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Programmable Off-the-Shelf Dendritic Cells as an Immunotherapy Discovery Platform

Award Number: DP2AI154417
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: 09/01/2021
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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Programmable Off-the-Shelf Dendritic Cells as an Immunotherapy Discovery Platform - Project Summary Adoptive Cell Immunotherapy using patient harvested T cells engineered against tumor-specific targets has ushered in a new therapeutic era. However, the lack of tumor-specific targets and T cell receptors limits the addressable cancers. A promising approach for solid tumors uses T cell receptors (TCRs) directed against tumor- specific antigens (TSAs) displayed on HLA receptors found on the surface of nearly every cell. Unfortunately, HLAs are highly polymorphic genes between people. This restricts both the TCRs and TSAs to a small number of patients. A platform that expands the number of HLA-restricted TSAs and TCRs will transform the entire immunotherapy pipeline. Here, I propose to address this unmet need by generating programmable Dendritic cells (DCs) – professional antigen presenting cells that function to mature and activate naive T cells. Programmable DCs would permit the discovery of new TCRs, validation of TSAs, and perhaps be used as "living" vaccines to marshal a patient’s own immune system against infectious disease and cancer. Thus far, efforts to leverage the potential of DCs have been limited principally by: (1) an inability to produce cells with HLAs matched to patients;; (2) an inability to robustly test and validate new TSAs against TCRs;; and (3) an inability to produce "off-the-shelf" DCs at industrial scale. As a new innovator, my vision is to produce off-the-shelf Dendritic Cells pre-engineered to match any HLA haplotype (even rare ones) and pre-encoded with any combination of TSAs. Using this new platform, my group will search for and validate "universal" TSAs/TCRs that can be used broadly in TCR-Therapy for any patient. Specifically, we will focus on peptides expressed from regions of the genome normally epigenetically silenced, but re-activated in tumor cells (such as endogenous retroviruses). To reach this goal, we will continue development of technology enabling the "writing" of millions of base-pairs of DNA in human induced pluripotent stem cells (iPSCs). This technology allows direct customization of the large HLA locus of iPSCs in a single step;; introduction of libraries of potential TSAs;; and integration of synthetic reporter constructs (which are excisable for safety) for enhancing the in vitro directed differentiation of iPSCs to DCs. Thus, allogeneic programmed DCs will catalyze a wide variety of immunotherapy applications and expand access of these advanced treatments for a greater number of patients.


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 = $371,104 )
2024	2024	NEW YORK UNIVERSITY	70 WASHINGTON SQ S	NEW YORK	NY	10012	NEW YORK	USA	Allergy and Infectious Diseases Research	001	4	8/14/2024	SUPPLEMENT FOR EXPANSION	$34,829
2024	2024	NEW YORK UNIVERSITY	70 WASHINGTON SQ S	NEW YORK	NY	10012	NEW YORK	USA	Allergy and Infectious Diseases Research	000	4	8/13/2024	NON-COMPETING CONTINUATION	$336,275
														Subtotal = $371,104

Issue Date FY: 2023 ( Subtotal = $542,003 )
2023	2023	NEW YORK UNIVERSITY	70 WASHINGTON SQ S	NEW YORK	NY	10012	NEW YORK	USA	Allergy and Infectious Diseases Research	000	2	1/18/2023	SUPPLEMENT FOR EXPANSION	$71,851
2023	2023	NEW YORK UNIVERSITY	70 WASHINGTON SQ S	NEW YORK	NY	10012	NEW YORK	USA	Allergy and Infectious Diseases Research	001	3	8/2/2023	NON-COMPETING CONTINUATION	$363,248
2023	2023	NEW YORK UNIVERSITY	70 WASHINGTON SQ S	NEW YORK	NY	10012	NEW YORK	USA	Allergy and Infectious Diseases Research	002	3	8/3/2023	SUPPLEMENT FOR EXPANSION	$106,904
														Subtotal = $542,003

Issue Date FY: 2022 ( Subtotal = $391,676 )
2022	2022	NEW YORK UNIVERSITY	70 WASHINGTON SQ S	NEW YORK	NY	10012	NEW YORK	USA	Allergy and Infectious Diseases Research	000	2	8/16/2022	NON-COMPETING CONTINUATION	$391,676
														Subtotal = $391,676

Issue Date FY: 2021 ( Subtotal = $377,000 )
2021	2021	NEW YORK UNIVERSITY	70 WASHINGTON SQ S	NEW YORK	NY	10012	NEW YORK	USA	Allergy and Infectious Diseases Research	000	1	7/12/2021	NEW	$377,000
														Subtotal = $377,000

Grand Total All Awards = $1,681,783

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Programmable Off-the-Shelf Dendritic Cells as an Immunotherapy Discovery Platform

Award Number: DP2AI154417

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: 09/01/2021

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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