A biotech startup seeking to establish the first federally approved microbiome test to provide a meaningful way to assess gut function has raised $6 million in financing and hopes to file its pre-submission packet to regulators this month.
Along with the funds, North Chicago-based Three Squared Biosciences, born out of the gut science of UChicago professors Dr. Eugene Chang, Dr. John Alverdy and Joseph Pierre — who is now a nutritional scientist at the University of Wisconsin — also announced several leadership additions and new scientific and business advisory board members.
CEO Peter Farmakis told Crain’s the company received $6 million in funding, on top of a $1.3 million funding raise last year, and expects to launch a Series A funding round for significantly more, in the tens of millions, in the near future.
The funding and solidifying of business and science expertise, he said, will drive efforts to get its diagnostic platform technology in front of the U.S. Food & Drug Administration, with hopes of approval within 18 months.
The diagnostic test Three Squared has developed takes gut microbiology testing a step further than simply assessing what microbes are present in the gut, to quantitatively evaluate whether those microbes are working together toward functional health or not.
The diagnostic management tool, a stool test, was developed using machine learning and mass spectrometry to provide clinically actionable results, Farmakis said, and eventually a vast amount of data to further gut health science.
Following FDA approval, the company plans to put the tool in the hands of academic gastroenterologists who are treating the most severe gut health issues in patients. Using what those physicians learn about utilizing the test and leveraging the test results, Three Squared would take the test to the wider gastrointestinal physician community and eventually to the public.
The company is also working on a therapeutic innovation that could be a first-of-its-kind non-antibiotic antimicrobial designed to prevent gut-derived bacterial infections. The first indication for that drug could be to reduce post-surgery infection rates and infection-related mortality without contributing to antibiotic resistance, if approved by the FDA. Farmakis said the company is now also investigating the drug for use in reducing infection rates for cancer patients on chemotherapy.
The company said in a release it is making parallel progress on the therapeutic candidate toward Phase I clinical trials.
Establishing a way to quickly test and treat the gut microbiome without the need for antibiotics will go a long way for preventive and proactive medicine, Farmakis said.
He said the company’s strength lies in its strong fundamental science, backed by respected researchers, and having tapped into business expertise, including people he worked with while at Johnson & Johnson and Abbott Laboratories.
The company earlier this week announced the appointment of five leaders to its scientific and business advisory boards:
• Dr. Purna Kashyap, co-director of the Microbiome Program at Mayo Clinic
• Dr. David Rubin, professor and section chief at the University of Chicago
• Dr. Jay Wohlgemuth, chief medical officer at Genesis BioCapital and former executive at Quest Diagnostics
• Jack Kalavritinos, CEO of JK Strategies and former director of intergovernmental and external affairs at the U.S. Department of Health & Human Services
• Don Potter, former executive at UnitedHealthcare Group
The company, which Farmakis said has eight employees along with a team of about 40 advisers and collaborators, expanded its executive team as well.
The company brought on Greg Aronin as chief operating officer. He was previously senior vice president at Paragon Biosciences, which was founded by his brother, Jeff Aronin, now chairman and CEO. Greg Aronin led corporate affairs at Marathon Pharmaceuticals and held leadership roles at Johnson & Johnson.
It promoted Dr. Patrick Hennessey to chief medical officer from earlier positions in leading diligence efforts and business development. It also brought on Sharon Ayd as chief regulatory officer after she consulted on bringing its candidates into the regulatory environment.
Jeff McCown was promoted to vice president of commercial operations and had worked with Farmakis at Abbott Labs. Andrew Headley, the new vice president of finance, data and AI strategy, also worked with Farmakis at Abbott. Finally, Kaitlyn Read was promoted to director of product development.
“Our expanded leadership team and advisory boards position us to scale operations and drive innovation across diagnostics and therapeutics,” Farmakis said.
