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Instantaneous Tumor Spray for Real-Time Surgical Guidance

Award Number: R44CA275434
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2022
PERIOD OF PERFORMANCE END DATE: 08/31/2024

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Instantaneous Tumor Spray for Real-Time Surgical Guidance - Early stage ovarian cancer is typically asymptomatic. Undiagnosed until the disease has reached an advanced stage, the disease presents extensive intra-abdominal peritoneal metastases. Standard of care treatment includes either a surgical cytoreduction to remove tumor bulk, then platinum-based chemotherapy or primary neoadjuvant chemotherapy followed by interval cytoreduction after tumor shrinkage. Despite successful initial treatments, 80–90% of women with advanced cancer experience tumor recurrence. Surgical outcomes can vary considerably since some cancerous lesions are not visible to naked-eye surveillance or palpation, the only tools available to the surgeon in real-time. There is significant evidence that an extended disease-free period or even a cure are causally related to how much cancerous tissue is excised. A sensitive, specific, easy to visualize dye which precisely highlights small (< 5mm) and otherwise hidden lesions would better differentiate healthy from cancerous tissue, enable better informed surgical decisions and lead to better outcomes for ovarian cancer patients. In this collaboration between Molecular Targeting Technologies, Inc. and Weill Cornell Medical School we are developing a novel, tumor-specific agent for intraoperative near-infrared fluorescence imaging to guide ovarian cancer surgeries in real-time. In preliminary feasibility studies we have identified an optimized pH-sensitive near-infrared fluorogenic dye (CypH-11) which is non-fluorescent in normal tissues, but fluoresces immediately when sprayed onto cancer tissue, whose microenvironment is slightly acidic. We hypothesize that the cancer selective staining by CypH-11 will make the surgical debulking procedure precise and effective by locating normally unseen small and occult lesions, achieving a better surgical outcome. This approach could herald a paradigm shift in surgical oncology. In direct to Phase II SBIR studies we will scale-up synthesis and manufacture of CypH-11 and the final formulated vial in compliance with cGMP; perform preclinical optimization and validation of the CypH-11 formulation in a subcutaneous murine model and validate its sensitivity and specificity in an orthotopic model that simulates the clinical setting; and obtain pharmacokinetic, biodistribution and toxicity data to support an exploratory IND filing. The application will be submitted to the FDA anticipating a Phase 0 first-in-human study.


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 = $999,432 )
2023	2023	MOLECULAR TARGETING TECHNOLOGIES, INC.	833 LINCOLN AVE	WEST CHESTER	PA	19380	CHESTER	USA	Cancer Treatment Research	000	2	7/31/2023	NON-COMPETING CONTINUATION	$999,432
														Subtotal = $999,432

Issue Date FY: 2022 ( Subtotal = $999,389 )
2022	2022	MOLECULAR TARGETING TECHNOLOGIES, INC.	833 LINCOLN AVE UNIT 9	WEST CHESTER	PA	19380	CHESTER	USA	Cancer Treatment Research	000	1	8/10/2022	NEW	$999,389
														Subtotal = $999,389

Grand Total All Awards = $1,998,821

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Instantaneous Tumor Spray for Real-Time Surgical Guidance

Award Number: R44CA275434

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/01/2022

PERIOD OF PERFORMANCE END DATE: 08/31/2024

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