Novome Biotechnologies — a South San Francisco-based biotech focused on genetically engineered microbial medicines (GEMMs) — raised $43.5 million in Series B funds on Tuesday.
The funding round was led by Tencent. Other investors — University of Minnesota, Navian Investments, Colorcon Ventures, Touchdown Ventures, DCVC Bio, 5AM Ventures, Alta Partners and Alexandria Venture Investments —also participated in the round.
Novome was founded in 2016 with a mission of using synthetic biology tools to tap into the power of the microbes in the gut. The biotech views the gut’s microbes as “living pharmacies,” and its platform enables the controllable engraftment of GEMMs in the gut to deliver therapies, Novome CEO Blake Wise said in an interview.
The company will use its Series B funds to advance clinical testing of its lead candidate, NOV-001. Through this GEMM, Novome is taking bacteria found in the gut and engineering it to break down oxalate, a naturally-occurring metabolite that forms kidney stones. The metabolite is common in people’s diets — oxalate-rich foods include spinach, chocolate, beets, peanuts and sweet potatoes.
“We’ve simply taken the most highly abundant bacteria that there is in the gut and then given them the ability to break down this thing that we often consume in our diet,” Wise said.
In November, Novome reported positive results from NOV-001’s Phase 1 trial. The company said the trial proved the therapy’s ability to safely treat the human gut with a genetically engineered microbe and control its abundance via once-daily dosing of porphyrin, a prebiotic polysaccharide.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The ongoing Phase 2a trial for NOV-001 is enrolling patients with enteric hyperoxaluria, which is a frequent complication that can occur as a result of an underlying gastrointestinal disorder, such as irritable bowel syndrome or Crohn’s disease. People with enteric hyperoxaluria absorb more oxalate and therefore excrete more oxalate in their urine.
The trial is measuring NOV-001’s ability to reduce the level of oxalate excretion in participants’ urine. High levels of urinary oxalate put a patient at risk of developing kidney stones, according to Wise.
In addition to clinical research for its lead candidate, Novome will also deploy “a big, meaningful portion” of its Series B funds to further develop multiple preclinical GEMM candidates for the treatment of inflammatory bowel disease, Wise said. The biotech plans to advance multiple candidates over the next few years, including ones wholly owned by Novome and ones that are part of a Genentech collaboration that the biotech announced last year.
Under the partnership, Novome is responsible for engineering and developing bacterial strains that will express therapeutically relevant proteins of interest for the targeted creation of drug candidates for inflammatory bowel disease. Genentech will take over when it comes time for clinical development and commercialization, Wise said. Novome received a $15 million upfront payment for the deal, as well as the opportunity to receive up to $590 million in additional milestone payments.
Novome is the only biotech to take bacteria that is naturally abundant in the human gut and genetically engineer it to deliver medicine, Wise claimed.
Many companies are pursuing engineered cell therapy with human cell types (like immune cells or stem cells), such as Kite, Juno and Rubius. But Wise maintained that Novome is the only company to pursue engineered cell therapy with microbes for the treatment of chronic diseases.
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