A Memphis-based biotech company announced in early August a partnership with a federal agency to work on a temperature stable, oral vaccine against two strains of the influenza virus.
US Biologic, known for its proprietary oral-delivery platform OrisBio, produces oral vaccines and therapeutics, which are currently being used in animals to prevent zoonotic diseases. The company describes its platform as “safe, efficacious, and cost-effective for other infectious diseases with pandemic potential.”
The Biomedical Advanced Research and Development Authority (BARDA) awarded funding worth $740,000 to US Biologic to collect data and submit an investigational new drug application to the U.S. Food and Drug Administration (FDA) for an oral influenza vaccine. The aim is to synthesize the platform’s technology for humans and get entry into phase 1 clinical trials.
“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,” BARDA said in a statement.
Influenza vaccines have strict temperature guidelines and are required to be stored at a temperature of 35 degrees to 46 degrees, either inside a refrigerator or inside a properly chilled insulated cooler.
US Biologic’s 18-month contract falls under BARDA’s Division of Research Innovation and Ventures, which in part focuses on developing alternative technologies for vaccines and therapeutics, without the need for needles, syringes, vials, and cold-chain distribution burdens.
The vaccine design at US Biologic proposes to eliminate the need for such temperature constraints and allows for “high throughput, low cost, and thermostability,” making it favorable to develop vaccines in a pandemic setting.
Jolieke G. van Oosterwijk, Ph.D., chief science officer at US Biologic said OrisBio is a very flexible and easily adaptable platform. The technology protects the vaccines from room temperature changes and can be safely, and effectively, delivered orally.
“The enteric coating protects the vaccine components from the gut so it can be delivered to (the) right area for the best impact,” van Oosterwijk said. “The way we are producing vaccines — making them orally available, reducing production costs, and increasing shelf life — we are increasing health care equity.”
Influenza strains continue to pose a threat to public health. According to the Centers for Disease Control and Prevention (CDC), an estimated 400,000 people in the U.S. were hospitalized with influenza in 2019-2020 — a season of moderate severity.
While US Biologic’s present contract is for flu vaccines, it could extend to any type of vaccine with potential, including COVID boosters.
“The goal is a thermostable vaccine that can be readily produced and is responsive to different variants of flu, with obvious applications later on to other diseases that we can help prevent like variants of COVID,” said Chris Przybyszewski, executive VP at US Biologic.
US Biologic will also work with the University of Tennessee Health Science Center (UTHSC), where the effort will be spearheaded by Amali Samarasinghe, Ph.D.
“As demonstrated by the current pandemic, respiratory infectious diseases are a major public health burden and projects such as this open doors to future research targeted as safeguarding the masses quicker,” Samarasinghe said. “Once developed by Dr. van Oosterwijk at US Biologic, my lab at UTHSC will assist them in testing the efficacy of this vaccine using our tried-and-true methodologies of influenza infection.”
With this project, US Biologic CEO Mason Kauffman aims to make Memphis the “hub for global vaccines.”
“Memphis is very good at health care innovation and at logistics. When you look at the medical institutions here, when you look at the land we have to expand on, and then you look at logistics networks like FedEx,” Kauffman said. “'Where else could you go [and] have as many assets, as much benefit, as we have here in Memphis?’”
