A trailblazing biotech with big ambitions and tiny organisms
CEO: Dr. Roger Pomerantz
Based: Cambridge, MA
Clinical focus: Microbiomics
The scoop: Inside every person is a sprawling ecosystem of more than 100 trillion microorganisms, making up what scientists have termed the microbiome. Like weather, small changes in microbiomic makeup can have precipitous effects on patients' health, a discovery that has led researchers on a quest to identify the role of each tiny, gut-dwelling being in hopes of finding a way to treat diseases. Leading the charge in biotech is Seres Health, an early stage company with a proprietary approach to microbiomics that could change how physicians approach infectious disease.
What makes Seres Health Fierce: As CEO Dr. Roger Pomerantz puts it, there's a lot of cool science out there related to microbiomics, but where his company stands out is in its practicality. Since its inception, Seres has been focused on translating microbiomic discoveries into actionable therapeutics, and that's why the biotech is already racing toward late-stage development despite emerging from stealth mode just last year.
Seres' top prospect is SER-109, a Tylenol-sized capsule designed to treat recurrent Clostridium difficile infections by correcting a microbiomic imbalance. The pill is loaded with spores of exactly the bacteria lacked by patients fighting C. difficile, designed to reconstitute the microbiome and shift the weather in the gut back toward health.
In a Phase I/II trial, SER-109 charted stunning efficacy, curing 29 of 30 patients with no major safety issues, Pomerantz said. And, because the treatment is made up of human bacteria, Seres can bypass Phase IIb, Pomerantz said, creating a speedy path to market. Now, the biotech has applied for the FDA's coveted breakthrough-therapy designation for SER-109, planning to kick off a Phase III study by early 2015.
Beyond its top prospect, the company is working up a slew of other infectious disease candidates while embarking on early-stage projects in metabolic and inflammatory diseases.
Key to each of Seres' candidates is a deductive approach to drug R&D that Pomerantz believes is the most sophisticated in the burgeoning space of microbiomics. The company begins by contrasting the gut composition of healthy patients with those afflicted with a target disease, employing proprietary algorithms to suss out the underlying networks of microorganisms at work in each. From there, the process is simple, at least in principle: Seres determines what in the former gut is missing from the latter and crafts a capsule full of corrective spores to right the ship.
Seres calls its method Ecobiotics, as each of its candidates is less a standalone treatment than a microecological catalyst designed to tune each patient's gastro feedback loop. That approach challenges the industry's current treatment paradigm, Pomerantz said, especially in combating infection.
"You have to look at C. diff not as a disease but as a downstream symptom of a proximal disease, which is a dysbiosis of the microbiome," he said.
And, much like the way SER-109 gets to skip Phase IIb, Seres' candidates are regulated more like devices than small molecules or biologics, Pomerantz said, meaning the biotech should be able to get its prospects from lab to clinic to market in record time. As it stands, Pomerantz believes Seres is on track to launch the world's first microbiomic treatment by the end of 2016.
Seres may eventually look to partner as it takes on more ambitious indications and eyes the global marketplace, but Pomerantz said his company has every intention of staying independent, taking a page from biotech trailblazers past.
"We want to grow out into the white space as the lead company in the microbiome, a lot like Amgen ($AMGN) and Centocor did in the 1980s with monoclonal antibodies," he said. "We want to become the Amgen of the microbiomic space."
Pomerantz came to Seres after a stint heading up infectious disease at Merck ($MRK), and he spent years in the same role at Johnson & Johnson ($JNJ). Walking away from Merck in 2013, Pomerantz told himself--and his wife--that he wouldn't get into another operational job in the industry. But, after having the privilege of working on 8 drugs that eventually won approval, the allure of another major success was too strong to turn down, he said.
"I believe this is my 9th drug at Seres, and that's why I'm here," Pomerantz said.
Investors: Flagship Ventures, Enso Ventures, Mayo Clinic, Alexandria Venture Investments
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-- Damian Garde (email | Twitter)