The Department of Health and Human Services (HHS) has lifted a stop work order on Vaxart’s phase 2b trial testing out an investigational COVID-19 vaccine pill, with the biotech resuming plans to enroll participants for the 10,000-person study.
In February, the HHS unexpectedly delivered notice that the South San Francisco-based company was to stop all work on the government-funded trial, except for a per protocol follow-up for a cohort of 400 participants. As a result, Vaxart laid off 10% of its workforce.
Now, the government has notified Vaxart that the study can resume, according to April 24 documents filed with the Securities and Exchange Commission (SEC). The HHS has not responded to Fierce Biotech's questions regarding the reasoning behind the order.
After receiving the lift notice last week, Vaxart had a virtual meeting with the HHS’ Biomedical Advanced Research and Development Authority (BARDA) and was informed that it could move forward with screening for the 10,000-participant portion of the trial, according to the SEC filing.
Over the last five days, Vaxart’s stock has risen nearly 38%, opening today at 43 cents per share compared to 33 cents at market open April 22.
Vaxart now plans on reactivating field sites and screening participants for enrollment. The biotech also intends to continue discussions with BARDA regarding dosing plans, according to the documents.
"Vaxart thanks the U.S. Department of Health and Human Services for its thorough review of our COVID-19 oral vaccine candidate and looks forward to continuing its collaboration with HHS and other government partners," a Vaxart spokesperson told Fierce Biotech.
The clinical trial is being funded by up to $460.7 million that Vaxart was awarded under BARDA and the National Institute of Allergy and Infectious Diseases’ Project NextGen initiative, designed to accelerate the development of new COVID-19 vaccines and therapeutics. The government continues to finance the trial, according to the Vaxart spokesperson.
"We also are evaluating our cost structure accordingly and remain committed to ensuring success with this trial and our ongoing norovirus program," the spokesperson said, referring to Vaxart's other oral vaccine currently being assessed in a phase 1 norovirus study.
The company’s study is testing an oral vaccine candidate against an approved mRNA COVID-19 vaccine in adults previously immunized against COVID-19 infection. The California biotech had completed enrollment of an initial tranche of 400 patients in November and had been waiting on BARDA’s green light to start the second part of the study, which includes enrolling 10,000 participants.
Instead, on Feb. 21, the government directed the company to “stop work on all its efforts on the COVID-19 phase 2b trial,” excluding the arm of 400 people. The company was not provided a reason for the order, Vaxart CEO Steven Lo told analysts on a March 20 earnings call.
The U.S. government has also delivered a stop work order related to Project NextGen to GeoVax Labs. Effective April 11, that order indicated that the government was terminating a contract for the Atlanta biotech’s COVID-19 vaccine program that was being tested in a midstage trial.
"The BARDA funding pursuant to Project NextGen was mostly earmarked for incremental spending, with a large portion going directly to the external clinical research organization to conduct the clinical trial," GeoVax President and CEO David Dodd told Fierce at the time. "Given the structure of the award, the financial impact to GeoVax is estimated at less than $750,000 annually, toward reimbursement of existing personnel and overhead costs.
“GeoVax therefore does not anticipate any significant changes to its ongoing operations resulting from the contract termination,” Dodd concluded.
Editor's note: This article was updated at 2:30 pm ET on April 28 to update information regarding the federal grant.