The U.S. government has pulled the rug out from under Pluri Biotech’s PLX-R18 cell therapy. Having put up funding to help bring the candidate to market, the government terminated the contract in a move that Pluri believes “may reflect broader federal budgetary and administrative adjustments."
Federal funding has been central to the development of PLX-R18, a potential treatment for a syndrome that can affect people exposed to high doses of radiation. When the National Institutes of Health (NIH) began financing the candidate with $528,607 in 2018, “the growing threat of terrorist events involving radiation” and lack of treatments for the delayed effects of acute radiation exposure were central to the pitch.
The NIH, working through the National Institute of Allergy and Infectious Diseases, provided money to advance PLX-R18 every year from 2018 to 2024. Starting in July 2023, the federal government ramped up support to about $1.4 million a year as part of a three-year contract, which has now been terminated.
Pluri received formal notice from the government Tuesday and told investors after the market closed Thursday. The contract was ended “for the government’s convenience,” Pluri said, and the termination is immediate.
“The company believes that the termination of the contract may reflect broader federal budgetary and administrative adjustments that have recently affected multiple health-related agencies, including the National Institutes of Health,” Pluri said in a Securities and Exchange Commission statement. “The company is monitoring these developments closely and will assess any potential implications for its ongoing programs.”
Pluri, an Israeli company previously called Pluristem Therapeutics, secured the $4.2 million deal as part of a collaboration with the U.S. Department of Defense’s Armed Forces Radiobiology Research Institute. The pact was designed to advance the cell therapy with the end goal of adding to the U.S.’ medical countermeasures.
The 2024 funding notice listed “in vitro characterization and production of CRISPR-modified cells, as well as irradiated rodent and [non-human primate] product efficacy studies” as upcoming activities. Pluri and its partners in the government were planning to show the efficacy of the human placenta-derived stromal cell therapy when given to animals at least 24 hours after radiation exposure.
"NIH remains dedicated to restoring our agency to its tradition of upholding gold-standard, evidence-based science," a Department of Health and Human Services spokesperson told Fierce Biotech regarding the contract termination. "As we begin to make America healthy again, it's important to prioritize research that directly affects the health of Americans. We will leave no stone unturned in identifying the root causes of the chronic disease epidemic as part of our mission to make America healthy again."
PLX-R18 could come to market without showing safety and efficacy in humans. The ethical and practical barriers to testing a treatment for radiation exposure in humans mean the cell therapy could be eligible for authorization under the FDA animal rule.