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SARS-CoV-2 vaccines based on RBDs with engineered glycosylation sites

Award Number: R44AI170392
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: 08/17/2023
PERIOD OF PERFORMANCE END DATE: 07/31/2026

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SARS-CoV-2 vaccines based on RBDs with engineered glycosylation sites - We are developing vaccine antigens for SARS-CoV-2 that focus the antibody response onto neutralizing epitopes in the receptor binding domain (RBD) of the viral Spike (S) protein. Booster antigens derived from variants of SARS-CoV-2 would especially benefit from being limited to the RBD, due to the preponderance of conserved but non-neutralizing epitopes in the full-length S protein. However, RBD-only vaccines face the technical limitations of aggregation and poor expression, due to hydrophobic patches on the RBD that form the inter-subunit interfaces in the native S protein. We have overcome these limitations by engineering N- linked glycosylation sites into the RBD. These glycans also help to focus the immune response away from off-target faces of the RBD, and onto the targets for potent neutralizing antibody responses. We will extend this strategy further, to focus the antibody response onto neutralizing epitopes in the RBD that are conserved among variants of SARS-CoV-2. The RBD antigens will be tested as lipid nanoparticle (LNP)-mRNA vaccines. In Phase I of this project, we will enhance the intrinsic immunogenicity of RBD antigens delivered as LNP-mRNA vaccines. In Phase II, we will build upon this platform to compare boosters based on variant- derived RBD versus variant-derived full-length S, and to optimize RBD antigens for focusing antibody responses onto neutralizing epitopes that are conserved among variants of SARS-CoV-2. The antigens generated by this project will exploit four levels of immunofocusing to elicit or boost antibody responses that recognize conserved epitopes in the RBD and neutralize antigenically-distinct variants of SARS-CoV-2.


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: 2025 ( Subtotal = $1,000,000 )
2025	2025	EMMUNE INC	620 MEMORIAL DR STE W-100	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Allergy and Infectious Diseases Research	001	4	8/5/2025	NON-COMPETING CONTINUATION	$1,000,000
2025	2022	EMMUNE INC	620 MEMORIAL DR STE W-100	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Allergy and Infectious Diseases Research	000	1	11/30/2024	NEW	$0
														Subtotal = $1,000,000

Issue Date FY: 2024 ( Subtotal = $1,000,000 )
2024	2024	EMMUNE INC	620 MEMORIAL DR STE W-100	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Allergy and Infectious Diseases Research	000	3	7/18/2024	NON-COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,000,000

Issue Date FY: 2023 ( Subtotal = $1,000,000 )
2023	2023	EMMUNE INC	14155 US HIGHWAY 1	JUNO BEACH	FL	33408	PALM BEACH	USA	Allergy and Infectious Diseases Research	002	2	8/17/2023	EXTENSION WITH OR WITHOUT FUNDS	$1,000,000
2023	2022	EMMUNE INC	14155 US HIGHWAY 1	JUNO BEACH	FL	33408	PALM BEACH	USA	Allergy and Infectious Diseases Research	001	1	7/3/2023	NEW	$0
2023	2022	EMMUNE INC	14155 US HIGHWAY 1	JUNO BEACH	FL	33408	PALM BEACH	USA	Allergy and Infectious Diseases Research	000	1	2/3/2023	NEW	$0
														Subtotal = $1,000,000

Issue Date FY: 2022 ( Subtotal = $300,000 )
2022	2022	EMMUNE, INC.	14155 US HIGHWAY 1 JUNO BEACH	JUNO BEACH	FL	33408	PALM BEACH	USA	Allergy and Infectious Diseases Research	001	1	8/11/2022	NEW	$0
2022	2022	EMMUNE, INC.	14155 US HIGHWAY 1 JUNO BEACH	JUNO BEACH	FL	33408	PALM BEACH	USA	Allergy and Infectious Diseases Research	000	1	8/8/2022	NEW	$300,000
														Subtotal = $300,000

Grand Total All Awards = $3,300,000

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SARS-CoV-2 vaccines based on RBDs with engineered glycosylation sites

Award Number: R44AI170392

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: 08/17/2023

PERIOD OF PERFORMANCE END DATE: 07/31/2026

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