The Perfect Enemy | Scoop: COVID vaccine pill maker posts positive Phase 2 results

San Francisco-based biotech Vaxart, an underdog in the COVID response that’s developing a vaccine that would be delivered in a pill, is reporting promising Phase 2 clinical trial data today, the company told Axios exclusively.

Why it matters: The two-dose vaccine candidate was “safe and well-tolerated” and produced immune responses against the wild strain of the virus, as well as subsequent strains including Omicron, officials said.

It also showed what’s called a mucosal antibody response which can provide an added layer of protection and help reduce viral transmission, they said.
“We believe that the positive findings for multiple immunologic responses may ultimately translate to enhanced protection against infection with, and/or transmission of, SARS-CoV-2,” said Sean Tucker, Vaxart’s founder and chief scientific officer.

Be smart: As the first part of a Phase 2 study, this is still a relatively small study. It was based on 66 people.

But it’s an important milestone as the first time an oral COVID vaccine has concluded a Phase 2 trial, they said.
They say the pill could be ultimately “groundbreaking” for the global delivery of COVID vaccines and help get ahead of new COVID variants.

By the numbers: The trial measured for immunogenicity, neutralizing antibodies, and mucosal responses, in addition to safety.

They found COVID-19-specific serum neutralizing antibodies increased between 1.2- and 2-fold, with higher increases for higher vaccine doses.
Among 18-to-55-year-old subjects previously vaccinated with mRNA vaccines, they found COVID-19-specific antibody levels in the blood increased 1.6-fold.
About half of the participants, as well as half of the subjects that previously received an mRNA vaccine, had at least a 1.5-fold increase in mucosal antibodies.

Yes, but: The response by immune cells known as T cells was not as strong as they previously observed with their other COVID-19 vaccine candidate.

What to watch: The company is working on new Omicron-based vaccine candidates to evaluate in preclinical models this year and to advance to clinical trials in the first half of 2023.