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Microbiome Drug Candidate Licensed in $525M Deal

C. difficile in petri dish

C. difficile bacteria in petri dish (CDC.gov)

1 July 2021. A therapy designed to regenerate healthy gut microbes for treating dangerous intestinal infections is licensed for commercialization to Nestlé Health Science. The deal with Nestlé could bring Seres Therapeutics Inc. in Cambridge, Massachusetts as much as $525 million if all terms of the agreement are met.

Seres Therapeutics discovers and develops therapies for disruptions in the microbiome, the complex aggregate community of diverse intestinal microbes associated with a wide range of health conditions. These disruptions to the microbiome known as dysbiosis  — resulting from pathogens, antibiotics, diet, or inflammation — are increasingly connected or contribute to many chronic and degenerative diseases.

The company’s lead product, code-named SER-109, is a treatment for Clostridium difficile or C. difficile infections, caused by bacteria often contracted in hospitals or clinics. According to Centers for Disease Control and Prevention, almost 224,000 C. difficile infections occurred in the U.S. in 2017, leading to 12,800 deaths. The infections are often contracted in health care facilities, causing inflammation in the colon, and symptoms including watery diarrhea, abdominal pain, nausea, loss of appetite, and fever. People who have other illnesses or conditions requiring prolonged use of antibiotics, and the elderly, are at greater risk of this disease.

Oral therapy made of purified Firmicute spores

Seres Therapeutics’ technology is based on a library of some 9,000 microbial strains collected from healthy human donors. From this library, Seres uses computational techniques to identify microbial communities in the gut associated with healthy and diseased states, then zeroes-in on specific microorganisms, which in the right combinations, can restore healthy functions in the gut from a state of dysbiosis. The company purifies these target microbial combinations into therapy candidates for testing in lab cultures and animals, and later in clinical trials.

SER-109, the drug licensed to Nestlé Health Science, is an oral therapy made of purified Firmicute spores, a type of bacteria in the gut associated with obesity and dysbiosis. The treatments, taken as capsules each day for four days, are designed to rebuild and balance healthy gut microbes after taking antibiotics for C. difficile. Data from a late-stage clinical trial show reductions in number and risk of infections among SER-109 recipients compared to placebo after eight weeks. A follow-on trial is assessing SER-109’s efficacy and safety among patients with recurring C. difficile cases. The company expects to file for a biologic license with Food and Drug Administration after it builds a safety database of at least 300 cases.

In the agreement with Nestlé Health Science, Seres Therapeutics is responsible for further clinical and pre-commercialization work with SER-109 in the U.S., while Aimmune Therapeutics, Nestlé’s pharmaceutical subsidiary in Brisbane, California, will take the lead on SER-109’s commercialization. Seres is receiving an initial $175 million payment from Nestlé, and is eligible for another $125 million once FDA approves SER-109. Seres is also eligible for another $225 million in sales milestone payments and the equivalent of 50 percent of commercial profits. Science & Enterprise reported on Aimmune’s $2.6 billion acquisition by Nestlé in August 2020.

Nestlé already partners with Seres Therapeutics on two other microbiome treatments for ulcerative colitis. “Nestlé Health Science has been a terrific collaborator,” says Seres Therapeutics CEO Eric Shaff in a statement, “in our quest to develop a new treatment option for patients suffering from recurrent C. difficile infection, and their support over the past few years has been critical in advancing SER-109 to address this unmet need.”

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