You are here

Non-Invasive Imaging of Oral Cavity Cancer

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R42CA254776-02
Agency Tracking Number: R42CA254776
Amount: $1,495,890.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: 102
Solicitation Number: PA19-271
Solicitation Year: 2019
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-09-01
Award End Date (Contract End Date): 2023-08-31
Small Business Information
Summit, NJ 07901-3335
United States
DUNS: 080458199
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (646) 421-4337
Business Contact
Phone: (646) 421-4337
Research Institution
NEW YORK, NY 10065-6007
United States

 Domestic Nonprofit Research Organization

Project Summary/Abstract
Counterintuitively, the incidence and societal impact of oral and oropharyngeal cancer are increasing in the US
despite the markedly decreased use of tobacco products. This trend is exacerbated by the fact that almost two-
thirds of patients have lymph node or distant metastases at the time of diagnosis, dramatically reducing 5-year
survival rates. Oral cavity cancers are overwhelmingly diagnosed late despite their superficial location, often
because they remain asymptotic – and early lesions are erroneously considered benign. The current standard
of care for detecting oral cancer is still visual examination in combination with biopsy-based histopathology,
which is not only labor-intensive but also requires highly trained personnel and a sophisticated infrastructure –
impenetrable economic barriers for most of the world’s population, and precisely the unmet clinical need we have
chosen to address.
We recently reported very encouraging first-in-human Phase I clinical trial data with PARPi-FL, a small molecule
with high specificity for PARP1. PARP1 is a quantitative and highly overexpressed biomarker for in vivo imaging
of oral cancer, and we showed that PARPi-FL identifies tumors with sensitivities and specificities andgt;95%.
Taking our drug to the next level and validating its clinical value in a Phase II trial, we have partnered with
Memorial Sloan Kettering Cancer Center (MSK) and assembled three Specific Aims (SAs). In SA1, we will
redesign the formulation and manufacturing of PARPi-FL, making it easier to formulate for the clinicians as well
as improving the taste of the gargling solution for the patient. In SA2, we will optimize workflows, thresholding
and image analysis, based on and informed by our Phase I clinical data. In SA3, we will test intraoperative
PARPi-FL imaging of the oral cavity to determine sensitivity and specificity in discriminating benign and malignant
If successfully, this project will provide a solid foundation for a multicenter Phase III clinical trial and ultimately
raise the clinical standard of care for oral cavity cancer.PROJECT NARRATIVE
This project proposes to use a fluorescent PARP1 imaging agent as a topically applied biomarker to non-
invasively assign margin status in oral cavity cancer with high specificity and sensitivity. It is based on preliminary
data in mice, human ex vivo biospecimen, and a first-in-human phase I clinical trial. By the end of this project,
we will have shown that the imaging agent improves the standard of care, laying the groundwork for a multicentric
phase III clinical trial.

* Information listed above is at the time of submission. *

US Flag An Official Website of the United States Government