Vaxart ups production as oral COVID-19 vaccine dosing begins

Vaxart agrees deal with Kindred Biosciences to expand manufacturing of COVID-19 vaccine candidate.

Yesterday, Vaxart announced that the first subject had been dosed in a Phase I study for its oral tablet COVID-19 vaccine candidate.

Prior to this, the biotech had agreed with Kindred’s contract development and manufacturing organization (CDMO) subsidiary, Centaur Biopharmaceutical Services, to increase the scale of production.

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As a result, Centaur will manufacture clinical trial material for the prospective vaccine out of its Elwood, Kansas, plant at 2,000 L scale. This builds on the previous deal, signed in May, which saw the CDMO provide production through mid-sized bioreactors at its Burlingame, California, facility.

At the same time as the original agreement, Vaxart also partnered with Emergent to provide additional manufacturing services.

Oral delivery

With the company differentiating its potential COVID-19 vaccine from others, due to its oral delivery, Vaxart completes the manufacturing process itself by drying the material and pressing it into tablets.

According to a company spokesperson, this confers the advantage of improving stability at elevated temperatures. While the company had previously told Bioprocess Insider that the ingestion of the tablets could provide improved protection against COVID-19 due to the “activation of mucosal immunity.”

Vaxart announced that it had dosed the first patients with tablet vaccine yesterday, with the company planning to recruit up to 48 individuals to participate in the trial.

The spokesperson outlined that the trial will complete in December of this year, though Vaxart would receive the first clinical data from the trial within “the next few weeks.”

Lawsuit in the background

Meanwhile, a class action lawsuit was launched against Vaxart last week regarding the company’s involvement in ‘Operation Warp Speed’ (OWS).

The US government initiative provides funding to those developers that are believed to be working on promising COVID-19 vaccines or providing manufacturing services to such companies. This has seen companies, such as Emergent and Novavax, receive multi-million dollar funding to accelerate timelines for a potential vaccine.

Following the announcement in June by Vaxart that it had been selected to be part of the OWS program, the value of the company rose from $8 to $15 per share a few weeks later.

The detail of the announcement itself stated that the company had been invited to participate in a non-human primate challenge study, which was organized and funded by OWS.

The lawsuit claims that “Vaxart exaggerated the prospects of its COVID-19 vaccine candidate, including its purported role or involvement in OWS…Instead, Vaxart’s COVID-19 vaccine candidate was merely selected to participate in preliminary US government studies to determine potential areas for possible OWS partnership and support.”

When asked to comment on the lawsuit, the spokesperson for Vaxart responded that the company will not discuss ongoing litigation.