Ex-FDA interim chief Giroir rejoins biotech world with eyes on $50M fundraising for new infectious disease company

Former FDA Acting Commissioner and Admiral Brett Giroir, M.D., is back in the private sector and jumping into securing a series A for his latest biotech. Altesa BioSciences, which broke cover Thursday, builds upon the work of the Emory scientists behind Merck's COVID-19 antiviral molnupiravir and a billion-dollar HIV treatment. 

“I like small teams that can change the world," Giroir said in an interview with Fierce Biotech. He's already in talks with VC shops and pharmas about raising a $50 million to $60 million round for the Atlanta biotech that he's been CEO of for about a month. 

The move marks a return to the C-suite after he served as CEO of AlloVir from October 2016 to February 2018. He has since served as a member of former President Donald Trump's coronavirus task force, as the assistant secretary for health at the Department of Health and Human Services and was U.S. representative to the World Health Organization until January 2021.

With $4 million and a duo of big-name scientists in the infectious disease world, Altesa hits the ground running with a six-molecule partnership with Drug Innovation Ventures at Emory, or DRIVE. Emory's DRIVE owns an undisclosed stake and serves as the drug discovery pipeline for Altesa. 

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First up on the agenda for the new chief executive is raising the series A in the second quarter to bankroll a phase 2 study this year for an in-licensed asset and a phase 1 trial next year for the first of the six Emory molecules, Giroir said. Venture outlets are in the diligence phase of the financing and Altesa has had "several very engaging discussions with strategic pharmaceutical" companies that might partake, as well, the CEO said. 

The biotech's co-founder George Painter, Ph.D., helped discover Merck and Ridgeback Biotherapeutics' COVID-19 antiviral molnupiravir. The drug, which has received emergency authorization for use during the pandemic, is expected to haul in $5 billion in 2022 sales for Merck. Altesa's second co-founder Dennis Liotta, Ph.D., helped create the HIV antiviral Emtriva, sold by Gilead, that is used by "90% of HIV patients around the world," Giroir said.

“We don’t want to turn into Merck or Pfizer. We want to be small, nimble, sort of a special operations-like that we can take molecules, get them into the best indication and prove them or make them fail early so that we can get them to patients," Giroir said of Altesa's goals. 

Proceeds from the future financing will fund a phase 2 trial of vapendavir, a once failed Aviragen drug for the common cold. Altesa in-licensed the drug, which missed the primary endpoint in a phase 2b trial in asthmatic patients with rhinovirus in February 2017, to develop it in chronic obstructive pulmonary disease (COPD).

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“It has a new formulation and we believe the indication is right for COPD," Giroir said of vapendavir. COPD, which blocks airflow, impacts about 16 million people in the U.S.

The new biotech will zero in on viral threats and disease in high-income countries with an unmet medical need and global viral threats such as flaviviruses. Altesa will begin human testing of the first of six molecules from DRIVE next year. The asset, dubbed ALT-2023, was "very active in preclinical tests against enteroviruses" and "against all the flaviviruses," Giroir said.

Enteroviruses are single-stranded RNA viruses, and flaviviruses are an umbrella for West Nile, dengue, tick-borne encephalitis, yellow fever, Zika and others. According to Giroir, diseases caused by flaviviruses are likely going to crop up more "as the climate changes."

What not to expect out of Altesa? SARS-CoV-2 treatments. It's an indication you might consider obvious from the molnupiravir team, and of Giroir, after his work with the pandemic response team.

RELATED: Pfizer's oral antiviral might be better, but Merck still expects $5B-plus from molnupiravir in 2022

“That’s not part of our license arrangement. We can go to any RNA respiratory viruses, and COVID is excluded because molnupiravir is their drug. They developed that; it’s already licensed to Ridgeback, and also there’s lots of people developing that. That is not part of this company," Giroir said.

Giroir headed back to biotech in recent months after taking "some time to recover" from a seven-day-a-week stint leading key positions in the federal government's pandemic response. He stayed in D.C. for a month after Trump's presidency to help with the Biden transition, and he has a book under review. 

"It’s much more of an academic than a salacious book, but it does have a lot of interesting stories behind the scenes that I do think need to be preserved in history and lessons learned in the future," Giroir said. 

The new gig comes days after Giroir testified to Congress about President Joe Biden's proposed new research agency ARPA-H.