Vaxart has laid off 10% of its staff after the U.S. government unexpectedly ordered the biotech stop work on a trial of its COVID-19 vaccine pill.
The South San Francisco-based company completed enrollment of an initial tranche of 400 patients in the study in November. The trial has been testing Vaxart’s oral vaccine candidate against an approved mRNA COVID-19 vaccine in adults previously immunized against COVID-19 infection.
The trial was being funded by up to $456 million that Vaxart was awarded under the Biomedical Advanced Research and Development Authority (BARDA) and National Institute of Allergy and Infectious Diseases’ Project NextGen initiative to accelerate the development of new COVID-19 vaccines and therapeutics.
Once the study’s independent data and safety monitoring board (DSMB) and the FDA had both reviewed data from the 400 patients, the plan had been for BARDA to give the nod to a second part of the study that would have enrolled around 10,000 participants.
As recently as mid-January, everything had appeared to be on track, with Vaxart stating at the time that it was “poised” to begin the 10,000-participant study extension after the DSMB had reviewed the safety data and given the go-ahead. As of Jan. 14, the company had been awaiting the final word from the FDA and BARDA.
But in its full-year earnings report yesterday, Vaxart revealed that a month later—on Feb. 21— the company received an order from the U.S. Department of Health and Human Services (HHS). The government directed the company to “stop work on all its efforts on the COVID-19 phase 2b trial, with the exception that Vaxart may continue work associated with the per protocol follow-up for the 400-person cohort," according to the report.
The company was “not provided a reason for the stop-work order,” Vaxart CEO Steven Lo told analysts on a March 20 earnings call.
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Following the order, a 90-day window commenced where Vaxart will learn whether the directive will be canceled, extended or the project itself will be terminated, Lo explained.
“To be clear, this does not apply to efforts associated with the 400-person SENTINEL cohort of the study and activities to monitor, and further assess this cohort continue,” the CEO said. “Vaxart is aligned with HHS and BARDA’s vision of improving efficiencies while protecting Americans from known and emerging disease threats.”
“We recognize and appreciate the importance of oversight, transparency and fiscal responsibility in government-funded biomedical research and we are committed to working collaboratively with [HHS] Secretary Kennedy, HHS, BARDA and other members of President Trump’s administration as they evaluate their priorities, as well as the data supporting the 10,000-participant portion of the phase 2b study and determine whether and how the study should move forward," the CEO continued.
As a result of the stop work order, Vaxart said it had been forced to lay off 10% of its workforce. The company entered the year with $51.7 million in the bank, which it expects to last into the fourth quarter.
Vaxart has another oral vaccine in the clinic in the form of a norovirus pill. A phase 1 study on that prospect is due to read out this year.
Vaxart isn’t the only vaccine company whose government-funded R&D plans have been thrown into question recently. In February, Bloomberg reported that HHS was reevaluating the $590 million contract from BARDA for Moderna to run two phase 3 studies of its mRNA vaccine against different strains of bird flu as well as bring four new influenza vaccines into phase 1 trials.
At the time, Moderna declined to comment while an HHS spokesperson told Fierce that “four years of the Biden administration’s failed oversight have made it necessary to review agreements for vaccine production.”