Gilead gets in on the microbiome game with a $38M pact, up to $1.5B in milestones
In what had been shaping up to be a major year for microbiome biotechs, Gilead is getting in on the action.
America’s newly most watched big biotech announced a four-year, $38 million upfront pact with Second Genome to identify biomarkers that can measure clinical response to Gilead’s inflammation and fibrosis drugs, among others, and to find up to 5 new inflammatory bowel disease targets or drug candidates. If all five of those candidates reach market — a rather unlikely occurrence — the deal could be worth up to $1.5 billion.
The pact comes as the microbiome field — the study of the trillions of bacteria in the gut, their role in disease, and their potential as both drugs and drug targets — awaits some of its first large readouts since 2016, when a major failure in a trial to treat C. diff infection curtailed the field. Seres, Finch and Rebiotix are all expected to readout for new C. diff trials later this year.
The bacterial infection is a first step, but the field broadly hopes to eventually expand into the inflammatory bowel diseases covered in the Gilead pact. All three of those biotechs also have earlier stage programs for IBD diseases such as ulcerative colitis or Crohn’s disease, and Second Genome has one in the “discovery” phase.
The connection between the microbiome and IBD or other inflammatory diseases is not fully understood, but a large group has linked changes in gut bacteria to the disease. One theory is that these changes in the microbiome lead to bacteria actually tearing through the barrier lining of the intestine, allowing bacteria to leak out into the muscles and triggering an immune response. Change the bacteria, some biotechs think, and fix the lining.
Although Big Pharma has not embraced the microbiome with the same vigor they have other emergent fields, this is far from the first such deal. J&J and Bristol Myers Squibb signed similar biomarker discovery pacts with microbiome biotechs in 2018 and 2016.
Gilead is not new to the IBD field. Their JAK-1 inhibitor filgotinib is expected to be approved this year and eventually become a blockbuster. They also have a series of earlier stage candidates for inflammatory disease, developed both in house and with their partner Galapagos. The California-based drugmaker rose to public and financial prominence building antiviral drugs for life-threatening infections — a role that has become acute amid the Covid-19 pandemic — but they have in recent years invested billions to expand their arsenal.