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TIM-1 blocking mAbs for the prevention of graft-versus-host disease in hematopoietic stem cell transplantation patients

Award Number: R44CA250639
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/22/2021
PERIOD OF PERFORMANCE END DATE: 04/13/2021

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TIM-1 blocking mAbs for the prevention of graft-versus-host disease in hematopoietic stem cell transplantation patients - PROJECT SUMMARY Graft-versus-host disease (GvHD) is the major complication of hematopoietic stem cell transplantation (HSCT), causing significant morbidity and mortality in patients despite the universal use of prophylaxis. Current methods of preventing GvHD rely on immunosuppressive drugs including tacrolimus (TAC) or cyclosporine (CSA) plus methotrexate (MTX) for prophylaxis, which have serious side effects, impair T cell reconstitution, and reduce graft- versus-tumor (GvT) effects. Triursus Therapeutics, Inc. has developed a monoclonal antibody (mAb) technology to treat GvHD in HSCT patients. Our lead candidate drug protects against acute GvHD while maintaining GvT effect in murine HSCT models. In this SBIR Fast-Track application, our goal is to further develop the lead candidate drug and complete the preclinical safety and efficacy studies. In Phase I, we will develop a humanized mAb and test the efficacy compared to untreated or immunosuppressive drug-treated control in the humanized mouse GvHD model. In Phase II, we will test our humanized mAb in a non-human primate model of HSCT/GvHD for safety and efficacy compared to immunosuppressive drug-treated controls. We will also advance the pharmaceutical development of our drug candidate by establishing a master cell bank, standardizing manufacturing, performing IND-enabling activities, and verifying that the proposed development plans are acceptable to regulatory agencies. At the completion of this project, we expect to have a humanized mAb that prevents GvHD and improves overall survival & GvHD scores when administered alone or in combination with one of the standards of care drugs, tacrolimus, in GvHD models. We will also have the safety and efficacy profile of the drug that will inform our plans for a human clinical study. This project is an important step forward in translating our mAb drug for GvHD from the bench to bedside.


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: 2023 ( Subtotal = -$29 )
2023	2021	TRIURSUS THERAPEUTICS INCORPORATED	3308 ADELAIDE WAY	BELMONT	CA	94002	SAN MATEO	USA	Cancer Treatment Research	000	1	4/28/2023	SUPPLEMENT FOR EXPANSION	-$29
														Subtotal = -$29

Issue Date FY: 2021 ( Subtotal = $52,000 )
2021	2021	TRIURSUS THERAPEUTICS INCORPORATED	3308 ADELAIDE WAY	BELMONT	CA	94002	SAN MATEO	USA	Cancer Treatment Research	000	1	3/3/2021	SUPPLEMENT FOR EXPANSION	$52,000
														Subtotal = $52,000

Issue Date FY: 2020 ( Subtotal = $399,715 )
2020	2020	TRIURSUS THERAPEUTICS INCORPORATED	3308 ADELAIDE WAY	BELMONT	CA	94002	SAN MATEO	USA	Cancer Treatment Research	000	1	9/9/2020	NEW	$399,715
														Subtotal = $399,715

Grand Total All Awards = $451,687

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TIM-1 blocking mAbs for the prevention of graft-versus-host disease in hematopoietic stem cell transplantation patients

Award Number: R44CA250639

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 02/22/2021

PERIOD OF PERFORMANCE END DATE: 04/13/2021

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