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An Antibody Immunoprotectant for Category B Toxins

Award Number: R01AI098774
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/08/2012
PERIOD OF PERFORMANCE END DATE: 05/31/2018

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An Antibody Immunoprotectant for Category B Toxins - Description (provided by the applicant): The potential for intentional dissemination of naturally occurring infectious and toxic agents adds a serious new dimension to the threats traditionally posed by these agents. These bioterrorism threats have greatly increased our sense of urgency for developing defenses against Select Agent toxins. The Category B toxins, which consist of Clostridium perfringens epsilon toxin (ETX), ricin, and staphylococcal enterotoxin B (SEB), are all extraordinarily potent, and are derived from common, readily-accessible plants (ricin) and bacteria (SEB and ETX). These toxins are relatively easily produced, and can be delivered in a stable aerosol form -- their use as bioweapons on the battlefield or in civilian populations would result in devastating morbidity and mortality. There ae currently no preventives or therapeutics for exposure to these toxins. We have identified monoclonal antibodies (mAbs) that individually protect against lethal ETX, ricin, and SEB challenge in animal models. The goal of this application is development of a broad-spectrum antibody cocktail against the Category B toxins (CBT-ab), manufactured in a rapid and cost-effective plant system, for prevention and post-exposure treatment of intoxication. Pursuing a single product (the mAbs will be manufactured individually and then combined into the final product) against these three toxins will manifest as savings in costs and time. Further, a single cocktail product is desirable for clinical use since intoxication with the Category B toxins result in similar symptoms and point of care diagnostics to rapidly identify the causative agent are not generally available and/or accessible. The Specific Aims of this application are: Specific Aim #1. Evaluate CBT-ab in vitro and in vivo. The preventive and post-exposure activity of the cocktail will be demonstrated to satisfy requirements for submission of an Investigation New Drug (IND) application. Specific Aim #2. Identify a CBT-ab formulation. An optimal liquid formulation for the cocktail will be identified to ensure an appropriate stability profile for the final product. Speciic Aim #3. Complete IND-enabling studies. CBT-ab will be manufactured and formulated under current Good Manufacturing Practices (cGMP). All IND-enabling pharmacology, toxicology, and Chemistry, Manufacturing and Controls (CMC) studies will be performed, with a final goal of filing an Investigational New Drug (IND) application to support a Phase 1 human safety trial.


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: 2019 ( Subtotal = -$219,062 )
2019	2016	MAPP BIOPHARMACEUTICAL, INC.	6160 LUSK BLVD STE 105	SAN DIEGO	CA	92121	SAN DIEGO	USA	Allergy and Infectious Diseases Research	000	5	11/30/2018	EXTENSION WITH OR WITHOUT FUNDS	-$219,062
														Subtotal = -$219,062

Issue Date FY: 2016 ( Subtotal = $1,195,183 )
2016	2016	MAPP BIOPHARMACEUTICAL INC	6160 LUSK BOULEVARD	SAN DIEGO	CA	92121	SAN DIEGO	USA	Allergy and Infectious Diseases Research	000	5	5/26/2016	EXTENSION WITH OR WITHOUT FUNDS	$1,195,183
														Subtotal = $1,195,183

Issue Date FY: 2015 ( Subtotal = $1,265,619 )
2015	2015	MAPP BIOPHARMACEUTICAL INC	6160 LUSK BOULEVARD	SAN DIEGO	CA	92121	SAN DIEGO	USA	Allergy and Infectious Diseases Research	000	4	5/13/2015	NON-COMPETING CONTINUATION	$1,265,619
														Subtotal = $1,265,619

Issue Date FY: 2014 ( Subtotal = $1,297,816 )
2014	2014	MAPP BIOPHARMACEUTICAL INC	6160 LUSK BOULEVARD	SAN DIEGO	CA	92121	SAN DIEGO	USA	Allergy and Infectious Diseases Research	000	3	5/12/2014	NON-COMPETING CONTINUATION	$1,297,816
														Subtotal = $1,297,816

Issue Date FY: 2013 ( Subtotal = $1,225,116 )
2013	2013	MAPP BIOPHARMACEUTICAL INC	6160 LUSK BOULEVARD	SAN DIEGO	CA	92121	SAN DIEGO	USA	Allergy and Infectious Diseases Research	000	2	5/20/2013	NON-COMPETING CONTINUATION	$1,225,116
														Subtotal = $1,225,116

Issue Date FY: 2012 ( Subtotal = $1,172,246 )
2012	2012	MAPP BIOPHARMACEUTICAL INC	6160 LUSK BOULEVARD	SAN DIEGO	CA	92121	SAN DIEGO	USA	Allergy and Infectious Diseases Research	000	1	6/7/2012	NEW	$1,172,246
														Subtotal = $1,172,246

Grand Total All Awards = $5,936,918

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An Antibody Immunoprotectant for Category B Toxins

Award Number: R01AI098774

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 06/08/2012

PERIOD OF PERFORMANCE END DATE: 05/31/2018

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