部分になるかと思います…。
全体的な内容をまとめてみると、
上級経済（？）アナリストのGeorge B. Zavoicoによると…
- 今回のPhase Iの結果は素晴らしいもので、HSVウイルスに対するT細胞の活性化を十分に促したという点では、治療に応用できる可能性を持ったおそらく初めてのワクチンということになるだろう
- 次のPhase IIが大きなカギになることは確かで、市場でも積極的に「買い」を進めていきたいと考えている
- QS21（多分、Agenusが開発を進めている免疫活性剤）がアメリカやヨーロッパでがん治療などのために正式に承認されれば、2015年には収益を上げることが出来ると思われる。
- そのほかにも、予定より数年遅れにはなるものの、Oncophage（がんワクチン？）のロシアでの販売が開始されれば、2014年にも収益を上げるようになるだろう
と予想されているようです。
Armen of Agenus added that over the next 18 months, the company expects pivotal data from other clinical programs that incorporate QS-21 and that are being developed by its corporate partners. The first will be a malaria vaccine for children on which GlaxoSmithKline plans to file for registration by the end of the year. Agenus will get royalties on sales once the vaccine is approved. GSK also has a non small cell lung cancer and melanoma vaccine that it has said it plans to file for registration on by the end of next year. In addition, plans call for Johnson & Johnson to advance an Alzheimer’s indication into Phase 3. All three use Agenus’s QS-21 technology.
また、Agenus側によれば、QS21は…、
- 小児マラリア（大手製薬メーカーのGlaxoSmithKlineが今年末に承認申請をおこなう予定）
- 肺の小胞にできるガンやメラノーマに対するワクチン、
- アルツハイマー治療薬（Johnson & JohnsonがPhase IIIを開始するかも…）
- これから1年半の間に、QS21に関連する重要なデータが集まると予想されることから
などに活用されており、これから1年半の間に、これらの治験で得られたQS21に関する重要なデータがあつまると期待されています。
これらの研究データが集まることにより、研究・開発が進展し、最終的にはHerpVの開発へと進んでいってほしいものですね！
Agenus advances herpes vaccine in clinic
http://www.masshightech.com/stories/2011/09/26/daily22-Agenus-advances-herpes-vaccine-in-clinic.html
By Lori Valigra, Mass High Tech correspondent
Agenus Inc., a therapeutic vaccine maker based in Lexington, said it has positive results from a Phase 1 study of its HerpV vaccine for genital herpes, and plans to move it into a Phase 2 study in 2012.
The results were published in the scientific journal Vaccine. The herpes simplex virus type 2 (HSV-2) vaccine is based on Agenus’ heat shock protein platform technology and contains the company’s proprietary QS-21 Stimulon adjuvant, an agent that modifies the effect of other agents.
HSV-2 affects more than 60 million Americans, or 16 percent of people aged 14-49, and there are 1.5 million new cases each year, according to the Centers for Disease Control and Prevention.
“This is the first evidence that a therapeutic genital herpes vaccine has elicited both CD4+ and CD8+ T-cell responses in humans,” said Anna Wald, MD and professor of Medicine, Epidemiology and Laboratory Medicine at the University of Washington, who was lead author of the paper. “We are very encouraged by these clinical results as published literature suggest that cellular immunity needs to be stimulated for successful treatment of genital herpes – a physically painful and emotionally debilitating disease that affects one in six adults in the U.S.”
In the Phase 1 study, 35 HSV-2 seropositive patients received the vaccine plus QS-21 (HerpV), the vaccine without QS-21, QS-21 alone, or placebo. Patients received three treatments at two-week intervals.
All patients who could be evaluated for an immune response and who received HerpV showed a statistically significant CD4+ T cell response to HSV-2 antigens. The majority of those patients showed a CD8+ T cell response. The vaccine was well tolerated, with injection site pain as the most common adverse event.
Garo Armen, chairman and CEO of Agenus, said the planned Phase 2 study in 2012 will measure the effect of vaccination on viral shedding in individuals infected with HSV-2, and that a reduction in clinical shedding could be clinically beneficial. He expects the trial to run 18 months and involve 60-70 people.
“The technology platform based on heat shock proteins is at the core of what we do,” Armen said. “They activate the immune system in a very targeted fashion. They can direct the immune system. This is a timely development because this is a major disease target, and to the best of my knowledge there isn’t a vaccine candidate in active development that has reached where we are with getting both a CD4+ and CD8+ mediated immune response.”
Heat shock proteins, also called stress proteins, are found in all cells and are believed to play an essential role in proteins on the cell surface to help the immune system recognize diseased cells. Agenus’ initial focus of development is HSV-2, but the company said heat shock protein technology can potentially be used for off-the-shelf treatment of infectious diseases including HPV, HIV, hepatitis, malaria and tuberculosis.
The trial results were well received by George B. Zavoico, senior equity analyst at McNicoll, Lewis, Vlak, who wrote in a Sept. 27 update note: “We consider Agenus’ achievement of developing what we think is the first potential therapeutic vaccine for genital herpes capable of eliciting critical T cell responses to be a key milestone. In our view, demonstration of efficacy in the next Phase 2 trial could be a significant value driver for the company. We look forward to the initiation of the Phase 2 trial and are maintaining our BUY recommendation with a one year price target of $2.50.”
Zavoico also noted that if development of vaccine and adjuvant candidates in Agenus’ pipeline proceeds without any significant delays, unfavorable trial results, or other negative surprises, Agenus could become profitable in 2015. That is based on regulatory approvals and the launch of QS-21 for use in therapeutic cancer and chronic disease vaccines in the United States and the successful development of at least one Prophage Series of vaccines in the United States and European Union. He added that after a several year delay, he also expects a distribution partner for Oncophage to soon be identified in Russia, which will allow Agenus to start collecting revenue in 2014.
Armen of Agenus added that over the next 18 months, the company expects pivotal data from other clinical programs that incorporate QS-21 and that are being developed by its corporate partners. The first will be a malaria vaccine for children on which GlaxoSmithKline plans to file for registration by the end of the year. Agenus will get royalties on sales once the vaccine is approved. GSK also has a non small cell lung cancer and melanoma vaccine that it has said it plans to file for registration on by the end of next year. In addition, plans call for Johnson & Johnson to advance an Alzheimer’s indication into Phase 3. All three use Agenus’s QS-21 technology.
In separate news, Armen said the company expects to resolve its issues with the Nasdaq exchange shortly. Agenus received a delisting notice in February from the Nasdaq Stock Market LLC because it has not met the minimum $1 per share price for 30 consecutive business days.
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