How a Peninsula Biotech Hopes to Give Bacteria a Boost to Boot Diseases
A Peninsula startup’s genetically engineered version of a naturally occurring bacteria — designed to break down a compound in the gut —is starting an early-stage clinical trial to treat people with chronic kidney stones. The “microbial medicine” from Novome Biotechnologies Inc. of South San Francisco is the first be studied in humans, so its findings later this year could be key to unlocking a new kind of treatment for a wide range of gastrointestinal conditions, including irritable bowel syndrome and ulcerative colitis. The 63-patient Phase I/IIa trial will start with healthy volunteers to assess the safety and tolerability of Novome’s combination treatment, called NOV-001. It then will move into a placebo-controlled study in patients withenteric hyperoxaluria, a condition that leads to significantly elevated levels of the compound oxalate in urine that is associated with kidney stones, chronic kidney disease and other kidney conditions.
The treatment relies on Bacteroides, a type of bacteria that naturally scurries around in the gut. But Novome’s genetically engineered strain of the bacteria is designed to play nicely with its bacterial neighbors, chowing down specifically on a powder extracted from seaweed.
While the variably dosed powder is taken once daily over 14 days, the engineered bacteria is given just once.
“Because we’re giving a food source that other bacteria can’t access, it sits in an ecological niche,” Novome CEO Blake Wise said.
The technology was developed by a team of Stanford University and University of California, Berkeley, grads — Will DeLoache, Wes Whitaker, Liz Shepherd and Zachary Russ — and backed in a $33 million Series A round early last year led by DCVC Bio.
Other investors include 5AM Ventures, Alta Partners, the Mayo Clinic and Alexandria Venture Investments, the venture arm of biotech landlord Alexandria Real Estate Equities Inc. (NYSE: ARE) whose new development on Haskins Way in South San Francisco is where Novome recently moved its 35 employees.
Novome’s approach is part of an explosion over the past decade in manipulating our guts to change the course of a wide range of diseases. Wise said Novome’s platform could be used to modulate the immune system even as a way to treat cancer.
But while a handful of companies have tried to introduce bacteria into the gut either to drive up production of a good bacterium or tamp down the impact of a bad bacterium, those have relied on finding a balance through natural but unguided strains. Novome’s strains are engineered to accomplish specific tasks, growing their population with the seaweed extract and staying focused on breaking down oxalate in urine.
Too much oxalate, which is found in many foods and binds to calcium in the stomach and intestines, is a leading cause of kidney stones.
The trial comes as Novome onboards Chief Medical Officer Lachy McLean, most recently head of research at Travere Therapeutics after a decade at Takeda Pharmaceuticals, where he oversaw R&D programs for several early- and mid-stage molecules.
Data from the single-site trial in Knoxville, Tennessee, is expected in the fourth quarter, Wise said. With those results in hand, Wise said, Novome will seek additional funding.
Ron Leuty
Staff Reporter
San Francisco Business Times