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Translation of a novel combination therapy approach for non-Hodgkin lymphoma

Award Number: U01CA272257
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2022
PERIOD OF PERFORMANCE END DATE: 08/31/2027

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Translation of a novel combination therapy approach for non-Hodgkin lymphoma - Translation of a novel combination therapy approach for non-Hodgkin lymphoma . Diffuse large B-cell lymphoma is the most common type of Non-hodgkin’s lymphoma (NHL) with limited treatment options in the relapsed or refractory (r/r) setting. This is true in humans and dogs. Immunotherapy with checkpoint inhibitors (CPIs) have demonstrated durable efficacy for Hodgkin’s lymphoma, but poor efficacy for NHL. There is an unmet clinical understand mechanisms of immunotherapy resistance and develop therapeutic approaches to improve clinical response for patients with advanced NHL and other cancers. DLBCL in companion dogs (cDLBCL) is treated with similar chemotherapy protocols and has a similarly poor prognosis in the r/r setting as human DLBCL. While genomic comparison shows limited overlap of the mutational landscape in canine and human DLBCLs, preliminary comparison of the tumor microenvironment (TME) shows conservation of stromal and immune compartments between the two species. Thus, cDLBLCL provide opportunities to prospectively investigate clinical toxicities and mechanisms of clinical response in a clinically realistic setting that recapitulates the pathology, heterogeneity, and TME of human cancers. Vesicular stomatitis virus (VSV) is a rapidly replicating, robustly immunogenic oncolytic virus (OV) platform that has been engineered for safe systemic therapy of disseminated cancer. Intravenous (IV) VSV therapy was shown preclinically in murine tumor models to rapidly infect, spread within, and kill tumor cells, and induce robust intratumoral immune infiltration, sensitizing tumors to checkpoint blockade. ONIx (oncoimmunology accelerator) is a novel, dual targeted CPI that targets both innate and adaptive mechanisms of tumor immune suppression to enhance antitumor immune responses mediated by macrophages and T-cells. We hypothesize that oncolytic VSV and ONIx will have complementary mechanisms of action (MOA), working in concert to kill tumor cells by direct viral lysis as well as phagocytosis, increase availability of tumor associated antigens (TAAs), promote antigen presentation and activate anti-tumor T-cell responses, to enhance immune mediated tumor killing and improve clinical responses in r/r DLBCL. Our proposal merges the expertise and resources of leading institutions in OV development (Mayo Clinic), comparative oncology (University of Minnesota), and lymphoma immunotherapy (Mayo Lymphoma SPORE) to perform a veterinary trial and correlative studies to evaluate the safety and preliminary efficacy of this novel combination therapy in r/r cDLBCL. The proposed studies will yield valuable insights into how an IV administered OV can infect heterogeneous DLBCL tumors and agitate the TME; if this disruption enhances the ability of CPIs (and potentially other immunotherapies) to activate immune mediated tumor killing; and how the tumor architecture differs in the context of clinical response versus non-response. The heterogeneity inherent in naturally occurring cDLBCL will inform the clinical utility of this combination therapy, define MOA, and identify biomarkers that can be explored clinically in human DLBCL.


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 = $581,804 )
2025	2025	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Cancer Treatment Research	002	4	9/4/2025	SUPPLEMENT FOR EXPANSION	$121,055
2025	2025	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Cancer Treatment Research	001	4	8/28/2025	NON-COMPETING CONTINUATION	$460,749
2025	2024	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Cancer Treatment Research	000	3	6/2/2025	NON-COMPETING CONTINUATION	$0
2025	2024	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Cancer Treatment Research	003	3	9/8/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $581,804

Issue Date FY: 2024 ( Subtotal = $828,309 )
2024	2024	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Cancer Treatment Research	002	3	8/29/2024	NON-COMPETING CONTINUATION	$643,654
2024	2024	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Cancer Treatment Research	003	3	8/31/2024	SUPPLEMENT FOR EXPANSION	$114,223
2024	2024	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Cancer Treatment Research	000	2	4/1/2024	SUPPLEMENT FOR EXPANSION	$70,432
2024	2023	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Cancer Treatment Research	001	2	7/31/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $828,309

Issue Date FY: 2023 ( Subtotal = $625,851 )
2023	2023	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Cancer Treatment Research	000	2	8/31/2023	NON-COMPETING CONTINUATION	$625,851
														Subtotal = $625,851

Issue Date FY: 2022 ( Subtotal = $584,891 )
2022	2022	MAYO CLINIC	200 FIRST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Cancer Treatment Research	000	1	7/21/2022	NEW	$584,891
														Subtotal = $584,891

Grand Total All Awards = $2,620,855

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Translation of a novel combination therapy approach for non-Hodgkin lymphoma

Award Number: U01CA272257

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/01/2022

PERIOD OF PERFORMANCE END DATE: 08/31/2027

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