# Development of an oxygen delivery biotherapeutic for the preservation of myocardial function during pediatric cardiopulmonary bypass

> **NIH NIH R44** · OMNIOX, INC. · 2023 · $999,580

## Abstract

1. PROJECT SUMMARY/ABSTRACT
Omniox is developing a unique oxygen delivery protein, OMX, as a treatment to preserve myocardial
and peripheral organ function and significantly reduce morbidity after neonatal cardiopulmonary
bypass (CPB) during surgical correction of congenital heart disease (CHD). Of the ~40,000 children born
annually with CHD, ~10,000 require urgent surgery to repair heart defects1, 2. Up to 60% of infants who
undergo CPB will experience post-operative complications that can result in peripheral organ dysfunction and
long-term neurological deficits3-15.
A critical driver of the myocardial and peripheral organ tissue damage is oxygen deprivation, or hypoxia3-15.
However, there are no current or promising therapeutic approaches that target hypoxia during CPB surgery to
stem or alleviate its damaging downstream effects. Omniox’s lead therapeutic candidate, OMX, is designed
to oxygenate hypoxic tissues. Supported by preliminary data from our Phase I/II Fast-Track SBIR and
generated with our collaborators, neonatal and pediatric care intensivists Drs. Fineman and Maltepe at the
University of California, San Francisco (UCSF), OMX has the potential to address a high unmet need of
preserving myocardial function and decreasing morbidity associated with neonatal CPB surgery.
The objective of this SBIR Phase IIB proposal is to advance development of OMX as a novel biologic for the
treatment of neonates undergoing CPB by demonstrating its therapeutic utility in oxygenating hypoxic tissue
and preserving myocardial and peripheral organ function. We propose to confirm that a more stable variant of
OMX preserves myocardial and peripheral organ function after CPB and identify the optimal dose regimen for
OMX efficacy (Aims 1 and 2), adapt and optimize a scalable production process suitable for transfer to a GMP
(Good Manufacturing Practice) contract development and manufacturing organization (CDMO), including
process and analytical development (Aim 3), and prepare and submit an IND for a Phase 1 clinical trial in
neonates (Aim 4). Pending good safety and efficacy data in neonatal and pediatric patients undergoing CPB,
Omniox plans to expand OMX use to other pediatric indications in which hypoxia drives disease pathology
such as persistent pulmonary hypertension in neonates16, 17 and birth asphyxia18-22.

## Key facts

- **NIH application ID:** 10761664
- **Project number:** 2R44HD094414-05
- **Recipient organization:** OMNIOX, INC.
- **Principal Investigator:** JEFFREY R FINEMAN
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $999,580
- **Award type:** 2
- **Project period:** 2017-08-01 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10761664

## Citation

> US National Institutes of Health, RePORTER application 10761664, Development of an oxygen delivery biotherapeutic for the preservation of myocardial function during pediatric cardiopulmonary bypass (2R44HD094414-05). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10761664. Licensed CC0.

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