# A Novel PET Imaging based Companion Diagnostic

> **NIH NIH R43** · CADENZAMED, LLC · 2020 · $299,987

## Abstract

Abstract
 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 benefit only a
subset of patients. Currently, there is a lack of target-specific biomarkers that can better identify responsive
patients. Consequently, the benefits from many mainstay treatments, including anti-angiogenic drugs, are still
limited. This adds significant costs to the healthcare system by the unnecessary treatment of patients that are
not likely to respond to a specific therapy. Therefore, the development of a non-invasive PET imaging-based
companion diagnostic (CD) using a radio-labeled version of the therapeutic agent itself, will help stratify
patients and improve disease outcomes. This is because the CD will i) provide quantitative measures of target
expression in patient tumors at the time of treatment to select patients; and ii) enable the staging of therapeutic
modulation, including increase/decrease of target prevalence during the treatment cycle; and iii) allow for
timely switches to alternative treatment when imaging shows the failure of the ongoing therapy.
 We propose to test the feasibility of developing a [18 F] labeled cys-tagged vascular endothelial growth
factor-3S (VEGF-3S) as a novel non-invasive PET-imaging based CD, to be used with VEGF-3S, a novel (and
patented) VEGF antagonist generated through targeted disruption of 3 heparin sulfate proteoglycan (HSPG)
binding residues in VEGF-A 165. The proposed CD will be based on VEGF-3S engineered with N-terminal 15-
aa fusion tag containing cysteine residue (cVEGF-3S) for site-specific 18F radiolabeling. A positive [18F]
cVEGF-3S PET signal from tumor sites in a patient will confirm the prevalence of VEGFRs targeted by VEGF-
3S only. Thus, VEGF-3S with the CD will have significant clinical advantages over the existing VEGF targeted
drugs providing precision medicine to individual patients.
 We will establish the target specificity of [18F] cysVEGF-3S in this proposal which will be the quantitative
milestone to progress to Phase II for IND enabling studies.

## Key facts

- **NIH application ID:** 10078029
- **Project number:** 1R43CA246853-01A1
- **Recipient organization:** CADENZAMED, LLC
- **Principal Investigator:** SUSANTA K SARKAR
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $299,987
- **Award type:** 1
- **Project period:** 2020-07-01 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10078029

## Citation

> US National Institutes of Health, RePORTER application 10078029, A Novel PET Imaging based Companion Diagnostic (1R43CA246853-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10078029. Licensed CC0.

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