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Developing a bank of purified myeloid progenitor cells as a bridging therapy for transient pancytopenia resulting from radiation injury

Award Number: R43AI155197
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/18/2020
PERIOD OF PERFORMANCE END DATE: 07/31/2021

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Developing a bank of purified myeloid progenitor cells as a bridging therapy for transient pancytopenia resulting from radiation injury - ABSTRACT Exposure to even moderate levels (<3 Gy) of ionizing radiation can result in severe pancyotopenia, placing patients as wells as victims of accidental exposure at high risks for infection and uncontrolled hemorrhaging. Accidental exposure differs from radiation therapy in that biodosimetry (e.g., type of radiation, dose and dose rate) is often uncertain; consequently, the optimal treatment regimen to ameliorate the effects of radiation is not immediately evident. Therefore, victims of accidental ionizing radiation exposure would benefit from bridging therapies to traverse extended periods of neutropenia and thrombocytopenia until the optimal course of medical care can be determined. Ossium Health proposes to develop a bank of myeloid progenitor cells (MPC) from deceased donor bone marrow (BM). The strategy employs commercially available immunomagnetic selection reagents and clinical-scale closed-system semi-automated devices to specific select MPC from whole BM based on defining cell surface markers CD34+CD38+. The proposed Phase I studies build on our previous success with selecting large numbers (>150 million) of stem and progenitor cells from organ donor BM. We will evaluate combinations of selection, depletion and ablation to purify MPC without contaminating T cells long-term repopulating stem cells to prevent graft versus host disease. The cells will be validated in vitro and in vivo in a mouse xenotransplantation study to evaluate reestablishment of short-term innate immunity. The overall product of this research program will be a compelling preclinical package to justify definitive studies to support FDA approval under the Animal Rule for a novel radiation/nuclear mass casualty medical countermeasure bridging therapy. Future commercial viability for both medical countermeasures and civilian uses is enhanced by the up to 5-fold lower cost for manufacturing compared to current technologies.


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: 2022 ( Subtotal = $0 )
2022	2020	OSSIUM HEALTH INC	78 TEHAMA ST	SAN FRANCISCO	CA	94105	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	000	1	1/28/2022	NEW	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $299,998 )
2020	2020	OSSIUM HEALTH, INC.	1121 HOWARD ST	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	000	1	8/18/2020	NEW	$299,998
														Subtotal = $299,998

Grand Total All Awards = $299,998

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Developing a bank of purified myeloid progenitor cells as a bridging therapy for transient pancytopenia resulting from radiation injury

Award Number: R43AI155197

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/18/2020

PERIOD OF PERFORMANCE END DATE: 07/31/2021

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