Benzinga | Nov 15, 2021 11:17AM EST

Humacyte Highlights Presentation Of 12-Month Data From Human Acellular Vessel Produced Using Commercial-Scale Manufacturing System

-- Performance of HAVs produced in the LUNA200(tm) commercial-scale system demonstrated efficacy that is similar to prior HAV performance in dialysis access trials --

-- 83% secondary patency observed at 12 months post-implantation --

-- Data presented today in keynote presentation at 6th World Congress of the Tissue Engineering and Regenerative Medicine International Society (TERMIS2021) --

Durham, N.C., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that data from a Phase 2 clinical trial of patients receiving the human acellular vessel (HAV) produced using its cutting-edge, large-scale manufacturing systems, known as "LUNA200", for vascular access in hemodialysis, demonstrated 12-month efficacy that is similar to trials of HAVs produced in the development-scale systems previously used in manufacturing the HAV.

The Phase 2, prospective, multicenter, open-label, single-arm study evaluated the safety, efficacy and immunogenicity of HAVs manufactured with the commercial-scale LUNA200 platform in 30 end-stage renal disease patients undergoing hemodialysis. One year after implantation, 83% of subjects still showed secondary, or functional, patency. Secondary patency rates of the HAVs produced using the prior, development-scale systems ranged from 82% to 89%. No instances of HAV rupture, aneurysm formation or acute mechanical failure were observed in the study. In addition, the HAV appears to resist infection as compared to synthetic conduits.

"Our LUNA200 commercial-scale manufacturing system is a groundbreaking bioengineering platform that represents the result of decades of work iterating our approach to be more modular, controlled and automated," said Laura Niklason, M.D., Ph.D., Founder, President and Chief Executive Officer of Humacyte. "We have demonstrated the LUNA200 functions comparably to our legacy systems, and this data demonstrates that manufacturing engineered tissues at commercial-scale is feasible, a critical milestone for our regenerative medicine platform and for Humacyte that supports our efforts toward commercialization of the HAV."

Each modular, automated LUNA200 system, with enhanced process controls, can grow 200 HAVs at a time. Humacyte's LUNA200 systems are housed in its 83,000-square-foot state-of-the-art bioprocessing facility in Durham, N.C., which has ample space to house enough systems to produce an annual capacity of approximately 40,000 HAVs per year. The Durham facility is fully operational, and in 2021 the FDA authorized the use of HAVs produced in the LUNA200 system to supply the Company's ongoing clinical trials in the United States. The facility also achieved compliance with EU good manufacturing practices (GMP) and Qualified Person Certification to allow product to be supplied to ongoing studies in Europe and Israel.

The 12-month data were presented at the 6th World Congress of the Tissue Engineering and Regenerative Medicine International Society (TERMIS2021). The secondary objective of this study is to evaluate the long-term safety and efficacy of the HAV manufactured with the LUNA system for up to 36 months after implantation, and the study is ongoing.