Humacyte makes “spare parts for people” and will hear from the Food and Drug Administration this week about whether those parts will be approved to treat patients.
Humacyte is a biotech company in Durham, NC, that makes artificial blood vessels. The Artificial Tissue Engineered Vessels or ATEVs have been in development for almost two decades, but so far have been available only to patients in clinical trials. But with an FDA decision coming up, that could change. And an approval would be a win not only for the company, but also for the growing research and development presence in the Triangle region.
Bringing an innovative product to the market
Humacyte’s ATEVs have been tested extensively in clinical trials for more than a decade, and have been in development since 2005. Humacyte’s CEO and co-founder Laura Niklason is hopeful that after many years of work, the FDA will approve the ATEVs for use on August 10.
“That will allow us to launch our product into hospitals where trauma surgeons and vascular surgeons will be able to use it to treat patients who are wounded,” she said.
Those could be patients who have been in car accidents or suffered gunshot wounds, and receiving an artificial blood vessel could salvage limbs or even save lives.
“Our engineered tissues, when we implant them, they don’t have any cells in them,” Niklason said. “But after they do get implanted, cells from the patient sort of crawl in and take up residence in the tissue and turn it into a living tissue. It becomes self.”
Scientists have dreamed about this kind of engineered tissue for decades, but so far Humacyte is the only company that has been able to make a product like that a reality.
“It’s very exciting for the company, because this represents an incredibly long journey,” Niklason said. “To get to this point where we’re getting to approval for something that’s really fundamentally new is pretty cool.”
Growing R&D presence in NC
Humacyte has also been ahead of the curve on research and development in the Research Triangle. While the Triangle’s biotech industry has been growing for decades, most of those jobs have been in manufacturing and contract clinical testing. But research and development in the region has slowly been growing as well, and Humacyte has been part of that trend. Last year they spent more $76 million on R&D, according to financial documents filed with the Securities and Exchange Commission, which accounted for over three-quarters of their annual operating costs.
Humacyte has been one of a handful of companies that have been able to take advantage of the highly skilled workforce coming out of local universities. And it’s a mutually beneficial situation for graduates who both want to apply their skills in life sciences research outside of academic research, and stay in North Carolina.
Kaleb Naegeli has been a scientist at Humacyte for about six years after receiving a PhD from Duke University and a brief stint at UNC Chapel Hill. He enjoyed research but wasn’t interested in a traditional academic research position, and wanted to do more applied science.
“I really wanted to be in a place where I could be doing R&D work that I could see its benefit to patients more readily,” he said. At that time, finding a job like that often meant moving to a city with a bigger biotech presence.
“When I moved here, everyone I knew who was older than me in grad school, they all left,” Naegeli said.
He and his family were hoping to stay in North Carolina, and that became possible when a recruiter reached out about a position at Humacyte. Naegeli noticed that more students who graduated around the same time as he did stayed and found jobs locally.
A diverse biotech ecosystem supports growth
Companies like Humacyte with strong R&D don’t just benefit individuals like Naegeli.
Mike Carnes, Vice President of Emerging Company Development at the North Carolina Biotechnology Center, said that success for a company like Humacyte benefits other companies, and creates more opportunities locally.
“The more success that we have with companies that are getting clinical approval or moving products to the marketplace, that helps shine a spotlight on North Carolina,” Carnes said. “And so that’s going to encourage additional venture capital investors to come into the state.”
While already known for its biotech sector, the Research Triangle has not yet attained the status or investment of other biotech hubs like Boston or the San Francisco bay area. And while biotech in North Carolina has grown over the last few decades, investment from venture capital was down in 2023 at around $550 million, compared to over $800 million in 2022 and over $1 billion in 2021.
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But success for Humacyte and companies at similar stages can signal to investors that North Carolina biotech companies can succeed, and can potentially make investment go farther than in expensive areas like Boston and San Francisco.
Carnes said the NC technology center has had a long relationship with Humacyte. He said that growth for Humacyte and other biotech companies that have come up in the Research Triangle helps to create a robust network of expertise and support for new and existing companies to tap into.
And that network can also make investors more confident backing companies that might take decades to deliver an ROI. “We continue to help our regional investment community understand that, you know, these are not overnight success stories, like it’s going to take time and they need capital, and when they’re successful, that they can be very successful,” Carnes said.
Even more potential to grow
An FDA approval for ATEVs to be used for vascular trauma would allow Humacyte to grow substantially, adding roles in R&D as well as in manufacturing and commercialization. But while Humacyte is under review for its first FDA approval, it isn’t likely to be their last. Humacyte has also conducted phase 3 clinical trials with ATEVs to treat kidney failure.
“We’re expecting to announce later this quarter, results on a kidney dialysis trial (for) patients with kidney failure, who’ve gotten our vessels for hemodialysis,” Niklason said. “And you know, if those trial results are positive, that may be the next application that we send to the FDA.”
Since Niklason spoke with WUNC, the results of that trial were confirmed to be positive.
The company has also conducted phase 2 clinical trials for use with the ATEVs to treat peripheral artery disease, and are conducting clinical trials to test the ATEVs for use in other vascular diseases as well. The team Naegeli works with is even doing early stage preclinical tests to see if the ATEVs could be used to treat type I diabetes.
Additional FDA approvals would mean more growth for the company, Niklason said. “I would imagine that in the next couple years, we would have other indications that are approved, perhaps in dialysis, perhaps in PAD and because the hospitals and the surgeons that are treating the patients with trauma are the same surgeons and hospitals that are treating the patients with kidney failure and pad I actually expect that the uptake of the vessel and how much it’s used with the subsequent approvals will grow rapidly.”
