Avoplacel (Pluristem Therapeutics)

Growing pipeline of industry-specific new potential products, services, collaborations and partnerships through PluriAgtech, PluriCDMO, PluriHealth, and PluriFoodRecent achievements include: new cell-based coffee business; new agtech division and first partners; new Contract Development and Manufacturing Organization division; $4.2 million Contract with the U.S. NIH and new partnership with Bar-Ilan UniversityLandmark collaboration with Tnuva Group continues to drive its technology forward with interest from global partners HAIFA, Israel, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Leading biotechnology company Pluri Inc. (NASDAQ:PLUR) (TASE:PLUR) (“Pluri” or the “Company”) today issued the following update from CEO and President, Yaky Yanay: Dear Fellow Shareholders, As we move into 2024, I’m proud to share my thoughts about all the exciting things happening at Pluri right now. As a purpose-driven company with goal-oriented leadership and a deep commitment to our shareholders, we enter 2024 with significant momentum in every area of our business, validating our approach and demonstrating strong execution. Over the past several months, we’ve launched PluriAgtech, a new business vertical focused on applying our cell-based technologies to improve agriculture; and PluriCDMO, a contract development and manufacturing organization (CDMO) division,with the goal to drive revenues and cash flow while continuing to advance healthcare therapeutics. We are building long-term strategic alliances and partnerships with companies that are leaders in their respective fields, have market access, employ a similar approach to innovation, and are committed to pioneering a biotech revolution with us, with the goal to accelerate time to market. Despite the myriad of challenges associated with scaling a business during these difficult times, the last few months have been especially exciting for Pluri, bringing significant progress in multiple areas. Just as Israel has demonstrated resilience, Pluri has also demonstrated immense strength over the last few months, showing our partners and customers that we deliver innovation no matter what the current circumstances are. In fact, we’re coming off a year of successes that offer a glimpse of the bright future ahead for Pluri: PluriAgtech’s innovative answer to the global coffee crisis: sustainable cell-based coffee In January 2024, we launched our cell-based coffee business, pioneering a new and game-changing way to address the rapidly growing $130 billion coffee industry in a more sustainable, eco-friendly way. The coffee industry is currently at risk as global warming is expected to slash the amount of land available for coffee production by up to 50% by 2050. Leveraging our proprietary 3D technology platform, our new vertical PluriAgtech can create high-quality cell-based coffee with 98% less water than traditional coffee production. We also estimate that our innovative new production process will reduce the amount of growing area by 95%, potentially preventing deforestation. We are receiving a lot of interest from partners and strategics around this unique project, that can potentially transform and solve some main challenges of the industry. Our goal is to build our cell-based coffee business as a new subsidiary focused on the coffee industry and we are working to secure sufficient funding to support the development process, scaleup and regulatory phase. PluriCDMO to support development of life-changing cell and gene therapies for biotech companies, and potentially generate revenues and cash flow for Pluri In January 2024, we launched our CDMO division, to provide services to innovative biotech companies in the rapidly growing $5.2 billion cell and gene therapy sector. PluriCDMO includes not only our experienced clinical and bio-manufacturing team but also our robust Good Manufacturing Practice (GMP) facility and our proprietary 3D cell-expansion technology. We believe PluriCDMO can be the launchpad so many companies need to take their cell and gene therapies to the next level. While we already started generating revenues from this division, we are receiving a lot of additional interest and are currently negotiating several CDMO agreements. PluriCDMO provides substantial value to our clients by offering; access to extensive knowledge, mass scale production opportunities and expedited time to market. We expect this division to boost Pluri’s revenues and cash flow through the utilization of our well-established technology and GMP-certified facility. PluriHealth & U.S. NIH advance development of PLX-R18 as countermeasure for H-ARS Russia’s invasion of Ukraine and Vladmir Putin’s dangerous rhetoric have raised the specter of nuclear war, and the global medical community must prepare for the worst-case scenario. Unfortunately, the world remains unprepared for a nuclear attack or a major accident. Medical responses to nuclear radiation poisoning have failed to keep pace, while nuclear weaponry has grown exponentially more powerful since World War II. In July 2023, we signed a 3-year, $4.2 million contract with the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to advance the development of our PLX-R18 cell therapy as a potential novel treatment for Hematopoietic Acute Radiation Syndrome (H-ARS). We are collaborating with the U.S. Department of Defense’s (DoD) Armed Forces Radiobiology Research Institute (AFRRI)/Uniformed Services University of Health Sciences (USUHS) in Maryland. PLX-R18 is being developed with the intention of being eligible for purchase by the U.S. Strategic National Stockpile as a medical countermeasure for exposure to nuclear radiation, following U.S. Food and Drug Administration (FDA) approval. Collaboration with Bar-Ilan University develops PLX cells to treat cocaine addiction Another example of executing our partnered-based strategy is the agreement we signed with BIRAD, the commercial division of Bar-Ilan University. BIRAD – Research & Development Company has the right to further develop and commercialize PLX cells as a product to treat cocaine addiction and Pluri is entitled to a 20% revenue share from future sales of the product. The lack of any FDA-approved medications to treat cocaine addiction presents a significant opportunity in a critical health area with significant unmet need. We expect that additional partnership agreements will continue to drive our current PluriHealth pipeline to commercialization. Ever After Foods’ promising development Within one year of its establishment, Ever After Foods announced a 700% increase in productivity compared to other cultivated meat companies, showing the great promise of our technology when it comes to scale and cost parity. Ever After Foods’ long-term goal is to serve as a technology enabler for the broader industry. Ever After Foods is led by a stellar management and operational team and we expect to share some exciting developments over the coming months. Transforming the world through cell-based technology, building high value companies, near-term revenues and cash flow We believe our technology is pivotal for solving some of the most important trials facing humanity today. As a global leader in cell-based technology, Pluri is setting the stage for a future full of hope in the areas of food security, climate change, sustainability, health and aging. Today I am proud to say that we are building the strongest pipeline of collaborations and negotiations that we've ever had. By creating novel cell-based products both independently and through partnerships, Pluri is showing what’s possible when we all work together. As such, our transformative technology is not only creating long-term value for our shareholders; it’s also making the world a better place. Thank you for your support. Best regards, Yaky YanayChief Executive Officer and President, Pluri Inc. 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 wellbeing 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 agtech and aims to establish partnerships that leverage the Company’s 3D cell-based technology to additional industries that require effective, mass cell production. To learn more, visit us at www.pluri-biotech.com or follow us on LinkedIn and 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 is using forward-looking statements when it discusses the potential benefits of its various products, its goals relating to its coffee business, the belief that PluriCDMO™ can be a launchpad for companies needing assistance with their cell and gene therapies, that it aims to build its cell-based coffee business as a new subsidiary and is working to secure sufficient funding to support the development process, scaleup and regulatory phase, that it is negotiating several CDMO agreements, that it expects its CDMO business to boost its revenues and cash flow, that it expects that additional partnership agreements will continue to drive its current PluriHealth pipeline to commercialization and that it expects Ever After Foods to share exciting developments over the coming months. 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 timely develop and introduce new technologies, 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. Media Contacts Investors: investor.relations@pluri-biotech.com / Jennifer Zimmons at Jen@quantum-corp.com Israel Media: Shachar Yental at Shacharye@gitam.co.il U.S. Media: Madeline Weirman at Maddie@quantum-corp.com / Jessica Daitch at Jessica@quantum-corp.com

▎药明康德内容团队报道近期，全球细胞和基因疗法（CGT）领域迎来系列进展。例如：科弈药业、睿源生物、方拓生物等公司创新疗法获批临床；香雪制药等多家公司的CGT产品在临床试验中取得积极结果；科济药业等公司达成新合作等。本文将节选其中部分重要进展做简单介绍，仅供读者参阅。图片来源：123RF———✦新药进展✦———科弈药业全资子公司科棋药业申请的KQ-2003自体嵌合抗原受体T细胞注射液在中国获批临床，拟用于治疗已经接受过三线或者更多线治疗的复发/难治性多发性骨髓瘤。这是一款新一代CAR-T产品，能同时靶向B细胞成熟抗原（BCMA）和CD19两个治疗靶点。此前，该产品已在治疗复发/难治性多发性骨髓瘤患者的研究者发起的临床研究（IIT）中，获得100%的总体反应率。睿源生物间充质干细胞药物RY_SW01细胞注射液在中国获批临床，拟用于治疗系统性硬化。此前，该产品已在中国获批开展治疗活动性狼疮肾炎的临床试验。早先，该产品已经完成IIT研究首例受试患者给药入组，初步结果显示了良好的安全性。方拓生物新型重组腺相关病毒（AAV）基因治疗产品FT-003注射液在中国获批临床，拟用于治疗糖尿病黄斑水肿等。临床前研究数据显示，FT-003注射后可高效感染动物视网膜多层细胞，使其持续表达和分泌抗血管生成因子，降低血管内皮通透性，抑制新生血管的生成。此前，该产品已在中国获批开展治疗新生血管性年龄相关性黄斑变性的临床试验。Artiva Biotherapeutics基于同种异体自然杀伤（NK）细胞的新型药物AB-101在美国获批临床，拟用于治疗活动性狼疮肾炎患者的系统性红斑狼疮。AB-101是一种源于脐带血的非基因修饰、同种异体的在研NK细胞疗法，可增强抗体依赖的细胞毒性（ADCC）。此前，该产品已在治疗B细胞非霍奇金淋巴瘤的临床1/2期试验中获得结果积极。ImmPACT Bio双特异性CD19/CD20靶向的CAR-T细胞疗法IMPT-514在美国获批临床，拟用于治疗系统性红斑狼疮等。IMPT-514采用了强效双特异性CAR和4-1BB共刺激结构域，旨在治疗活动性难治性系统性红斑狼疮。在临床前研究中，它能够高效地从狼疮肾炎和系统性红斑狼疮患者体内制造出来，并显示出强效的自体B细胞清除能力和适度的细胞因子特征。ViGeneron公司基因疗法产品VG901获得欧洲药品管理局（EMA）批准临床，拟用于治疗CNGA1相关的视网膜色素变性症（RP）等。VG901是一种基因替代疗法，通过玻璃体内注射（IVT）递送CNGA1基因，从而降低视网膜损伤风险。临床前研究显示，应用单次玻璃体内注射并在治疗后观察6个月的GLP安全性研究证实了VG901具有良好的安全性。Nexcella公司宣布，其自体CAR-T细胞疗法NXC-201获得美国FDA孤儿药资格，用于治疗危及生命的多发性骨髓瘤。NXC-201是一款靶向BCMA的CAR-T疗法。此前，该产品已在治疗复发/难治性多发性骨髓瘤与轻链淀粉样变性（AL）的1期临床试验中获得积极结果，数据显示其具有良好的安全性，且达成90%的总缓解率。易慕峰宣布，其基于该公司合成性天然杀伤受体（SNR）技术平台研发的新一代自体CAR-T产品IMC008已获得FDA孤儿药资格，用于治疗胃癌患者。该SNR技术平台专为克服肿瘤异质性，有助于突破实体瘤治疗。在动物肿瘤模型中，IMC008已展现出良好的安全性和对异质性肿瘤的清除能力。图片来源：123RF———✦临床进展✦———香雪制药发布新闻稿称，Cell Reports Medicine刊发了其TCR-T细胞免疫治疗产品TAEST16001的1期临床研究成果。TAEST16001是高亲和力NY-ESO-1特异性TCR-T细胞。试验表明，该产品在晚期软组织肉瘤中显示了良好的抗肿瘤信号和耐受性，客观缓解率（ORR）为41.7%，中位无进展生存期（PFS）为7.2个月，中位缓解持续时间（DOR）为13.1个月。另外，多项预先指定的生物标记物与患者反应相关。Généthon实验室宣布，在研基因疗法GNT0003治疗Crigler-Najjar综合征的1/2期临床试验结果在《新英格兰医学杂志》上发表，试验显示该基因疗法具有良好的安全性，并且在最高剂量表现出疗效。Crigler-Najjar综合征是一种由特异性肝酶UGT1A1缺乏引起的罕见遗传性代谢疾病，GNT0003利用腺相关病毒8（AAV8）载体表达编码UGT1A1的转基因，旨在通过一次性治疗，让患者的肝脏细胞自己生成UGT1A1，降低胆红素的水平。Mustang Bio公司公布其靶向CD20的自体CAR-T细胞疗法MB-106治疗复发或难治性B细胞NHL和慢性淋巴细胞白血病（CLL）的1/2期临床试验数据。初步结果显示，CAR-T细胞在6个多月后仍能存活，MB-106的安全性数据良好。4名复发/难治性惰性NHL患者均实现了缓解；2名滤泡性淋巴瘤患者通过PET-CT和骨髓检查均获得了完全缓解；1名华氏巨球蛋白血症（WM）患者达到了代谢学完全缓解；1名毛细胞白血病变异型患者治疗后病情持续稳定。Pluri公司公布其胎盘扩增间充质样细胞PLX-R18治疗造血细胞移植（HCT）后的血液系统急性辐射综合征（ARS）的1期临床试验积极数据。PLX-R18细胞能分泌大量造血因子，促进造血细胞的再生、成熟和分化，并刺激它们向外周血迁移。1期结果显示，HCT术后造血功能未完全恢复的患者在接受了PLX-R18后长达12个月的时间里血细胞计数都有所增加，输血需求也有所减少。此外，PLX-R18的耐受性良好，安全性也很高。图片来源：123RF———✦合作✦———科济药业宣布其与美德纳公司已启动了一项合作协议，以研究科济药业靶向Claudin18.2的CAR-T候选产品CT041与美德纳的试验性Claudin18.2 mRNA癌症疫苗的组合效果。CT041是一种靶向Claudin18.2蛋白的自体CAR-T细胞候选产品，正在中国和北美开展多项临床研究。美德纳正在开发一种试验性的现货型mRNA癌症疫苗，该疫苗编码靶向肿瘤相关抗原Claudin18.2蛋白。CytoMed Therapeutics宣布与杭州CNK Therapeutics开展研究合作，以增强其异体CAR γδ T细胞的体内持久性。CytoMed公司专注于利用其专有技术开发用于治疗各种癌症的新型供体衍生细胞免疫疗法。根据协议，CytoMed公司可以利用CNK公司的PiggyBac技术，通过非病毒基因编辑方法将CAR基因永久移植到其γδ T细胞中。除了上述动态，近期细胞和基因疗法领域还有一些其它进展，限于篇幅，本文不再一一介绍。希望该领域迎来更多的新进展和突破，惠及更多患者。本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。