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HUMAN ANTIBODY THERAPEUTICS AGAINST ANTHRAX

Award Number: U01AI061311
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: HEALTH SERVICES
PERIOD OF PERFORMANCE START DATE: 07/15/2004
PERIOD OF PERFORMANCE END DATE: 06/30/2007

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HUMAN ANTIBODY THERAPEUTICS AGAINST ANTHRAX - DESCRIPTION (provided by applicant): The long-term objective of our research is to develop fully human antibodies as immunotherapeutics against anthrax infection in humans. Mab 83K7C and Mab 63LID are two lead candidates identified using phage display technology that protect rats in vivo against a lethal anthrax toxin challenge. These two antibodies neutralize potently via differing mechanisms. In order to determine efficacy against an inhalational anthrax infection and possibly discriminate between these candidates so as to move at least one toward therapeutic use, this application is specifically targeted to the performance of preclinical pharmacokinetic and spore challenge studies in rabbits and monkeys. If protection is shown, these studies will be used to begin to fulfill the requirements for the two animal models requested by the FDA for biodefense therapeutics that cannot undergo Phase II and Phase III clinical testing in humans for ethical reasons (21CFR 314.610 and 601.91). The project has been broken down into five specific aims. 1) Sufficient antibody must be produced and purified for the trials under consideration, and this will be performed at Kemp Biotechnologies, Inc. (Frederick, MD). Material will be analyzed and trial dosages prepared and validated by applicant. 2) Pharmacokinetic trials in rabbits will be performed at Charles River Laboratories (CRL) (Worcester, MA) to help establish appropriate dosing and route of administration for spore challenge trials. 3) Rabbit spore challenge trials will be performed at Battelle Medical Research and Evaluation Facility (MREF) (Jefferson, OH). 4) If efficacy in rabbits is demonstrated, monkey pharmacokinetic trials with one or both antibodies will be performed at CRL. 5) Spore challenge trials in monkeys will be performed at Battelle MREF. GLP conditions will be used in production and for both the pharmacokinetic and spore challenge studies such that data obtained from these trials could be acceptable for FDA submittal. If spore challenge trials in monkeys are successful, we will continue with additional preclinical and Phase I human trials outside the scope of this grant.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2006 ( Subtotal = $1,194,683 )
2006	2006	ALEXION PHARMACEUTICALS, INC	352 KNOTTER DRIVE	CHESHIRE	CT	06410	CAPITOL	USA	Allergy and Infectious Diseases Research	000	3	8/11/2006	NON-COMPETING CONTINUATION	$1,194,683
														Subtotal = $1,194,683

Issue Date FY: 2004 ( Subtotal = $737,620 )
2004	2004	ALEXION PHARMACEUTICALS, INC	352 KNOTTER DRIVE	CHESHIRE	CT	06410	CAPITOL	USA	Microbiology and Infectious Diseases Research	000	1	7/6/2004	NEW	$737,620
														Subtotal = $737,620

Grand Total All Awards = $1,932,303

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HUMAN ANTIBODY THERAPEUTICS AGAINST ANTHRAX

Award Number: U01AI061311

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: HEALTH SERVICES

PERIOD OF PERFORMANCE START DATE: 07/15/2004

PERIOD OF PERFORMANCE END DATE: 06/30/2007

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