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this stem cell production process. It’s looking to many different kinds of cells—skin, hair, blood, or anything that might be easy to sample—and using its Catalyst technique to induce them into the stem-cell like state. Then it is seeking to turn them into the adult, differentiated cell that’s desired, like a neuron. The scientists then look to compare the newly induced neuron to an actual neuron from the brain to see if they are really the same.
If these newly grown cells are in fact the same, and they can be consistently reprogrammed in a matter of days instead of a matter of months, then the big drugmakers really get interested, Wolchko says. “If your reprogramming takes a couple months, and the differentiation takes a couple months, that’s not really practical,” Wolchko explains.
At least in the beginning, Fate is mostly interested is in creating models of disease in the lab and for toxicology testing to see which drug candidates have the best odds of success. There’s less interest in creating replacements cells that can be injected in the body as regenerative therapies of their own. “We’re not a cell therapy company. It’s more about the process of creating,” Wolchko says.
While part of the Fate business model relies on getting partners to help build up this industrial-scale stem cell production platform, the other part is about building up its own portfolio of drug candidates. There wasn’t as much to discuss about this side of the business when I visited last week. Fate started its first clinical trial in May, and seeks to use a conventional small-molecule chemical drug to spur growth of blood-forming stem cells that ought to help restore bone marrow function after leukemia and lymphoma patients undergo transplants.
The trial has so far enrolled three of the 12 patients it seeks to recruit at the Dana-Farber Cancer Institute in Boston, Yingling says. The company has since added a second clinical site at Massachusetts General Hospital, and it hopes to have pulled in enough patients to get results by the end of March, Wolchko says. If the drug is found safe in that study, he says it could be ready for a pivotal trial that would begin by the end of 2010.
Before I left, the conversation came back to the platform for industrialized production of induced pluripotent stem cells. That platform should be useful for creating such a wide array of cell types that it’s expected to give rise to more drug opportunities than any one company could pursue on its own. Some of those drug development opportunities will go to partners who help pay to develop the technology, and Fate will keep some of those opportunities for itself.
The intellectual property is being structured in a way that Fate and Stemgent won’t be entitled to royalties or “reach-throughs” if partners discover drugs using the platform technology, Wolchko says.
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