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Gilead goes after a young biotech’s data to break into kidney diseases

  • Gilead is tapping into a young drugmaker’s technology and stores of patient data to find new treatments for diabetic kidney disease and a couple less common kidney conditions.
  • The R&D collaboration centers around Goldfinch Bio’s biology platform of human-induced, pluripotent, stem cell-derived kidney cells and kidney organoids, which the partner companies say can validate disease targets. Goldfinch also has access to genomic, transcriptomic and proteomic data from a propriety registry of kidney disease patients.
  • Per deal terms, Gilead will pay its new partner $55 million upfront, including a $5 million equity investment, plus another $54 million to build out the company’s patient registry with diabetic kidney disease patients. Goldfinch CEO Tony Johnson told BioPharma Dive the plan is to grow the registry by tens of thousands of patients.

Gilead turned to pipeline diversification over the last year as market challenges continued to threaten its core HIV and hepatitis C businesses. Recent R&D deals inked by the big biotech have focused on cell therapy, immuno-oncology and a fatty liver disease known as NASH.

Kidney diseases are the latest addition to that list. The collaboration with Goldfinch encompasses three: diabetic kidney disease or DKD, minimal change disease or MCD, and focal segmental glomerulosclerosis or FSGS.

Notably, Goldfinch’s two most advanced candidates, which are under investigation as treatments for some kind of FSGS, are not part of its pact with Gilead.

Johnson said his company already has data on roughly 2,500 FSGS patients and on a several times higher number of healthy patients without the condition. A main objective of the Gilead deal, however, will be collecting information on diabetic patients both with and without kidney disease. The Centers for Disease Control and Prevention estimated that in 2017, 44% of end stage renal disease cases were caused by diabetes.

“If we’re really trying to find what genetic drivers are causing people with diabetes to get kidney disease, we need to be able to compare them with people that have diabetes without kidney disease,” Johnson said in an interview.

Adding data from tens of thousands of patients to Goldfinch’s registry will require considerable work, but Johnson said there are some tailwinds. Unlike diseases of the liver, for example, Goldfinch won’t need to do a “massive amount” of biopsies because much of the desired kidney information can be found in urine tests.

“The urine provides a source of excellent biomarkers or potential biomarkers that we can study to help categorize or segment patient populations for clinical trials,” he said. “So in terms of discovery and development, being in the kidney is a real advantage from that point of view.”

Goldfinch also retains the option to equally share U.S. profits with Gilead in certain pre-defined kidney indications for select products that may stem from the collaboration. Development costs for such products will be shared between the two companies “in a manner commensurate with product rights,” according to deal terms.

The small biotech is eligible for nearly $2 billion in milestone payments for the first five collaboration programs, in addition to tiered royalties on future product sales.

Johnson pointed out to BioPharma Dive that the collaboration has an initial time frame of five years, though there could be extensions. Because of that structure, the companies may advance more than five targets — in fact, they initially modeled eight, according to Johnson.

The first serious deal talks with Gilead began in January 2018, Johnson said.