Pluri, Ukraine cord blood bank to advance cell therapy as radiation countermeasure

In an effort to address Ukraine’s urgent need for radiation preparedness, Israel-based biotech Pluri announced a collaboration with Ukrainian umbilical cord blood bank Hemafund to stockpile, distribute and support potential clinical advancement of Pluri’s investigational cell therapy for hematopoietic complications of acute radiation syndrome (H-ARS).

Per the exclusive three-year agreement, Pluri will produce and supply its PLX-R18 cell therapy as a potential treatment for H-ARS, which is caused by exposure to life-threatening amounts of nuclear radiation. The condition is characterized by a dose-dependent bone marrow suppression, leading to severe neutropenia (low white blood cells), thrombocytopenia, anemia, and a heightened risk of mortality.

Hemafund will leverage its infrastructure and expertise in biostorage, logistics and regulatory processes to support local distribution and ensure compliance with Ukrainian and European biobank standards. Pluri and Hemafund will work toward securing external funding to build an initial stockpile 12,000 doses of PLX-R18, which is expected to be sufficient to treat 6,000 individuals.

PLacental eXpanded (PLX) cells are placenta-derived, ex vivo, expanded, mesenchymal-like, stromal cells that are designed to be administered to patients without the need for tissue or genetic matching. Pluri’s PLX-R18 cells release a combination of therapeutic proteins in response to a damaged or poorly functioning hematopoietic system, stimulating blood cell regeneration and potentially mitigating the effects of radiation exposure.

The U.S. FDA approved an IND application for PLX-R18 for the treatment of H-ARS in 2018. The therapy, which was granted orphan drug designation, has demonstrated a 68% survival rate compared to placebo in clinical studies and a significant increase in three critical blood lineages: platelets, white blood cells, and red blood cells.