Emiplacel (Pluristem Therapeutics)

Agreement signed following positive pre-clinical data demonstrating a one-time treatment with PLX-PAD significantly increased neurogenesis, offering immediate, long-term therapeutic effect in treating cocaine addictionThere are no FDA-approved medications to treat cocaine addiction, a severely unmet need as demand for treatment increases in the U.S. and EuropeBar-Ilan University through its tech transfer arm BIRAD Research & Development Company Ltd. receives the right to develop and commercialize the product, Pluri entitled to 20% revenue sharing from future sales of PLX cells as anti-addiction product HAIFA, Israel, Dec. 21, 2023 (GLOBE NEWSWIRE) -- Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”), a leading biotech company that transforms cells into solutions that promote well-being and sustainability, announced it has signed an agreement assigning the joint patent rights to develop Pluri’s PLX cells in the treatment of cocaine addiction, to BIRAD–Research & Development Company Ltd., the commercial arm of Bar-Ilan University. Under the agreement, Bar-Ilan University via BIRAD will receive the right to further develop and commercialize PLX cells as a cocaine anti-addiction product, and Pluri is entitled to 20% revenue sharing from future sales of the product for anti-addiction. The agreement stems from a collaboration between Pluri and Bar-Ilan University researchers that presented compelling findings. Data from the studies were published in the peer-reviewed journal Pharmaceutics. PLX-PAD Cells (PAD) attenuate cocaine craving in animal model for drug addiction (level presses indicate the compulsive demand of a rat to inject cocaine intravenous) **The control group indicates rats that were trained to inject (lever pressing) cocaine; the sham group was trained to consume a non-addictive substance (saline) instead of cocaine; the PAD group indicates rats trained to inject cocaine that were treated with PAD. The studies evaluated PLX-PAD cells’ efficacy in treating cocaine addiction in animal models. Findings demonstrate that PLX-PAD cells: Reduced cocaine-seeking behavior by migrating to specific mesolimbic regions of the brain and restoring neurogenesisSignificantly increased neurogenesisDecreased cocaine cravings during withdrawalSignificantly decreased drug cravings following drug relapse at 14 days and 28 days following treatmentPLX Cells remained detectable in addiction-related brain areas 28 days post-injection Prof. Gal Yadid of The Leslie and Susan Gonda Multidisciplinary Brain Research Center of Bar-Ilan University, a leading neuropsychopharmacologist focused on developing novel neuropsychiatric therapeutics for various indications such as addictions, depression, PTSD and more, including peptide drugs, microbiotics and others commented, “Based on several models, PLX offers great hope as a healing modality for the treatment of cocaine addiction as compared to traditional pharmacological methods that only address symptoms such as depression and anxiety, resulting in high relapse rate to drug usage even after long time of detoxification. The data suggest PLX offers a noninvasive one-time treatment that produces an immediate, long-term effect. We look forward to further exploring PLX’s mechanism of action, which we believe is likely through the cells’ migration to specific mesolimbic regions of the brain, thereby improving the regions’ plasticity by restoring neurons in the hippocampus.” “PLX cells showed great data to act as a potential treatment for the millions of people around the world who suffer from cocaine addiction,” said Pluri Chief Executive Officer and President Yaky Yanay. “Pluri’s collaboration with BIRAD and Bar-Ilan is a great example of our co-development strategy, utilizing our advanced technology together with partners to develop life-changing products.” In the U.S. alone, 1.2 million people suffered from cocaine use disorder in 2021, and approximately 24,500 people died from an overdose involving cocaine. Across North America and Europe, demand for treatment has steadily increased over the last decade, according to the U.N. Office on Drugs and Crime. About BIRAD BIRAD – Research & Development Company Ltd. was established in order to translate new inventions made at Bar-Ilan University into useful products that can be effectively commercialized, thus strengthening the economy, promoting innovation and improving lives. BIRAD's innovative approach, combined with Bar-Ilan University’s rapid growth leading Israel's growth in students' number, including the largest Nanotechnology center in Israel and new Medical School in Safed, provides BIRAD with a wide range of opportunities. Thus, BIRAD offer corporate partnerships and alliances, intellectual property management, and technology commercialization through venture creation and licensing. About PLX-PAD PLX-PAD cells have a “nose” that can recognize pathological tissue and navigate directly to this target, home in and release their cargo. Hence, they exhibit regenerative potential due to their capacity to release specific loaded factors in response to distress signals from tissues that have been damaged by muscle trauma, ischemia, or inflammation. These factors harness the body’s repair mechanisms to support tissue regeneration and differentiation. PLX-PAD cells also exhibit immune-modulating capabilities, playing a central role in the body’s response to tissue injury. About Pluri Inc. Pluri is pushing the boundaries of science and engineering to create cell-based products for commercial use and is pioneering a biotech revolution that promotes global well-being and sustainability. The Company’s technology platform, a patented and validated state-of-the-art 3D cell expansion system, advances novel cell-based solutions for a range of initiatives — from medicine and climate change to food scarcity, animal cruelty, and beyond. Pluri’s method is uniquely accurate, scalable, cost-effective, and consistent from batch to batch. Pluri currently operates in the field of regenerative medicine, food-tech, and biologics and aims to establish partnerships that leverage the Company’s 3D cell-based technology in additional industries that require effective, mass cell production. To learn more, visit us at pluri-biotech.com or follow us on LinkedIn and X (formerly known as Twitter). Safe Harbor Statement This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluri uses forward-looking statements when it discusses the potential of PLX-PAD cells to treat people with cocaine addictions. These forward-looking statements and their implications are based on the current expectations of the management of Pluri only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements about Pluri: changes in technology and market requirements; Pluri may encounter delays or obstacles in launching and/or successfully completing its clinical trials, if necessary; its products may not be approved by regulatory agencies, its technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; it may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with its processes; its products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; its patents may not be sufficient; its products may harm recipients or consumers; changes in legislation with an adverse impact; inability to develop and introduce new technologies in a timely fashion, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluri to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluri undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluri, reference is made to Pluri's reports filed from time to time with the Securities and Exchange Commission. Pluri Contacts Investors: investor.relations@pluri-biotech.com Israel Media: Shachar Yental at shacharye@gitam.co.il U.S. Media: Nathan Miller at nathan@miller-ink.com / Brianna Ziegler at brianna@miller-ink.com Bar-Ilan University Contact Anat Lev - Confortes: anat.lev1@biu.ac.il A graph accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/2896e248-f7d2-4866-a943-3f04343b9ed9

自1999年美国《科学》杂志将干细胞研究列为十大科学成就之首以来，细胞疗法就一跃成为精准医学发展中不可忽视的技术之一。细胞疗法具有选择性高、局部浓度高、可个性化定制三大优势。截至2021年，全球共有2073种细胞治方案用于临床（研究），较2020年增长38%。在动脉橙不完全统计的临床管线中，过半的管线集中在头部企业，如Athersys、Mesoblast等，覆盖140多种疾病，主要集中在肌肉骨骼疾病和血液系统疾病治疗。据头豹研究院分析，预计2021-2025年，中国细胞疗法市场规模（以成本计价）将由13亿元升至162亿元，复合年增长率为87.9%。伴随着未来越来越多的细胞疗法产品获批，预计到2030年达到584亿元，2025-2030年增长复合率为29.2%。随着生命科学与医学的飞速发展，细胞疗法在肿瘤、炎症、组织再生、抗衰老等多个领域取得重大进展。Baxter、Talaris Therapeutics等多家自研企业获得大额投资，细胞疗法领域进入蓬勃发展期。2021年，累计完成33次融资，尽管总额不及2020年，但也可看出资本对该领域创业公司关注加大。我国细胞疗法起步较晚，但随着医药外包服务一体化的兴起，国产CAR-T疗法获批在即，细胞疗法开发试验数量增加，细胞疗法产业链具有高成长性。那么，在一个极具成长性的赛道中，要如何找准定位、站稳脚跟、稳步发展？来自以色列的再生医疗公司Pluri（曾用名：Pluristem Therapeutics）给出了自己的答案。  以色列创新细胞疗法，浙商创投注资三千万美元Pluri是一家2003年创办于以色列的临床阶段再生医疗公司，专注于使用胎盘细胞和3D细胞扩增平台开发应用于广泛疾病的细胞疗法，包括炎症和缺血的多种适应症，如外周动脉疾病、肌肉损伤、先兆子痫和移植物抗宿主病等。Pluri也是目前唯一一家使用3D生物反应器制造大量胎盘基细胞产品的公司，现已在纳斯达克（NASDAQ:PLUR）敲钟上市。Shai Meretzki 是Pluri的创始人，曾担任首席执行官兼首席技术官。Meretzki是以色列理工学院的生物技术博士，在生物技术行业有超20年的从业经验。在校期间，Meretzki就加入了Polyheal 负责生物化学研发，两年后创办Pluri并担任五年的首席执行官和首席技术官。作为一个连续创业者，Meretzki之后连续创办了开发活性化合物的创新生物技术公司Polyol Biotech和专注细胞疗法的生物技术公司BonUs Therapeutic，后者已在特拉维夫证券交易所（TLV）上市。此间，Meretzki还在BIOLOGICAL INDUSTRIES （BI）担任主席，这是一个致力于细胞疗法的生物技术公司。Yaky Yanay 是Pluri的现任首席执行官兼总裁，毕业于以色列应用科技大学，是以色列的注册会计师。Yaky拥有丰富的财务管理经验，加入Pluri之前，Yaky担任Elbit首席财务官。自2006年以来，就一直在Pluri工作。另外，Yaky还是以色列先进技术产业协会（IATI）的前任联合主席和董事会成员。IATI是以色列规模最大的生命科学和高科技产业协会。目前，Pluri拥有专业化的组织结构，多样化的产品研发管道。2016年，中国VC浙商创投（ZSVC）向其投资3000万美元。截至2022年，Pluri融资金额已达1.625亿美元。   3D细胞扩增平台生产可再生、免疫调解性PLX干细胞细胞疗法的干细胞培育主要来源有胚胎、胎盘组织、脂肪组织和其他来源分离。其中，胎盘组织具有“干细胞宝库”之称，是宝贵的生命资源。胎盘组织作为“免疫特区”，具有提取方便、胎盘间充质干细胞含量高、配型要求低等优势，成为细胞疗法中具有广泛应用场景的干细胞培育来源。Pluristem 就选用了胎盘中纯化的成年干细胞。Pluri利用特有的3D细胞扩增平台（PLX Bioreactor）生产出主要产品PLacental eXpanded (PLX) 细胞，该平台已通过FDA、EMA、PMDA等监管机构标准。3D细胞扩增平台（PLX Bioreactor）为细胞提供类似于人体的3D环境，在此环境中细胞会迅速扩张并保持健康和效力，其效率较普通集成器提高七十倍。为了能在商业规模上生产大批量高质量细胞产品，3D细胞扩增平台被集成自动化无菌电池生产设施中。此外，该设施被安置于500平米的洁净室，以支持临床试验和获得上市批准后的初始商业需求。PLX细胞是一种胎盘衍生的具有免疫调节特性的间充质干细胞（mesenchymalstem cells，MSCs），无需匹配即可分泌可溶性生物分子，如细胞因子、趋化因子和生长因子，以旁分泌和内分泌的方式刺激身体自身的再生机制，促进受损组织的愈合。另外，PLX细胞会诱导免疫系统的天然调节性T细胞和M2巨噬细胞，逆转免疫系统的过度激活。PLX细胞能够被用于应对炎症、肌肉损伤、血液疾病和辐射暴露等问题。基于此，Pluri构建了几种临床开发计划。● PLX-PADPLX-PAD细胞是Pluri的第一个PLX产品，被应用于治疗髋部骨折手术后肌肉损伤、末期外周血管疾病（PAD）和慢性移植物抗宿主病（cGvHD）等。股骨颈骨折是最常见的髋部骨折形式，在美国，每年的治疗费用在100亿至150亿美元之间，受人口老龄化影响，死亡率高达20%。PAD的末期疾病为重症下肢缺血（CLI），引发下肢间歇性跛行、缺血性静息痛、溃疡及坏疽，严重影响患者的生活质量，甚至导致截肢或死亡。PAD是一种常见的循环障碍，估计全球有2.02亿人患有此类疾病，大约20%的老年人患有症状和无症状的PAD。移植物抗宿主病（GvHD）是供血干细胞移植（HCT）手术的术后并发症。慢性移植物抗宿主病（cGvHD）大概发生在术后100天，预计到2023年，GvHD市场规模将超过5亿美元。PLA-PAD能够释放因子以响应因肌肉创伤或炎症而受损的组织的化学信号，触发身体的修复机制，刺激组织更新，分化和调解免疫系统的炎症，表现出良好的再生潜力。PLA-PAD的几个疾病管线临床研究数据呈现出良好的试验结果。来自两个Ⅰ期的临床试验数据表明，PLA-PAD细胞对于治疗末期PAD是安全且潜在有效的。此前进行的一个动物模型试验数据证明，当局部给药时，PLX细胞在神经疼痛和肌肉损伤方面也有潜在的疗效；而全身给药时对炎症性肠病、MS（多发性硬化）和中风也有潜在疗效。PLX-PLD治疗髋部骨折手术后肌肉损伤的III期研究结果显示，尽管试验还未到达主要终点，但与安慰剂对照组相比，接受PLX-PAD治疗的患者腿部髋关节外展强度（HAS）显著增加（n=120）。临床前研究表明，PLX-PAD细胞可能减轻cGVHD症状。目前正由特拉维夫苏拉斯基医疗中心（伊奇洛夫医院）进行Ⅰ/Ⅱ期实验研究。● PLX-R18PLX-R18细胞可以通过刺激受损骨髓的再生，促进所有血细胞类型（白细胞、红细胞和血小板）的增殖。目前主要针对治疗骨髓缺乏症、急性辐射综合症（ARS）引起的骨髓衰竭以及其他血液学适应症。PLX-R18Ⅰ期临床试验结果显示，在21名经过造血细胞移植（HCT）手术的患者中，12个月间死亡率从29%降到18%，所有三种血细胞类型水平升高（血小板p<0.001，血红蛋白p=0.01，嗜中性粒细胞p=0.15）。目前，因PLX-R18对造血干细胞移植（HCT）手术后恢复不完全造血功能及ARS治疗的潜在性，FDA已授予其孤儿药称号。在NIH下设过敏和传染病研究所（NIAID）的支持下，Pluri已完成多项关于PLX-R18用于ARS的研究。此外，Pluristem已与日本福岛医科大学签订合作协议，共同探索PLX-R18用于治疗ARS和胃肠道（GI）的可能性。 部分开发计划进展 来源：Pluri官网● PLX-ImmunePLX-Immune是肿瘤坏死因子（TNF-α）和动物干扰素-γ（IFN-g）诱导出的细胞，能够短暂改变细胞分泌谱。PLX-Immune已在临床前研究中进行评估，研究了该细胞在人类癌细胞中的作用。结果表明，PLX-Immune对45%的癌细胞表现出抗增殖作用，对乳腺癌、直肠癌、肾癌、肝癌、皮肤癌等50多种癌细胞具有强抑制作用。在对携带人类三阴性乳腺癌（TNBC）的雌性小鼠进行的另一项临床前研究表明，与未治疗组相比，每周肌内注射（IM）细胞使治疗组平均肿瘤大小显著减小（P=0.025），30%的小鼠在治疗后表现出完全肿瘤缓解。除上述外，Pluri正在对与COVID-19相关的急性呼吸窘迫综合征（ARDS）进行开发，据公开报告显示，六名冠状病毒高危患者接受了Pluri公司干细胞产品的临床治疗后，存活率为100%。目前已获得以色列卫生部批准，根据德国监管机构Paul Ehrlich Institute（PEI）批准的方案，已开始在以色列进行COVID-19二期临床试验患者招募。  与NASA、NIH等机构合作，开拓多行业商业化潜力2019年，在NASA的ARIA项目拨款下，Pluri与NASA旗下Ames Research Center共同开启了“Therapeutic Stromal Cells for Health in Space”计划，旨在预防和评估PLX细胞疗法在预防和治疗太空任务期间引起的医疗状况方面的潜力，包括与血液、骨骼、肌肉、大脑和心脏有关的适应症。宇航员在长期太空探索任务中面临的三大医疗问题是肌肉萎缩、骨骼流失和辐射暴露。在5-10天的飞行中，肌肉萎缩高达20%，如果飞行任务时间更长，宇航员将以每月1-2%的速度降低骨密度。PLX细胞具有帮助肌肉再生的潜力、以及在暴露于辐射后保护和再生血液系统的能力，这使得PLX细胞疗法有望解决太空旅行对人体和其他持续性的负面影响。该项目获得2019 NASA ARIA创新奖。基于PLX细胞疗法具有多种场景的应用潜力，Pluri与阿布扎比干细胞中心（ADSCC）、kENUP基金、Cha Biotech、Thermo Fisher Scientific、Chart Industries以及美国国防部DOD武装部队放射生物学研究所（AFRRI）和美国国立卫生研究院（NIH）等机构签署战略合作协议，在PLX系列细胞临床开发、商业化等方面建立合作。2022年1月，Pluri与以色列最大食品生产商Tnuva成为战略伙伴，共同推出一家新公司“NewCo”。NewCo将获得Pluri的专有技术知识产权的全球独家许可，用于养殖肉类的开发，目标于2023年推出首款生鲜肉产品。2022年7月，公司宣布从Pluristem Therapeutics更名为Pluri，以强调其利用3D细胞扩展技术为医疗之外的食品技术、农业技术、生物制剂等多个行业开发细胞产品的新战略。3D细胞扩展技术能够大规模、低成本扩展高质量的人类、动物和植物细胞。左右滑动查看更多近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。动脉网，未来医疗服务平台