Two firms win NIAID support for Ebola-Marburg vaccines

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Oct 8, 2008 (CIDRAP News) – Two biotechnology companies—Crucell, based in the Netherlands, and Integrated BioTherapeutics, based in Germantown, Md.—recently announced that they have received $30 million and $22 million contracts, respectively, from the National Institutes of Allergy and Infectious Diseases (NIAID) to develop single vaccines that would protect against both Ebola and Marburg viruses.

The two hemorrhagic fever viruses are sources of emerging infectious diseases in humans, particularly in sub-Saharan Africa, and are considered category A bioterrorism agents by the US government. Both diseases are known for their high case-fatality rates, and there are no specific treatments or vaccines for Marburg and Ebola fevers.

NIAID contracts for both companies provide further funding if the National Institutes of Health (NIH) exercises additional options for the vaccines: $40 million for Crucell and an extra $43 million for Integrated BioTherapeutics, according to press releases from both firms.

Crucell pursues adenovirus vector technology
Jaap Goudsmit, Crucell's chief scientific officer, said in the company's Oct 3 statement that the NIAID contract will support the development of its multivalent filovirus vaccine that uses its proprietary AdVac technology.

"This award recognizes the scientific bases for using rare adenovirus serotypes to develop vaccines," he said. "The contract builds upon earlier work Crucell has performed with the Vaccine Research Center at the NIH and brings us a step closer to being able to provide effective countermeasures against a highly lethal infectious disease."

Crucell said its AdVac technology involves inserting genetic material from a virus or pathogen into a "vector" that delivers the material directly to the immune system to stimulate an immune response.

The AdVac technology is also designed to avoid problems with preexisting immunity to the most commonly used recombinant vaccine vector, adenovirus serotype 5, according to the company. Instead, the new technology is based on adenoviruses that don't regularly occur in humans, such as Ad35, which may enable the vaccine to provoke a more robust immune response.

Integrated BioTherapeutics advances VLP approach
Javad Aman, president and chief scientific officer of Integrated BioTherapeutics, said in an Oct 2 statement from the company that the NIAID contract will support advanced development of its virus-like particle (VLP) vaccine against Ebola and Marburg viruses.

"This is a significant step forward in our mission to improving public health and developing countermeasures for biodefense," he said. "The contract will fund a major portion of the preclinical and clinical activities required to confirm and refine the activity in animals and verify the activity in humans."

The company said it is collaborating with researchers at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) to develop a VLP vaccine that that has broad-spectrum activity toward different strains of Ebola and Marburg viruses. It said the vaccine has been shown to provide broad protection in nonhuman primates.

With the initial $22 million phase of the grant, Integrated BioTherapeutics said it will conduct preclinical activities and studies. If NIAID exercises its contract option, the extra fund would cover phase 1 and 2 clinical trials and lay the manufacturing groundwork.

See also:

Oct 3 Crucell press release
http://cws.huginonline.com/C/132631/PR/200810/1256673_5_5.html

Oct 2 Integrated BioTherapeutics press release
http://www.integratedbiotherapeutics.com/news.html

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