Gilead, Goldfinch take aim at kidney disease

All told, the total deal value could reach over $2B if all milestones are met

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FOSTER CITY, Calif. & CAMBRIDGE, Mass.—In its first deal for the year—and its largest by price since the company was established—Goldfinch Bio Inc. has announced a collaboration with Gilead Sciences Inc. for the discovery, development and commercialization of a pipeline of therapeutics for diabetic kidney disease (DKD) and select orphan kidney diseases.
Per the agreement, Gilead will pay Goldfinch $55 million up front, which includes a $5-million equity investment, as well as $54 million to support the development of the Kidney Genome Atlas (KGA) platform for diabetic kidney disease. Goldfinch also stands to receive up to $1.95 billion in additional payments for the first five collaboration programs if certain milestones are met, as well as tiered royalties on sales of products that result from this agreement. The company will also have the option to share equally in U.S. profits for certain products in select indications. Development costs for the profit share products will be shared in keeping with product rights.
“We are excited to partner with Gilead Sciences, a biopharmaceutical company known for its science-driven innovation and productivity,” said Dr. Tony Johnson, president and CEO of Goldfinch. “There is significant unmet need to improve health outcomes for patients with kidney diseases. This partnership will leverage Goldfinch’s KGA platform to identify new therapeutic targets and Gilead’s proven track record of efficiently advancing life-saving therapies for patients.”
For its part, Gilead will be granted exclusive options to license worldwide rights to certain products directed against targets identified by Goldfinch’s proprietary KGA registry of kidney disease patients. Goldfinch will apply its biology platform for this work, which consists of human induced pluripotent stem cell-derived kidney cells and kidney organoids to help validate targets. According to Johnson, Goldfinch is responsible for research and development through Phase 1b or 2a for KGA 1.0, and for KGA 2.0, the company is responsible for research and development through "any point between development candidate stage and following IND-enabling research at Gilead's choice."
Johnson notes that this is the first time the companies have worked together, though they have been in discussions for several months.
“Gilead really wanted to invest in the kidney, and I think that's because chronic kidney disease is very prevalent, it's deadly and it's very, very expensive to the community—it costs about $8 billion a year for Medicare alone,” Johnson tells DDNews. “However, why they want to invest in us is, I think, primarily because we have our Kidney Genome Atlas coupled with our human biology platform, and these together will help identify novel targets, all human genetics-driven. In addition, they'll help us validate those targets with our human biology validation system. That's part A. Part B of why Gilead wanted to work with us is we're applying a precision medicine approach to discovering and developing drugs for patients with kidney disease.”
At present, Johnson says, the KGA features 23,000 individuals, which includes patients with kidney disease as well as matched controls. All individuals have undergone whole-genome sequencing, as well as longitudinal and clinical phenotyping, and Goldfinch has also collected multiomics data—transcriptomic and proteomic data—on a subset. He notes that Gilead is interested in expanding it by another 80,000 participants, 40,000 of whom will have kidney disease and 40,000 of whom will be matched controls.
Goldfinch will expand the KGA to include diabetic kidney disease, identifying and validating targets as well as leading discovery and development activities prior to the exercise of any option rights by Gilead.
“Goldfinch has established unique genetic and biology platforms that will allow for the identification and validation of novel targets for kidney disease and for the discovery and development of novel compounds,” remarked Dr. John McHutchison, chief scientific officer and head of research and development at Gilead Sciences. “We look forward to partnering with our research collaborators at Goldfinch, as we seek to advance novel treatment options for people living with DKD and other serious kidney diseases.”

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