UB-312 is the first Parkinson's candidate to reduce pathology as measured by a seed amplification assay, and suggest clinical improvement on motor experiences of daily living.

UB-312是第一个通过种子扩增测定法减少病理的帕金森氏病患者，并建议临床改善日常生活的运动体验。

Data demonstrates target engagement and immunogenicity of the active immunotherapy UB-312 targeting pathological alpha-synuclein.

数据显示靶向病理性α-突触核蛋白的主动免疫疗法UB-312的靶标参与和免疫原性。

CAPE CANAVERAL, Fla., June 20, 2024 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (OTC: VAXX), a U.S. company pioneering the development of a new class of medicines known as AIMs (active immunotherapy medicines), announced today that Nature Medicine has published groundbreaking exploratory data from the Company’s Phase 1 clinical trial of UB-312 in patients with Parkinson's disease (PD).

佛罗里达州卡纳维拉尔角（CAPE CANAVERAL），2024年6月20日（GLOBE NEWSWIRE）--Vaxxinity，Inc.（OTC:VAXX），一家美国公司，率先开发一类新的药物，称为AIMs（主动免疫治疗药物），今天宣布Nature Medicine发布了该公司在帕金森病（PD）患者中进行的UB-312第一阶段临床试验的开创性探索性数据。

The successful trial included measures of clinical efficacy, as well as exploratory research funded by The Michael J. Fox Foundation (MJFF) assessing target engagement in collaboration with the Mayo Clinic and UTHealth Houston..

这项成功的试验包括临床疗效的测量，以及由迈克尔·福克斯基金会（MJFF）资助的探索性研究，该基金会与梅奥诊所和UTHealth休斯顿合作评估目标参与度。。

UB-312-induced antibodies significantly decreased levels of aggregated α-synuclein (αSyn), a key pathology in PD and other synucleinopathies, as measured by a semi-quantitative seed amplification assay (SAA). This suggests that UB-312 can help to eliminate the buildup of harmful, toxic forms of the protein αSyn in the brain.

通过半定量种子扩增测定（SAA）测量，UB-312诱导的抗体显着降低了聚集的α-突触核蛋白（αSyn）的水平，这是PD和其他突触核蛋白病的关键病理。这表明UB-312可以帮助消除大脑中有害的有毒形式的蛋白质αSyn的积累。

Patients with detectable UB-312-induced antibodies in cerebrospinal fluid (CSF) exhibited significant improvement in motor experiences of daily living as measured by the MDS-UPDRS Part II, a commonly accepted clinical scale. This marks a potentially significant milestone in the pursuit of innovative PD care.

通过MDS-UPDRS第二部分（一种普遍接受的临床量表）测量，脑脊液（CSF）中可检测到UB-312诱导抗体的患者在日常生活中的运动体验方面表现出显着改善。这标志着追求创新PD护理的潜在重要里程碑。

The Phase 1 successfully met its primary outcome measures, demonstrating UB-312 was generally well-tolerated and induced anti-αSyn antibody responses in healthy volunteers and PD patients. 12 out of 13 PD patients who completed dosing developed anti-αSyn antibodies..

第一阶段成功地达到了其主要结局指标，证明UB-312在健康志愿者和PD患者中通常具有良好的耐受性并诱导了抗αSyn抗体反应。完成给药的13名PD患者中有12名产生了抗αSyn抗体。。

“The publication of this data in Nature Medicine immortalizes the profound impact of UB-312, leading the charge against the very core of Parkinson’s,” added Lou Reese, Co-Founder and Executive Chairman of Vaxxinity. “It sparks a beacon of hope and anticipation for a future where Parkinson's no longer determines the trajectory of lives.

Vaxxinity联合创始人兼执行主席卢·里斯（LouReese）补充道：“这一数据在《自然医学》杂志上的发表使UB-312的深远影响永生不衰，导致了对帕金森氏症核心的指控。”。。

This is more than just a scientific breakthrough; it's a battle cry for change, declaring that the status quo in Parkinson's care is no longer acceptable.'.

这不仅仅是一项科学突破；这是一场变革的呐喊，宣告帕金森病护理的现状不再可接受。”。

Parkinson’s disease, a progressive neurodegenerative condition, currently lacks an approved disease-modifying treatment. Alpha-synuclein, a key protein in PD pathology, forms aggregates known as Lewy bodies that contribute to neuronal degeneration. UB-312 is designed to stimulate a targeted immune response against pathological forms of αSyn..

帕金森氏病是一种进行性神经退行性疾病，目前缺乏经批准的疾病缓解治疗方法。α-突触核蛋白是PD病理学中的关键蛋白，形成称为路易体的聚集体，导致神经元变性。UB-312旨在刺激针对αSyn病理形式的靶向免疫应答。。

Notable highlights from the exploratory Phase 1 data published in Nature Medicine include:

《自然医学》上发表的探索性第一阶段数据的显著亮点包括：

Two exploratory CSF biomarkers show promise as measures of target engagement.

两种探索性脑脊液生物标志物有望作为目标参与的衡量指标。

aggregated αSyn, as measured by an SAA

聚集的αSyn，由SAA测量

phosphorylated αSyn (pS129-αSyn)

磷酸化的aSyn（pS129-aSyn）

PD patients with UB-312-induced antibodies in CSF had significantly less αSyn aggregation (p <0.01) and pS129-αSyn (p <0.05) compared to patients without detectable CSF antibody titers.

与未检测到CSF抗体滴度的患者相比，脑脊液中UB-312诱导抗体的PD患者的αSyn聚集（p＜0.01）和pS129-αSyn（p＜0.05）明显减少。

PD patients with UB-312-induced antibodies in CSF showed significant improvement in the MDS-UPDRS Part II motor experiences of daily living compared to patients without detectable CSF antibody titers (p<0.05).

与未检测到脑脊液抗体滴度的患者相比，脑脊液中有UB-312诱导抗体的PD患者的MDS-UPDRS第二部分日常生活运动体验显着改善（p＜0.05）。

In vitro, UB-312-induced antibodies preferentially bind to aggregated forms of αSyn as measured by dot blot, and slow the aggregation of αSyn as measured by seed amplification.

在体外，通过斑点印迹法测量，UB-312诱导的抗体优先与聚集形式的αSyn结合，并通过种子扩增法测量，减缓αSyn的聚集。

”UB-312 has the potential to become an important and potent disease-modifying therapy for Parkinson’s disease. It would be truly amazing if we could vaccinate people against Parkinson’s disease in the future!” says Professor Geert Jan Groeneveld, neurologist and principal investigator of the Phase 1 clinical trial performed at the Centre for Human Drug Research in Leiden, the Netherlands..

“UB-312有可能成为帕金森病的重要且有效的疾病缓解疗法。如果我们能在未来为人们接种帕金森氏病疫苗，那将真是太棒了！”在荷兰莱顿人类药物研究中心进行的第一阶段临床试验的神经学家兼首席研究员吉尔特·扬·格罗内维尔德教授说。。

The publication in Nature Medicine follows the completion of Part B of the Phase 1 clinical trial, which involved 20 patients with early PD (Hoehn & Yahr stage ≤ III) dosed with one of two priming regimens of UB-312 or placebo, and followed for 24 weeks of observation. Vaxxinity plans to continue its research and development efforts to advance UB-312 as candidate for PD.

《自然医学》杂志的发表是在完成第一阶段临床试验的B部分之后进行的，该试验涉及20名早期PD（Hoehn＆Yahr分期≤III）患者，他们服用了UB-312或安慰剂的两种启动方案之一，随后进行了24周的观察。Vaxxinity计划继续其研发工作，以推动UB-312成为PD的候选人。

Results from Part A of the trial in 50 healthy volunteers, aged 40 to 85 years, were published in Movement Disorders in 2022 (Yu et al.). The exploratory biomarker and target engagement research portion of the trial was funded by The Michael J. Fox Foundation (MJFF), and marked a two-year collaborative project between Vaxxinity, the Mayo Clinic, and UTHealth Houston to analyze CSF collected from patients..

2022年，50名年龄在40至85岁之间的健康志愿者的A部分试验结果发表在《运动障碍》（Yu等人）上。该试验的探索性生物标志物和目标参与研究部分由迈克尔·福克斯基金会（MJFF）资助，标志着Vaxxinity，梅奥诊所和UTHealth Houston之间的一个为期两年的合作项目，用于分析从患者身上收集的脑脊液。。

About UB-312

关于UB-312

UB-312 is an AIM designed to slow or stop Parkinson's progression by addressing the root cause of the disease. In the first patient trial, it safely induced antibodies against toxic alpha-synuclein (αSyn) aggregates, representing a potential disease-modifying therapy. It is the first active immunotherapy to demonstrate target engagement in patient CSF using the αSyn seed amplification assay..

UB-312旨在通过解决帕金森病的根本原因来减缓或阻止帕金森病的进展。在第一项患者试验中，它安全地诱导了针对有毒α-突触核蛋白（αSyn）聚集体的抗体，代表了一种潜在的疾病缓解疗法。。。

About Vaxxinity

关于Vaxxinity

Vaxxinity, Inc. is a purpose-driven biotechnology company committed to democratizing healthcare across the globe. The company is pioneering a new class of medicines known as AIMs (active immunotherapy medicines) with the goal of disrupting the existing treatment paradigm for chronic disease, increasingly dominated by monoclonal antibodies, which suffer from prohibitive costs and cumbersome administration.

Vaxxinity，Inc.是一家目标驱动的生物技术公司，致力于全球医疗保健民主化。该公司正在开创一种名为AIMs（主动免疫治疗药物）的新型药物，旨在打破慢性病的现有治疗模式，这种治疗模式越来越多地由单克隆抗体主导，单克隆抗体成本高昂，管理繁琐。

The company’s proprietary AIM technology platform has enabled the innovation of novel synthetic peptide immunotherapy candidates designed to bring the efficiency of active immunotherapies to the treatment of chronic diseases, including Alzheimer’s disease, Parkinson’s disease, migraine, and hypercholesterolemia.

该公司专有的AIM技术平台实现了新型合成肽免疫疗法候选物的创新，旨在将主动免疫疗法的效率带到慢性疾病的治疗中，包括阿尔茨海默病，帕金森病，偏头痛和高胆固醇血症。

The technology is also implemented as part of a COVID-19 vaccine program. Vaxxinity has optimized its pipeline to achieve a potentially historic, global impact on human health..

该技术也是新型冠状病毒肺炎疫苗计划的一部分。Vaxxinity已优化其管道，以实现对人类健康的潜在历史性全球影响。。

For more information about Vaxxinity, Inc., visit http://www.vaxxinity.com and follow us on social media @vaxxinity.

有关Vaxxinity，Inc.的更多信息，请访问http://www.vaxxinity.com。

About the Centre for Human Drug Research

关于人类药物研究中心

The Centre for Human Drug Research (CHDR) is an independent institute that specializes in cutting-edge, early-phase clinical drug research. CHDR develops and uses state-of-the-art methods and research tools to collect as much information as possible about candidate drugs in the early phases of clinical development, helping sponsors make informed decisions regarding the further development of their product.

人类药物研究中心（CHDR）是一个独立的研究所，专门从事尖端的早期临床药物研究。CHDR开发并使用最先进的方法和研究工具，在临床开发的早期阶段收集尽可能多的候选药物信息，帮助赞助商就其产品的进一步开发做出明智的决定。

For more information about CHDR, visit: www.chdr.nl..

有关CHDR的更多信息，请访问：www.CHDR.nl。。

Forward-looking Statements

前瞻性声明

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including 'believe,' 'may,' 'continue,' 'advancing,' 'will' and similar expressions, are intended to identify forward-looking statements. Forward-looking statements include statements, other than statements of historical fact, regarding, among other things: the plans for, or progress, scope, initiation, duration, enrollment, results or timing for availability of results of, development of any of Vaxxinity’s product candidates or programs; the target indication(s) for development or approval, the size, design, population, location, conduct, cost, objective, enrollment, duration or endpoints of any clinical trial, or the timing for initiation or completion of or availability or reporting of results from any clinical trial; the potential future regulatory authorization or approval and commercialization of Vaxxinity’s product candidates; the potential benefits or competitive position of any Vaxxinity product candidate or program or the commercial opportunity in any target indication; and Vaxxinity’s plans, expectations or future operations, financial position, revenues, costs or expenses.

本新闻稿包括1995年《私人证券诉讼改革法案》所指的前瞻性声明。某些词语的使用，包括“相信”、“可能”、“继续”、“前进”、“意志”和类似的表达，旨在识别前瞻性陈述。前瞻性声明包括除历史事实声明外的其他声明：Vaxxinity任何候选产品或项目的开发计划或进展、范围、启动、持续时间、注册、结果或结果可用时间；；Vaxxinity候选产品的潜在未来监管授权或批准和商业化；任何Vaxxinity候选产品或计划的潜在利益或竞争地位，或任何目标指示中的商业机会；以及Vaxxinity的计划、预期或未来运营、财务状况、收入、成本或支出。

These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of Vaxxinity’s management about the development of a new class of immunotherapeutic vaccines and the innovation and efficacy of Vaxxinity’s product candidates.

这些前瞻性陈述涉及重大风险和不确定性，包括基于Vaxxinity管理层目前对新型免疫治疗疫苗开发以及Vaxxinity候选产品创新和功效的期望和假设的陈述。

Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements, including, but not limited to: whether UB-311, UB-312, UB-31.

各种重要因素可能导致实际结果或事件与我们的前瞻性声明可能表达或暗示的结果或事件存在重大差异，包括但不限于：UB-311、UB-312、UB-31。

Investor Contact

投资者联系人

Mark Joinnides

Mark Joinnides

ir@vaxxinity.com

ir@vaxxinity.com

Press Contact

新闻联系人

McKenna Miller

麦肯纳·米勒

vaxxinity@kcsa.com

vaxxinity@kcsa.com