Humacyte hopes its regenerative medicine approach to blood vessels can offer a better and longer-lasting alternative to synthetic implants used to replace blocked veins. Now it has $9.9 million more to support its work in late-stage clinical trials.
The Durham, NC-based biotech company said Monday that it has received $9.9 million from the California Institute for Regenerative Medicine (CIRM), the California state agency created to support new regenerative medicine technologies. The funding comes nearly 10 months after Humacyte raised $150 million in a Series B round to support Phase 3 clinical trials for its technology. That trial started in May.
Humacyte has developed a way to make blood vessels in a lab using smooth muscle cells from humans. These cells are grown on tube-shaped scaffolds. After the structure forms, the human cells are washed away leaving a collagen framework. Washing away the human cells means that it’s less likely the patient’s body will reject the implanted blood vessel, the company says.
The Humacyte technology, originally developed at Duke University, is intended to produce “off-the-shelf” blood vessels that could be could be produced for and implanted in any patient. Humacyte is testing its bioengineered blood vessel technology, called Humacyl, in patients with kidney failure who require hemodialysis. When Humacyte reported results from a 60-patient Phase 2 trial, the company said that the study suggested that Humacyte’s acellular veins showed potential for staying open for a longer time, a problem with synthetic blood vessels. In Phase 3, Humacyte will evaluate this capability compared to synthetic veins. The trial is enrolling 350 patients at 35 sites in the United States, Europe, and Israel.
San Francisco-based CIRM has retooled in the last couple of years in an attempt to better meet objectives set when the agency was formed more than a decade ago—to bring new regenerative medicine therapies to patients. A Humacyte spokesman said that the CIRM funding is in addition to the company’s $150 million round raised last year, adding that the CIRM dollars are a grant, not an equity investment. Last year, CIRM told Xconomy that its awards are technically loans, not grants, but companies only need to pay CIRM back if their products are successful. To date, CIRM says it has made 735 awards for projects with a total value of more than $2 billion.