Humacyte Announces U.S. Patent Allowance for BioVascular Pancreas (BVP™)

Humacyte Inc., a clinical-stage biotechnology firm focused on developing bioengineered human tissues, has announced the allowance of a U.S. Patent for its BioVascular Pancreas (BVP) product candidate, aimed at treating type 1 diabetes. This patent, titled "Bioartificial Vascular Pancreas," covers the design and composition of the BVP, and is owned by Yale University but exclusively licensed to Humacyte. The BVP utilizes Humacyte’s investigational acellular tissue engineered vessel (ATEV™) to deliver and maintain the survival of insulin-producing islets within the body.

Type 1 diabetes affects approximately 1.45 million Americans, with around 64,000 new cases diagnosed annually. The global prevalence of this condition is increasing, presenting a substantial economic burden and requiring continuous blood sugar monitoring and insulin management for affected individuals. Despite the capability of insulin management to regulate blood glucose levels, the lifelong necessity of such monitoring poses significant challenges for patients lacking their own islets to automatically control blood sugar levels.

The BVP is designed to improve the implantation and survival of insulin-producing islets, which could revolutionize the treatment of diabetes. In June 2024, Humacyte shared promising results from preclinical studies indicating the potential effectiveness of the BVP in delivering insulin-producing islets. During the Breakthrough T1D Beta Cell Consortium Meeting, Humacyte scientists presented data showing that stem cell-derived islets could restore normal blood sugar levels in diabetic mice. These islets, derived from human stem cells, could serve as the foundation for those ultimately delivered through the BVP.

Furthermore, at the American Diabetes Association annual meeting, Humacyte reported successful BVP implantation in non-human primates. The study demonstrated islet survival and sustained insulin production over three months, with the islets developing capillaries to support the survival of insulin-producing cells. These findings underscore the BVP's potential to transform diabetes care by providing a reliable method for islet implantation and survival.

"The recent presentations of preclinical results highlight the potential of the BVP to improve the care of patients with type 1 diabetes," stated Laura Niklason, M.D., Ph.D., CEO of Humacyte. "We are pleased to achieve this significant milestone in U.S. patent protection in collaboration with Yale University, and we look forward to continuing our efforts to advance this critical initiative."

Humacyte is known for its disruptive biotechnology platform, which aims to deliver universally implantable bioengineered human tissues and organ systems to enhance patient care and medical practices. The company's initial product candidates, part of a portfolio of ATEVs, are in late-stage clinical trials for various vascular applications, including trauma repair, arteriovenous (AV) access for hemodialysis, and peripheral artery disease. Humacyte’s 6mm ATEV received the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation, the first of its kind, and has also been granted FDA Fast Track designation. Additionally, the ATEV has received priority designation for vascular trauma treatment by the U.S. Secretary of Defense.

While the ATEV and BVP are still investigational and have not yet received approval for sale from the Food and Drug Administration or any international regulatory body, the promising preclinical results and patent allowance mark significant strides in Humacyte's efforts to develop advanced treatments for type 1 diabetes and other conditions.