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Clinical Evaluation of an Innovative PSMA-targeted Radiotherapy, CTT1403, in Prostate Cancer

Award Number: R44CA239461
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/02/2019
PERIOD OF PERFORMANCE END DATE: 12/31/2022

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Clinical Evaluation of an Innovative PSMA-targeted Radiotherapy, CTT1403, in Prostate Cancer - PROJECT ABSTRACT Prostate-Specific Membrane Antigen (PSMA) is an ideal tumor biomarker as it is expressed on >90% of all prostate cancers and expression increases as the cancer progresses. Cancer Targeted Technology (CTT) has developed a unique phosphoramidate-based scaffold that binds irreversibly to PSMA leading to > 90% rapid internalization and selective accumulation in tumor cells. With previous SBIR grant support, CTT created an 18F- labeled PET diagnostic imaging agent, CTT1057, and in Aug 2017 completed a Phase I clinical trial in patients with metastatic prostate cancer. CTT1057 demonstrated significant uptake in PSMA-avid bone and visceral lesions with far greater specificity and sensitivity than standard of care scans. In Jan 2018, CTT licensed this PET imaging agent to Advanced Accelerator Applications/Novartis. Prostate cancer is radiosensitive, but only Radium-223, which is neither specific nor selective, has been commercialized as a radiotherapeutic for advanced stage disease. Under an additional SBIR Phase I/II fast track contract, CTT modified the original CTT1057 PSMA-binding scaffold to develop a specific and potent companion therapeutic, CTT1403, radiolabeled with 177Lu. CTT1403, unlike other PSMA-targeting agents under development, is highly innovative in that it binds irreversibly to PSMA and uses an albumin-binding motif to dramatically slow clearance, resulting in an unprecedented tumor uptake of >80% injected dose/g of tumor tissue and a significant survival advantage in animal models. Under the SBIR Phase II contract, GMP-manufacturing, radiolabeling and IND- enabling pharmacology, dosimetry and initial animal safety studies were completed. An FDA pre-IND meeting was held, and the IND will be filed Q4 2018. The objective of this SBIR Phase IIB application is to support the first in human Phase 1 clinical trial of CTT1403 and to position the drug for further clinical development and rapid commercialization. Specific aims: AIM 1: Phase 1 clinical trial of CTT1403 in metastatic castration-resistant prostate cancer (mCRPC), assessing safety and initial efficacy: CTT will conduct an accelerated dose escalation/expansion trial in patients with mCRPC. Increased uptake of the albumin-binding, PSMA-targeted, 177Lu-labeled CTT1403 drug is hypothesized to translate into a meaningful survival advantage. AIM 2: Assess GLP late radiation safety: CTT will evaluate long term tolerance of repeat-dose CTT1403 in dogs to meet FDA late radiation safety recommendations prior to start of Phase 2 trials. AIM 3: Process development in support of further clinical development: CTT will develop and scale CTT1403 manufacturing methods in support of multiple dose trials. This innovative work harnesses the ideal performance of a cell-penetrating irreversible small-molecule PSMA-targeted drug that uses albumin binding to increase circulation half-life and tumor targeting and decrease renal toxicity. CTT1403 should have considerable significance for metastatic prostate cancer therapy by reducing toxic side effects in a patient population with a substantial unmet need.


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: 2024 ( Subtotal = $0 )
2024	2021	CANCER TARGETED TECHNOLOGY LLC	100 DAIRY ROAD ROOM 479 FULMER HALL	PULLMAN	WA	99164	WHITMAN	USA	Cancer Treatment Research	000	6	10/11/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $365,867 )
2021	2021	CANCER TARGETED TECHNOLOGY LLC	FULMER HALL STE 479	PULLMAN	WA	99164	WHITMAN	USA	Cancer Treatment Research	000	6	8/23/2021	NON-COMPETING CONTINUATION	$365,867
														Subtotal = $365,867

Issue Date FY: 2020 ( Subtotal = $1,441,580 )
2020	2020	CANCER TARGETED TECHNOLOGY LLC	14241 NE WOODINVILLE-DUVALL RD. #143	WOODINVILLE	WA	98072	KING	USA	Cancer Treatment Research	000	5	6/9/2020	NON-COMPETING CONTINUATION	$1,441,580
														Subtotal = $1,441,580

Issue Date FY: 2019 ( Subtotal = $1,375,908 )
2019	2019	CANCER TARGETED TECHNOLOGY LLC	14241 NE WOODINVILLE-DUVALL RD. #143	WOODINVILLE	WA	98072	KING	USA	Cancer Treatment Research	000	4	7/5/2019	COMPETING CONTINUATION	$1,375,908
														Subtotal = $1,375,908

Grand Total All Awards = $3,183,355

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Clinical Evaluation of an Innovative PSMA-targeted Radiotherapy, CTT1403, in Prostate Cancer

Award Number: R44CA239461

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 07/02/2019

PERIOD OF PERFORMANCE END DATE: 12/31/2022

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