Vaxart reports promising norovirus vaccine trial results

SOUTH SAN FRANCISCO - Vaxart, Inc. (NASDAQ:VXRT), currently trading near its 52-week low at $0.47 per share, has announced the publication of complete data from its Phase 1b trial of the oral norovirus vaccine candidate in elderly adults, showing promising immune responses. According to InvestingPro analysis, the company, with a market capitalization of $107 million, maintains a stronger cash position than debt on its balance sheet, though it’s currently experiencing rapid cash burn. The findings, published in Science Translational Medicine, indicate the vaccine’s potential to induce strong and durable antibody responses, even in older adults who typically exhibit diminished immune reactions to injected vaccines.

The trial involved two age groups of healthy older adults, ranging from 55 to 80 years old, who received the vaccine orally in three different dose levels. The study was designed to evaluate the safety and immunogenicity of the vaccine, with participants randomized in a 2:1 ratio to receive either the vaccine or a placebo. A total of 63 volunteers completed the study, which included follow-up assessments through day 390.

Key results from the trial showed that the vaccine candidate elicited significant serum antibody responses across all dosing cohorts compared to the placebo group. Additionally, the vaccine induced age-independent mucosal-homing antibody-secreting B cells and T cells, which are crucial for protection against persistent infections. The vaccine also stimulated robust IgA responses in saliva and the nasal cavity, important for mucosal immunity.

The vaccine was generally well-tolerated, with the most common symptoms being mild to moderate headache and malaise/fatigue, which occurred at similar rates in the placebo group. No grade 3 adverse events related to the vaccine were reported.

Vaxart’s CEO, Steven Lo, expressed optimism about the vaccine’s potential to protect older individuals from norovirus, which can cause severe acute gastroenteritis. He highlighted that the oral vaccine could offer a safe and effective alternative for this high-risk population, which often responds less effectively to injected vaccines.

Previous studies by Vaxart have shown promising results, including a Phase 2 challenge study that demonstrated a significant reduction in infection rate and viral shedding. Additionally, a Phase 1 study in lactating mothers indicated that the vaccine could boost norovirus antibodies in breast milk, potentially offering passive protection to infants. While the company’s revenue grew significantly by 303% in the last twelve months, InvestingPro data shows analysts anticipate continued sales growth in the current year, despite challenges with profitability.

The company plans to initiate a Phase 1 trial comparing second-generation oral norovirus vaccine constructs to the first-generation in the first half of 2025.

This article is based on a press release statement from Vaxart, Inc. and reflects the current stage of the vaccine’s clinical development without speculating on its future market potential or broader industry impact.

In other recent news, Moderna is facing scrutiny as the U.S. government reviews a $590 million contract for its bird flu vaccine. This reassessment is part of a broader examination of mRNA-based vaccine expenditures, potentially impacting Moderna’s plans for large-scale trials. Meanwhile, Vaxart Inc. has encountered a stop work order from Advanced Technology International, affecting its Phase 2b study of an oral COVID-19 vaccine. Despite this, Vaxart secured an additional $105.9 million in funding from BARDA, bringing total support for the trial to approximately $240.1 million. Oppenheimer has maintained an Outperform rating on Vaxart, indicating confidence in the company’s prospects despite the recent halt. Additionally, Vaxart announced the appointment of Kevin Finney to its Board of Directors, bringing significant healthcare expertise to the company. These developments highlight ongoing shifts and strategic decisions within both Moderna and Vaxart as they navigate challenges and opportunities in the vaccine sector.

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