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DEVELOPMENT OF A NEXT GENERATION ANTHRAX VACCINE, AV7909

Award Number: U01AI078169
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: 07/01/2008
PERIOD OF PERFORMANCE END DATE: 06/30/2013

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DEVELOPMENT OF A NEXT GENERATION ANTHRAX VACCINE, AV7909 - DESCRIPTION (provided by applicant): Project Summary-This application focuses on completion of preclinical work supporting initiation of a clinical trial to identify the optimum dose and schedule of a next generation anthrax vaccine, AV7909. AV7909 is composed of Emergent BioSolutions' FDA-approved BioThrax (25) anthrax vaccine and the immunostimulatory oligonucleotide compound CPG7909 (VaxImmuneTM) developed by Coley Pharmaceutical Group. In a previous Phase 1/2 clinical trial evaluating safety and immunogenicity of a first generation AV7909 vaccine, AV7909 increased peak anti-protective antigen (PA) liters 6-fold and reduced the time to peak titer by 21 days compared to BioThrax alone. Also, only 2 doses of AV7909 were required to elicit the same serum anti-PA IgG levels achieved by three doses of BioThrax alone. No anthrax vaccine developed to date, delivered by any means, has demonstrated such dramatic immunogenicity so rapidly. The specific aims for this proposal include: 1) cGMP manufacture of AV7909; 2) nonclinical GLP safety and toxicity evaluation; and 3) development of a guinea pig post-exposure prophylaxis (PEP) aerosol challenge model appropriate for AV7909. A key component required of the next generation anthrax vaccine is its ability to be used in conjunction with antibiotics in a post-exposure situation. To be effective when administered therapeutically, the vaccine must induce high anti-protective antigen (PA) titers quickly and with a minimum number of doses. Additionally, the vaccine must be easy to administer in a massive post-exposure vaccination scenario. Even though the first generation AV7909 showed excellent immune responses in a previous Phase 1/2 trial, the vaccine was manufactured in two separate vials and mixed just before administration. To make the vaccine more user- friendly, Emergent is developing a co-formulation method in a single vial. All specific aims for this proposal will be conducted with the new cGMP AV7909 vaccine lots manufactured by the new method. Also, even though rabbits and non-human primates (NHP) are generally considered the two preferred animal models for anthrax infection and have been widely used in anthrax vaccine efficacy studies, the rabbit model may not be suitable for evaluation of AV7909. Since studies indicate rabbits respond poorly to CpG molecules, we need to develop an alternative small animal model (e.g., guinea pig model) to satisfy the FDA's "Animal Rule" which requires two relevant animal models for evaluation of biodefense vaccines.


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: 2012 ( Subtotal = $274,278 )
2012	2012	EMERGENT IMMUNOSOLUTIONS INC/BIOPORT CORP	300 PROFESSIONAL DRIVE	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	003	5	6/7/2012	NON-COMPETING CONTINUATION	$246,331
2012	2011	EMERGENT IMMUNOSOLUTIONS INC/BIOPORT CORP	300 PROFESSIONAL DRIVE	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	002	4	1/30/2012	NON-COMPETING CONTINUATION	$15,062
2012	2010	EMERGENT IMMUNOSOLUTIONS INC/BIOPORT CORP	300 PROFESSIONAL DRIVE	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	3	1/18/2012	NON-COMPETING CONTINUATION	$12,885
2012	2008	EMERGENT IMMUNOSOLUTIONS INC/BIOPORT CORP	300 PROFESSIONAL DRIVE	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	001	1	1/18/2012	NEW	$0
														Subtotal = $274,278

Issue Date FY: 2011 ( Subtotal = $294,927 )
2011	2011	EMERGENT IMMUNOSOLUTIONS INC/BIOPORT CORP	300 PROFESSIONAL DRIVE	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	4	8/4/2011	NON-COMPETING CONTINUATION	$294,927
														Subtotal = $294,927

Issue Date FY: 2010 ( Subtotal = $291,478 )
2010	2010	EMERGENT IMMUNOSOLUTIONS INC/BIOPORT CORP	300 PROFESSIONAL DRIVE	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	001	3	7/16/2010	NON-COMPETING CONTINUATION	$291,478
2010	2009	EMERGENT IMMUNOSOLUTIONS INC/BIOPORT CORP	300 PROFESSIONAL DRIVE	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	2	12/11/2009	NON-COMPETING CONTINUATION	$0
														Subtotal = $291,478

Issue Date FY: 2009 ( Subtotal = $462,222 )
2009	2009	EMERGENT IMMUNOSOLUTIONS INC/BIOPORT CORP	300 PROFESSIONAL DRIVE	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	2	9/22/2009	NON-COMPETING CONTINUATION	$462,222
														Subtotal = $462,222

Issue Date FY: 2008 ( Subtotal = $1,471,421 )
2008	2008	EMERGENT IMMUNOSOLUTIONS INC/BIOPORT CORP	300 PROFESSIONAL DRIVE	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	1	6/27/2008	NEW	$1,471,421
														Subtotal = $1,471,421

Grand Total All Awards = $2,794,326

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DEVELOPMENT OF A NEXT GENERATION ANTHRAX VACCINE, AV7909

Award Number: U01AI078169

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: 07/01/2008

PERIOD OF PERFORMANCE END DATE: 06/30/2013

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