A strategic initiative with Hemafund that helps Ukraine deal with radiation hazards and treat victims. Hemafund's infrastructure ensures safe storage and rapid deployment of emergency care
Biotechnology company Flory, which leverages its cell manufacturing platform to create a collaborative network of ventures, today announced that it has signed an exclusive collaboration agreement with Hemafund, a Ukrainian cord blood bank with clinical and research laboratories and advanced cell preservation and cold storage facilities. The purpose of the collaboration is to establish a strategic initiative for the storage, distribution and clinical development of Flory’s novel cell therapy, PLX-R18, as a countermeasure for acute radiation syndrome (“H-ARS”) in Ukraine. The agreement will be effective for an initial period of three years and may be extended by the parties for an additional three-year period, subject to certain conditions.
H-ARS, also known as radiation poisoning, is caused by uncontrolled exposure to life-threatening amounts of ionizing radiation, such as in the case of nuclear accidents or warfare. H-ARS is characterized by severe damage to bone marrow function, leading to life-threatening neutropenia and thrombocytopenia, which can lead to death. Today, radioactive radiation is considered one of the greatest dangers to humanity, with radiation-affected areas remaining uninhabited for a long time, and affected people suffering from its consequences for years. Radiation injuries can be caused by damage to nuclear reactors, and in extreme cases even by direct damage to countries. There is a real fear of such an event on Ukrainian soil, where the war with Russia has been going on for over a year and there are several active reactors. Such an event could seriously harm the lives of hundreds of thousands of people
Under the collaboration agreement, Flory will manufacture and supply PLX-R18 as a potential treatment for H-ARS victims following radiation exposure. Hemafund will apply its expertise in cell storage, logistics and regulatory processes for local distribution and ensure compliance with Ukrainian and European standards for blood bank management. The parties will work to raise funding to establish sufficient manufacturing capacity for PLX-R18 and are expected to sign a separate agreement upon securing funding.
The agreement was signed in the wake of heightened radiological threats, including a Russian drone attack on the Chernobyl nuclear power plant, which caused a fire in the reactor's containment. Although the fire was extinguished without an increase in radiation levels, the incident highlights the critical need for effective and readily available radiation protection measures in the region.
As part of the collaboration, Flory and Hemafund will work together to secure external funding to build an initial capacity of 12,000 doses of PLX-R18 to ensure emergency preparedness in the event of a nuclear disaster. The PLX-R18 doses will be stored and managed by Hemafund, utilizing its advanced blood bank infrastructure and logistics network to ensure rapid distribution should the need arise.
The collaboration, if successful, could generate a value of more than $100 million for both parties, based on the estimated cost per dose and the estimated need to stockpile 12,000 doses, which is expected to be sufficient to treat 6,000 patients (with each patient expected to require two doses). This calculation is based on the actual availability of response agents in the US Strategic National Stockpile for its population. This approach is consistent with leading preparedness measures designed to ensure the availability of H-ARS protective agents in response to health emergencies1.
Strategic goals of the collaboration:
• Storage and distribution: Hemafund will establish secure storage and manage the logistics of supplying PLX-R18 to medical institutions across Ukraine.
• Regulation and compliance with standards: The parties will work to obtain the required approvals from the Ukrainian Ministry of Health and ensure compliance with regional regulations for the use of PLX-R18.
• Clinical development: Flory and Hemafund will explore options for clinical trials to establish PLX-R18 as a treatment for acute radiation syndrome.
• Raising public and private funding: This collaboration aims to attract funding from the public and private sectors to support the development and availability of PLX-R18 in Ukraine and other potential regions.
"As a company committed to harnessing multi-cell technology to address humanity's grand challenges, we see this collaboration as a proactive step to ensure that our PLX-R18 therapy is available where it is needed," said Yaki Yanai, CEO and President of Flory. "We believe that Hemafund's expertise in the Ukrainian biotechnology industry makes them an ideal partner to ensure local accessibility, storage, and regulatory integration of our solution."
Yaroslav Isakov, Founder of Hemafund Ltd., added: “We are excited to join forces with Flory to address this vital medical need together. We believe that our advanced cold storage facilities and logistics network position us well to support the introduction of PLX-R18 as a potentially vital treatment in preparation for a nuclear emergency in Ukraine. While we hope that such treatments will remain as a preventative measure only, our goal is to be ready to distribute this drug in the event of an emergency.”
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