- Gilead has struck a deal with Second Genome to identify microbiome-based markers that can indicate whether patients are responding to experimental Gilead medicines.
- Second Genome, a developer of microbiome therapeutics, will receive $38 million upfront from Gilead through the deal, announced Monday by the companies. The South San Francisco-based biotech could land another $1.5 billion if all five projects that the two companies plan to develop together make it through to market.
- The pact is one of several inked by large biopharmaceutical companies to use microbiome research to aid in their drug discovery work. If successful, those efforts could help unearth new treatments for a range of different diseases linked to bacteria in the gut.
Research into the human microbiome, the trillions of bacteria that live in and on our bodies, remains in its relative infancy. No microbiome-based drugs have been approved and clinical success has been hard to come by.
A crippling clinical failure for Seres Therapeutics in 2016 highlighted how much researchers still don't understand about the field, although data due this year could mark progress. Second Genome was stung by failure just last year, when it stopped a Phase 2 study of a potential liver disease drug due to safety problems, according to clinicaltrials.gov.
The microbiome's potential has remained intriguing to biotech startups and top drugmakers because of the way the microbiome may play a role in a variety of different maladies — from infectious, autoimmune and brain diseases to cancer and more.
Startups across the U.S. and abroad are advancing efforts to turn microbiome research into drugs and diagnostics. Some, like Seres Therapeutics and Vedanta Biosciences, aim to use live bacteria as therapeutics. Others, among them Second Genome, aim to develop drugs that tweak the way bacteria interact with their host's gut. Second Genome, for instance, has a medicine in development for inflammatory bowel disease that should begin its first human test next year. That one was developed in-house, unlike the liver drug that failed last year, which Second Genome licensed from Evotec, a spokesperson told BioPharma Dive.
Results from clinical trials run by Seres, Rebiotix and Finch Therapeutics are expected this summer, and could either give the field needed validation or set it back anew.
Second Genome is also using its work to help larger biotechs and pharmas either discover new medicines or find subgroups of patients who might best respond to them. It's not alone: Johnson & Johnson teamed with BiomX in 2018 to find microbiome-based markers related to IBD. Bristol Myers Squibb and Enterome started a similar pact, targeting cancer, in 2016. J&J didn't disclose financial details. Bristol Myers paid Enterome $15 million up front.
Gilead's effort with Second Genome appears to be more wide-ranging and lucrative. Though, like J&J, Gilead hopes to unearth a new drug for IBD through the work, the Foster City, California company also aims to find biomarkers that could predict response to five experimental medicines for inflammation, fibrosis, and other diseases.
The $38 million guaranteed check aside, Second Genome could get up to $300 million per program in the deal, though that cash is tied to various milestones the two may never hit. Gilead can opt in to full rights for each drug that comes out of the alliance.