Science Translational Medicine Publishes Results That Humacyte’s “Human Acellular Vessels Recellularize and Evolve into Living Blood Vessels following Human Implantation”

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–Humacyte,
an innovator in biotechnology and regenerative medicine, announced
publication in the medical journal Science
Translational Medicine, of pivotal scientific work demonstrating
Humacyte’s human acellular vessels (HAVs) repopulate with the patient’s
own cells to form a living vascular tissue. 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. The
results suggest that the HAV may be an innovative advancement as a
bioengineered vessel that develops characteristics of a living tissue
over time.

Heather Prichard, Ph.D., Humacyte’s Chief Operations Officer and former
Senior Vice-President of Product Development, is the senior author of
the report. Science Translational Medicine, a weekly
peer-reviewed medical journal, is one of the world’s leading medical
publications devoted to publishing research and issues of strong
interest to the translational medicine community.

Humacyte’s HAVs received the FDA’s
Fast Track Designation in 2014 and the Regenerative
Medicine Advanced Therapy (RMAT) designation in 2017. The
foundational scientific data published today provides support for the
biocompatibility and regenerative nature of the HAV in patients. The
HAVs are acellular at the time of implantation into human recipients.
However, according to the published analysis of clinical tissue samples,
the HAVs became populated with numerous types of the patient’s own
cells. Over time, the patient’s cells transform the HAV into a
multi-layered living tissue similar to native blood vessels. 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.

“As a regenerative medicine product, we’re excited to see evidence of
functional tissue recellularization in actual patients, which may have
the potential to enhance long term efficacy and safety,” said Dr.
Prichard.

Highlights from the Published Study Include:

• Scanning electron microscopy shows that the HAV is composed of
  densely-packed and aligned extracellular matrix fibers.
• Following implantation, histological evidence demonstrated
  recellularization of the HAVs over time, with multiple cell
  populations from the patient. Cell types identified include smooth
  muscle and endothelial progenitor cells that mature over time. The
  histological evidence also suggests that these cells may form distinct
  tissue layers in the HAV similar to that of native blood vessels.
  These layers include a surrounding neoadventitial layer containing
  microcapillaries and progenitor cells, a dense and circumferentially
  aligned medial smooth muscle layer, and the presence of a potentially
  functional endothelium on the lumen.
• Regions of the HAV wall that were previously injured or disrupted by
  needle cannulation during dialysis showed evidence of restoration by
  host cell populations, which suggests a self-healing potential of
  recellularized HAVs.
• No evidence of adverse inflammatory or immune reaction to the HAV was
  observed in the clinical tissue samples.

Humacyte is currently supporting two Phase
III 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 End-Stage Renal Disease (ESRD)
requiring renal replacement therapy. To explore additional clinical
indications, the company is also conducting a U.S. Phase II clinical
trial, investigating use of the HAVs
as an arterial bypass vessel in patients with peripheral arterial
disease (PAD) and a U.S. Phase
II vascular trauma clinical trial, investigating the HAVs in the
setting of vascular trauma in patients who require vascular repair.

Additional Authors: Robert D. Kirkton Ph.D., Maribel
Santiago-Maysonet B.A. HTL, Jeffrey H. Lawson M.D. Ph.D., William E.
Tente M.S., Shannon L.M. Dahl Ph.D., and Laura E. Niklason, M.D. Ph.D.

About Humacyte:

Humacyte, Inc., a privately held company founded by Dr. Laura E.
Niklason, M.D., Ph.D., in 2004, is a medical research, discovery and
development company with clinical and pre-clinical stage investigational
products. Humacyte is primarily focused on developing and
commercializing a proprietary novel technology based on human
tissue-based products for key applications in regenerative medicine and
vascular surgery. The company uses its innovative, proprietary platform
technology to engineer human, extracellular matrix-based tissues that
can be shaped into tubes or sheets, with properties similar to native
tissues. These are being developed for potential use in many specific
applications, with the goal to significantly improve treatment outcomes
for many patients, including those with vascular disease and those
requiring hemodialysis. The company’s proprietary technologies are
designed to create off-the-shelf products that, once approved, can be
utilized in any patient. The company web site is www.humacyte.com.

All statements, other than statements of historical fact, included in
this announcement are forward-looking statements. In some cases, you can
identify forward-looking statements by terminology such as “will”,
“anticipate”, “expect”, “believe”, “intend” and “should” or the negative
of these terms or other comparable terminology. These statements relate
to future events or Humacyte’s clinical development programs, reflect
management’s current beliefs and expectations and involve known and
unknown risks, uncertainties and other factors that may cause Humacyte’s
actual results, performance or achievements to be materially different.
Except as required by law, Humacyte assumes no obligation to update
these forward-looking statements.

Contacts

Media Contact:
Nirav Suchak
ICR, PR for Humacyte
646.277.1257
[email protected]