INTRODUCTION RESULTS OBJECTIVES CONCLUSIONS CONTACT & ACKNOWLEDGEMENTS REFERENCES Scientific and medical understanding are essential for bringing regenerative medicine products to the clinic. Furthermore, translation of regenerative medicine products requires cutting-edge technology, scaled manufacturing, and clinical trial and regulatory expertise. Since its founding in 2005, Humacyte has worked to sequentially solve the translational hurdles related to the production of Human Acellular Vessels, or HAVs. Humacyte’s platform involves the use of differentiated human vascular cells that are cryopreserved and are leveraged to generate engineered vascular tissues of a shape and size dictated by the bioreactor and polymer scaffolding of our manufacturing process. To date, HAVs have been implanted into more than 450 patients having diseases ranging from kidney failure, to peripheral arterial disease, to vascular trauma. MATERIALS & METHODS At Month 3, primary patency and primary assisted patency were maintained in 29 of 30 subjects, and all subjects showed secondary graft patency. HAV infections and indications of mechanical failure or weakness of the HAV were not observed. The percentage of subjects who exhibited elevation from Baseline in Class I PRA levels at Month 2 (7%) is consistent with previous clinical studies of Aura- or Terra-produced HAVs in patients requiring hemodialysis (6%). At Month 12 (Day 365), primary patency was observed in 17 subjects (57%), primary assisted patency in 19 subjects (63%), and secondary graft patency in 23 subjects (77%). The Kaplan-Meier probabilities to retain patency at Month 12 were 60% for primary, 67% for primary assisted, and 83% for secondary patency. The proportion of subjects who exhibited elevation from Baseline in PRA levels at Month 12 (33%) is higher than in previous clinical studies of Aura- or Terra-produced HAVs in patients requiring hemodialysis (6%). However, PRA levels subsequently decreased back to baseline over time in the majority of patients and the increase in PRA levels across all subjects were found not to be attributed to the HAV. This was a Phase 2, prospective, multicenter, open-label, single-arm study in subjects with end-stage renal disease (ESRD) who required hemodialysis and were targeted for implantation of an arteriovenous (AV) graft for dialysis access. A total of 30 eligible subjects were enrolled, received a human acellular vessel (HAV) on Day 0, and were followed up for 12 months post-implantation regardless of the HAV’s patency status at routine study visits scheduled at Day 7, Day 28, Month 2, Month 3, Month 6 and Month 12. After 12 months, only subjects with a patent HAV will be followed up (while the HAV remains patent) at study visits every 6 months for up to 3 years (36 months). The primary analysis was performed after the last subject completed 3 months of follow-up. A second analysis was performed after all subjects had completed 12 months of follow-up. The final analysis will be performed after the last subject has completed 36 months of follow-up. The HAVs for this Phase 2 study were produced in the Luna200 system. The Luna200 equipment consists of 4 cage fluidic modules (CFM), housed in an incubator, which controls the temperature of the system to support the HAV growth and decellularization stages. Each CFM consists of five (5) drawers, and each drawer contains ten (10) bioreactor bags. The materials management module (MMM) supplies each CFM with culture media from a media reservoir to maintain cell growth. The MMM also delivers process gases, decellularization buffers, and removes waste from the CFMs. A network of tubing sets, control valves, flow controllers, pressure sensors, and fluid pumps are used to supply culture media, process gases, and decellularization buffers to the bioreactor bags for HAV production. A control panel is used to run automated batch recipes that control and monitor the Luna200 system. The primary objective of this study is to evaluate the safety, efficacy and immunogenicity over 3 months after implantation of HAVs manufactured using the commercial manufacturing system LUNA. The secondary objective of this study is to evaluate the long-term safety and efficacy of the HAV (manufactured with the LUNA system) over a period of up to 36 months after implantation. Funding was provided by Humacyte, Inc. We thank our Clinical Operations team. Please reach out to clinical@humacyte .com with further questions or inquiries. § At Month 12, primary patency and primary assisted patency were maintained in 17 and 19 subjects, respectively, and 23 subjects still showed secondary graft patency. § HAV infections and indications of mechanical failure or weakness of the HAV were not observed. § Overall, the results of the LUNA-produced HAV to date do not indicate any particular safety or immunogenicity issues. § These data show that HAVs, produced in the commercial-scale manufacturing system, function as expected when used as dialysis access grafts. SAFETY, EFFICACY, AND IMMUNOGENICITY ASSESSMENT OF HUMACYTE’S HUMAN ACELLULAR VESSEL FOR DIALYSIS VASCULAR ACCESS: LUNA SYSTEM Jeffrey Lawson 1 , Jakub Turek 2 , Wojciech Witkiewicz 3 , Maciej Zielinski 4 1 Humacyte, Inc., Durham NC, 2 The Regional Specialist Hospital of Wroclaw, Poland, 3 Poznan University of Medical Sciences 1. Bylsma LC et al, Eur J Vasc Endovasc Surg (2017) 54, 513e522 2. Chang WG & Niklason LE, NPJ Regen Med. 2017 ; 2: . doi:10.1038/s41536-017-0011-6. 3. Dahl SL, et al., Cell Transplant. 2003;12(6):659-66. 4. Lawson J, et al. Lancet 2016; 387: 2026–34