Valion Bio (NASDAQ: VBIO) has announced that the regulatory dossier for its lead candidate, Entolimod for acute radiation syndrome (ARS), has been accepted by Ukraine’s Ministry of Health (MoH) for formal review under the country’s Regulatory Equivalency pathway.
Entolimod represents a paradigm shift in the treatment of ARS. Growth-factor therapies currently held in the U.S. Strategic National Stockpile — such as Neupogen (filgrastim) and Neulasta (pegfilgrastim), both G-CSF agents, and Leukine(sargramostim), a GM-CSF agent — are effective at stimulating the recovery of white blood cells after depletion, but they do not address the lethal damage caused to the gastrointestinal (GI) tract at higher radiation doses.
As a selective TLR5 agonist, Entolimod activates the NF-κBsignaling pathway, through a cascade of cell signaling pathways, actively preventing programmed cell death (apoptosis) in both bone marrow and GI epithelial tissues. This dual-system protection offers a comprehensive survival benefit that currently approved G-CSF therapies cannot provide, positioning Entolimod as a unique and essential candidate for national defense and emergency response.
Entolimod is being developed in the United States under the FDA’s Animal Rule, which allows the Agency to approve new drugs and biological products based on animal efficacy studies when human clinical trials are unethical or not feasible, such as in the case of ARS. It has also received FDA Fast Track and Orphan Drug designations.
Ukraine operates a facilitated “recognition” registration pathway for biological products that is based on the regulatory reviews of select foreign authorities, including the FDA. Accordingly, thecompany anticipates that the MoH review may rely on the FDA’s current review status and documentation for Entolimod, which the company believes could allow the technical review to be completed in as little as 45 days — with actual timing dependent on the Ministry’s questions and its operational circumstances.
In a statement, Michael Handley, CEO of Valion, commented, “This marks an exciting milestone for Valion Bio and, more importantly, for the patients, civilians and military personnel who could one day benefit from Entolimod. For the first time, a sovereign health ministry has not only requested our submission but has accepted Entolimod for formal regulatory review. We believe this reflects both the importance of this unmet need and growing international recognition of Entolimod’s potential as a medical countermeasure against acute radiation syndrome.”
“As geopolitical risks continue to evolve, governments are placing renewed emphasis on preparedness for radiological and nuclear emergencies. We believe Entolimod has the potential to become an important component of that preparedness—not only for the United States and its warfighters, but also for allied nations seeking to strengthen their medical countermeasure capabilities. Ukraine’s decision to accept Entolimod for formal review represents an important milestone toward realizing that broader opportunity,” Mr. Handley added.
