SEATTLE / Jul 09, 2024 / Business Wire / Pluristyx, a leading provider of tools, technologies, and services for the development of cellular therapies, is pleased to announce a license agreement with Humacyte, Inc., a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale. Humacyte has licensed Pluristyx’s clinical-grade PluriBank™ induced Pluripotent Stem Cell (iPSC) line as starting materials for manufacturing insulin-producing cells for their BioVascular Pancreas (BVP™) product candidate. This partnership includes access to Pluristyx’s revolutionary panCELLa™ platform that enables the generation of “hypoimmune” cells for clinical implantation. PluriBank™ iPSCs are derived from regulatory-compliant donors, extensively characterized, and expanded and banked to provide purity, identity, and genetic integrity for patient safety, available with custom edits and Pluristyx’s proprietary FailSafe® and iACT™ edits with a goal of providing improved safety and efficacy.

“The combination of Humacyte’s Acellular Tissue Engineered Vessel (ATEV™) with insulin-producing cells derived from Pluristyx’s best-in-class iPSC lines brings us one step closer to curing insulin dependent diabetes,” said Dr Benjamin Fryer, Pluristyx’s CEO. “We are excited to assist therapeutic developers in using clinical-grade PluriBank™ iPSC starting materials to bring Tomorrow’s Cell Therapies, Today®.”

The License Agreement grants Humacyte access to Pluristyx’s PluriBank™ cell lines for application in their BioVascular Pancreas development program. Pluristyx is also performing custom clinical gene editing on the iPSC line to generate a universally applicable line for all patients. The BVP is designed to revolutionize type 1 diabetes treatment by enabling delivery and survival of insulin-producing islets inside the body. The Acellular Tissue Engineered Vessel and the BVP are investigational products and have not been approved for sale by the Food and Drug Administration or any international regulatory agency.

About Pluristyx

Pluristyx, through its panCELLa™ platform, offers a portfolio of unique iPSC-based technologies, proprietary genetic engineering, and related tools, products, and services to provide end-to-end support throughout our customer’s product lifecycle. Pluristyx is the pioneering provider of immune system-tolerated and safety switch-enabled gene-edited iPSC and cell therapy solutions, accelerating customers’ path to clinic, and providing the best, fastest, and widest route to commercialization for cell-based therapeutic products. For more information on Pluristyx, please visit www.pluristyx.com.

About Humacyte

Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial opportunity, a portfolio of Acellular Tissue Engineered Vessels, is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, AV access for hemodialysis, and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm vessel for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm vessel for urgent arterial repair following extremity vascular trauma also has received RMAT designation. The Acellular Tissue Engineered Vessel also received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.