RESEARCH TRIANGLE PARK – Humacyte, a regenerative medicine company based in Durham, has demonstrated that its human acellular vessels (HAVs) repopulate with a patient’s own cells to form a living vascular tissue.
The results of Humacyte’s work, published in the medical journal, Science Translational Medicine, suggest that the HAV may be an innovative advancement as a bioengineered vessel that develops characteristics of a living tissue over time.
The published study presents a comprehensive microscopic evaluation of HAV samples retrieved 16 weeks to 4 years after implantation in patients enrolled in the company’s Phase II clinical trials providing vascular access for hemodialysis.
Humacyte
The results were not entirely a surprise, according to Heather Prichard, Ph.D, Humacyte’s chief operating officer, “We had always hoped that by providing a biologic acellular vessel, the patient’s own body would respond by transforming the vessel into a cellular living blood vessel following implantation. However, no one has ever shown the regeneration of an acellular vessel in human patients. We’re really excited to see this hypothesis get realized through this published comprehensive study.”
The Science Translational Medicine article notes that “Vascular access is critically important for hemodialysis. An arteriovenous fistula generated from native blood vessels has long been thought to be optimal for long-term access; however, some people with kidney disease require vascular grafts.”
The study also showed evidence of ongoing cellular repair of HAV tissues that had been previously injured during cannulation with dialysis needles. These findings may suggest that the recellularized HAV is capable of self-healing, the company said.
Phase 3 trial compares HAV against fistulas
“An arteriovenous fistula is the connection of a patient’s own vein to an artery, which is surgically created for vascular access in hemodialysis patients with end-stage renal disease (ESRD), which is kidney failure,” Prichard said in response to questions from the North Carolina Biotechnology Center.
“The patients in this published study required renal replacement therapy and were not candidates for fistulas,” she added. “However, we do currently have a Phase 3 clinical trial comparing our HAV against fistulas. Since we have shown in this publication that our HAV becomes a living vessel similar to a fistula, we believe we have the possibility to be the first line of treatment for many hemodialysis patients.”
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There are approximately 660,000 ESRD patients in the US. About 468,000 of them must undergo hemodialysis procedures to eliminate deadly toxins from blood in order to stay alive.
Traditional vascular grafts constructed from synthetic polymers, cadaveric human or animal tissues are currently used to create vascular access for patients, but those often come with serious complications.
“Alternative solutions are needed to establish durable long-term vascular access for dialysis with reduced infection rates and lower complications, and help patients obtain better quality of health care,” Prichard explained.
Humacyl platform technology engineers the tissues
Humacyte uses a proprietary platform technology known as Humacyl to engineer human, extracellular matrix-based tissues that can be shaped into tubes, sheets or particulate conformations, with properties similar to native tissues.
The resulting HAVs could potentially be used in hospitals as readily available, off-the-shelf products when needed. They are intended to improve patient efficacy, safety and treatment outcomes.
The U.S. Food and Drug Administration gave the company’s HAVs a Fast Track designation in 2014 and granted Humacyte the Regenerative Medicine Advanced Therapy (RMAT) designation in 2017.
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Humacyte is currently supporting two Phase 3 trials across 40 sites in the U.S., Europe and Israel. The studies are evaluating the efficacy and safety of the blood vessel as a conduit for hemodialysis in patients with ESRD requiring renal replacement therapy. It expects to release results from a pivotal Phase 3 trial later this year.
Exploring additional clinical indications, the company is conducting a U.S. Phase 2 clinical trial, investigating use of the HAVs as an arterial bypass vessel in patients with peripheral arterial disease (PAD) and a U.S. Phase 2 vascular trauma clinical trial, investigating the HAVs for vascular repair in trauma patients, an indication of particular interest to the U.S. military.
Company is well-financed
Humacyte was founded in 2004 by Laura Niklason, M.D., Ph.D., together with co-founders Shannon Dahl and Juliana Blum.
The North Carolina Biotechnology Center awarded Humacyte a $150,000 Small Business Research Loan in 2006. Now the company is funded by a global consortium of investors, raising $480 million to date. In 2015 it raised $150 million in a Series B preferred stock financing ̶ among the largest ever by a life science company in North Carolina. In March 2018 it raised another $75 million in a Series C preferred stock financing, led by a consortium of private and new investors.
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In June last year, Humacyte formed a global partnership with Fresenius Medical Care, the world’s largest provider of dialysis products and services. It received a $150 million equity investment as part of the deal, while Fresenius obtained exclusive global rights to commercialize Humacyl, and took a 19 percent ownership stake in Humacyte.
Also in 2018, Humacyte completed construction of a new, state-of-the-art research and development and bioprocessing facility in Durham. The company has 140 employees and said it continues to increase its headcount.
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