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A Universal Flu Vaccine Based On Conformationally Locked Soluble Headless HA

Award Number: R44AG059371
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/15/2015
PERIOD OF PERFORMANCE END DATE: 11/30/2020

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A Universal Flu Vaccine Based On Conformationally Locked Soluble Headless HA - An Influenza pandemic remains an acute threat to world health; and stockpiling a universally protective Influenza vaccine provides a strong defense against this potential catastrophe. The hemagglutinin (HA) protein is the primary target of humoral Ab responses to Influenza; the majority of broadly protective mAbs (bnAbs) against influenza isolated from humans recognize conserved and conformation-specific epitopes in the HA Stalk. But, strain-specific, immunodominant epitopes in the Head of HA overwhelm immune responses to the Stalk. An HA immunogen from which the Head domain has been removed will elicit anti-Stalk antibodies that protect broadly against seasonal, as well as pandemic, Influenza. Despite significant progress, it has so far not proved possible to design a stable Headless HA that assumes its fully native conformation and thereby elicits universally protective Ab responses. None of the most promising, recent designs have progressed to clinical development. Avatar has developed a strategy to produce a conformationally intact Headless HA that overcomes these limitations. This strategy involves first locking the structure of the conserved Stalk with target dityrosine (DT) crosslinks, so that it can no longer lose its native conformation. Then we remove the variable and immunodominant Head domain with a site-specific protease, using engineered recognition sites. This DT- Headless HA immunogen is in its fully native conformation, and responses to this more perfect immunogen will improve Ab titers and affinities to conserved epitopes, and thus protect broadly against all strains of Influenza. In Phase I, we successfully designed and characterized our DT-Headless HA (AI118087). In Phase II we will demonstrate heterologous protection in Balb/c mouse challenge studies, and confirm efficacy of this product in ferret challenge studies (Aims 1 & 2). We will also transfer our design into a Group II HA and test its heterologous protection in mouse and ferret lethal challenge studies (Aim 3 & 4). By inducing higher avidity, higher titer Ab responses to the conserved Stalk, Avatar's Headless HA immunogen will give rise to broad protection against homologous and drift variants, as well as Group 1 & 2 heterologous challenge. We will compare the results obtained with our Group I and II Headless HA immunogens and select a product candidate for preclinical and clinical development.


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: 2023 ( Subtotal = $170,621 )
2023	2019	AVATAR MEDICAL, LLC	140 58TH ST BLDG A STE 8J	BROOKLYN	NY	11220	KINGS	USA	Aging Research	000	3	5/26/2023	NON-COMPETING CONTINUATION	$170,621
														Subtotal = $170,621

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	CALDER BIOSCIENCES INC.	140 58TH ST STE 8J	BROOKLYN	NY	11220	KINGS	USA	Aging Research	000	5	4/14/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $887,615 )
2020	2020	CALDER BIOSCIENCES INC.	140 58TH ST STE 8J	BROOKLYN	NY	11220	KINGS	USA	Aging Research	000	5	11/27/2019	NON-COMPETING CONTINUATION	$887,615
														Subtotal = $887,615

Issue Date FY: 2019 ( Subtotal = $987,193 )
2019	2019	AVATAR MEDICAL, LLC	140 58TH ST BLDG A STE 8J	BROOKLYN	NY	11220	KINGS	USA	Aging Research	002	3	8/13/2019	NON-COMPETING CONTINUATION	-$374,928
2019	2019	AVATAR MEDICAL, LLC	140 58TH ST BLDG A STE 8J	BROOKLYN	NY	11220	KINGS	USA	Aging Research	001	3	11/9/2018	NON-COMPETING CONTINUATION	$987,193
2019	2019	CALDER BIOSCIENCES INC.	140 58TH ST STE 8J	BROOKLYN	NY	11220	KINGS	USA	Aging Research	003	4	8/14/2019	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$374,928
2019	2018	AVATAR MEDICAL, LLC	140 58TH ST BLDG A STE 8J	BROOKLYN	NY	11220	KINGS	USA	Aging Research	000	2	10/27/2018	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $987,193

Issue Date FY: 2018 ( Subtotal = $986,704 )
2018	2018	AVATAR MEDICAL, LLC	140 58TH ST BLDG A STE 8J	BROOKLYN	NY	11220	KINGS	USA	Aging Research	000	2	1/9/2018	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$986,704
2018	2018	AVATAR MEDICAL, LLC	140 58TH ST BLDG A STE 8J	BROOKLYN	NY	11220	KINGS	USA	Aging Research	001	2	2/9/2018	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $986,704

Grand Total All Awards = $3,032,133

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A Universal Flu Vaccine Based On Conformationally Locked Soluble Headless HA

Award Number: R44AG059371

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 02/15/2015

PERIOD OF PERFORMANCE END DATE: 11/30/2020

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