Vaxart (VXRT) recently held their quarterly call and discussed their expected upcoming milestones including the selection of COVID-19 vaccine construct to be used in the UK human challenge study is expected in Q4 2022, reports John McCamant, editor of The Medical Technology Stock Letter.
The chosen construct will also be tested in its upcoming India trials. VXRT expects to start the Phase II trial of their bivalent norovirus vaccine candidate in Q4 2022 or Q1 2023. This will be followed closely by top-line data from the ongoing Phase II norovirus challenge trial which is expected at the end of Q1 2023 or early Q2 2023.
VXRT is cautiously optimistic regarding the upcoming results in the norovirus human challenge study at the end of Q12023 or at the start of the second quarter of 2023.
In our view, the noravirus had good chance for a positive read out based on the proof-of-concept data in COVID-19 vaccine Phase II clinical data which shows it stimulates mucosal immunity. The company is increasing its focus on the norovirus program, with two additional clinical trials planned to start in the next six months.
The company has shown that its VXRT’s Spike/Nucleocapsid (S+N) candidate stimulated SARS-CoV-2-specific IgA antibodies in saliva and nasal samples from human subjects and was cross-reactive to many different coronaviruses.
The choice of construct will be important for both the U.K, challenge and India trials should provide important vaccine development data points that will guide pivotal development and could lead to a partnership.
We are comfortable buying VXRT at current levels as the recent tax loss selling pressure has not affected the big picture and the potential for value creation in 2023. The oral COVID-19 vaccine still has long term potential as the vaccine market is not likely to disappear. We also believe that a cross reactive vaccine has potential to provide long term protection against current and future COVID-19 variants.
In our view, the noravirus program is under appreciated as VXRT is mostly viewed as an oral COVID vaccine company. And while the COVID vaccine program has not advanced as fast as we would like, the data has actually de-risked the noravairus program.
The proof-of-concept data in the COVID-19 vaccine Phase II clinical data shows it stimulates mucosal immunity which could be key for a successful noravirus vaccine.
Positive noravirus data has the potential to serve as a significant catalyst for VXRT and could also de-risk the rest of the oral vaccine platform; COVID-19 and flu.