DEVELOPMENT OF PLX-R18 CELL THERAPY AS A COUNTERMEASURE FOR HEMATOPOIETIC ACUTE RADIATION SYNDROME

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The goal of this proposal is to develop human placenta-derived stromal cells, PLX-R18 cell therapy, for mitigation of H-ARS. Pluri Biotech’s main subcontractor is the Armed Forces Radiobiology Research Institute, and the Offeror proposes extensive in vitro characterization and production of CRISPR-modified cells, as well as irradiated rodent and NHP product efficacy studies. The Contractor shall perform studies to support the development of PLX-R18 as a novel cellular MCM for the prevention, mitigation, and treatment of all aspects of H-ARS. Studies will evaluate the efficacy and mechanism of action of PLX-R18 in vitro and in animal models of H-ARS, when administered at least 24 hours after radiation exposure. This project is expected to deliver all information required to justify and design future adequate and well-controlled studies to support licensure of PLX-R18. Importantly, the proposed study aims to demonstrate efficacy of PLX-R18 even when administered 48 hours or later after radiation exposure. In addition, the Contractor shall perform the necessary regulatory steps towards FDA approval under the US FDA Animal Rule.