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Canine Immuno Neurotherapeutics

Award Number: U01CA224151
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2017
PERIOD OF PERFORMANCE END DATE: 08/31/2025

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Canine Immuno Neurotherapeutics - ABSTRACT: The dog is an ideal large animal model for diagnostic and therapeutic studies and can be used to translate successes to human patients while providing compassionate care to animals and advancing the field of veterinary medicine. Pet dogs share their environment, and oftentimes their diet, with their owners. Dogs and humans develop sporadic benign and malignant brain tumors at about the same rate and with similar histopathology. Dogs are often euthanized due to the cost of care. Thus, the spontaneously occurring canine brain tumor represents an ideal opportunity to improve the lives of people as well as pets through comparative oncology and genomics and the “One Medicine” approach to research and direct clinical application. We propose a multi-institutional consortium to test an innovative combinatorial immunotherapeutic approach in dogs that spontaneously and sporadically develop malignant glial brain tumors that resemble in most important aspects, high-grade malignant gliomas in humans. Our approach will inject a clinical grade oncolytic herpes simplex virus (HSV) M032 that expresses human interleukin-12 (IL-12) into the resected tumor bed. Dog lymphocytes fully respond to human IL-12 [1] and oncolytic HSV infect and kill canine (as well as mouse, non-human primate, human) tumor cells, creating a potent local inflammatory response and an antigen-rich tumor cell debris field. Therefore, we would anticipate that this virally-based immunotherapeutic approach would likely be as effective in dogs with brain tumors as in humans with brain tumors. We will conduct longitudinal safety, survival and correlative biology evaluations as a means of assessing the dog as an appropriate and informative model for design and implementation of clinical studies in humans with high-grade malignant brain tumors. To extend these findings, we propose, in subsequent studies, to combine the HSV immunotherapy approach with molecules that block the action of innate checkpoint inhibitor(s). These studies are designed to address key issues of safety and efficacy of combinatorial immunotherapy in the dog that can be translated to humans with malignant gliomas. Malignant gliomas are the most common primary brain tumors in humans, accounting for 30% of all primary central nervous system (CNS) tumors in adults. [2] With few major advances in decades, there has been no significant reduction in mortality and only a modest improvement in median survival. Recently, objective responses and long-term survivals have been observed in human glioma patients who have received oncolytic virotherapy and a Phase I trial is currently underway at UAB in patients using M032 alone. New approaches to utilize checkpoint inhibitors promises improved efficacy, but the ability to develop more effective combinatorial approaches has been slow, in large part due to lack of a faithful model of spontaneous glioblastoma multiforme (GBM) in immunocompetent hosts. Thus, the spontaneously occurring canine brain tumor represents an ideal opportunity to improve the lives of people and pets through comparative oncology and genomics using the “One Medicine“ approach to research and direct clinical application.


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: 2026 ( Subtotal = -$309,428 )
2026	2021	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	3	12/22/2025	NON-COMPETING CONTINUATION	-$309,428
														Subtotal = -$309,428

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2021	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	3	9/19/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2021	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	001	3	9/18/2023	NON-COMPETING CONTINUATION	$0
2023	2021	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	3	7/19/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	002	3	7/25/2022	NON-COMPETING CONTINUATION	$0
2022	2021	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	003	3	8/1/2022	NON-COMPETING CONTINUATION	$0
2022	2020	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	001	2	10/22/2021	EXTENSION WITH OR WITHOUT FUNDS	$106
2022	2017	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	1	10/22/2021	NEW	-$106
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $520,152 )
2021	2021	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	003	3	9/1/2021	NON-COMPETING CONTINUATION	$520,152
2021	2020	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	002	2	6/4/2021	EXTENSION WITH OR WITHOUT FUNDS	$0
2021	2020	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	001	2	2/14/2021	EXTENSION WITH OR WITHOUT FUNDS	$741,445
2021	2017	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	1	2/14/2021	NEW	-$741,445
														Subtotal = $520,152

Issue Date FY: 2020 ( Subtotal = $520,152 )
2020	2020	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	2	9/21/2020	EXTENSION WITH OR WITHOUT FUNDS	$520,152
														Subtotal = $520,152

Issue Date FY: 2017 ( Subtotal = $1,596,668 )
2017	2017	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	1	9/25/2017	NEW	$1,596,668
														Subtotal = $1,596,668

Grand Total All Awards = $2,327,544

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Canine Immuno Neurotherapeutics

Award Number: U01CA224151

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/30/2017

PERIOD OF PERFORMANCE END DATE: 08/31/2025

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