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

Award Number: R44HD094414
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Development of an oxygen delivery biotherapeutic for the preservation of myocardial function during pediatric cardiopulmonary bypass - 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 defects. Up to 60% of infants who undergo CPB will experience post-operative complications that can result in peripheral organ dysfunction and long-term neurological deficits. A critical driver of the myocardial and peripheral organ tissue damage is oxygen deprivation, or hypoxia. However, there are no current or promising therapeutic approaches that target hypoxia during CPB surgery to stem or alleviate its damaging downstream effects. Omniox' lead therapeutic candidate, OMX, is designed to restore physiologic oxygen levels in hypoxic tissues. Thus, OMX has the potential to address a high unmet need of preserving myocardial function and improving morbidity associated with neonatal CPB surgery. Together with our collaborators, neonatal and pediatric care intensivists Drs. Fineman and Maltepe at the University of California, San Francisco (UCSF), we have demonstrated that OMX attenuates hypoxia- induced myocardial dysfunction in lambs. Furthermore, our preliminary data demonstrate that OMX: 1) restores physiologic oxygen levels specifically in oxygen-deprived tissues; 2) prevents hypoxia-induced cell death after brain ischemia; 3) is stable, safe, and well tolerated in multiple species; and 4) does not increase free radical production or scavenge nitric oxide. The objective of this Fast-Track SBIR Phase I/II proposal is to complete preclinical 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 1) demonstrate OMX preserves myocardial and peripheral organ function during and after CPB in intact newborn lambs (Phase I), then 2) demonstrate OMX' efficacy in a clinically relevant neonatal lamb CHD model undergoing CPB (Phase II). These data will inform an IND application for a neonatal and pediatric clinical trial. 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 neonates and birth asphyxia.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $995,592 )
2024	2024	OMNIOX INC	181 2ND ST	SAN FRANCISCO	CA	94105	SAN FRANCISCO	USA	Child Health and Human Development Extramural Research	001	6	8/11/2024	NON-COMPETING CONTINUATION	$995,592
2024	2020	OMNIOX INC	181 2ND ST	SAN FRANCISCO	CA	94105	SAN FRANCISCO	USA	Child Health and Human Development Extramural Research	000	4	1/23/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $995,592

Issue Date FY: 2023 ( Subtotal = $999,580 )
2023	2023	OMNIOX INC	181 2ND ST	SAN FRANCISCO	CA	94105	SAN FRANCISCO	USA	Child Health and Human Development Extramural Research	000	5	8/29/2023	COMPETING CONTINUATION	$999,580
														Subtotal = $999,580

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	OMNIOX, INC	75 SHOREWAY RD STE B	SAN CARLOS	CA	94070	SAN MATEO	USA	Child Health and Human Development Extramural Research	000	4	5/20/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $232,127 )
2020	2020	OMNIOX, INC	75 SHOREWAY RD STE B	SAN CARLOS	CA	94070	SAN MATEO	USA	Child Health and Human Development Extramural Research	001	4	8/18/2020	NON-COMPETING CONTINUATION	$232,127
2020	2019	OMNIOX, INC	75 SHOREWAY RD STE B	SAN CARLOS	CA	94070	SAN MATEO	USA	Child Health and Human Development Extramural Research	000	3	7/16/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $232,127

Issue Date FY: 2019 ( Subtotal = $681,601 )
2019	2019	OMNIOX, INC	75 SHOREWAY RD STE B	SAN CARLOS	CA	94070	SAN MATEO	USA	Child Health and Human Development Extramural Research	003	3	9/5/2019	NON-COMPETING CONTINUATION	$681,601
2019	2018	OMNIOX, INC	75 SHOREWAY RD STE B	SAN CARLOS	CA	94070	SAN MATEO	USA	Child Health and Human Development Extramural Research	002	2	8/28/2019	EXTENSION WITH OR WITHOUT FUNDS	$12,990
2019	2018	OMNIOX, INC	75 SHOREWAY RD STE B	SAN CARLOS	CA	94070	SAN MATEO	USA	Child Health and Human Development Extramural Research	000	2	2/14/2019	EXTENSION WITH OR WITHOUT FUNDS	$0
2019	2017	OMNIOX, INC	75 SHOREWAY RD STE B	SAN CARLOS	CA	94070	SAN MATEO	USA	Child Health and Human Development Extramural Research	001	1	8/28/2019	NEW	-$12,990
														Subtotal = $681,601

Issue Date FY: 2018 ( Subtotal = $1,032,262 )
2018	2018	OMNIOX, INC	75 SHOREWAY RD STE B	SAN CARLOS	CA	94070	SAN MATEO	USA	Child Health and Human Development Extramural Research	000	2	8/31/2018	EXTENSION WITH OR WITHOUT FUNDS	$1,032,262
														Subtotal = $1,032,262

Issue Date FY: 2017 ( Subtotal = $298,396 )
2017	2017	OMNIOX, INC	75 SHOREWAY RD STE B	SAN CARLOS	CA	94070	SAN MATEO	USA	Child Health and Human Development Extramural Research	000	1	8/2/2017	NEW	$298,396
														Subtotal = $298,396

Grand Total All Awards = $4,239,558

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

Award Number: R44HD094414

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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