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As AI powers a U.S. nuclear buildout, Valion’s needle-free Entolimod could bring radiation preparedness to population scale

Rising electricity demand from AI and data centers is driving plans to expand nuclear power capacity, possibly including on-site small modular reactors (SMRs).

This made international headlines earlier this week as Google (NASDAQ: GOOG) and Constellation Energy (NASDAQ: CEG) announced a long-term strategic clean energy collaboration that is expected to provide 890 megawatts of new nuclear capacity to the PJM Interconnection grid.

The expansion of the U.S. nuclear-energy landscape is highlighting the importance of resilient emergency preparedness and medical countermeasures for potential radiological and nuclear events.

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Against this backdrop, Valion Bio, Inc. (NASDAQ: VBIO) believes the evolving U.S. nuclear energy landscape reinforces the importance of advancing medical countermeasures that could be deployed rapidly and at population scale in the event of a radiological or nuclear emergency.

“The significance of the changing nuclear landscape extends beyond how electricity is generated — it also raises important questions about how communities and emergency systems prepare for low-probability, high-consequence radiation events,” said Dean Zikria, Interim Chief Executive Officer of Valion Bio, in a statement.

Entolimod, Valion’s investigational drug biologic being developed for acute radiation syndrome (ARS), is designed to potentially protect cells from severe damage or death both prophylactically (pre-exposure) and therapeutically (post-exposure). Historically administered by intramuscular injection, Entolimod is now the subject of an oral mucosal formulation-development program with Shear Kershman Laboratories (SKL) utilizing SKL’s proprietary BioViscid drug-delivery platform.

Valion and SKL recently successfully completed formulation work under their ongoing program to develop a novel oral mucosal formulation of Entolimod. The resulting BioViscid-Entolimod formulation is designed to enable absorption through the oral mucosa, potentially providing a needle-free alternative to injectable administration.

If successfully developed and approved, Valion believes a needle-free formulation of Entolimod could potentially change how a radiation countermeasure is stored, distributed and administered. Potential operational advantages include:

  • Utility potential before and after radiation exposure: Published animal studies of injected Entolimod have demonstrated protection against lethal radiation when administered before exposure, including protection involving both hematopoietic and gastrointestinal tissues. Separate non-human-primate research has reported improved survival and recovery of bone marrow and intestinal tissue when Entolimod was administered after radiation exposure. These findings support the scientific rationale for investigating Entolimod as a potential countermeasure across different phases of a radiation event.
  • Potential multi-tissue cytoprotection: Current FDA-approved medical countermeasures for ARS address the hematopoietic, or bone-marrow, component of radiation injury in patients exposed to myelosuppressive doses of radiation. No treatment is currently approved for the gastrointestinal component of ARS. Entolimod’s development program is investigating its potential to provide broader cytoprotection, including effects involving both hematopoietic and gastrointestinal tissues.
  • Needle-free administration at potentially unprecedented scale: In a mass-casualty radiological or nuclear event, the number of people requiring medical countermeasures could quickly exceed the capacity of conventional healthcare delivery systems. A successfully developed oral mucosal formulation could potentially reduce dependence on trained personnel to administer injections and create new models for rapid distribution and administration across large populations.
  • Two potential paths to preparedness, injectable and needle-free: Valion’s oral mucosal program is intended to create an additional development and deployment pathway alongside its injectable Entolimod program. Different formulations could ultimately serve different preparedness requirements depending on pharmacokinetics, stability, dosing, regulatory status and procurement needs.

“Nuclear power, AI-driven data centers and the push for resilient critical infrastructure are converging at the same time, and we believe medical preparedness should evolve alongside them,” Mr. Zikria added. “Our goal is to create the ability to administer Entolimod in a more flexible, scalable and field-deployable approach to radiation protection for both military and civilian populations.“

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