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Engineering immunotherapeutic probiotics to mitigate irAE

Award Number: U01CA247573
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 01/21/2020
PERIOD OF PERFORMANCE END DATE: 12/31/2024

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Engineering immunotherapeutic probiotics to mitigate irAE - PROJECT SUMMARY/ABSTRACT In recent years, the field of cancer immunotherapy has seen a renaissance – with the use of monoclonal antibodies that target immune checkpoints to activate anticancer immune responses demonstrating unparalleled clinical success. Several of these therapies have now gained FDA approval and are part of routine treatment regimens for several malignancies. Despite the overall success of immunotherapeutic regimens, existing modalities present complications that current research efforts seek to overcome: (1) systemic delivery of checkpoint blockade monoclonal antibodies lead to diverse and unpredictable immune-related adverse events (irAE), (2) boosting responses from the endogenous antitumor repertoire often relies on the existence of pre- primed antitumor T cells, which in the case of highly immunosuppressive tumors or those with low mutational burden may be extremely rare, and (3) attempts to combine immunotherapies to additively boost T cell responses demonstrate increased on-target, off-tumor toxicity. Thus, to circumvent toxicity and immunosuppression, contemporary strategies focus on developing methods to deliver potent immunostimulants directly into a tumor, locally priming antitumor T cells to attack disseminated metastases exhibiting a similar antigenic profile. Bridging these observations, the goals of this proposal are to engineer probiotic strains of bacteria that selectively colonize colorectal cancer (CRC) and locally release immune checkpoint blockade. We hypothesize that this approach will result in more robust and diversified antitumor T cell immunity and promote the clearance of colonized primary and metastatic colorectal cancer lesions and systemically growing CRC-derived foci. The primary innovations of this proposal are in engineering probiotics as an immunotherapeutic delivery vector to locally release high-dose immune checkpoint blockade. Specifically, the proposed system has several advantages over current therapeutic strategies, including: (1) tumor-specific production of immunotherapies and LPS adjuvant, (2) bacteria lysis, leading to effective release of novel immunotherapeutics and LPS, (3) local delivery of novel immunotherapeutics that are toxic to deliver systemically, and (4) oral delivery of probiotics that selectively colonize CRC metastases. This work seeks to shift current research and clinical practice paradigms to overcome current limitations of immunotherapies, by providing a unique vehicle to locally deliver immunotherapies that stimulate antitumor immunity while preventing systemic toxicity and mitigating irAE.


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 = -$635 )
2025	2024	THE TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK	615 W 131ST ST	NEW YORK	NY	10027	NEW YORK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	5	8/19/2025	NON-COMPETING CONTINUATION	-$635
														Subtotal = -$635

Issue Date FY: 2024 ( Subtotal = $571,668 )
2024	2024	THE TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK	615 W 131ST ST	NEW YORK	NY	10027	NEW YORK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	001	5	4/17/2024	NON-COMPETING CONTINUATION	$30,088
2024	2024	THE TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK	615 W 131ST ST	NEW YORK	NY	10027	NEW YORK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	5	12/20/2023	NON-COMPETING CONTINUATION	$541,580
														Subtotal = $571,668

Issue Date FY: 2023 ( Subtotal = $599,683 )
2023	2023	TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK, THE	202 LOW LIBRARY 535 W 116 ST MC 4309,	NEW YORK	NY	10027	NEW YORK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	4	5/12/2023	NON-COMPETING CONTINUATION	$599,683
														Subtotal = $599,683

Issue Date FY: 2022 ( Subtotal = $584,146 )
2022	2022	TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK, THE	202 LOW LIBRARY 535 W 116 ST MC 4309,	NEW YORK	NY	10027	NEW YORK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	3	1/26/2022	NON-COMPETING CONTINUATION	$596,099
2022	2022	TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK, THE	202 LOW LIBRARY 535 W 116 ST MC 4309,	NEW YORK	NY	10027	NEW YORK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	001	3	5/4/2022	NON-COMPETING CONTINUATION	-$11,953
														Subtotal = $584,146

Issue Date FY: 2021 ( Subtotal = $595,682 )
2021	2021	TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK, THE	116TH AND BDWY	NEW YORK	NY	10027	NEW YORK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	001	2	11/13/2020	NON-COMPETING CONTINUATION	$565,898
2021	2021	TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK, THE	116TH AND BDWY	NEW YORK	NY	10027	NEW YORK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	003	2	1/21/2021	NON-COMPETING CONTINUATION	$29,784
2021	2021	TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK, THE	116TH AND BDWY	NEW YORK	NY	10027	NEW YORK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	002	2	12/17/2020	NON-COMPETING CONTINUATION	$0
2021	2020	TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK, THE	116TH AND BDWY	NEW YORK	NY	10027	NEW YORK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	1	11/3/2020	NEW	$0
														Subtotal = $595,682

Issue Date FY: 2020 ( Subtotal = $586,329 )
2020	2020	TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK, THE	116TH AND BDWY	NEW YORK	NY	10027	NEW YORK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	1	1/21/2020	NEW	$586,329
														Subtotal = $586,329

Grand Total All Awards = $2,936,873

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Engineering immunotherapeutic probiotics to mitigate irAE

Award Number: U01CA247573

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 01/21/2020

PERIOD OF PERFORMANCE END DATE: 12/31/2024

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