Successful Development of Broad Spectrum Human Monoclonal Antibodies Against Major Influenza Viruses (H1N1 and H5N1)

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   Roche licenses new flu-fighting technology

Mon Feb 8, 2010 11:18am EST

* Uses antibodies to fight influenza
* In studies, antibodies proved widely effective (Adds details of technology, background, byline)

By Maggie Fox, Health and Science Editor

WASHINGTON, Feb 8 (Reuters) - Roche AG's (ROG.VX) Genentech unit has licensed an experimental new technology that uses antibodies to fight influenza, including H1N1 swine flu, Harvard's Dana Farber Cancer Institute said on Monday.

Dana-Farber said it and the Sanford-Burnham Medical Research Institute had signed a license agreement with Genentech, giving the company exclusive rights to manufacture, develop and market human monoclonal antibodies to treat and protect against group 1 influenza viruses.

Dr. Wayne Marasco at Dana-Farber, Robert Liddington at Sanford-Burnham and Ruben Donis of the the Centers for Disease Control and Prevention discovered the antibody technology and reported on it a year ago this month.

The antibodies -- immune system proteins that attach to invaders such as viruses -- can be used as direct treatment for flu. They also might be used to protect front-line workers and others at high risk during pandemics.

In studies, the antibodies -- generated from the blood of 57 volunteers -- neutralized a wide range of influenza viruses.

Influenza viruses cloak themselves in lollipop-shaped proteins called hemagglutinin and neuraminidase, which mutate regularly and give influenza A strains the "H" and "N" designations in their names.

Vaccines target hemagglutinin, while drugs called neuraminidase inhibitors, including Roche's Tamiflu and GlaxoSmithKline's (GSK.N) (GSK.L) Relenza, attack neuraminidase.

Because of virus mutations, vaccines have to be reformulated every year, and the viruses can develop resistance to the neuraminidase inhibitors, as they have to older antivirals.

The antibodies attach to a less mutation-prone part of the virus, on the "stick" part of the lollipop, the researchers said.

The researchers used the natural antibodies as the basis for lab-engineered versions, called human monoclonal antibodies.

Marasco has said it should be straightforward to develop the antibodies as drugs, because they are already used broadly in cancer therapy.

Cancer monoclonal antibodies can cost tens of thousands of dollars a year, but Marasco said companies have learned how to make them more cheaply recently. (Reporting by Maggie Fox; editing by John Wallace)
http://www.reuters.com/article/idUSN0811320100208

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Jen147 Forum Moderator Joined: August 28 2009 Online Status: Offline Posts: 4499	Topic: Potential New Treatment for both H1N1 & H5N1 Posted: February 08 2010 at 2:53pm
	Roche licenses new flu-fighting technology Mon Feb 8, 2010 11:18am EST * Uses antibodies to fight influenza * In studies, antibodies proved widely effective (Adds details of technology, background, byline) By Maggie Fox, Health and Science Editor WASHINGTON, Feb 8 (Reuters) - Roche AG's (ROG.VX) Genentech unit has licensed an experimental new technology that uses antibodies to fight influenza, including H1N1 swine flu, Harvard's Dana Farber Cancer Institute said on Monday. Dana-Farber said it and the Sanford-Burnham Medical Research Institute had signed a license agreement with Genentech, giving the company exclusive rights to manufacture, develop and market human monoclonal antibodies to treat and protect against group 1 influenza viruses. Dr. Wayne Marasco at Dana-Farber, Robert Liddington at Sanford-Burnham and Ruben Donis of the the Centers for Disease Control and Prevention discovered the antibody technology and reported on it a year ago this month. The antibodies -- immune system proteins that attach to invaders such as viruses -- can be used as direct treatment for flu. They also might be used to protect front-line workers and others at high risk during pandemics. In studies, the antibodies -- generated from the blood of 57 volunteers -- neutralized a wide range of influenza viruses. Influenza viruses cloak themselves in lollipop-shaped proteins called hemagglutinin and neuraminidase, which mutate regularly and give influenza A strains the "H" and "N" designations in their names. Vaccines target hemagglutinin, while drugs called neuraminidase inhibitors, including Roche's Tamiflu and GlaxoSmithKline's (GSK.N) (GSK.L) Relenza, attack neuraminidase. Because of virus mutations, vaccines have to be reformulated every year, and the viruses can develop resistance to the neuraminidase inhibitors, as they have to older antivirals. The antibodies attach to a less mutation-prone part of the virus, on the "stick" part of the lollipop, the researchers said. The researchers used the natural antibodies as the basis for lab-engineered versions, called human monoclonal antibodies. Marasco has said it should be straightforward to develop the antibodies as drugs, because they are already used broadly in cancer therapy. Cancer monoclonal antibodies can cost tens of thousands of dollars a year, but Marasco said companies have learned how to make them more cheaply recently. (Reporting by Maggie Fox; editing by John Wallace) http://www.reuters.com/article/idUSN0811320100208
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Jen147 Forum Moderator Joined: August 28 2009 Online Status: Offline Posts: 4499	Posted: March 09 2010 at 6:18am
	Successful Development of Broad Spectrum Human Monoclonal Antibodies Against Major Influenza Viruses (H1N1 and H5N1) INCHEON, South Korea, March 9 /PRNewswire/ -- Celltrion, Inc., a South Korean biopharmaceutical company, has developed novel human monoclonal antibodies against influenza virus infection, which neutralize a broad spectrum of influenza viruses, including pandemic H1N1 and the deadly H5N1 avian influenza virus. Preliminary tests in laboratory animals indicate that the novel human monoclonal antibodies can be used to prevent disease when given either before or after infection. The discovery is the result of an international collaboration among the U.S. CDC Influenza Division, the Severance Hospital and Seoul National University Hospital in Korea, SC World, Inc. in Japan, and Celltrion. Celltrion's monoclonal antibodies were evaluated by in vitro microneutralization assays and in vivo animal studies using seasonal or pandemic H1, pandemic H2, and endemic H5 virus subtypes. In preclinical testing, Celltrion monoclonals were more efficacious than similar antibody candidates reported previously. One of the antibodies, CT120, blocked infection by all the viruses mentioned above in microneutralization test and showed prophylactic and therapeutic effect on H5N1 and prophylactic effect on pandemic and seasonal H1 viruses in mice. Celltrion plans to develop human monoclonal antibodies as a universal biopharmaceutical to treat influenza infections and its complications in humans. This monoclonal antibody is also a potential candidate for treating H5 avian influenza virus infection or other potentially pandemic or zoonotic influenza viruses. Mr. Jung-Jin Seo, Chairman and CEO of Celltrion, stated that, "We are very excited with these results, and we will do our best to move forward as quickly as possible into clinical trials with a view to bringing this new product to the clinic in record time. We are very pleased to collaborate with the U.S. CDC, Severance Hospital and SC World, Inc. on this important public health initiative." This type of innovative new biological product with broad efficacy against multiple potentially pandemic influenza viruses from animals could transform pandemic preparedness and influenza control strategies. Globally, approximately one billion people are infected by influenza viruses annually, with eight million people being hospitalized every year. In addition, the new antibody screening platform technology used to develop these therapeutic antibodies, can be applied to new therapeutics for other infectious disease. This press release contains forward-looking statements that involve risks and uncertainties. The forward-looking statements contained herein represent the judgment of Celltrion as of the date of this release. These forward-looking statements are no guarantees for future performance, and the forward-looking events discussed in this press release may not occur. Celltrion disclaims any intent or obligation to update any of these forward-looking statements. About Celltrion Celltrion, Inc. is a leading biopharmaceutical company in South Korea that focuses on the development, manufacture and distribution of biologics, specifically monoclonal antibodies, for the treatment of human diseases. Based on its world-class technology in monoclonal antibody manufacturing, Celltrion has entered into many strategic collaborations with global pharmaceutical companies. In addition, Celltrion is in a strong position to capitalize on the newly emerging global monoclonal antibody biosimilar market due to its advanced development technology and state-of-the-art manufacturing facility. Celltrion is currently developing numerous biosimilars of blockbuster biologics. http://www.prnewswire.com/news-releases/successful-development-of-broad-spectrum-human-monoclonal-antibodies-against-major-influenza-viruses-h1n1-and-h5n1-87104172.html
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