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- New U.S. patent covers the design and composition of the BVP -

-新的美国专利涵盖了BVP的设计和组成-

- Positive results from ongoing preclinical studies support the potential of the BVP to deliver insulin-producing islets as a potential treatment for type 1 diabetes -

-正在进行的临床前研究的积极结果支持BVP提供产生胰岛素的胰岛作为1型糖尿病潜在治疗方法的潜力-

DURHAM, N.C., Sept. 19, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced the allowance of a U.S. Patent covering its BioVascular Pancreas (BVP) product candidate for the treatment of type 1 diabetes.

北卡罗来纳州达勒姆，2024年9月19日（环球通讯社）--Humacyte，Inc.（纳斯达克：HUMA），一家临床阶段生物技术平台公司，以商业规模开发通用植入式生物工程人体组织，今天宣布允许其生物血管胰腺（BVP）候选产品用于治疗1型糖尿病的美国专利。

The BVP is designed to enable the delivery and survival of insulin-producing islets inside the body, using Humacyte’s investigational acellular tissue engineered vessel (ATEV™) as a carrier for the islets. The new U.S. Patent, titled “Bioartificial Vascular Pancreas,” covers the design and composition of the BVP.

BVP旨在使用Humacyte的研究性无细胞组织工程血管（ATEV™）作为胰岛的载体，使体内产生胰岛素的胰岛得以输送和存活。这项新的美国专利名为“生物人工血管胰腺”，涵盖了BVP的设计和组成。

The patent is owned by Yale University and is exclusively licensed to Humacyte..

该专利归耶鲁大学所有，仅授权给Humacyte。。

Approximately 1.45 million Americans are currently living with type 1 diabetes, with 64,000 more Americans diagnosed each year. The incidence of type 1 diabetes is on the rise worldwide, impacting the lives of millions and causing significant economic burden. The disease requires constant vigilance and measurement of blood sugars, with patients having to continuously balance insulin intake throughout the day.

目前约有145万美国人患有1型糖尿病，每年有64000多名美国人被诊断出患有1型糖尿病。1型糖尿病的发病率在全球范围内呈上升趋势，影响了数百万人的生活，并造成了巨大的经济负担。这种疾病需要不断提高警惕并测量血糖，患者必须全天持续平衡胰岛素摄入量。

While insulin management can regulate blood glucose levels and keep people alive, continuous and lifelong monitoring of blood sugar is difficult for patients who have no islets of their own to automatically control blood sugar levels..

虽然胰岛素管理可以调节血糖水平并使人存活，但对于没有自己胰岛的患者来说，很难连续终身监测血糖以自动控制血糖水平。。

The BVP is designed to enable the delivery and survival of insulin-producing islets inside the body. Such technology could overcome many of the hurdles currently associated with implantation of islets into diabetic patients. In June 2024, Humacyte reported positive results from two sets of ongoing preclinical studies, supporting the potential of the BVP product candidate to deliver insulin-producing islets as a treatment for type 1 diabetes.

BVP旨在使体内产生胰岛素的胰岛能够输送和存活。这种技术可以克服目前与将胰岛植入糖尿病患者相关的许多障碍。2024年6月，Humacyte报告了两组正在进行的临床前研究的阳性结果，支持BVP候选产品提供产生胰岛素的胰岛作为1型糖尿病治疗的潜力。

At a presentation at the Breakthrough T1D Beta Cell Consortium Meeting, Humacyte’s scientists presented data in which stem cell-derived islets restored normal blood sugar in diabetic mice. Islets manufactured from human stem cells may provide the basis for the islets that are ultimately delivered using the BVP product candidate.

在突破性T1Dβ细胞联盟会议上的一次演讲中，Humacyte的科学家介绍了干细胞衍生的胰岛恢复糖尿病小鼠正常血糖的数据。由人类干细胞制造的胰岛可能为最终使用BVP候选产品递送的胰岛提供基础。

At the American Diabetes Association annual meeting, Humacyte reported successful implantation of BVPs into non-human primate recipients. In the study, primate BVP implants showed islet survival and continued insulin production throughout the three-month duration of the study. Islets also developed capillaries to support survival of the insulin-producing cells..

在美国糖尿病协会年会上，Humacyte报道了将BVP成功植入非人灵长类动物受体中。在这项研究中，灵长类BVP植入物在整个研究的三个月期间显示出胰岛存活和持续的胰岛素产生。胰岛还形成毛细血管以支持胰岛素产生细胞的存活。。

“The recent presentations of preclinical results highlight the potential of the BVP to improve the care of patients with type 1 diabetes, and we look forward to continuing advancement of this important initiative aimed at treating patients with a profoundly debilitating disease,” said Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte.

。

“As development has progressed, we are pleased to achieve, in collaboration with Yale University, this major milestone in the U.S. patent protection of our BVP product candidate.”.

“随着开发的进展，我们很高兴与耶鲁大学合作，在美国专利保护BVP候选产品方面取得了这一重大里程碑。”。

The ATEV and BVP are investigational products and have not been approved for sale by the Food and Drug Administration or any international regulatory agency.

ATEV和BVP是研究产品，尚未获得食品和药物管理局或任何国际监管机构的批准销售。

About Humacyte

关于腐殖酸盐

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，Inc.（纳斯达克股票代码：HUMA）正在开发一个颠覆性的生物技术平台，以提供普遍植入的生物工程人体组织，先进的组织构建体和器官系统，旨在改善患者的生活并改变医学实践。该公司开发和制造无细胞组织，用于治疗各种疾病、伤害和慢性病。

Humacyte’s initial product candidates, a portfolio of ATEVs, are currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous (AV) access for hemodialysis, and peripheral artery disease. A Biologics License Application for the ATEV in the vascular trauma indication is currently under review by the FDA and was granted Priority Review.

。目前，FDA正在审查ATEV在血管创伤适应症中的生物制剂许可证申请，并获得优先审查。

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 ATEV 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.

冠状动脉旁路移植术，儿科心脏手术，1型糖尿病治疗以及多种新型细胞和组织应用的临床前开发也在进行中。Humacyte用于血液透析AV通路的6mm ATEV是第一个获得FDA再生医学高级治疗（RMAT）指定的候选产品，并且还获得了FDA快速通道指定。

Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received an RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com..

Humacyte的6mm ATEV用于肢体血管创伤后的紧急动脉修复和高级PAD也已获得RMAT指定。ATEV被美国国防部长优先指定用于治疗血管创伤。。。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements that are 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,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.

本新闻稿包含基于信念和假设以及当前可用信息的前瞻性声明。在某些情况下，您可以通过以下词语来识别前瞻性陈述：“可能”，“将”，“可能”，“将”，“应该”，“期望”，“打算”，“计划”，“预期”，“相信”，“估计”，“预测”，“项目”，“潜在”，“继续”，“正在进行”或这些术语或其他类似术语的否定词，尽管并非所有前瞻性陈述都包含这些词语。

These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain.

这些声明涉及风险、不确定性和其他因素，这些因素可能导致实际结果、活动水平、绩效或成就与这些前瞻性声明所表达或暗示的信息存在重大差异。。

Forward-looking statements in this press release include, but are not limited to, the statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials, including our BVP program; the anticipated characteristics and performance of our ATEV and the BVP; our ability to successfully complete preclinical and clinical trials for our ATEVs and the BVP; the anticipated benefits of the BVP relative to existing alternatives; the anticipated commercialization of our ATEVs and our ability to manufacture at commercial scale; the implementation of our business model and strategic plans for our business; and the timing or likelihood of regulatory filings, acceptances, and approvals.

本新闻稿中的前瞻性声明包括但不限于关于我们的临床前和临床试验（包括我们的BVP计划）的开始，时间，进展和结果的声明；；我们成功完成ATEV和BVP的临床前和临床试验的能力；BVP相对于现有替代方案的预期收益；我们ATEV的预期商业化以及我们的商业规模制造能力；我们业务模式和战略计划的实施；以及监管备案、接受和批准的时间或可能性。

We cannot assure you .

我们不能向你保证。

Humacyte Investor Contact:Joyce AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.cominvestors@humacyte.com

Humacyte投资者联系人：Joyce AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.cominvestors@humacyte.com

Humacyte Media Contact:Rich LuchettePrecision Strategies+1-202-845-3924rich@precisionstrategies.commedia@humacyte.com

Humacyte媒体接触：Rich-LuchettePrecision策略+1-202-845-3924rich@precisionstrategies.commedia@humacyte.com

Source: Humacyte, Inc

资料来源：Humacyte，Inc