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Vaxart, Inc. develops oral recombinant pill vaccines based on a proprietary delivery platform. The clinical-stage biotechnology company’s programs include vaccine candidates for coronavirus, norovirus and influenza, as well as a therapeutic human papillomavirus vaccine as its first immune-oncology indication. Its pill-based vaccines are designed for oral administration, storage and shipping without refrigeration, and avoidance of needle-stick risk.
Vaxart news centers on clinical data and scientific publications, business updates, financial results, financing arrangements, collaborations, intellectual property around adenovirus and TLR3 agonist oral vaccination technology, and governance changes as the company advances its oral vaccine pipeline.
Vaxart, Inc. (NASDAQ: VXRT) provides a business update, reporting a net loss of $70.5 million for 2021 compared to $32.2 million in 2020. Revenue dropped to $892,000 from $4.0 million. As of December 31, 2021, the company had $182.7 million in cash and equivalents. Significant advancements in COVID-19 and norovirus vaccine programs are ongoing, with Phase II trials underway. Key data readouts are expected in 2022, including initial results from the COVID-19 vaccine trials and norovirus studies.
A recent study on Vaxart’s S-only COVID-19 vaccine candidate has shown promising results, demonstrating cross-reactivity against multiple variants including beta, delta, alpha, and gamma. The vaccine, now in Phase II trials, induced a remarkable 1,000-fold increase in nasal IgA responses, potentially reducing community transmission. Unlike current vaccines, this candidate effectively generates antibodies at mucosal sites where infections occur, suggesting enhanced protection against variants, particularly omicron. The data indicates robust antibody responses, positioning Vaxart's candidate as a significant advancement in vaccine development.
Vaxart, Inc. (NASDAQ: VXRT) has appointed Edward B. Berg as its first in-house General Counsel, effective immediately. With over 30 years of legal experience, Berg joins Vaxart from BioMarin Pharmaceutical, where he was VP and Deputy General Counsel. His extensive background in biotechnology and pharmaceuticals is expected to strengthen Vaxart's leadership team, enhancing the company’s ability to address regulatory and compliance challenges as it develops innovative oral vaccines. The appointment reflects Vaxart's commitment to public health and its mission to improve vaccination accessibility worldwide.
Vaxart, Inc. (Nasdaq: VXRT) will participate in the H.C. Wainwright BioConnect Virtual Conference from January 10-13, 2022. Key executives, including CEO Andrei Floroiu, will engage in a fireside chat available on the company's Events & Presentations page starting at 7:00 a.m. ET on January 10. Vaxart is advancing the only oral COVID-19 vaccine in Phase II clinical trials, which began in October 2021. The company's innovative oral vaccine technology aims to provide a safer, needle-free alternative suitable for a range of infectious diseases.
Vaxart, Inc. (NASDAQ: VXRT) announced plans to test its oral COVID-19 vaccine candidate's cross-reactivity against the Omicron variant through two studies starting next month. The first study will assess samples from Phase II clinical participants, while the second will involve an animal challenge study. Vaxart's COVID-19 vaccine is engineered to potentially offer broader protection against variants, leveraging mucosal immunity differences compared to conventional vaccines. Initial Phase I results suggested significant cross-reactivity against other coronaviruses, supporting expectations for responsiveness to Omicron.
Vaxart, Inc. (NASDAQ: VXRT) has acquired manufacturing equipment and a GMP facility from Kindred Bioscience to enhance its production capabilities. This transaction, closed on Nov. 30, 2021, provides Vaxart with greater control over manufacturing schedules and quality control, allowing for parallel development of multiple oral vaccine candidates. The facility is set to become operational in Q1 2022 and will support the production of COVID-19 and norovirus vaccine tablets. Vaxart is also advancing its clinical trials, including a Phase II study for its COVID-19 vaccine.
Vaxart, Inc. (NASDAQ: VXRT) announced that Dr. Sean Tucker will present at the World Vaccine & Immunotherapy Congress on November 30, 2021, discussing Vaxart’s oral COVID-19 vaccine candidate. This vaccine is unique as it is the only oral candidate with clinical data supporting its immunological potential and is currently in Phase II trials, which began in October 2021. Vaxart focuses on developing oral recombinant vaccines that can be stored without refrigeration, eliminating needle-related risks. The company is advancing vaccines for various infectious diseases, including norovirus and HPV.
Vaxart's investigational oral flu vaccine VXA-A1.1 demonstrated significant cellular immune responses in a Stanford study, published in Cell Host and Microbe. The study revealed that protection against influenza may rely on cellular correlates rather than serum antibodies. The Phase II study indicated that VXA-A1.1 outperformed traditional injected vaccines by offering greater protection against viral shedding. This research could accelerate vaccine development by predicting immunity from early immune responses. The findings highlight the potential of oral vaccines in combating influenza.
Vaxart's oral COVID-19 vaccine shows promise in a study published in the Journal of Infectious Diseases. The research indicates that the vaccine significantly reduces viral load in the lungs of vaccinated hamsters. Vaxart's Chief Scientific Officer emphasized its potential for broader public health impact, especially in areas with limited healthcare infrastructure. Key findings include complete protection in vaccinated hamsters, no significant weight loss post-infection, and a notable drop in lung inflammation. Vaxart plans to release further data from its ongoing clinical studies in early 2022.
Vaxart, Inc. (Nasdaq: VXRT) announced participation in virtual fireside chats at two upcoming conferences. The first chat at the Jefferies London Healthcare Conference will be available on-demand from November 18, while the second at the 33rd Annual Piper Sandler Healthcare Conference starts on November 22. Both webcasts will be accessible on the Company’s Events & Presentations page. Vaxart’s oral COVID-19 vaccine is currently the only one in Phase II trials, which commenced in October 2021.