VXRT - Vaxart stock rises as COVID pill vaccine shows response safety in trial

Vaxart ( NASDAQ: VXRT ) said its Wuhan S-only oral pill COVID-19 vaccine VXA-CoV2-1.1-S. met the main safety and secondary immunogenicity goals in the first part of a planned two-part phase 2 trial.

Part 1 of the study enrolled 66 healthy adults, including people who had or had not received prior mRNA COVID-19 vaccine, aged 18 years to 55 years and 56 years -75 years. The participants were divided in six groups based on age, vaccination history and dose and received either a high or low dose of the vaccine.

Serum neutralizing antibodies rose after oral vaccination and the increase was particularly notable in people who had previously received an mRNA vaccine, the company said in a Sept. 1 press release.

The geometric mean titer (GMT) increase of novel coronavirus specific serum neutralizing antibodies from Day 1 to Day 57 ranged by group between 1.2- and 2-fold, with higher increases for higher doses, the company noted.

Vaxart added that in people aged 18 years to 55 years who had previously received mRNA vaccines, the GMT increased 1.6-fold, from 481 AU/ml at Day 1 to 778 AU/ml at Day 57.

The company said that, people who had a mucosal immune response to the Wuhan-based vaccine had responses which cross-reacted with the Omicron variants, including BA 4/5, and other coronaviruses.

In addition, SARS-CoV-2-specific T cell responses were seen in majority of people after the second dose of VXA-CoV2-1.1-S.

"The results reported today clearly indicate that the S-only construct improved antibody responses compared with the data we previously generated for the S+N construct (VXA-CoV2-1), and also boosted immune responses in subjects who previously received an mRNA vaccine," said Vaxart's Founder and Chief Scientific Officer Sean Tucker.

The VXA-CoV2-1.1-S vaccine construct was safe and well-tolerated and no vaccine-related grade 3 adverse events (AEs) and serious adverse events (SAEs) were reported, according to the company.

Vaxart said it is the first company to advance an oral pill COVID-19 vaccine into phase 2 development.

The company added that it is also evaluating new Omicron-based constructs as Omicron-only monovalent vaccine and bivalent candidates in combination with its Wuhan constructs.

VXRT +8.06% to $3.35 premarket Sept. 1

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