Development of COVID-19 Vaccine, Tests Advancing in Montana

University of Montana receives federal funding to further vaccine research; two private research firms involved in coronavirus work have ties to Whitefish venture capitalist Mike Goguen

By Myers Reece
Dr. Jay Evans, cofounder, president and CEO of Inimmune, a Missoula-based biotech company that raised $22 million last year in a Series A funding round led by Whitefish-based venture capital firm Two Bear Capital. Photo courtesy of University of Montana

Researchers at the University of Montana and two Missoula-based biotech companies with ties to venture capitalist Mike Goguen are engaged in separate efforts to develop a COVID-19 vaccine and gain authorization for a mass-scalable viral test.

Inimmune, a private company involved in UM’s vaccine work and founded by nationally reputed vaccine scientists, is also gearing up to test an intranasal spray that researchers say has proven in animal testing to protect against other diseases and could offer protection against coronavirus. That testing will be conducted at the Rocky Mountain Laboratories in Hamilton.

Additionally, the biotech firm FYR Diagnostics is seeking emergency-use authorization from the U.S. Food and Drug Administration for a viral-detection test that it developed and which it believes could offer a viable solution to mass testing in Montana and elsewhere. Two Bear Capital, the Montana-based venture capital firm that Goguen launched in 2019, has provided FYR with seed funding and additional investments.

Goguen said this week that Two Bear Capital is also in venture capital funding discussions with Inimmune.

Inimmune’s co-founder and CEO is Dr. Jay Evans, director of UM’s Center for Translational Medicine and a research professor in biological sciences who is also the principal investigator on the university’s research team that was recently awarded $2.5 million from the National Institutes of Health (NIH) to identify and advance a COVID-19 vaccine candidate.

Evans and two other scientists founded Inimmune in 2016 after their employer, the pharmaceutical giant GlaxoSmithKline, closed its research and development center in Hamilton, leaving a stable of respected vaccine researchers out of a job. The founders established a partnership with UM and launched Inimmune in conjunction with the formation of the college’s Center for Translational Medicine to maintain and expand scientific research in Montana.

Evans said the relationship between the company and university is a mutually beneficial public-private partnership that bolsters research, funding and commercialization opportunities. The center alone has brought the university nearly $70 million in vaccine research funding since 2016.

The research center boasts unique expertise in adjuvants, which are the components added to vaccines to improve the immune response, and “novel delivery systems to ensure vaccines are safely and efficiently delivered to the right cells.”

“These technologies now are being used for the COVID-19 project to rapidly advance a safe and effective vaccine toward human clinical trials,” UM stated.

Evans said the 40 people at UM and additional personnel at Inimmune who are involved in vaccine discovery and development form a powerhouse research team. And he’s hoping to recruit 10 more researchers as the university center grows.

“There’s a reason that NIH comes to our team when there’s a national crisis and they need a vaccine developed quickly with good delivery systems and adjuvants,” Evans said in an interview earlier this week.

“I don’t know of another group in the world that has the capacity we do,” he added. “When we say that we’re a world-class vaccine discovery and development team, I don’t think that’s an overstatement.”

The university notes that its research team works on a range of “new or improved vaccines for influenza virus, tuberculosis, pertussis, Pseudomonas aeruginosa, Lyme disease, E. coli and opioid addiction.” After the NIH contacted the university in February, the researchers shifted their attention to developing a vaccine for SARS-CoV-2, the virus strain that causes COVID-19.

“We quickly adjusted lower-priority vaccine projects to focus our efforts on this urgent need,” Evans said, adding that researchers have navigated school closures, stay-at-home orders and social distancing to “rapidly advance this vaccine and continue working on other essential research projects of critical importance to our community and the nation.”

“It’s not every day you can be involved in an essential vaccine project with global health implications,” added Dr. Stephanie Lathrop, a UM immunologist and COVID-19 project leader who has been instrumental in designing studies and coordinating staff schedules during the pandemic. “It has been amazing to see the UM community rally behind us in support of our efforts.”

Evans said the UM team is currently conducting animal testing on COVID-19 vaccine candidates. Although the university was the sole recipient of the recent NIH award, the vaccine development work involves technology produced by both UM and Inimmune.

“The $2.5 million allows us to take the technology that currently exists at the university and Inimmune and apply that technology to identify a coronavirus vaccine candidate,” Evans said.

After UM’s testing is complete, likely in a couple months, the university’s partner in the research, the Icahn School of Medicine at Mount Sinai in New York City, will conduct further testing, moving it closer to human clinical trials, which will require another infusion of funding.

“In theory, in six months, we could be in a position to apply for a larger batch of funding that could take us through Phase 1 clinical trials,” Evans said, noting that such additional funding could come from agencies or private sources such as venture capital.

“That’s where someone like Mike Goguen could really come into the story,” he added, noting that Goguen has been assisting Inimmune in an unofficial capacity by helping navigate “the different aspects of how to make a company successful in this environment.”

More broadly, Evans said Two Bear Capital has emerged as a critical driver of the biotech sphere in Montana.

“What Mike is doing for biotech in Montana is pretty incredible,” Evans said. “Between Next Frontier Capital and Two Bear, if you’re a biotech company in Montana, they’re propping up the whole system.”

Inimmune has worked for years, independent of UM, to develop an intranasal spray that can protect against certain diseases such as influenza and RSV. If found to work on COVID-19, Evans said the spray could be administered every couple weeks for prolonged protection.

“There’s a strong reason to believe these treatments would be effective with the current coronavirus outbreak,” Evans said.

Since launching last year, Goguen’s venture capital firm has focused much of its attention on biotech companies. One such firm is FYR Diagnostics, a Missoula-based molecular diagnostics company that has been developing a mass-scalable and cost-effective COVID-19 viral infection test.

The FDA has approved two different types of COVID-19 tests: antibody tests that detect an individual’s immune response to the virus and viral tests that detect the presence of the SARS-CoV-2 virus itself. FYR Diagnostics’ product is a rapid virus-detection test called Adaptive Low Resource Testing (ALRT), which the company says is effective at identifying a potentially active and contagious infection, even in asymptomatic individuals, but not effective at identifying those who have recovered from the virus.

“We are proud to be doing our part to address the COVID-19 crisis,” said FYR Diagnostics CEO Chris Booth, Ph.D.

FYR President Sarjubhai Patel is a research professor at UM. Another company cofounder, Braxton Norwood, Ph.D., grew up in Kalispell and graduated from Flathead High School in 1999.

Officials at FYR Diagnostics say several viral-detection diagnostic tests have been approved by the FDA and are in use across the country, but supply chain and equipment shortages have inhibited their capability on a mass scale.

“FYR Diagnostics’ ALRT test opens this bottleneck through alternative reaction components and technologies that do not require scarce equipment or costly specialized devices,” the company states. “The ALRT test is designed to be low cost, simple to administer without specialized training, and suitable for use at low-resource testing sites beyond hospitals and clinics. It can produce a yes/no test result in 30-40 minutes.”

Patel said emergency-use authorization from the FDA would allow for the test’s deployment on a broad scale. Goguen, who is FYR Diagnostics’ executive chairman, noted that “insufficient testing capacity here in Montana and throughout the U.S. is amplifying and prolonging the COVID-19 crisis while putting more lives at risk.”

“FYR’s highest priority is to quickly enable mass COVID-19 testing in our home state, and then expand elsewhere,” Goguen said.

Goguen founded Two Bear Capital after previously spending 20 years at one of the world’s leading venture capital firms in Silicon Valley, Sequoia Capital. He said the research and development occurring in the state, from universities to private companies, is a badge of honor for Montanans.

“In my opinion, we have a lot to be proud of in Montana to have such important work being done right here in our state because of the expertise of folks at UM and at these companies,” Goguen said.