Funding and support provided by Bill & Melinda Gates Foundation
Study will focus on determining the ability of oral vaccine tablets to induce breast milk antibodies and transfer of antibodies to young infants
SOUTH SAN FRANCISCO, Calif., Dec. 01, 2022 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced it will commence a new study of Vaxart’s oral pill norovirus vaccine candidate focused on protecting breastfeeding mothers and their infants.
The study will receive significant funding and support from the Bill & Melinda Gates Foundation (“Gates Foundation”). This funding follows Vaxart’s previous collaboration with Duke University on a pre-clinical COVID-19 transmission study also funded by the Gates Foundation.
“Currently, there are no approved vaccines that prevent norovirus, which is responsible for a $10.5 billion annual disease burden in the United States alone. Vaxart’s oral norovirus vaccine pill may make it possible for mothers to protect their infants against this highly contagious disease that has serious health consequences,” said Dr. James Cummings, Vaxart’s Chief Medical Officer. “We believe this is just one part of the broader promise of our norovirus vaccine program, which could be of great benefit to at-risk populations such as the elderly, children under age 5, the military, first responders and healthcare workers, both here in the U.S. and globally.”
The study will examine whether Vaxart’s vaccine candidate induces antibodies in the breast milk of lactating mothers and whether infants up to 6 months of age can acquire those antibodies. Vaxart believes there are potential advantages to this approach. Young children have an immature immune system that makes them particularly susceptible to highly contagious diseases, and direct immunization can be challenging. Passive transfer of antibodies from mother to infant that are induced in milk may protect breastfeeding infants from infectious pathogens.
“By triggering mucosal immunity in addition to protecting those vaccinated, our vaccines may also reduce transmission - the key mechanism by which viral infections spread, further increasing their overall effect on the broader population. This study investigates inducing mucosal immunity at an important site that ultimately might result in positively impacting transmission,” said Andrei Floroiu, Vaxart’s Chief Executive Officer. “We are pleased with the funding and support from the Gates Foundation, which will help realize the potential impact of our vaccine technology on global public health.”
Norovirus sickens approximately 21 million people in the United States each year, and 15% of children under age 5 catch norovirus annually. This would translate into about 3 million sets of parents needing to take time from work (approximately 2.2 days on average) to care for their children. Globally, in countries that have adopted a rotavirus vaccine program, norovirus has become the leading cause of pediatric gastroenteritis in health care settings.1 Pediatric deaths in the United States due to norovirus are rare, but much more common in the developing world.
As a grant recipient, Vaxart has agreed to a global access commitment for use of its vaccine candidate, if proven effective and approved, in breastfeeding mothers from low- and middle-income countries.
Vaxart is also currently studying its norovirus vaccine candidate in a challenge study that will provide the vaccine 30 days before exposure to actual norovirus, and then determine whether people get infected or have severe gastroenteritis.
1 Shah and Hall, Infect Dis Clin North Am. 2018 Mar; 32(1): 103-118.
Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using pills that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary pill vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Vaxart’s development programs currently include pill vaccines designed to protect against coronavirus, norovirus, seasonal influenza, and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immune-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.
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Source: Vaxart, Inc.