After raising $150 million in one of the state’s largest ever biotech fundings in 2015, Triangle-based Humacyte has added another $10 million from the California Institute for Regenerative Medicine.
The funding will support the upcoming global phase three clinical trials of Humacyte’s investigational human acellular blood vessel, HUMACYL. Humacyte is engineering the implantable blood vessels from the vessel cells of donors. The technology has received U.S. Food and Drug Administration fast-track designation, to streamline the approval process.
The California institute has more than $3 billion in funding and is involved in some 300 stem cell programs. The CIRM, as it is known, is touted as “the world’s largest institution dedicated to helping people by bringing the future of cellular medicine closer to reality.”
CIRM obviously sees considerable potential in Humacyte’s science. Humacyte is based in Morrisville.
“This approach has the potential to significantly improve our ability to care for people with kidney disease,” says C. Randal Mills, CEO of CIRM, in the funding announcement. “Being able to reduce infections and clotting problems, and increase the consistency of care hemodialysis patients get, would meaningfully impact the quality of their lives.”
The trial will include 350 patients and cover some 35 sites acrous the U.S., Europe and Israel.
“We are honored to earn this investment from CIRM,” said Carrie Cox, Humacyte’s chair and CEO. “We’ve achieved a significant milestone for the company with the commencement of our Phase III clinical trial. These funds will greatly help us make strides in the development of our bioengineered human acellular vessel.”
The backstory
Humacyte is developing HUMACYL for patients suffering from the severe kidney deterioration called end stage renal disease. The patients require hemodialysis, a process of cleansing blood, because their kidneys no longer function adequately, Jim Shamp, NC Biotech Writer, reported last fall.
The funding will also support Humacyte’s development of future tissue-replacement products with the potential to improve treatment outcomes in such procedures as coronary artery bypass, trachea and esophagus replacements, and bypass surgeries to treat peripheral arterial disease.
Humacyte was founded in 2004 by Laura Niklason, M.D., Ph.D., a world leader in tissue engineering and creator of Humacyte’s technology.
Humacyte received the fast track designation for HUMACYL for vascular access in hemodialysis patients from the U.S. Food and Drug Administration in 2014.
Subsequent to the initial NCBiotech awarding of the $150,000 Small Business Research Loan to Humacyte in 2006, the company also has raised about $50 million in debt financing and another $4.5 million in federal research funding.
