First landmark, peer-reviewed publication of successful in vivo CAR T-cell data in an immune competent NHP model

第一个具有里程碑意义的同行评审出版物，在具有免疫能力的NHP模型中成功发布了体内CAR T细胞数据

Data validate the VivoVec™ platform in a translationally relevant model and support its transition into human clinical testing, offering a potential paradigm shift in the field of CAR T-cell therapies

数据在翻译相关模型中验证了VivoVec™平台，并支持其向人类临床测试的过渡，为CAR T细胞疗法领域提供了潜在的范式转变

SEATTLE, June 13, 2024 (GLOBE NEWSWIRE) -- Umoja Biopharma, Inc. (Umoja), a transformative immunotherapy company creating off-the-shelf treatments that aim to extend the reach and effectiveness of CAR T-cell therapies in oncology and autoimmunity, today announced that pre-clinical non-human primate (NHP) data on its VivoVec in vivo CAR T delivery system was published in Blood, the flagship journal of the American Society of Hematology.

2024年6月13日，西雅图（环球通讯社）--Umoja Biopharma，Inc.（Umoja），一家变革性免疫治疗公司，创建了现成的治疗方法，旨在扩大CAR T细胞疗法在肿瘤学和自身免疫中的范围和有效性，今天宣布其VivoVec体内CAR T递送系统的临床前非人灵长类动物（NHP）数据发表在美国血液学会的旗舰期刊《血液》上。

Results showed that in the absence of lymphodepleting chemotherapy, VivoVec lentiviral particles successfully generated CAR positive T (CAR+ T) cells targeting CD20 in vivo leading to the complete and durable depletion of B cells in excess of 10 weeks..

结果显示，在没有淋巴消耗化疗的情况下，VivoVec慢病毒颗粒在体内成功产生靶向CD20的CAR阳性T（CAR+T）细胞，导致B细胞在超过10周的时间内完全持久地消耗。。

Key Study Findings

主要研究结果

VivoVec particles (VVPs) incorporating CD80 and CD58 costimulation proteins exhibit enhanced capacity for in vivo CAR T-cell generation and produce CAR T-cells with increased antitumor functionality compared to those produced from VVPs displaying anti-CD3 scFvs alone.

与单独显示抗CD3 scFv的VVP产生的那些相比，掺入CD80和CD58共刺激蛋白的VivoVec颗粒（VVP）表现出增强的体内CAR T细胞产生能力，并产生具有增加的抗肿瘤功能的CAR T细胞。

Combining the anti-CD3 scFv together with the ligand binding domains of CD80 and CD58 into a single multi-domain fusion (MDF) protein markedly augments the particles’ ability to bind, activate, and transduce T-cells.

将抗CD3 scFv与CD80和CD58的配体结合结构域结合成单个多结构域融合（MDF）蛋白显着增强了颗粒结合，激活和转导T细胞的能力。

VVPs incorporating MDF compatible with NHP T-cell activation and costimulation potently generate anti-CD20 CAR T-cells in vivo, comprising up to 65% of circulating T-cells, and results in complete B-cell depletion for up to 76 days.

掺入与NHP T细胞活化和共刺激相容的MDF的VVP在体内有效产生抗CD20 CAR T细胞，其包含高达65%的循环T细胞，并导致B细胞完全消耗长达76天。

“Currently approved ex vivo CAR T-cell therapies have significantly improved treatment outcomes in cancers like non-Hodgkin's lymphoma and multiple myeloma. However, their adoption and patient access are limited by the need for extensive infrastructure such as apheresis facilities, and the lengthy process of manufacturing patient-by-patient lots of CAR T-cells,” said Byoung Ryu, Ph.D., Executive Vice President of Vector Biology and In Vivo Sciences at Umoja Biopharma added, “We are excited to move several VivoVec drug candidates into initial human trials later this year, aiming to address these challenges.”.

“目前批准的离体CAR T细胞疗法已显着改善了非霍奇金淋巴瘤和多发性骨髓瘤等癌症的治疗效果。然而，由于需要广泛的基础设施，如单采设备，以及由患者制造大量CAR T细胞的漫长过程，它们的采用和患者的使用受到限制，”Umoja Biopharma载体生物学和体内科学执行副总裁Byoung Ryu博士补充说，“我们很高兴在今年晚些时候将一些VivoVec候选药物转移到初步人体试验中，以应对这些挑战。”。

“We are encouraged by these data that show continued validation of our VivoVec platform demonstrating the successful generation of CAR+ T-cells directly in vivo, eliminating the need for external cell collection, genetic modification, and extensive testing,” said Christopher Nicolai, Ph.D., lead author of the publication..

该出版物的主要作者克里斯托弗·尼科莱博士说：“我们对这些数据感到鼓舞，这些数据表明我们的VivoVec平台继续得到验证，证明了直接在体内成功生成CAR+T细胞，从而无需进行外部细胞收集，基因修饰和广泛测试。”。。

The VivoVec platform utilizes advanced lentiviral particles that are surface engineered with a multidomain fusion protein to drive particle binding to T-cells, and subsequent activation and transduction, resulting in CAR expression. The CAR transgene is delivered to reprogram the T-cells to target specific cancer cells..

VivoVec平台利用先进的慢病毒颗粒，这些颗粒通过多结构域融合蛋白进行表面工程改造，以驱动颗粒与T细胞的结合，并随后激活和转导，从而产生CAR表达。CAR转基因被传递以重新编程T细胞以靶向特定的癌细胞。。

The data published in Blood were collected in collaboration with the Washington National Primate Research Center. Umoja plans to initiate first-in-human trials of VivoVec-generated candidates in the second half of 2024.

血液中公布的数据是与华盛顿国家灵长类动物研究中心合作收集的。Umoja计划在2024年下半年启动VivoVec产生的候选人的首次人体试验。

About VivoVec

VivoVec

Umoja’s VivoVec gene delivery platform combines third generation lentiviral vector gene delivery with a novel T-cell targeting and activation surface complex. VivoVec is designed to enable T-cells in the body to manufacture their own cancer-fighting CAR T-cells in vivo. This has the potential to eliminate many challenges associated with traditional CAR T approaches, including reliance on gathering a patient’s own or donor cells which are modified externally before being delivered back to the patient, the associated time lag and manufacturing challenges of ex vivo cell modification, and the need for patient’s lymphodepletion..

Umoja的VivoVec基因传递平台将第三代慢病毒载体基因传递与新型T细胞靶向和激活表面复合物相结合。VivoVec旨在使体内的T细胞能够在体内制造自己的抗癌CAR T细胞。这有可能消除与传统CAR T方法相关的许多挑战，包括依赖于收集患者自己的或供体细胞，这些细胞在被递送回患者之前被外部修饰，离体细胞修饰的相关时滞和制造挑战，以及对患者淋巴结消除的需求。。

About Umoja Biopharma

关于团结项目生物制药

Umoja Biopharma, Inc. is a clinical-stage biotechnology company aiming to develop off-the-shelf therapeutics that improve the reach, effectiveness, and access of CAR T-cell therapies in both oncology and autoimmunity. Umoja’s VivoVec in vivo gene delivery technology is intended to empower a patient’s own immune system to fight disease.

Umoja Biopharma，Inc.是一家临床阶段生物技术公司，旨在开发现成的治疗方法，以提高CAR T细胞疗法在肿瘤学和自身免疫中的应用范围，有效性和可及性。Umoja的VivoVec体内基因传递技术旨在增强患者自身的免疫系统抵抗疾病。

Enabling its core technology is the Company’s state-of-the-art lentiviral vector development and manufacturing facility in Louisville, Colorado. Umoja believes its approach can provide broader access and improved effectiveness of the most advanced immunotherapies, enabling more patients to live better, fuller lives.

使其核心技术得以实现的是该公司位于科罗拉多州路易斯维尔的最先进的慢病毒载体开发和制造设施。Umoja相信，它的方法可以提供更广泛的途径，提高最先进的免疫疗法的有效性，使更多的患者能够过上更好、更充实的生活。

To learn more, connect with Umoja on LinkedIn and visit http://umoja-biopharma.com/..

要了解更多信息，请在LinkedIn上与Umoja联系并访问http://umoja-biopharma.com/..

Umoja Forward-Looking Statements:

Umoja前瞻性声明：

This press release contains forward-looking statements about Umoja Biopharma, Inc. (the “Company,” “we,” “us,” or “our”). The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs.

本新闻稿包含关于Umoja Biopharma，Inc.（以下简称“公司”、“我们”、“我们”或“我们”）的前瞻性声明。该公司的这些前瞻性报表主要基于其对未来事件和财务趋势的当前预期、估计、预测和预测，该公司认为这些未来事件和财务趋势可能会影响其财务状况、经营成果、业务战略和财务需求。

In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results to vary materially, including, among others, the risks inherent in drug development such as those associated with the initiation, cost, timing, progress and results of the Company’s current and future research and development programs, preclinical and clinical trials, as well as any economic, market and social disruptions.

鉴于这些前瞻性陈述中存在重大不确定性，您不应将前瞻性陈述视为对未来事件的预测。这些声明受到可能导致实际结果发生重大变化的风险和不确定性的影响，其中包括药物开发固有的风险，例如与公司当前和未来研发计划的启动，成本，时间，进度和结果相关的风险，临床前和临床试验，以及任何经济，市场和社会干扰。

Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason..

除法律要求外，公司无义务以任何理由公开更新任何前瞻性声明。。

Investors

投资者

Stephen Jasper

斯蒂芬·贾斯珀

Gilmartin Group, LLC

吉尔马丁集团有限责任公司

stephen@gilmartinir.com

stephen@gilmartinir.com

Media

媒体

Matt Wright

马特·赖特

Real Chemistry

真正的化学

mwright@realchemistry.com

mwright@realchemistry.com