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TUMOR RADIOSENSITIZATION USING A NITRIC-OXIDE-NEUTRAL, TUNABLE OXYGEN-BINDING PRO

Award Number: R44CA138006
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/25/2008
PERIOD OF PERFORMANCE END DATE: 08/31/2015

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TUMOR RADIOSENSITIZATION USING A NITRIC-OXIDE-NEUTRAL, TUNABLE OXYGEN-BINDING PRO - PROJECT SUMMARY/ABSTRACT Through Phase I and II SBIR NCI support, Omniox has developed a breakthrough oxygen carrying protein, OMX-4.80, that delivers oxygen to tumors and greatly reduces hypoxia. This Phase IIB proposal describes IND-enabling studies and Phase 1b clinical trials in certain cancers, with the potential to expand to a range of other hypoxic solid cancers, to enhance radiation therapy (RT). Backed by leaders in the field of tumor hypoxia and RT, and led by experts in protein-based oxygen carriers and oncology drug development, Omniox is focused on translating promising preclinical data of OMX-4.80 into patients. Omniox has received commitments from high net worth investors and venture capital groups to match NCI funding for ~$1million per year for three years; the initial series A termsheet describes a $1million funding commitment that is conditional on the funding of this proposal. Hypoxia, a common feature of solid tumors, is considered a major obstacle for the clinical management of cancer by radiation therapy (radiotherapy, RT). Oxygen is required by ionizing radiation to damage DNA and kill cancer cells. Cancer patients with significantly hypoxic tumors tend to have a poor prognosis for survival. Given the clinical relevance of hypoxia, a long-time objective in the field of RT has been to effectively radiosensitize solid tumors by attenuating or exploiting this pathophysiological state. The heme-nitric oxide/oxygen-binding (H-NOX) proteins were initially discovered at the University of California, Berkeley and are exclusively licensed to Omniox for therapeutic development. H-NOX are neutral towards nitric oxide (NO), comparing favorably with the high NO reactivity and hypertensive properties of hemoglobin-based oxygen carriers; can be tuned to achieve specific oxygen affinities; are structurally stable above 80 ¿C, and chemically stable for weeks at room temperature; and can be surface-modified to alter size, oncotic properties, or tissue targeting. Preclinical data on the lead H-NOX, OMX-4.80, established that it demonstrates clinically relevant tumor biodistribution after IV administration, and significantly reduces hypoxia over multiple hours. Additionally, in orthotopic tumor models, the lead candidate generated a significant reduction in tumor growth and an extension in overall survival when coupled with RT. Finally, in toxicity testing, the H-NOX protein demonstrated a strong safety profile, without any of the significant safety or toxicity concerns that have plagued other tumor oxygenation technologies. This Phase IIB proposal has been prepared in accordance with guidelines for developing radiation enhancement therapies (DIRM report) as published by the NCI¿s Radiation Modifier Working Group and describes the continued preclinical research, safety testing, and clinical development through Phase 1 trials. Successful completion of this study should result in significant investor interest in supporting further clinical development.


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: 2014 ( Subtotal = $1,000,000 )
2014	2014	OMNIOX INC	1010 HADDON DRIVE	SAN MATEO	CA	94402	SAN MATEO	USA	Cancer Treatment Research	000	7	8/27/2014	NON-COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,000,000

Issue Date FY: 2013 ( Subtotal = $961,000 )
2013	2013	OMNIOX INC	1010 HADDON DRIVE	SAN MATEO	CA	94402	SAN MATEO	USA	Cancer Treatment Research	000	6	9/17/2013	NON-COMPETING CONTINUATION	$961,000
														Subtotal = $961,000

Issue Date FY: 2012 ( Subtotal = $1,949,265 )
2012	2012	OMNIOX INC	1010 HADDON DRIVE	SAN MATEO	CA	94402	SAN MATEO	USA	Cancer Treatment Research	000	4	3/15/2012	NON-COMPETING CONTINUATION	$949,265
2012	2012	OMNIOX INC	1010 HADDON DRIVE	SAN MATEO	CA	94402	SAN MATEO	USA	Cancer Treatment Research	001	5	9/26/2012	COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,949,265

Issue Date FY: 2011 ( Subtotal = $1,494,655 )
2011	2011	OMNIOX INC	1010 HADDON DRIVE	SAN MATEO	CA	94402	SAN MATEO	USA	Cancer Treatment Research	000	3	2/24/2011	NON-COMPETING CONTINUATION	$1,494,655
														Subtotal = $1,494,655

Issue Date FY: 2010 ( Subtotal = $535,024 )
2010	2010	OMNIOX INC	1010 HADDON DRIVE	SAN MATEO	CA	94402	SAN MATEO	USA	Cancer Treatment Research	001	2	9/30/2010	COMPETING CONTINUATION	$518,809
2010	2010	OMNIOX INC	1010 HADDON DRIVE	SAN MATEO	CA	94402	SAN MATEO	USA	Cancer Treatment Research	000	2	9/30/2010	COMPETING CONTINUATION	$16,215
														Subtotal = $535,024

Grand Total All Awards = $5,939,944

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TUMOR RADIOSENSITIZATION USING A NITRIC-OXIDE-NEUTRAL, TUNABLE OXYGEN-BINDING PRO

Award Number: R44CA138006

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/25/2008

PERIOD OF PERFORMANCE END DATE: 08/31/2015

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