# Development of PET imaging biomarkers to predict enhanced glioblastoma radiotherapy by a novel H-NOX oxygen carrier

> **NIH NIH R01** · OMNIOX, INC. · 2020 · $704

## Abstract

1. Project Summary/Abstract
Hypoxia (low oxygen) is a known key driver of tumor aggressiveness and tumor resistance to radiation
treatment (RT) in a variety of solid cancers. Given that about 50% of cancer patients receive RT (~800,000
cases per year in the US), Omniox has developed a novel oxygen carrier protein, OMX, which is engineered to
specifically deliver oxygen to low oxygen regions of tumors and enhance RT efficacy. Omniox is supported by
NCI SBIR (Phase I, II, IIb) and Wellcome Trust translational awards to test its lead drug candidate as an
adjuvant to standard-of-care RT for the treatment of newly diagnosed glioblastoma (GB) patients. Omniox has
received FDA pre-IND support for, and is currently conducting, IND-enabling manufacturing and GLP
toxicology studies for the first-in-human clinical trial scheduled at the University of California, San Francisco
(UCSF) for 2017. Importantly, non-invasive PET imaging with hypoxia-selective agents has shown that hypoxic
volume in GB tumors is strongly associated with rapid disease progression and poor survival1 due to its
blunting effects on standard-of-care RT. Previous efforts to oxygenate tumors in human clinical trials have
shown ambiguous results due in part to heterogeneity in tumor hypoxic burden and the lack of targeted
approach for patient selection. Therefore, the goal of this proposal is to develop predictive non-invasive
PET imaging biomarkers that will identify the GB patient population that can substantially benefit from
OMX therapy.
Omniox and the UC Davis School of Veterinary Medicine completed a Phase 0 canine clinical trial to evaluate
the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of OMX in canine patients presenting with
brain tumors. As part of the trial, Omniox partnered with Brain Biosciences to use their PET scanner designed
specifically for brain imaging (CerePET™). Omniox and the key collaborators on this AIP grant, Drs. Simon
Cherry (Aim 1) and Allison Zwingenberger (Aim 2) at UC Davis, and David Beylin of Brain Biosciences (Aims 1
and 2) are developing protocols for PET imaging of canine brain patients, with successful initial scans already
generated. In this proposal, we will build on our positive preliminary results in rodents and canines to evaluate
imaging of tumor hypoxia and OMX tumor accumulation as predictive biomarkers of OMX activity in an
intracranial rat GB model and in canine glioma patients. These data will then be used to inform an IND
application and a human biomarker clinical trial.
Developed from the thermostable H-NOX protein family discovered at UC Berkeley, OMX is a trimerized,
PEGylated H-NOX oxygen (O2)-binding variant engineered to diffuse deep into hypoxic tumor tissue commonly
associated with leaky blood vessels. The H-NOX moiety has been engineered to have a high affinity for O2
whereby it retains O2 in normoxic tissue and specifically releases it in regions of severe hypoxia.
Omniox has completed a series of preclinical studie...

## Key facts

- **NIH application ID:** 9952345
- **Project number:** 5R01CA204723-04
- **Recipient organization:** OMNIOX, INC.
- **Principal Investigator:** Simon R Cherry
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $704
- **Award type:** 5
- **Project period:** 2017-05-01 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9952345

## Citation

> US National Institutes of Health, RePORTER application 9952345, Development of PET imaging biomarkers to predict enhanced glioblastoma radiotherapy by a novel H-NOX oxygen carrier (5R01CA204723-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9952345. Licensed CC0.

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