BARDA’s Division of Research Innovation and Ventures (DRIVe) is partnering with US Biologic Inc. to advance the development of an oral vaccine for two strains of the influenza virus. This partnership aligns with the goals of BARDA DRIVe’s Beyond the Needle program: to make vaccines and therapeutics easier to administer and more widely available, without the need for needles, syringes, vials, and cold-chain distribution burdens.
Vaccination is an invaluable, lifesaving tool to prevent influenza and the vast majority of influenza vaccines are administered as intramuscular injections using needles and syringes. Current influenza vaccines have complex manufacturing processes and cold chain requirements that, in a pandemic, may result in critical delays in making vaccination available to the U.S. and the world. US Biologic currently has an oral delivery platform for animal vaccines that has been demonstrated to be safe, efficacious, and cost-effective for other infectious diseases with pandemic potential. This contract will allow US Biologic to collect sufficient data to submit an IND application to the U.S. Food and Drug Administration with the goal of entry into Phase I clinical trials for an oral influenza vaccine using this platform technology for humans.
The US Biologic OrisBio platform utilizes a series of complementary tools that protect antigens from the harsh stomach environment and allows for targeted gut delivery of almost any protein vaccine to protect against disease. The specific formulation of the gut-stabilized antigen allows release in the duodenum and induces immune stimulation and protection. The platform supports the use of recombinant antigens and avoids the use of inactivated or live attenuated pathogens in vaccines. The vaccine design allows for high throughput, low cost, and thermostability, all factors that are favorable to the development of vaccines in a pandemic setting.
About US Biologic Inc.:
The following information is provided by the company and does not indicate endorsement by the federal government of the company or its products.
US Biologic "Delivers Disease Prevention”. OrisBio, the company’s proprietary oral-delivery platform, is changing global disease prevention, allowing safe, effective, and cost-efficient delivery of vaccines and therapeutics. Its board of directors includes leaders who have served as a CDC director, a CEO of Sanofi Pasteur, and a Secretary of the U.S. Health & Human Services, respectively.