Vaxart (VXRT) announced that they have dosed the first subject in its Phase II COVID-19 oral tablet vaccine clinical trial which will enroll 96 subjects at four sites in the first part of its Phase II trial, notes John McCamant, biotech sector specialist and editor of The Medical Technology Stock Letter.
The U.S. trial will be followed by an international trial involving a larger pool of subjects. The U.S. portion of the trial will be a randomized, open-label dose and age escalation lead-in segment in naïve and previously vaccinated subjects, to be followed by an international placebo-controlled efficacy trial.
The full data set from the U.S. trial is expected in Q1:22. The start of Phase II and the addition of the second manufacturing plant position the company for success if the next data read out is positive.
VXA-COV2-1.1-S Phase II Trial Design
The Phase II study is designed to enroll 96 subjects aged 18-55 years old, and then enroll subjects aged 56-75 years old, in eight subgroups. Subjects will be randomized into eight cohorts stratified by age, vaccination history, dose size and placebo. The study drug will be an oral tablet administered on Days 1 and 29. The endpoints are safety, immunogenicity and efficacy.
Vaxart has recently brought online its own GMP manufacturing facility and is now producing vaccines at two GMP plants in parallel. This allowed the company to manufacture all of the COVID-19 vaccine oral tablets for the clinical trials planned to start in 2021, and to start manufacturing vaccines for its upcoming norovirus Phase II trials.
With the start of Phase II and a second manufacturing plant up and running VXRT has positioned the company to transition to the next level. The Phase II trial will test a broad range of subjects that have been previously vaccinated and unvaccinated.
The company will also test their oral vaccine in both the elderly and children. Given the relatively small size of the 96 subject trial we except it to enroll rapidly. Oral delivery and mucosal protection remain the key and differentiated strengths for VXRT, which in our view, make it the "Best of Class" amongst the second generation COVID-19 vaccines. VXRT is a buy under $15 with a target price of of $30.