FluGen May Seek Funding from $12M Gates-Backed Flu Vaccine Challenge

Xconomy Wisconsin — 

Last week, the Bill and Melinda Gates Foundation announced that it plans to provide researchers with up to $12 million in funding as part of a new initiative to support the development of a universal influenza vaccine.

The dollar amount isn’t huge: The National Institute of Allergy and Infectious Diseases reportedly spent about $64 million on universal flu vaccine research in the most recent fiscal year.

However, the Gates Foundation’s commitment to improving on the status quo in flu vaccines underscores the threat a major flu outbreak would pose to public health, says Paul Radspinner. He’s the co-founder and CEO of FluGen, a Madison, WI-based startup that develops flu vaccine candidates designed to protect against multiple strains of the disease.

“We will be looking into the Gates program, as we do for all non-dilutive funding opportunities for universal flu vaccine,” Radspinner says. “We’re excited to see [a] heavyweight nonprofit continue to support influenza vaccine research and development.”

Recent years have highlighted the potential benefit of successfully bringing a universal flu vaccine to market. In 2014 and 2015, U.S. and global health agencies’ predictions of predominant strains for the upcoming flu season largely missed the mark, meaning flu vaccines distributed those years weren’t as effective as they could have been.

Radspinner notes that Bill Gates—who recently expounded on topics such as global health during a talk at Harvard University—and his foundation have for years been calling attention to the potentially dire consequences of a global flu pandemic, and have supported research aimed at averting such an event. The foundation’s new initiative, officially called the Universal Influenza Vaccine Development Grand Challenge, is timed with the 100-year anniversary of the 1918 Spanish flu pandemic, which claimed an estimated 50 million lives worldwide.

Half of the funding doled out as part of the Grand Challenge will come from the Gates Foundation, and the family of Google co-founder Larry Page will provide the rest, according to The Verge.

The initiative’s backers plan to provide researchers with “pilot awards” of $250,000 to $2 million to help them advance “bold and innovative” ideas related to universal flu vaccine development. That money might allow recipients to test experimental vaccines on animals, and gather some of the proof-of-concept data that must be reviewed by regulators before the vaccines move into human trials. The Gates Foundation says it expects to invite one or more of the projects that receive a pilot award to apply for a “full award” of up to $10 million, which could be used to help fund clinical studies.

The foundation says it’s seeking to fund the development of universal flu vaccines that would be ready to start clinical trials by 2021.

New vaccines “should have the potential to be used in all age groups around the world, especially in developing countries,” according to the foundation, which is known for its work to inoculate people in the developing world against different types of disease, and help those who are infected get treatment.

Radspinner, the FluGen CEO, says flu vaccines tend to be slightly less effective among children and the elderly. However, the company’s vaccine candidates are designed for patients of all ages, he says.

FluGen’s lead experimental vaccine, known as RedeeFlu, is made up of a replicating live flu virus from which a key gene has been deleted. The vaccine virus is able to live in a patient’s body just long enough to elicit a strong immune response, but thanks to the deleted gene it cannot cause disease or spread to other people.

In October, the U.S. Department of Defense awarded FluGen a $14.4 million grant to support clinical studies of RedeeFlu. Prior to receiving the award, the startup had already completed a Phase 1a trial that evaluated RedeeFu’s safety and subjects’ antibody and T-cell responses to the vaccine.

FluGen said last year that the DoD funding, which is being awarded over three years, will help support multiple “challenge” studies of RedeeFlu. These types of trials are aimed at showing the vaccine can effectively fight a strain of the disease that doesn’t precisely match the strain RedeeFlu is designed to combat—a so-called “drifted” strain. FluGen plans to kick off its first challenge study later this year, Radspinner says.