Jefferies analyst Kelechi Chikere initiated coverage of Vaxart with a Buy rating and $13 price target. Vaxart is developing oral vaccines for infectious diseases and its lead oral COVID-19 vaccine has "shown some encouraging early results," Chikere tells investors. While investor interest seems to be on COVID, Chikere is "particularly interested" in the norovirus vaccine program that the analyst said could be a $1B+ market opportunity.
: News: FDA Clears Vaxart's IND Application
FDA Clears Vaxart's IND Application for S-Only Oral Tablet COVID-19 Vaccine Candidate
?Vaccine candidate expressing S-only protein produced higher serum antibodies than construct expressing both S and N in NHP study
?Phase II clinical trial with S-only candidate to begin in 2H21
?Development of this and other S-only constructs will proceed in parallel with that of S+N construct, as previously announced
SOUTH SAN FRANCISCO, Calif., Aug. 2, 2021 /PRNewswire/ -- Vaxart, Inc., (NASDAQ: VXRT), a clinical-stage biotechnology company developing oral vaccines administered by tablet, announced today that the U.S. Food and Drug Administration has cleared Vaxart's Investigational New Drug application for an S-only oral tablet SARS-CoV-2 vaccine candidate.
"This is great news because it allows us to move forward with our first S-only vaccine construct," said Andrei Floroiu, Vaxart's Chief Executive Officer. "As we said at the end of the first quarter, we will explore multiple S-only constructs in clinical trials alongside the S+N construct that has already completed its Phase I trial.
"Together, the S-only and S+N constructs are part of our unique oral tablet COVID-19 vaccine candidate portfolio, which we believe could make a significant contribution to the fight against COVID-19 globally."
"Preliminary data from our current Non-Human Primate study indicates that the S-only vaccine produced much higher serum antibodies than the one expressing both S and N proteins," said Dr. Sean Tucker, Vaxart's Chief Scientific Officer. "Our Phase I results from the S+N vaccine candidate showed remarkable T-cell responses and a mucosal antibody response, but not as strong serum antibody responses.
"This new clinical trial will allow us to compare the S-only and S+N vaccine candidates and put us in a position to decide which approach offers the best way forward for our COVID-19 vaccine development program, particularly in the face of emerging variant strains."
Vaxart announced in February that it had completed a Phase 1 clinical trial for its oral S+N COVID-19 vaccine. The results from that study found that the investigational oral vaccine triggered multiple immune responses against SARS-CoV-2 antigens, while reaching primary and secondary endpoints of safety and immunogenicity, respectively.
The Phase II clinical trial with the S-only construct is expected to start in 2H21.
Vaxart announces the addition of highly regarded biotech leader Julie M. Cherrington, Ph.D. to the company?s board of directors.
Dr. Cherrington brings decades of research and development experience and executive leadership to Vaxart's Board
SOUTH SAN FRANCISCO, Calif., Aug. 23, 2021 /PRNewswire/ -- Vaxart, Inc. (NASDAQ: VXRT) today announced the addition of Julie M. Cherrington, Ph.D., to the company's board of directors. Dr. Cherrington is an experienced life science executive with extensive insights into taking drugs through the development process to commercialization?..
Meiner Meinung nach ist Vaxart von einer Zulassung noch weit entfernt. Die Zugänge des Fachpersonals stimmen mich aber für die Zukunft sehr positiv. Ein Durchbruch wäre endlich mal Finanzierung, warten wir mal die weiteren Studienergebnisse ab. Ist hier halt hochspekulativ, Daumen drücken ist angesagt!
?The booster data could be huge if the vaccine can protect against the Delta variant. In our view, the recent noravirus data where VXRT demonstrated the ability to boost the immune response in patients who had previously received the VXRT vaccine candidate bodes well for the upcoming booster data in COVID-19.
Importantly, the company has also made progress on the manufacturing front with an announcement expected by year end on the progress. VXRT has the potential to be both a major player and part of the long-term vaccine solution. The stock is a buy under $15 with a target price of $30 per share.
New Duke University-led Study Shows That Vaxart's Oral COVID-19 Vaccine Candidate Reduces Airborne Transmission of SARS-CoV-2 Infection in Animal Model
October 7, 2021 at 4:13 PM EDT
Data published in bioRxiv confirmed previous findings suggesting mucosal vaccines could reduce transmission of airborne viruses such as COVID-19 and flu more than injectable vaccines Study suggests mucosal vaccines may protect not only vaccinated, but also unvaccinated animals
SOUTH SAN FRANCISCO, Calif., Oct. 7, 2021 /PRNewswire/ -- A Duke University-led study published in bioRxiv showed that Vaxart, Inc.'s (NASDAQ: VXRT) investigational oral tablet vaccine reduced the airborne transmission of SARS-CoV-2 virus in an animal model.
These results are consistent with those from Vaxart's Phase II human flu challenge study, which showed that Vaxart's oral tablet vaccine was better at reducing shedding than the injectable flu vaccine comparator.
A limitation of the currently approved injected COVID-19 vaccines is that airborne transmission occurs in people who have received them. The preclinical study also demonstrated that Vaxart's oral vaccine platform induces robust systemic and mucosal responses.
Researchers vaccinated hamsters orally or intranasally with Vaxart's S-only vaccine candidate and then exposed them to significant levels of the COVID-19 virus to promote vaccine breakthrough. Vaccinated hamsters cleared infectious virus in the nose and lungs quickly. Before clearing the infection, the vaccinated hamsters were exposed to unvaccinated hamsters via aerosol. The mucosally vaccinated hamsters infected fewer hamsters and created less severe clinical symptoms than did unvaccinated hamsters.
"These findings show that our vaccine candidate can reduce transmission of SARS-CoV-2, even when there is infection breakthrough in vaccinated subjects," said Dr. Sean Tucker, the study's lead author and Chief Scientific Officer at Vaxart.
"Existing injected vaccines don't always protect against viral shedding and transmission to other people. A vaccine that reduces shedding and reduces the probability of infection could make a big difference in protecting lives and public health, particularly given the large number of unvaccinated individuals. This study used the same vaccine candidate Vaxart is using in its development of an oral tablet vaccine," added Dr. Tucker.
Earlier this week, Vaxart initiated recruiting for a global Phase II clinical trial of its oral tablet COVID-19 vaccine candidate, which targets the SARS-CoV-2 viral spike (S) protein.
"Vaxart previously published data from a human influenza challenge study that demonstrated our oral flu vaccine candidate inhibited shedding of viral RNA better than injectable vaccines. The data reported provides further evidence that our oral vaccine could offer both an easier, more attractive mode of administration and potentially superior protection against respiratory viruses," said Andrei Floroiu, Vaxart's Chief Executive Officer.
The mucosal surface of the upper respiratory tract is the initial site of SARS-CoV-2 replication and the primary site of infection. Vaccines that induce robust mucosal immune responses may have the greatest impact on reduction of SARS-CoV-2 transmission. Approved COVID-19 vaccines, all of which are administered via intramuscular injection, stimulate systemic immune responses but have minimal effects on mucosal immunity.
Vaxart Announces Acquisition of Second GMP Manufacturing Facility
SOUTH SAN FRANCISCO, Calif., Dec. 01, 2021 (GLOBE NEWSWIRE) -- Vaxart, Inc. (NASDAQ: VXRT) has entered into an agreement with Kindred Bioscience, Inc. (?KindredBio?) for the purchase of KindredBio?s manufacturing equipment and sublease of its GMP (Good Manufacturing Practices) manufacturing facility in Burlingame, California, giving Vaxart control of its second GMP manufacturing facility?..
?This acquisition gives us greater flexibility to manage our manufacturing needs by allowing Vaxart to exercise more control over our quality control program and the timing of our manufacturing activities,? said Andrei Floroiu, Vaxart?s Chief Executive Officer.