Sunday, October 6, 2024 10/6/2024

Manufacture a protein encoding CAP256.wk34.c80 OPT4 envelope for induction of V2 Apex bnAbs

Award Number: UM1AI144371
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Request to DAIDS to Manufacture a protein encoding CAP256.wk34.c80 OPT4 envelope for induction of V2 Apex bnAbs Induction of an effective HIV-1 vaccine is a global priority; yet, no HIV-1 vaccine regimen reproducibly elicits broadly neutralizing antibodies (bnAbs) in humans. The complex immunology underlying human bnAb development suggests that a successful vaccine will likely contain a series of immunogens that guide bnAb development 1-3. Such complex vaccines will require iterative design and evaluation in humans, necessitating rapid cGMP production of potent immunogens. We and others have found that multimerizing HIV-1 Env on nanoparticles (NPs) can augment its immunogenicity. HIV-1 Env trimer NP immunogens have been made previously by encoding HIV-1 Env fused to NP subunits as a single gene. These fusion protein NPs display a mixture of high-quality and low-quality, misfolded HIV-1 Env on their surfaces that can elicit immunodominant non-neutralizing antibodies. Thus, laborious, time-consuming development work must be performed to optimize the HIV-1 envelope production such that predominately well-folded envelope is fused to nanoparticle subunits. Additionally, we have found during cGMP cell line development that protein yields of Env trimer NP may be insufficient to enable cGMP manufacturing. The significance of this Project is that it will utilize an already successful cGMP process to rapidly manufacture higher quality HIV-1 Env trimer NPs than previous NPs encoded by single genes. We have already utilized this technology to overcome the pitfalls incurred with fusion NPs, by using our innovative conjugation method that generates NPs with only well-folded HIV-1 Env on their surface. This method utilizes the high specificity of sortase A conjugation to link highly purified, well-folded HIV-1 Env to ferritin NPs. These sortase A-conjugated NPs (scNPs) can be assembled rapidly and preserve the antigenic character of the HIV-1 Env, features critical for a vaccine regimen aiming to elicit durable, protective bnAbs. This innovative, rapid NP platform is universal in nature, having been used for HIV-1 Env trimers of various clades, SIVcpz Env trimers, and Spike proteins from other human pathogens such as SARS- CoV-2. We will utilize this platform in combination with CAP256w34.80 designed to guide affinity maturation of V2 Apex bnAbs in humans.


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 = $36,217,089 )
2024	2024	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	003	6	7/24/2024	SUPPLEMENT FOR EXPANSION	$3,169,510
2024	2024	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	002	6	7/8/2024	NON-COMPETING CONTINUATION	$21,000,000
2024	2024	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	006	6	8/7/2024	SUPPLEMENT FOR EXPANSION	$3,192,992
2024	2024	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	007	6	8/14/2024	SUPPLEMENT FOR EXPANSION	$5,303,216
2024	2024	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	004	6	7/25/2024	SUPPLEMENT FOR EXPANSION	$809,741
2024	2024	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	005	6	8/6/2024	SUPPLEMENT FOR EXPANSION	$2,741,630
2024	2023	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	000	5	11/2/2023	NON-COMPETING CONTINUATION	$0
2024	2023	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	001	5	1/17/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $36,217,089

Issue Date FY: 2023 ( Subtotal = $30,401,371 )
2023	2023	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	002	5	6/29/2023	NON-COMPETING CONTINUATION	$20,999,999
2023	2023	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	003	5	8/2/2023	NON-COMPETING CONTINUATION	$9,401,372
2023	2022	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	001	4	4/26/2023	NON-COMPETING CONTINUATION	$0
2023	2022	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	000	4	3/28/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $30,401,371

Issue Date FY: 2022 ( Subtotal = $27,892,292 )
2022	2022	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	001	4	6/29/2022	NON-COMPETING CONTINUATION	$21,000,000
2022	2022	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	002	4	7/28/2022	NON-COMPETING CONTINUATION	$6,528,199
2022	2022	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	003	4	8/10/2022	NON-COMPETING CONTINUATION	$364,093
2022	2021	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	000	3	5/11/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $27,892,292

Issue Date FY: 2021 ( Subtotal = $27,785,406 )
2021	2021	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	003	3	8/26/2021	NON-COMPETING CONTINUATION	$3,563,360
2021	2021	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	004	3	9/1/2021	NON-COMPETING CONTINUATION	$0
2021	2021	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	002	3	8/4/2021	NON-COMPETING CONTINUATION	$3,222,046
2021	2021	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	001	3	7/13/2021	NON-COMPETING CONTINUATION	$21,000,000
2021	2020	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	000	2	3/23/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $27,785,406

Issue Date FY: 2020 ( Subtotal = $26,347,892 )
2020	2020	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	003	2	8/26/2020	NON-COMPETING CONTINUATION	$5,347,842
2020	2020	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	004	2	9/14/2020	NON-COMPETING CONTINUATION	$50
2020	2020	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	002	2	8/7/2020	NON-COMPETING CONTINUATION	$21,000,000
2020	2019	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	000	1	3/31/2020	NEW	$0
2020	2019	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	001	1	4/8/2020	NEW	$0
														Subtotal = $26,347,892

Issue Date FY: 2019 ( Subtotal = $21,000,000 )
2019	2019	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	000	1	7/15/2019	NEW	$21,000,000
														Subtotal = $21,000,000

Grand Total All Awards = $169,644,050

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Manufacture a protein encoding CAP256.wk34.c80 OPT4 envelope for induction of V2 Apex bnAbs

Award Number: UM1AI144371

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

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