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ANTHRAX IMMUNE GLOBULIN TO PREVENT & TREAT ANTHRAX: ADVANCED PRODUCT DEVELOPMENT

Award Number: U01AI070486
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/15/2006
PERIOD OF PERFORMANCE END DATE: 12/31/2011

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ANTHRAX IMMUNE GLOBULIN TO PREVENT & TREAT ANTHRAX: ADVANCED PRODUCT DEVELOPMENT - DESCRIPTION (provided by applicant): While antimicrobials are effective against the early stages of anthrax infection, delayed initiation of antimicrobial therapy or infection with an antibiotic resistant strain can produce a life-threatening toxemic state for which antimicrobials are not effective. In such cases, neutralization of the toxin is required because antimicrobials kill vegetative cells and have no effect on the toxin. Polyclonal antibodies to the B. anthracis exotoxin have the potential to immediately neutralize the toxin, providing a life-saving medical countermeasure and filling an important unmet need. The effectiveness of antibodies to the licensed vaccine BioThrax(r) or its major protein component, protective antigen (PA), to prevent and treat inhalational anthrax has been demonstrated in animal studies. In addition, human immune globulins have a long history of safety and success in treating infectious disease, and in particular, bacterial toxemia. Proposed herein is the advanced development of anthrax immune globulin for intravenous use (AIGIV). AIGIV is derived from Source Plasma from BioThrax-immunized donors and is produced using an FDA-approved immune globulin purification process. The use of a proven technology and a licensed manufacturing process provides a low- risk approach for the development of an effective, licensable antitoxin compared to other high-risk unproven technologies. EIS, through its sister company BioPort, has access to the only FDA-approved anthrax vaccine, and thus is in the unique position to generate the quantities of BioThrax Source Plasma necessary to produce AIGIV on a long-term basis. The AIGIV advanced development plan allows for release of a cGMP AIGIV lot by December 2006, which could make AIGIV doses available for use under Emergency Use Authorization within 18 months of award. The product would be indicated for treatment of inhalational anthrax due to antibiotic-susceptible or antibiotic-resistant B. anthracis in persons 18-65 years of age. An additional indication will be sought for the prophylaxis of inhalational anthrax for individuals at risk for having contact with, or who have contacted, either antibiotic-resistant or antibiotic-susceptible B. anthracis (pre-exposure and post-exposure prophylaxis). The Specific Aims for advanced development of AIGIV are to: 1) Conduct pharmacokinetic and tolerability studies, and pivotal Animal Rule efficacy studies in the rabbit and rhesus macaque models using cGMP AIGIV, and 2) Develop and validate anti-PA IgG and TNA assays to support manufacturing and for the measurement of AIGIV activity in animal sera. The initial cGMP lot of AIGIV will be used for Animal Rule studies to define the dose which provides prophylactic and therapeutic protection against aerosolized B. anthracis spore challenge.


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: 2011 ( Subtotal = $0 )
2011	2009	EMERGENT IMMUNOSOLUTIONS INC/BIOPORT CORP	300 PROFESSIONAL DRIVE	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	4	5/9/2011	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2010 ( Subtotal = $0 )
2010	2009	EMERGENT IMMUNOSOLUTIONS INC/BIOPORT CORP	300 PROFESSIONAL DRIVE	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	4	4/30/2010	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2009 ( Subtotal = $34,029 )
2009	2009	EMERGENT IMMUNOSOLUTIONS INC/BIOPORT CORP	300 PROFESSIONAL DRIVE	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	001	4	9/24/2009	NON-COMPETING CONTINUATION	$34,029
2009	2008	EMERGENT IMMUNOSOLUTIONS INC/BIOPORT CORP	300 PROFESSIONAL DRIVE	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	3	1/5/2009	NON-COMPETING CONTINUATION	$0
														Subtotal = $34,029

Issue Date FY: 2008 ( Subtotal = $105,204 )
2008	2008	EMERGENT IMMUNOSOLUTIONS INC/BIOPORT CORP	300 PROFESSIONAL DRIVE	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	3	8/21/2008	NON-COMPETING CONTINUATION	$105,204
														Subtotal = $105,204

Issue Date FY: 2007 ( Subtotal = $1,485,126 )
2007	2007	EMERGENT IMMUNOSOLUTIONS INC/BIOPORT CORP	300 PROFESSIONAL DRIVE	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	2	8/21/2007	NON-COMPETING CONTINUATION	$1,485,126
														Subtotal = $1,485,126

Issue Date FY: 2006 ( Subtotal = $1,998,521 )
2006	2006	EMERGENT IMMUNOSOLUTIONS INC/BIOPORT CORP	300 PROFESSIONAL DRIVE	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	1	8/14/2006	NEW	$1,998,521
														Subtotal = $1,998,521

Grand Total All Awards = $3,622,880

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ANTHRAX IMMUNE GLOBULIN TO PREVENT & TREAT ANTHRAX: ADVANCED PRODUCT DEVELOPMENT

Award Number: U01AI070486

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/15/2006

PERIOD OF PERFORMANCE END DATE: 12/31/2011

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