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A novel monobody-drug conjugate to treat mutant Ras multiple myeloma

Award Number: R44CA250616
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/15/2020
PERIOD OF PERFORMANCE END DATE: 07/31/2026

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A novel monobody-drug conjugate to treat mutant Ras multiple myeloma - Tezcat is an early-stage, biopharmaceutical company developing novel biologics with a unique mechanism of action to treat the most recalcitrant cancers, such as mutant RAS multiple myeloma. Multiple myeloma is an incurable hematologic malignancy with an expected median survival of 7-8 years. Despite an initial response rate approaching 90% to proteasome inhibitor- containing combinations, all patients relapse and eventually become resistant to any treatments. Approximately 70% of these relapse/refractory patients harbor a mutation in RAS. We have observed that mutant RAS multiple myeloma cells display high levels of macropinocytosis, a nutrient scavenging process that facilitates the bulk engulfment of extracellular fluid and its solutes. Our drug candidate, TZT-102, utilizes our proprietary macropinocytosis-selective monobody that carries an FDA-approved cytotoxic payload. Results from our Phase I STTR project demonstrate that TZT-102 has robust anti-tumor activity in mutant RAS MM xenograft models without showing toxicity issues. Based on the success of our Phase I aims, we propose a Phase II SBIR program for investigators at Tezcat to advance TZT-102 through Specific Aims that will pursue bioanalytical assay development (Aim 1) and non-GLP toxicology studies in rats (Aim 2) to prepare for a pre-IND meeting with the FDA (Aim 3). Tezcat has entered into a license agreement with NYU Langone Health for exclusive, worldwide rights to the technology being developed. The commercialization strategy will be based on further development through Phase II SBIR studies and towards IND status and first-in-human clinical trials through a strategic partnership. Thus, we expect this Phase II SBIR to provide additional support for pursuit of GMP protocols and GLP safety and toxicity studies to support IND submission with the FDA.


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 = $0 )
2026	2024	TEZCAT BIOSCIENCES, INC.	470 JAMES STREET	NEW HAVEN	CT	06513	SOUTH CENTRAL CT	USA	Cancer Treatment Research	000	3	8/12/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $205,593 )
2025	2025	TEZCAT BIOSCIENCES, INC.	470 JAMES STREET	NEW HAVEN	CT	06513	SOUTH CENTRAL CT	USA	Cancer Treatment Research	000	3	5/13/2025	SUPPLEMENT FOR EXPANSION	$205,593
														Subtotal = $205,593

Issue Date FY: 2024 ( Subtotal = $928,011 )
2024	2024	TEZCAT BIOSCIENCES, INC.	470 JAMES STREET	NEW HAVEN	CT	06513	SOUTH CENTRAL CT	USA	Cancer Treatment Research	000	3	7/29/2024	NON-COMPETING CONTINUATION	$928,011
														Subtotal = $928,011

Issue Date FY: 2023 ( Subtotal = $1,062,082 )
2023	2023	TEZCAT BIOSCIENCES, INC.	470 JAMES STREET	NEW HAVEN	CT	06513	SOUTH CENTRAL CT	USA	Cancer Treatment Research	000	2	7/20/2023	COMPETING CONTINUATION	$1,062,082
														Subtotal = $1,062,082

Grand Total All Awards = $2,195,686

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A novel monobody-drug conjugate to treat mutant Ras multiple myeloma

Award Number: R44CA250616

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 07/15/2020

PERIOD OF PERFORMANCE END DATE: 07/31/2026

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