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Optimizing eCD4-Ig for eradication and a functional cure

Award Number: R01AI129868
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: 08/16/2017
PERIOD OF PERFORMANCE END DATE: 07/31/2022

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Optimizing eCD4-Ig for eradication and a functional cure - PROJECT SUMMARY One strategy for eradicating the HIV-1 viral reservoir combines a means of activating viral gene expression in latently infected T cells (a ‘kick’) with a way to eliminate these activated cells (a ‘kill’). The TLR7 agonist GS-9620 is a safe, well tolerated latency reversing agent that indirectly induces latently infected T cells to produce virus. Preliminary data indicates that it can partially reduce, or in some cases perhaps completely eliminate, the SIV reservoir in rhesus macaques. eCD4-Ig is an antibody- like entry inhibitor with unmatched breadth and very potent neutralizing and antibody-dependent cell- mediated cytotoxicity (ADCC) activities against HIV-1, HIV-2 and SIV. Moreover, it can protect macaques against from repeated high-dose challenges with two divergent viruses – SIVmac239 and SHIV-AD8. Finally a single dose of an IgG1 form of human eCD4-Ig protein can suppress infection in macaques by 2.5 logs without evidence of viral escape. eCD4-Ig’s potent neutralization and ADCC activities, and its exceptional breadth, suggest that it may uniquely overcome the diversity of the viral reservoir and facilitate the elimination of most reactivated cells. Accordingly, we will test the hypothesis that the effector functions of eCD4-Ig can accelerate reduction of the latent reservoir observed in GS-9620-treated macaques. To do so, we will first optimize the half- life, immunogenicity, neutralization potency, and ADCC activities of eCD4-Ig. We will then optimize the schedule, dosing, and route of administration of GS-9620, and establish the relationship between GS- 9620-induced virus ‘blips’ and reservoir reduction. Finally, we will compare GS-9620, eCD4-Ig, and both therapies combined, for their abilities to reduce the size of the latent reservoir and/or establish a stable state of virologic control. If successful, these studies will lay a foundation for future human clinical trials combining GS-9620 and eCD4-Ig.


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 = -$26,026 )
2023	2021	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Allergy and Infectious Diseases Research	002	6	1/3/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$1,430
2023	2021	SCRIPPS RESEARCH INSTITUTE, THE	130 SCRIPPS WAY	JUPITER	FL	33458	PALM BEACH	USA	Allergy and Infectious Diseases Research	001	5	1/3/2023	NON-COMPETING CONTINUATION	-$1,430
2023	2021	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Allergy and Infectious Diseases Research	003	6	1/4/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$26,026
2023	2020	SCRIPPS RESEARCH INSTITUTE, THE	130 SCRIPPS WAY	JUPITER	FL	33458	PALM BEACH	USA	Allergy and Infectious Diseases Research	000	4	1/3/2023	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = -$26,026

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	SCRIPPS RESEARCH INSTITUTE, THE	130 SCRIPPS WAY	JUPITER	FL	33458	PALM BEACH	USA	Allergy and Infectious Diseases Research	000	5	5/3/2022	NON-COMPETING CONTINUATION	-$24,596
2022	2021	SCRIPPS RESEARCH INSTITUTE, THE	130 SCRIPPS WAY	JUPITER	FL	33458	PALM BEACH	USA	Allergy and Infectious Diseases Research	002	5	5/12/2022	NON-COMPETING CONTINUATION	$0
2022	2021	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Allergy and Infectious Diseases Research	001	6	5/3/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$24,596
2022	2020	SCRIPPS RESEARCH INSTITUTE, THE	130 SCRIPPS WAY	JUPITER	FL	33458	PALM BEACH	USA	Allergy and Infectious Diseases Research	003	4	7/21/2022	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $698,681 )
2021	2021	SCRIPPS RESEARCH INSTITUTE, THE	130 SCRIPPS WAY	JUPITER	FL	33458	PALM BEACH	USA	Allergy and Infectious Diseases Research	000	5	7/1/2021	NON-COMPETING CONTINUATION	$698,681
														Subtotal = $698,681

Issue Date FY: 2020 ( Subtotal = $1,615,674 )
2020	2020	SCRIPPS RESEARCH INSTITUTE, THE	130 SCRIPPS WAY	JUPITER	FL	33458	PALM BEACH	USA	Allergy and Infectious Diseases Research	003	4	8/21/2020	SUPPLEMENT FOR EXPANSION	$0
2020	2020	SCRIPPS RESEARCH INSTITUTE, THE	130 SCRIPPS WAY	JUPITER	FL	33458	PALM BEACH	USA	Allergy and Infectious Diseases Research	000	3	4/3/2020	SUPPLEMENT FOR EXPANSION	$331,181
2020	2020	SCRIPPS RESEARCH INSTITUTE, THE	130 SCRIPPS WAY	JUPITER	FL	33458	PALM BEACH	USA	Allergy and Infectious Diseases Research	002	4	8/11/2020	SUPPLEMENT FOR EXPANSION	$343,458
2020	2020	SCRIPPS RESEARCH INSTITUTE, THE	130 SCRIPPS WAY	JUPITER	FL	33458	PALM BEACH	USA	Allergy and Infectious Diseases Research	001	4	7/22/2020	NON-COMPETING CONTINUATION	$941,035
														Subtotal = $1,615,674

Issue Date FY: 2019 ( Subtotal = $940,275 )
2019	2019	SCRIPPS RESEARCH INSTITUTE, THE	130 SCRIPPS WAY	JUPITER	FL	33458	PALM BEACH	USA	Allergy and Infectious Diseases Research	000	3	7/24/2019	NON-COMPETING CONTINUATION	$940,275
														Subtotal = $940,275

Issue Date FY: 2018 ( Subtotal = $941,073 )
2018	2018	SCRIPPS RESEARCH INSTITUTE, THE	130 SCRIPPS WAY	JUPITER	FL	33458	PALM BEACH	USA	Allergy and Infectious Diseases Research	000	2	7/19/2018	NON-COMPETING CONTINUATION	$941,073
														Subtotal = $941,073

Issue Date FY: 2017 ( Subtotal = $966,508 )
2017	2017	SCRIPPS RESEARCH INSTITUTE, THE	130 SCRIPPS WAY	JUPITER	FL	33458	PALM BEACH	USA	Allergy and Infectious Diseases Research	000	1	8/16/2017	NEW	$966,508
														Subtotal = $966,508

Grand Total All Awards = $5,136,185

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Optimizing eCD4-Ig for eradication and a functional cure

Award Number: R01AI129868

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: 08/16/2017

PERIOD OF PERFORMANCE END DATE: 07/31/2022

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