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PyroTIMER Technology: Enabling T-Cell Persistence in Immunosuppressive Tumor Microenvironments

Award Number: R44CA295355
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/23/2024
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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PyroTIMER Technology: Enabling T-Cell Persistence in Immunosuppressive Tumor Microenvironments - Abstract The challenge of effectively treating cancer is further complicated by the limitations of current CAR-T cell therapies, especially when confronted with the immunosuppressive tumor microenvironment (TIME). Central to this issue is the transforming growth factor-beta (TGF-β), which induces T cell exhaustion and curtails their antitumor potency. Current methodologies to inhibit the TGF-β pathway have yielded suboptimal results due to transient effects. This project introduces PyroTIMER CAR-T cells, an innovative approach that promises durable inhibition of all TGF-β isoforms within the TIME. This robust strategy not only targets TGF-β with unprecedented potency but also incorporates multiple technical advancements, enhancing T cell cytotoxicity and leveraging patient-derived xenograft (PDX) models for a more accurate representation of the tumor milieu. The overarching research plan is to thoroughly assess PyroTIMER CAR-T cells in both immunocompetent syngeneic models and PDX models. Employing multi-parametric flow cytometry, we aim to delve into the immune dynamics within tumors, elucidating how PyroTIMER CAR-T cells interact with and potentially remodel the TIME. Our objectives are four-fold: 1. Deciphering the influence of TGF-β on PyroTIMER CAR-T cells. 2. Profiling cytokine production to gauge risks, particularly concerning cytokine release syndrome (CRS). 3. Investigating potential exhaustion scenarios in PyroTIMER CAR-T cells. 4. In-depth in vivo evaluations of the safety and efficacy of PyroTIMER CAR-T cells. Our long-term trajectory is underpinned by a commitment to patient safety and therapeutic efficacy. By forging collaborations with pharmaceutical entities, refining manufacturing strategies for scalability, and seeking FDA endorsement, we aspire to position PyroTIMER CAR-T cells at the forefront of personalized cancer therapies. This initiative represents a harmonious blend of advanced scientific inquiry, patient well-being, and strategic commercial planning. Through this endeavor, we aim to redefine CAR-T cell therapy, presenting a novel, potent, and safer treatment paradigm for cancer 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: 2025 ( Subtotal = $999,283 )
2025	2025	PYROJAS INC	180 VARICK ST FL 6	NEW YORK	NY	10014	NEW YORK	USA	Cancer Treatment Research	001	2	8/28/2025	NON-COMPETING CONTINUATION	$999,283
2025	2024	PYROJAS INC	180 VARICK ST FL 6	NEW YORK	NY	10014	NEW YORK	USA	Cancer Treatment Research	000	1	10/16/2024	NEW	$0
														Subtotal = $999,283

Issue Date FY: 2024 ( Subtotal = $748,337 )
2024	2024	PYROJAS INC	180 VARICK ST FL 6	NEW YORK	NY	10014	NEW YORK	USA	Cancer Treatment Research	001	1	9/20/2024	NEW	-$42,818
2024	2024	PYROJAS INC	180 VARICK ST FL 6	NEW YORK	NY	10014	NEW YORK	USA	Cancer Treatment Research	002	1	9/23/2024	NEW	$0
2024	2024	PYROJAS INC	180 VARICK ST FL 6	NEW YORK	NY	10014	NEW YORK	USA	Cancer Treatment Research	000	1	9/19/2024	NEW	$791,155
														Subtotal = $748,337

Grand Total All Awards = $1,747,620

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PyroTIMER Technology: Enabling T-Cell Persistence in Immunosuppressive Tumor Microenvironments

Award Number: R44CA295355

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/23/2024

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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