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– Performance of the HAVs produced in the LUNA200 â„¢ the commercial scale system demonstrated similar efficacy to previous performance of HAV in dialysis access trials –
– 83% secondary patency observed 12 months after implantation –
– Data presented today in a keynote presentation at the 6th World Congress of the Tissue Engineering and Regenerative Medicine International Society (TERMIS2021) –
Durham, NC, November 15, 2021 (GLOBE NEWSWIRE) – Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company that develops universally implantable bioengineered human tissues on a commercial scale , today announced that data from a Phase 2 clinical trial of patients receiving the human acellular vessel (HAV) produced using its advanced large-scale manufacturing systems, known as of “LUNA200”, for vascular access in hemodialysis, has demonstrated 12-month efficacy which is similar to assays for HAVs produced in developmental-scale systems previously used in the manufacture of HAV.
The phase 2, prospective, multicenter, open-label, single-arm study evaluated the safety, efficacy and immunogenicity of HAVs manufactured with the commercial LUNA200 platform in 30 patients with end-stage renal disease under hemodialysis. One year after implantation, 83% of subjects still had secondary or functional patency. Secondary patency rates of HAVs produced using prior developmental scale systems ranged from 82% to 89%. No cases of HAV rupture, aneurysm formation or acute mechanical failure were observed in the study. Additionally, HAV appears to resist infection compared to synthetic ducts.
“Our LUNA200 commercial scale manufacturing system is a revolutionary bioengineering platform that represents the result of decades of work iterating our approach to be more modular, controlled and automated,†said Laura Niklason, MD, Ph .D., Founder, President and CEO. Managing Director of Huacyte. “We have demonstrated the functions of LUNA200 in a manner comparable to our existing systems, and this data demonstrates that manufacturing modified tissues on a commercial scale is feasible, a critical step for our regenerative medicine platform and for Humacyte which supports our efforts towards commercialization of HAV. “
Each modular and automated LUNA200 system, with improved process controls, can develop 200 HAVs at a time. Humacyte’s LUNA200 systems are housed in its state-of-the-art 83,000 square foot bioprocessing facility in Durham, NC, which has enough 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 cleared the use of the HAVs produced in the LUNA200 System to power the Company’s ongoing clinical trials in the United States. The facility has also achieved compliance with EU Good Manufacturing Practices (GMP) and Qualified Person certification to enable supply of the product to ongoing studies in Europe and Israel.
The 12-month data was presented at the 6th World Congress of the Tissue Engineering and Regenerative Medicine International Society (TERMIS2021). The secondary objective of this study is to assess the safety and long-term efficacy of HAV made with the LUNA System up to 36 months after implantation, and the study is ongoing.
About HAV
Human acellular vessels (HAVs) are ready-to-use replacement vessels originally designed for vascular repair, reconstruction and replacement. HAV is intended to overcome long-standing limitations in repairing and replacing vascular tissue – it can be manufactured on a commercial scale, it eliminates the need to remove a vessel from a patient, and clinical evidence suggests that it is non-immunogenic, resistant to infection, and can grow into long-lasting living tissue. HAV is currently being evaluated in two phase 3 arteriovenous access trials and one phase 2/3 vascular trauma trial, and has been used in over 460 patient implantations. It is the first product to receive the Advanced Regenerative Medicine (RMAT) designation from the United States Food and Drug Administration (FDA) and has also received the Fast Track designation from the FDA.
About Humacyte
Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues and organs designed to improve patient lives and transform the practice of medicine. The Company develops and manufactures acellular tissue to treat a wide variety of illnesses, injuries and chronic illnesses. The initial opportunity for Humacyte, a human acellular vessel (HAV) portfolio, is currently in advanced clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous access for hemodialysis and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric cardiac surgery, the treatment of type 1 diabetes, and multiple new cellular and tissue applications. Humacyte’s HAVs were the first product to receive the accelerated review designation of Advanced Regenerative Therapy in Regenerative Medicine (RMAT) from the FDA and received priority designation for the treatment of vascular trauma by the U.S. Secretary for the Regenerative Medicine (RMAT). Defense. For more information visit www.humacyte.com.
Forward-looking statements
This press release contains forward-looking statements based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may”, “will”, “could”, “would”, “should”, “expect”, “intend”, “,” Believe “,” estimate “,” anticipate “,” project “,” potential “,” continue “,” in progress “or the negative of these terms or other comparable terminology, although all forward-looking statements do not contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to differ materially from the information expressed or implied by such forward-looking statements. While we believe we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that such statements are based on a combination of facts and factors known to us now and on our projections for the future, about which we cannot be certain. Forward-looking statements contained in this press release include, without limitation, statements regarding the initiation, timing, progress and results of our clinical trials; the characteristics and anticipated performance of our VHAs; our ability to successfully complete preclinical and clinical trials of our HAVs; the anticipated advantages of our HAVs over existing alternatives; the planned commercialization of our HAVs and our ability to manufacture on a commercial scale; the implementation of our business model and our strategic plans for our company; our rights and obligations under our partnership with Fresenius Medical Care; the extent of protection we are able to establish and maintain for intellectual property rights covering our HAVs and related technology; the timing or likelihood of regulatory filings and approvals; the timing, scope and rate of reimbursement of our HAVs; and our estimated available market opportunity. We cannot assure you that any forward-looking statements contained in this press release will prove to be correct. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, the impact of COVID-19 on Humacyte’s business. , changes in applicable laws or regulations, the possibility that Humacyte will be affected by other economic, business and / or competitive factors, and other risks and uncertainties, including those included under the heading ” risk â€in the registration statement on Form S-1 filed by Humacyte with the SEC. Most of these factors are beyond Humacyte’s control and are difficult to predict. In addition, if forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the material uncertainties in these forward-looking statements, you should not take such statements as a representation or guarantee by us or any other person that we will achieve our goals and plans within a specified time frame, or not at all. The forward-looking statements contained in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will change our perspective. However, although we may choose to update these forward-looking statements at any time in the future, we currently have no intention of doing so, except to the extent required by applicable law. Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.
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