Shares of Vaxart Inc. (VXRT) closed at a two-year high of $6.26 on Thursday, thanks to the Company’s pipeline progress, especially the COVID-19 vaccine program.
Vaxart is a clinical-stage biotechnology company developing oral recombinant vaccines that are delivered by tablet rather than injection. The Company’s oral vaccines are based on its proprietary oral vaccine platform known as VAAST and are designed to activate the immune system of the gut, generating broad systemic and local responses.
We had alerted our readers to Vaxart on February 25, 2020, when it was trading around $1.27 (Report titled “Vaxart (VXRT) – A Long Shot Or Perfect Shot?”).
The Company initiated a program to develop a COVID-19 vaccine based on its VAAST oral vaccines platform in January of this year and has been evaluating multiple vaccine candidates in its preclinical models.
On April 21, the Company announced that it has obtained positive pre-clinical results for its COVID-19 vaccine candidates, with several of the vaccine candidates generating immune responses in all tested animals after a single dose. The news sent the stock up 45 percent that day to a high of $3.45.
Vaxart has a manufacturing collaboration with Emergent BioSolutions (EBS) to produce bulk cGMP vaccine in time for initiation of a phase I study of its COVID-19 vaccine candidate.
The Company will be joining the broad-market Russell 3000 Index at the conclusion of the 2020 Russell indexes annual reconstitution, effective Monday, June 29, 2020, after the U.S. market opening.
Yesterday, (June 25, 2020), Vaxart entered into a Memorandum of Understanding with Attwill Medical Solutions Sterilflow LP (AMS), which specializes in the lyophilization and related processing of pharmaceutical intermediates, medical devices, and specialty food and nutritional ingredients.
As per the agreement, Attwill Medical will be a resource for lyophilization development and large scale manufacturing including tableting and enteric coating for Vaxart’s oral COVID-19 vaccine.
Attwill Medical’s experience coupled with its ability to manufacture a billion or more doses per year would enable the large scale manufacturing and ultimate supply of Vaxart’s COVID-19 vaccine for the US, Europe, and other countries in need, according to Andrei Floroiu, CEO of Vaxart. Floroiu was appointed CEO as recently as June 15.
Vaxart is planning to seek FDA clearance for conducting a phase I study of its oral COVID-19 vaccine soon, and if all goes well, the clinical study is expected to be initiated this summer.
However, Vaxart is not just about oral COVID-19 vaccines. Its development programs also include oral tablet vaccines that are designed to protect against norovirus, seasonal influenza, and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV).
The Company has a research collaboration agreement with Janssen Vaccines & Prevention B.V. that was signed last July, under which Vaxart-Janssen oral universal influenza vaccine is tested in a pre-clinical challenge model. Results from the preclinical study are due in the first half of this year.
Upon completion of the study, Janssen will have an exclusive option to negotiate an exclusive worldwide license to the Vaxart technology encompassing the Janssen antigens.
Had you bought Vaxart shares in February, you would have already made a gain of more than 400%, based on yesterday’s intraday high price of $6.48. But that said, as Vaxart gears up for its phase I study of the oral COVID-19 vaccine program and data-readout of oral universal influenza vaccine, it is worth keeping an eye on this stock.
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