For Vaxart, oral vaccines offer significant benefits beyond avoiding needles (VXRT)


Check out Seeking Alpha’s full interview with Vaxart executives James Cummings and Sean Tucker in the above video.

Going to get a vaccine is rarely a painless experience, but Vaxart (NASDAQ:VXRT) is aiming to change that as the biotech is focused exclusively on developing vaccines that are in pill form.

The South San Francisco, Calif., based company has garnered attention from scientists and investors due to the development of its COVID-19 oral vaccine, which is currently in phase 2 of development. In the clinic, Vaxart (VXRT) is also working on oral vaccines for seasonal influenza and norovirus.

But the company touts that that the benefits of a pill vaccine go beyond avoiding a needle. Executives say that the way they work can actually induce immune responses that are better than with existing vaccines and can potentially target multiple variants.

Vaxart (VXRT) Chief Medical Officer James Cummings and Chief Scientific Officer Sean Tucker, who recently spoke with Seeking Alpha, both emphasized that their oral vaccines target the body’s mucosal areas — namely the gut, nose, and mouth — precisely the areas where a pathogen is likely to enter the body.

“One of the differentiators of our product is the mucosal immunity, the IgA response, which is much stickier of an immune response that could provide protection against variants,” Cummings said in regards to its COVID vaccine pill.

A recent Vaxart (VXRT) phase 1 study published in medRxiv found that its COVID pill induced significant antibodies in mucosal areas of the nose and mouth. These areas are “the first line of defense from the standpoint of a respiratory pathogen,” Tucker noted.

Cummings added that instead of reacting to new variants as they occur by changing the composition of injectable vaccines — as the U.S. FDA has advised in the face of Omicron subvariants BA.4 and BA.5 — a better way “is through a product that can handle those variants as they occur.”

In a Vaxart (VXRT) COVID oral vaccine study, a subset of patients had an increased antibody response to SARS-CoV-2, the virus that causes COVID. The company discovered that these people also had a response to SARS-CoV-1, the respiratory infection that led to the early 2000s SARS outbreak, Middle East Respiratory Syndrome (MERS), and alpha and beta coronaviruses.

This cross-reactivity — a vaccine providing an immune response against pathogens not specifically targeted — is a kind of bonus. “We think that mucosal responses are generally are much more cross-reactive by nature,” said Tucker.

More than 650 people have received a Vaxart (VXRT) oral vaccine considering all of its clinical programs. Cummings noted that the company’s vaccines have a very clean safety profile, and avoid a common side effect seen with traditional vaccines — injection site pain.

He referenced a study that Vaxart (VXRT) did with the federal government’s Biomedical Advanced Research and Development Authority (BARDA) that tested its influenza oral vaccine against a marketed injectable vaccine. It was a challenge study, so participants were purposely infected with influenza through their noses 90-120 days after receiving either one of the vaccines.

Results were published in 2020 in The Lancet Infectious Diseases.

“We observed that our vaccine did just as well at protecting against illness but may have done a better job at protecting against infection and potentially decreasing viral shedding,” Cummings said.

He added that Vaxart (VXRT) is planning on conducting a challenge study in 2023 in the UK testing its COVID oral vaccine and the Omicron variant. If the results show their vaccine leads to less viral shedding, it could be an indicator that the tablet can lead to decreased transmission.

Oral vaccines makes sense from a logistics standpoint, the execs argue. Unlike traditional vaccines that need to be kept at a certain temperature, “you could essentially mail out something that’s room-temperature stable rather than wait in line” for a jab, noted Tucker.

A spring 2021 study Vaxart (VXRT) commissioned found that an oral COVID vaccine could indeed increase the number of people vaccinated. Results showed that while 23% of those interviewed didn’t plan on get vaccinated, 32% of that number would if a pill was an option. That would equate 18.7M more Americans vaccinated against COVID, according to the company.

Regarding development timelines, Vaxart (VXRT) is expected to release data from its COVID vaccine that targets the spike protein this quarter, according to Tucker. Timing for regulatory submissions will depend on future data and how COVID progresses, with Tucker adding it can be accelerated if needed.

Even if the COVID pill eventually wins approval, it would still have to compete with already marketed injectable vaccines. However, Cummings sees the company’s oral COVID vaccine as complementary to existing vaccines. And in addition, it would greatly boost vaccination rates in the developing world.

Cummings added that the ease of dispensing an oral COVID vaccine would shrink the amount of time to inoculate a population from six months to a matter of weeks. “This is favorable when trying to achieve herd immunity, and get in front of the curve with these circulating variants.”

Seeking Alpha’s Quant Rating views Vaxart (VXRT) as a hold.

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