Hebrew University receives its largest NIH research grant ever -- $5.6 million biodefense award

September 25, 2005

Jerusalem - A research grant of $5.6 million in the field of biodefense has been awarded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), to a Hebrew University of Jerusalem researcher for the development of a broadly effective drug against a family of toxins called superantigens.

The award is the largest competitive grant ever made to the Hebrew University and to an Israeli researcher from the NIH. Funds were awarded under the NIAID Biodefense Challenge Grants program, which encourages private industry to work with academic investigators in order to develop countermeasures against potential agents of bioterrorism.

Product development will be done in collaboration with Atox Bio, a company established by Yissum, the Technology Transfer Company of the Hebrew University, in keeping with its strategy of commercializing promising technologies by establishing new companies.

Superantigens are deadly toxins produced by staphylococcal and streptococcal bacteria that even in very low amounts can incapacitate humans, posing a bioterror threat. These toxins are also responsible for a majority of fatal toxic and septic shock cases, yet no drug or vaccine against them is available. The toxins released by these bacteria are insensitive to antibiotics.

The $5.6-million award was made to Dr. Raymond Kaempfer to support research and product development leading up to clinical trial of the toxin antagonist. The NIH review panel has termed the research unique in the world.

Kaempfer, who is the Philip Marcus Professor of Molecular Biology and Cancer Research in the Department of Molecular Virology at the Hebrew University Faculty of Medicine, and his colleague, Dr. Gila Arad, previously uncovered a novel molecular mechanism by which the superantigen toxins elicit a vastly exaggerated immune response that leads to death.

The researchers used this insight to design peptides (short stretches of protein) that block this harmful response in animals, thereby protecting and rescuing them from lethal toxic and septic shock. What remained was an immune response that was adequate to halt the toxins but without the excess that brings on shock. Indeed, once protected, the survivors became immune to further toxin challenges.

Prof. Kaempfer's earlier research which led up to the NIAID award was funded by the US Department of Defense and by its Defense Advanced Research Projects Agency (DARPA) with a series of grants in excess of $6.5 million.

Kaempfer's laboratory will conduct basic research on antagonist mode of action, essential for eventual drug approval. Preclinical development, which will take the bulk of the award, will be carried out by UK and US subcontractors under the direction of Atox Bio which holds the license to the intellectual property. Zeev Weiss, head of life sciences strategic consulting, PriceWaterhouseCoopers, Israel, was instrumental in building and supporting the team that led to the successful application.

"The grant will fund development of Atox Bio's drug for biodefense, using a shortened pathway towards US Food and Drug Administration approval that requires only the completion of Phase I clinical trials for licensure," said Uri Danon, CEO, Atox Bio. "This will allow us to reach a break-even point fast in order to finance future advanced development of drugs to treat diseases with unmet medical needs."

Atox Bio is applying its unique technology platform to develop a biodefense product and to additional therapeutics for treatment of autoimmune diseases and septic shock.
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The Hebrew University of Jerusalem

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