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MR191_ An Immunoprotectant for Marburg Virus

Award Number: SB1AI082744
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: 04/01/2009
PERIOD OF PERFORMANCE END DATE: 06/30/2021

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MR191_ An Immunoprotectant for Marburg Virus - PROJECT SUMMARY Mapp Biopharmaceutical, Inc. (Mapp) is developing antibody-based therapeutics to treat a number of infectious agents, including some of the most dangerous known to man: the filoviruses. Marburg virus is a filovirus endemic to Africa and causes an often lethal hemorrhagic fever. Presently there are no approved vaccines or therapeutics to treat Marburg virus infections and this remains a major unmet medical need. Along with its collaborators, Mapp has screened over 100 antibodies from a number of different species that bind to or neutralize Marburg virus in vitro. Several of these have been shown to block the infection of cells and a few have shown potency when tested in animal models of Marburg. Recently, several fully-human monoclonal antibodies have been identified and recovered from a Marburg virus infection survivor. MR191, the lead candidate and the focus of this proposal, has been shown to completely protect non-human primates when challenged with a lethal dose of Marburg virus or the related Ravn virus. Mapp proposes to develop MR191 as a therapeutic candidate to treat Marburg and Ravn virus infections. A Chinese Hamster Ovary (CHO) cell line to produce MR191 will be created, characterized, and cell banks will be generated. This cell line will support production of MR191 at a research scale that will be tested in a non-human primate model of Marburg virus infection to determine the therapeutic window (i.e., how late after infection can MR191 be administered and still result in 100% efficacy) as well as dose determination studies (i.e., what is the lowest dose that gives 100% efficacy). Additionally, the toxicity of MR191 will be evaluated in non-human primates and the data will enable the submission of a New Investigational Drug Application (IND) to the U.S. Food and Drug Administration. Upon completion of the scope of this project, Mapp will be positioned to produce MR191 in compliance with current Good Manufacturing Practices (cGMPs) in advance of submitting the IND. This will enable the conduct of the first-in-human studies for this important filovirus MCM.


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: 2022 ( Subtotal = -$31,423 )
2022	2019	MAPP BIOPHARMACEUTICAL, INC.	4921 DIRECTORS PLACE STE 100	SAN DIEGO	CA	92121	SAN DIEGO	USA	Allergy and Infectious Diseases Research	000	8	4/8/2022	NON-COMPETING CONTINUATION	-$31,423
														Subtotal = -$31,423

Issue Date FY: 2019 ( Subtotal = $1,000,000 )
2019	2019	MAPP BIOPHARMACEUTICAL, INC.	6160 LUSK BLVD STE 105	SAN DIEGO	CA	92121	SAN DIEGO	USA	Allergy and Infectious Diseases Research	000	8	6/12/2019	NON-COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,000,000

Issue Date FY: 2018 ( Subtotal = $1,000,000 )
2018	2018	MAPP BIOPHARMACEUTICAL, INC.	6160 LUSK BLVD STE 105	SAN DIEGO	CA	92121	SAN DIEGO	USA	Allergy and Infectious Diseases Research	000	7	6/26/2018	NON-COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,000,000

Issue Date FY: 2017 ( Subtotal = $1,000,000 )
2017	2017	MAPP BIOPHARMACEUTICAL, INC.	6160 LUSK BLVD STE 105	SAN DIEGO	CA	92121	SAN DIEGO	USA	Allergy and Infectious Diseases Research	000	6	5/1/2017	COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,000,000

Grand Total All Awards = $2,968,577

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MR191_ An Immunoprotectant for Marburg Virus

Award Number: SB1AI082744

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: 04/01/2009

PERIOD OF PERFORMANCE END DATE: 06/30/2021

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