# Clinical translation of a PD-L1 PET tracer to optimize immune checkpoint therapy in patients with non-small cell lung cancers

> **NIH NIH R01** · JOHNS HOPKINS UNIVERSITY · 2022 · $624,800

## Abstract

Project Summary.
Despite the efficacious application of immune checkpoint therapy (ICT) across a broad range of cancers, only a
subset of patients experience remarkable clinical responses and survival. The challenge facing clinicians and
researchers alike is how to deliver the most effective and timely immunotherapy to patients. From clinical trial
data it is becoming increasingly evident that a single biomarker is unlikely to capture the scope and breadth of
clinical responses to ICT. Rather, incorporation of multiple biomarker panels, including both pharmacodynamic
and predictive biomarkers, has become a necessity. However, the number of tests that can be performed with
baseline and on-treatment biopsies is limited by the amount of biopsy tissue, and has several shortcomings
including inter- and intra-tumoral heterogeneity and sampling errors. Those problems are compounded in
patients with metastatic disease and difficult-to-access locations. Imaging methods such as positron emission
tomography (PET) enable repetitive evaluation of the whole body and facilitate real-time quantification of
pharmacodynamic effects. Also, in recent years on-demand kit formulations of radiopharmaceutical preparations
have enabled widespread and routine clinical use of PET in cancer care. However, PET is underutilized in guiding
ICT due to the limited access to molecularly targeted radiotracers that accurately report on the activity of the
immune infiltrate. Generator-produced Gallium-68-labeled radiopharmaceuticals, in kit formulation or otherwise,
are increasingly used in the US and across the globe as theranostic tools for cancer but have not been reported
with a focus on advancing ICT. Our project addresses the need for non-invasive biomarkers for guiding ICT with
an objective to develop, translate and disseminate a radiopharmaceutical for measuring programmed death
ligand 1 (PDL1). We will develop a peptide-based Gallium-68-labeled radiopharmaceutical for measuring PDL1
levels to guide ICT and conduct a first-in-human study in cancer patients. Moreover, we will create a single vial
kit formulation of that agent to enable convenient radiopharmaceutical preparation and dissemination. Our
radiotracer is peptide-derived and uniquely capable of measuring pharmacodynamic effects of any PD(L)-1
therapeutic in situ in 60 min. We expect that the proposed approach will be a valuable addition to ICT, especially
as a non-invasive biomarker. The results generated will enable a fundamental advance in clinical management
of patients undergoing ICT and carried out in close partnership with industry with an eye towards dissemination
and broad access.

## Key facts

- **NIH application ID:** 10418064
- **Project number:** 1R01CA269235-01
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** Sridhar Nimmagadda
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $624,800
- **Award type:** 1
- **Project period:** 2022-06-14 → 2027-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10418064

## Citation

> US National Institutes of Health, RePORTER application 10418064, Clinical translation of a PD-L1 PET tracer to optimize immune checkpoint therapy in patients with non-small cell lung cancers (1R01CA269235-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10418064. Licensed CC0.

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