Geron's stem cell assets were given a new lease in early January when former CEO Tom Okarma, now heading a subsidiary of BioTime of Alameda, California, signed a definitive agreement for the latter to take control of the human embryonic stem cell (hESC) program. At the same time, the US Supreme Court ended a recent battle over hESC research when it declined to hear Sherley vs. Sebelius, a case that challenged federal funding for hESCs. James Thomson, professor of cell and regenerative biology at the University of Wisconsin in Madison, and the first to derive an hESC cell line in 1998, says, “Now there will be a way for Geron's work in this area to move forward,” adding, “after years of controversy there is finally a reasonable policy for stem cell research.”
As the first company to run a clinical trial using hESC-derived cells, Geron was once a flagship for stem cell research translation. The phase 1 trial had treated five acute spinal cord injury patients with its oligodendrocyte product, OPC1, when Geron discontinued its program in November 2011 (Nat. Biotechnol. 30, 12–13, 2012). At that time, the company shifted its business focus to telomerase-based cancer drugs, and although Geron indicated it was seeking partners for the stem cell program, there were no takers, until Thomas Okarma, who left Geron when it shelved its hESC program, and BioTime's Michael West, also a former Geron CEO, approached the company. Last November, they struck a deal. West hired Okarma to head a new subsidiary of BioTime—BioTime Acquisition (or BAC)—to incorporate Geron's stem cell assets.
According to the terms of the deal, Geron will contribute intellectual property and other assets, including the phase 1 clinical trial, to BAC. BioTime will contribute $5 million in cash, common shares, certain rights to patents and technologies, and will also pay royalties to Geron on sales of any commercialized products. A private, unnamed investor will also make $5-million equity investments in BAC and also in BioTime in conjunction with the transaction.
“What we really have here is a startup, or restartup, of Geron,” Okarma says. Although an immediate goal is to resume the clinical trial and integrate the two companies' research, it will take about six months to assess Geron's assets—cell lines, contracts and good manufacturing practice material—to see if they are viable and thus whether the deal can be finalized. Depending on what BAC researchers find, the hope is to move earlier-stage programs forward, including research on cardiomyocytes and chondrocytes for disc degeneration, as well as to extend the oligodendrocyte–acute spinal cord indication to two others. Okarma is optimistic about the trial moving forward, as some efficacy and no toxicity has been seen in the first five patients. Okarma is reviewing the data now and hopes to meet with the US Food and Drug Administration soon to discuss the trial and other possible indications.
“Geron invested an enormous amount of resources into that OPC1 program, and it seems promising,” says Paul Knoepfler associate professor of cell biology and human anatomy at University of California, Davis. Although Thomson sees an opportunity for BioTime now to accrue some early successes with its combined portfolio, he says that paralysis is “a remarkably difficult target,” in contrast to macular degeneration. In the meantime, phase 1 and 2 trials using hESC-derived cells for two types of macular degeneration are ongoing, sponsored by Advanced Cell Technology, of Santa Monica, California, which West founded in 1999.
Although it is too early to know what programs will be viable, Okarma is speaking with former employees and collaborators, and consolidating intellectual property, with the hope of restarting research into Geron's five cell types and integrating it into BioTime's stem cell subsidiaries. “Ultimately, we want to share expertise in the company and build a universe of companies that are cooperative, not competitive, and get products into patients,” Okarma says. He will be looking for new sources of funding in South America and Asia, and to conduct trials abroad as well as in the US.
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Brower, V. BioTime acquires Geron's stem cell program. Nat Biotechnol 31, 94 (2013). https://doi.org/10.1038/nbt0213-94a