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Improving the pharmacokinetics, potency, and immunogenicity of eCD4-Ig

Award Number: R44AI145491
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: 05/19/2020
PERIOD OF PERFORMANCE END DATE: 04/30/2023

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Improving the pharmacokinetics, potency, and immunogenicity of eCD4-Ig - PROJECT SUMMARY We have developed an antibody-like HIV-1 entry inhibitor, eCD4-Ig, composed of the first two domains of CD4 fused to an antibody Fc domain and a short tyrosine-sulfated CCR5-mimetic peptide. eCD4-Ig has properties that make it an exceptionally promising tool in the fight against the HIV-1 pandemic. Specifically, it is broader than any broadly neutralizing antibody (bNAb), at least as potent at neutralization and antibody-dependent cell-mediated cytotoxicity (ADCC), more difficult to escape, less immunogenic, and uniquely capable of amplifying the ADCC activity of non-neutralizing antibodies in patient sera. When expressed by an adeno-associated virus (AAV) vector, it can protect rhesus macaques from SHIV and SIV challenges more effectively than any conventional vaccine strategy, and, as we show here, it can suppress viral rebound after cessation of combined antiretroviral therapies (cART). In short, the case for optimizing eCD4-Ig is strong. Here we describe a series of cell-culture and animal studies that will further extend eCD4-Ig’s half-life, improve its potency, and reduce its immunogenicity. These improvements will increase the safety and efficacy of eCD4-Ig as an infused protein and as an AAV-expressed transgene, and bring us closer to our goals of sustained drug-free HIV- 1 remission and effective long-term prophylaxis against HIV-1 infection.


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: 2024 ( Subtotal = $0 )
2024	2022	EMMUNE INC	620 MEMORIAL DR STE W-100	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Allergy and Infectious Diseases Research	000	4	2/20/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $907,386 )
2022	2022	EMMUNE, INC.	14155 US HIGHWAY 1 JUNO BEACH	JUNO BEACH	FL	33408	PALM BEACH	USA	Allergy and Infectious Diseases Research	001	4	4/15/2022	NON-COMPETING CONTINUATION	$907,386
2022	2021	EMMUNE, INC.	14155 US HIGHWAY 1 JUNO BEACH	JUNO BEACH	FL	33408	PALM BEACH	USA	Allergy and Infectious Diseases Research	000	3	1/14/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $907,386

Issue Date FY: 2021 ( Subtotal = $870,946 )
2021	2021	EMMUNE, INC.	14155 US HIGHWAY 1 JUNO BEACH	JUNO BEACH	FL	33408	PALM BEACH	USA	Allergy and Infectious Diseases Research	004	3	4/16/2021	NON-COMPETING CONTINUATION	$870,946
2021	2020	EMMUNE, INC.	14155 US HIGHWAY 1 JUNO BEACH	JUNO BEACH	FL	33408	PALM BEACH	USA	Allergy and Infectious Diseases Research	002	2	4/14/2021	EXTENSION WITH OR WITHOUT FUNDS	$657
2021	2020	EMMUNE, INC.	14155 US HIGHWAY 1 JUNO BEACH	JUNO BEACH	FL	33408	PALM BEACH	USA	Allergy and Infectious Diseases Research	000	2	4/13/2021	EXTENSION WITH OR WITHOUT FUNDS	$0
2021	2020	EMMUNE, INC.	14155 US HIGHWAY 1 JUNO BEACH	JUNO BEACH	FL	33408	PALM BEACH	USA	Allergy and Infectious Diseases Research	006	2	9/15/2021	EXTENSION WITH OR WITHOUT FUNDS	-$657
2021	2019	EMMUNE, INC.	14155 US HIGHWAY 1 JUNO BEACH	JUNO BEACH	FL	33408	PALM BEACH	USA	Allergy and Infectious Diseases Research	001	1	4/14/2021	NEW	-$657
2021	2019	EMMUNE, INC.	14155 US HIGHWAY 1 JUNO BEACH	JUNO BEACH	FL	33408	PALM BEACH	USA	Allergy and Infectious Diseases Research	003	1	4/15/2021	NEW	$0
2021	2019	EMMUNE, INC.	14155 US HIGHWAY 1 JUNO BEACH	JUNO BEACH	FL	33408	PALM BEACH	USA	Allergy and Infectious Diseases Research	005	1	9/15/2021	NEW	$657
														Subtotal = $870,946

Issue Date FY: 2020 ( Subtotal = $886,103 )
2020	2020	EMMUNE, INC.	14155 US HIGHWAY 1 JUNO BEACH	JUNO BEACH	FL	33408	PALM BEACH	USA	Allergy and Infectious Diseases Research	000	2	5/19/2020	EXTENSION WITH OR WITHOUT FUNDS	$886,103
														Subtotal = $886,103

Issue Date FY: 2019 ( Subtotal = $300,000 )
2019	2019	EMMUNE, INC.	130 SCRIPPS WAY BLDG B ROOM 112	JUPITER	FL	33458	PALM BEACH	USA	Allergy and Infectious Diseases Research	001	1	8/6/2019	NEW	$0
2019	2019	EMMUNE, INC.	130 SCRIPPS WAY BLDG B ROOM 112	JUPITER	FL	33458	PALM BEACH	USA	Allergy and Infectious Diseases Research	000	1	7/30/2019	NEW	$300,000
														Subtotal = $300,000

Grand Total All Awards = $2,964,435

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Improving the pharmacokinetics, potency, and immunogenicity of eCD4-Ig

Award Number: R44AI145491

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: 05/19/2020

PERIOD OF PERFORMANCE END DATE: 04/30/2023

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