# A Novel PET Imaging based Companion Diagnostic

> **NIH NIH R43** · CADENZAMED, LLC · 2021 · $97,494

## Abstract

Abstract
 This application is being submitted in response to the Notice of Special Interest (NOSI) identified as NOT-
CA-20-012.
 High attrition rates—particularly at the late stage of drug development—contribute to the estimated $2.0B
cost of bringing a drug to the market. Furthermore, many of the drugs that reach the market. including anti-
angiogenics, benefit only a subset of patients. Companion diagnostics (CDs) that identify patients who are
likely to respond these drugs are not available. This adds significant costs to the healthcare system through the
unnecessary treatment of patients that are not likely to respond to specific therapies.
Our overall strategy is to develop VEGF-3S (a VEGF antagonist) as a novel anti-angiogenic theranostic
agent for cancer therapy, where VEGF-3S will be the therapeutic and [18F] cVEGF-3S will be the
corresponding PET CD to stratify patients that would benefit from the drug. We believe that our novel approach
will have significant clinical advantages to benefit these patients because patients selected with positive [18F]
cVEGF-3S PET tumor signals are expected to be most responsive to VEGF-3S, making it a highly efficient
therapy. This will help reduce the cost to the healthcare system of treatment.
 Our currently funded SBIR Phase I feasibility studies to develop the CD, [18F] cVEGF-3S, to be used during
the late preclinical and clinical development of VEGF-3S, have evolved rapidly. In order to accelerate our
progress, we will need to conduct a supplementary study to determine clinical targets for VEGF-3S. This will
help position our project for a stronger Phase II application and generate further interest from private strategic
partners. A defined clinical target is necessary for the clinical study design for the IND studies of the CD, [18F]
cVEGF-3S. In other words, identifying which cancer is ideal for VEGF-3S treatment in the clinic will make us
more competitive for Phase II. That can only be achieved by evaluating the in vivo efficacy of VEGF-3S in
multiple tumor models. Therefore, we propose here to measure in vivo efficacy of VEGF-3S in mouse models
of breast, colon and lung cancer. Accomplishing this goal will provide the evidence-based foundation for
selecting a clinical target for VEGF-3S.
 Pairing our completed Phase I results—which will establish the feasibility of [18F] cVEGF-3S as a novel
PET imaging-based CD—with the selection of a clinical target for VEGF-3S will be the quantitative milestones
to progress to Phase II for IND enabling studies. These combined results will make us highly competitive for
our Phase II application and will accelerate the development of the SBIR product to advance it toward
commercialization. Since our unique product will fulfill a major unmet medical need, allowing for more
personalized treatment for patients, we believe that it will be attractive to our private sector partners as well.

## Key facts

- **NIH application ID:** 10362895
- **Project number:** 3R43CA246853-01A1S1
- **Recipient organization:** CADENZAMED, LLC
- **Principal Investigator:** SUSANTA K SARKAR
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $97,494
- **Award type:** 3
- **Project period:** 2021-07-01 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10362895

## Citation

> US National Institutes of Health, RePORTER application 10362895, A Novel PET Imaging based Companion Diagnostic (3R43CA246853-01A1S1). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10362895. Licensed CC0.

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