This study is a single center trial to assess the safety and initial efficacy of intra-articular administration of Allocetra to patients with Temporomandibular Joint Osteoarthritis (TMJ-OA)

开始日期2024-12-15

申办/合作机构

Sheba Medical Center

[+1]

NCT06522035

/ Recruiting临床1期

Evaluation of Allocetra by Intra-articular Injection for the Treatment of Psoriatic Arthritis

This is an open label study to evaluate the safety and initial efficacy of intra-articular administration of Allocetra in patients with Psoriatic Arthritis (PsA).

开始日期2024-08-01

申办/合作机构

Enlivex Therapeutics Ltd.

CTIS2023-508748-23-00

/ Recruiting临床1/2期

A Phase 1/2a Randomized, Double-Blind Placebo-controlled Study of Intra-articular Allocetra in Knee Osteoarthritis - ENX-CL-05-001

开始日期2024-04-16

申办/合作机构

Enlivex Therapeutics Ltd.

100 项与 Leukocyte cell therapy (Enlivex Therapeutics) 相关的临床结果

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100 项与 Leukocyte cell therapy (Enlivex Therapeutics) 相关的转化医学

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100 项与 Leukocyte cell therapy (Enlivex Therapeutics) 相关的专利（医药）

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项与 Leukocyte cell therapy (Enlivex Therapeutics) 相关的文献（医药）

2024-08-19·Military Medicine

Apoptotic Cell–Based Therapy for the Modification of the Inflammatory Response to Hemorrhagic Shock

Article

作者: Nachman, Dean ; Kolben, Yotam ; Kessler, Asa ; Kenig, Ariel ; Mevorach, Dror ; Lutsker, Maya ; Wagnert-Avraham, Linn ; Aliev, Emil

ABSTRACTIntroductionMany trauma patients die from hemorrhagic shock in the military and civilian settings. Although two-thirds of hemorrhagic shock victims die of reasons other than exsanguination, such as the consequent cytokine storm, anti-inflammatory therapies failed to be utilized. Apoptotic cell–based treatments enhance innate ability to exert systemic immunomodulation as demonstrated in several clinical applications and hence might present a novel approach in hemorrhagic shock treatment.Materials and MethodsTwenty-two rats underwent a pressure-controlled hemorrhagic shock model and followed up for 24 hours. An infusion of apoptotic cells (Allocetra-OTS, Enlivex Therapeutics Ltd, Nes Ziona, Israel) was administered to the treatment group. Hemodynamics, blood counts, biochemistry findings, and cytokine profile were compared to a saline-resuscitated control group.ResultsThe treatment group’s mean arterial pressure decreased from 94.8 mmHg to 28.2 mmHg, resulting in an 8.13 mg/dL increase in lactate and a 1.9 g/L decrease in hemoglobin, similar to the control group. White blood cells and platelets decreased more profoundly in the treatment group. A similar cytokine profile after 24 hours was markedly attenuated in the treatment group 2 hours after bleeding. Levels of pro-inflammatory cytokines such as interleukin (IL)-1a (28.4 pg/mL vs. 179.1 pg/mL), IL-1b (47.4 pg/mL vs. 103.9 pg/mL), IL-6 (526.2 pg/mL vs. 3492 pg/mL), interferon γ (11.4 pg/mL vs. 427.9 pg/mL), and tumor necrosis factor α (19.0 pg/mL vs. 31.7 pg/mL) were profoundly lower in the treatment group.ConclusionIn a pressure-control hemorrhagic shock model in rats, apoptotic cell infusion showed preliminary signs of a uniform attenuated cytokine response. Apoptotic cell–based therapies might serve as a novel immunomodulatory therapy for hemorrhagic shock.

2023-04-13·Journal of hematology & oncology

Cancer and COVID-19: unravelling the immunological interplay with a review of promising therapies against severe SARS-CoV-2 for cancer patients.

Review

作者: Park, Chandler H. ; Joshi, Muskan ; Erick, Timothy K. ; Cappelli, Jared ; Wilkerson, William B. ; Menon, Gayathri P. ; Leyfman, Yan ; Emmanuel, Nancy ; Sharma, Pushpa

Cancer patients, due to their immunocompromised status, are at an increased risk for severe SARS-CoV-2 infection. Since severe SARS-CoV-2 infection causes multiple organ damage through IL-6-mediated inflammation while stimulating hypoxia, and malignancy promotes hypoxia-induced cellular metabolic alterations leading to cell death, we propose a mechanistic interplay between both conditions that results in an upregulation of IL-6 secretion resulting in enhanced cytokine production and systemic injury. Hypoxia mediated by both conditions results in cell necrosis, dysregulation of oxidative phosphorylation, and mitochondrial dysfunction. This produces free radicals and cytokines that result in systemic inflammatory injury. Hypoxia also catalyzes the breakdown of COX-1 and 2 resulting in bronchoconstriction and pulmonary edema, which further exacerbates tissue hypoxia. Given this disease model, therapeutic options are currently being studied against severe SARS-COV-2. In this study, we review several promising therapies against severe disease supported by clinical trial evidence-including Allocetra, monoclonal antibodies (Tixagevimab-Cilgavimab), peginterferon lambda, Baricitinib, Remdesivir, Sarilumab, Tocilizumab, Anakinra, Bevacizumab, exosomes, and mesenchymal stem cells. Due to the virus's rapid adaptive evolution and diverse symptomatic manifestation, the use of combination therapies offers a promising approach to decrease systemic injury. By investing in such targeted interventions, cases of severe SARS-CoV-2 should decrease along with its associated long-term sequelae and thereby allow cancer patients to resume their treatments.

2023-01-01·Frontiers in immunology

Apoptotic cells for treatment of acute respiratory distress syndrome associated with COVID-19.

Article

作者: Mevorach, Dror ; Abutbul, Avraham ; Makram, Nassar ; Nachshon, Akiva ; Shabat, Yehudit ; Reicher, Barak ; Hershkovitz, Oren ; Abu Jabal, Kamal ; Maayan, Shlomo ; Binder, Lior ; Naama, Ahmad ; van Heerden, Peter Vernon

BackgroundHyper-inflammatory immune response, a hallmark of severe COVID-19, is associated with increased mortality. Acute respiratory distress syndrome (ARDS) is a common manifestation. We undertook two phase I/II studies in five and then 16 subjects with severe/critical COVID-19 to assess the safety and preliminary efficacy of apoptotic cells (Allocetra™-OTS, Enlivex Therapeutics), a cellular immunomodulatory therapy that reprograms macrophages to reduce hyper-inflammatory response severity.MethodsEligible patients presenting to the Emergency Room with severe COVID-19 and respiratory dysfunction received one intravenous administration of Allocetra™-OTS and were monitored for adverse events (AEs) for 28 days. The primary aim was to determine the safety profile of treatment; secondary aims were recovery from ARDS, intensive care unit (ICU) and hospital length-of-stay, and mortality. Immune modulator markers were measured to elucidate the mechanism of action of Allocetra™-OTS.Results21 patients with severe-critical COVID-19 of Gamma, Alpha and Delta variants, were treated with a single dose of apoptotic cells. 19/21 patients had mild-to-severe ARDS at presentation. Median age was 53 years, 16/21 were males, 16/21 were overweight/obese. No serious related adverse events (SAEs) were reported. All 21 study subjects survived to day 28 (end of study); 19/21 recovered completely. Comparable mortality rates at the hospital were 3.8%-8.9% for age- and gender-matched patients, and 39%-55% for critical patients. Recovering patients exhibited rapid ARDS resolution and parallel resolution of inflammation markers and elevated cytokines/chemokines.ConclusionIn patients with severe/critical COVID-19 associated with ARDS, Allocetra™-OTS was safe, well-tolerated, and showed promising results for resolution of respiratory failure and inflammation.Trial registrationhttps://clinicaltrials.gov/ct2/show/study/NCT04513470, https://clinicaltrials.gov/ct2/show/study/NCT04590053, Identifiers NCT04513470, NCT04590053.

项与 Leukocyte cell therapy (Enlivex Therapeutics) 相关的新闻（医药）

2025-03-17

·GlobeNewswire-Health Care

Enlivex Receives Notice of Allowance for Chinese Patent Application Covering the Use of Allocetra in Patients with Osteoarthritis

Nes-Ziona, Israel, March 17, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the China National Intellectual Property Administration (CNIPA) issued a notice of allowance for patent application number 2020800620493. Once issued, the resulting patent will provide Enlivex with added intellectual property protection in China through at least 2040 with claims covering methods of using Allocetra™ to treat subjects with osteoarthritis. The Company expects that this new patent will be issued in China during the first half of 2025. Enlivex recently reported positive interim six (6) months efficacy data from the first stage of its ongoing randomized, multi-country Phase I/II Allocetra™ trial in patients with moderate to severe knee osteoarthritis. Key highlights: Statistically significant, 47.0% average reduction of reported pain (P=0.0001), compared to average pain level at baseline46% improvement in joint function and 40% improvement in joint stiffness83% of the patients were still considered as responders to treatment1 after 6 monthsNo serious adverse eventsEfficacy continues to display strong persistence and durability over time, maintaining the 3-month positive effect Oren Hershkovitz, Ph.D, CEO of Enlivex, commented, “We are very pleased to receive the first patent allowance for the use of AllocetraTM as a potential treatment in patients with osteoarthritis. We believe that this allowance provides high assurance that similar patent allowances will be obtained across all major jurisdictions as part of our IP portfolio rollout.” ABOUT KNEE OSTEOARTHRITIS2 Osteoarthritis is by far the most common form of arthritis, affecting more than 32.5 million Americans and more than 300 million individuals worldwide. About half of knees with ACL injuries develop osteoarthritis within 5 to 15 years. 78 million Americans are projected to have osteoarthritis by the year 2040. Symptomatic knee osteoarthritis is particularly prevalent and disabling, with 40% of men and 47% of women developing knee osteoarthritis in their lifetimes. Osteoarthritis accounts for over one million hospitalizations annually in the United States, primarily for total joint replacement. The burden of osteoarthritis is enormous, and the need for treatments that reduce pain and attendant disability for persons with osteoarthritis is critical. There are currently no medications approved by either the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) that have been demonstrated to arrest, slow or reverse progression of structural damage in the joint. ABOUT ENLIVEX Enlivex is a clinical stage macrophage reprogramming immunotherapy company developing Allocetra™, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening and life debilitating conditions. For more information, visit https://enlivex.com/. Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “would,” “could,” “intends,” “estimates,” “suggests,” “has the potential to” and other words of similar meaning, including statements regarding expected cash balances, expected clinical trial results, market opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRATM programs. All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex’s business and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRATM product line could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Enlivex’s filings with the Securities and Exchange Commission, including in the Company’s most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law. ENLIVEX CONTACT Shachar Shlosberger, CFOEnlivex Therapeutics, Ltd.shachar@enlivexpharm.com INVESTOR RELATIONS CONTACT Dave Gentry, CEORedChip Companies Inc.1-407-644-4256ENLV@redchip.com _______________________________________ 1 According to the OMERACT-OARSI criteria (Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International)2 Source: The Arthritis Foundation, Disease modification in osteoarthritis; pathways to drug approval, Katz et. Al., Osteoarthritis and Cartilage Open (2) (2020)

临床结果免疫疗法临床研究

2025-03-09

·药明康德

快速持久降解目标蛋白超80%的小分子疗法；有望使患者停止激素替代治疗的创新生物器官疗法…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. 小分子蛋白降解剂BHV-1300的1期临床试验结果积极，目标IgG快速、深度和持续地降低，降幅最高达84%，中位降幅为80%。 2. 创新生物混合器官Cell Pouch获批一项新的IND申请，它与自体甲状腺细胞疗法相结合，旨在恢复自然的甲状腺功能，使患者无需使用甲状腺激素替代药物或免疫抑制疗法。 3. 巨噬细胞疗法Allocetra治疗中度至重度膝骨关节炎，在一项1/2期临床试验中使患者报告的疼痛平均减少47.0%，关节功能改善46%。药明康德内容团队整理 BHV-1300：公布1期临床试验的新数据 Biohaven公司公布了其皮下给药的在研小分子蛋白降解剂BHV-1300的1期临床试验的新结果。BHV-1300在选择性清除目标IgG（IgG1、IgG2和IgG4）方面具有独特优势，同时保留IgG3水平。IgG3在对抗细菌、寄生虫和病毒中发挥关键作用。BHV-1300的设计目标是避免与其他IgG降低方法相关的广泛免疫抑制，同时在治疗自身免疫性疾病的过程中允许免疫系统对潜在感染做出反应。在为期四周的1期研究中，每周皮下注射1000 mg剂量的BHV-1300可使总IgG快速、深度和持续地降低，降幅最高达84%，中位降幅为80%。在每次给药后的数小时内，患者的IgG就会逐渐降低，并且与基线值相比，在四周内持续降低。BHV-1300在高达2000 mg的皮下给药剂量下安全性和耐受性良好。大多数不良事件轻微，可自行消退，没有因与研究药物相关的不良事件而停药，也没有严重的不良事件。 ▲BHV-1300的作用方式和1期临床试验结果（图片来源：参考资料[7]） Cell Pouch：IND申请获得FDA许可 Sernova Biotherapeutics公司宣布，美国FDA已批准其IND申请，允许在因结节性甲状腺疾病接受甲状腺手术的患者中评估Cell Pouch与自体移植甲状腺细胞的联合疗法。Sernova公司的Cell Pouch是一种创新的生物混合器官，由非生物材料与活体组织结合而成，旨在恢复或增强受损器官的功能。Cell Pouch与自体甲状腺细胞疗法相结合，旨在通过提供一种稳定、长期的生理解决方案，恢复自然甲状腺功能，而无需使用甲状腺激素替代药物或免疫抑制疗法。临床前研究表明，在没有免疫抑制的情况下，将甲状腺组织重新植入预先血管化的Cell Pouch中，成功地将两种主要的甲状腺激素——甲状腺素（T4）和三碘甲状腺原氨酸（T3）恢复到甲状腺切除术前水平，而无需激素补充。放射性同位素成像和组织学分析证实，植入后5个月内Cell Pouch内存在健康、功能性的甲状腺组织。 Allocetra：公布1/2期临床试验的中期数据 Enlivex Therapeutics公司公布了其巨噬细胞疗法Allocetra治疗中度至重度膝骨关节炎的1/2期临床试验的中期数据。败血症、骨关节炎、银屑病关节炎等疾病会使巨噬细胞失去平衡状态。这些非稳态巨噬细胞在很大程度上导致了相应疾病的严重性。Allocetra是一种通用、现货型细胞疗法，通过对巨噬细胞进行重编程，旨在恢复其稳态（homeostasis），进而治疗疾病。Allocetra提供创新的免疫调节机制，具潜力作为单药或组合疗法治疗这些具未竟医疗需求的疾病。此次公布的结果显示，治疗后第6个月，患者报告的疼痛平均显著减少了47.0%（P=0.0001），关节功能改善了46%。此外，83%接受治疗的患者在6个月时仍被认为对治疗有应答。这表明Allocetra作为骨关节炎的潜在突破性治疗方法，具有良好的持久性和持续疗效。安全性方面，没有报告严重的不良事件。 PER-001：公布1/2a期临床试验数据 Perfuse Therapeutics公司公布了其玻璃体内植入疗法PER-001在青光眼患者中的首次人体1/2a期试验的24周数据。PER-001是一种新型的小分子长效内皮素受体拮抗剂。内皮素是人体内最强的血管收缩剂，在青光眼中上调，并通过其在视网膜血管和神经视网膜细胞中的受体参与炎症和细胞死亡。PER-001是一种生物可降解的植入疗法，通过一次性25号注射器注入眼球玻璃体腔中。该疗法被设计为每6个月给药一次，能够持续释放药物。 24周的数据表明，PER-001具有良好的耐受性，仅有一例药物相关不良事件（轻微且短暂的玻璃体飞蚊症），没有严重药物相关不良事件或眼内炎症报告。接受PER-001治疗的患者从第1周开始，视神经头血流量较基线平均增加了至少10%，并持续至第24周。第24周时，光学相干断层扫描（OCT）显示，PER-001治疗组患者的视野平均偏差改善了1 dB/年，视网膜神经纤维层厚度平均增加了3微米。相比之下，假手术对照组患者的视野平均偏差下降了0.63 dB/年，OCT视网膜神经纤维层厚度减少了1.3微米。这些结果表明，PER-001在青光眼患者中不仅安全性良好，还显示出显著的功能和结构改善，为其作为青光眼治疗的潜在疗法提供了概念验证。 RPESC-RPE-4W：公布1/2a期临床试验数据 Luxa Biotechnology公司公布了一项1/2a期临床试验的数据，该试验评估了其专有的视网膜色素上皮（RPE）细胞疗法RPESC-RPE-4W在干性年龄相关性黄斑变性（AMD）患者中的应用。RPESC-RPE-4W是一种基于成人RPE干细胞的疗法，旨在通过替换受损的RPE细胞来恢复视力功能。干性AMD是一种导致中心视力模糊或丧失的退行性眼病，目前尚无有效治疗方法。在1/2a期试验的最低剂量组中，6名干性AMD患者被分为视力较差组和视力较好组。视力较差组的3名患者在12个月的随访中，平均在ETDRS视力表上获得了21.67个字母的改善，视力较好组的3名患者在3个月时，平均改善了3.3个字母。 VXA-G1.1-NN：公布1b期临床试验数据 Vaxart公司宣布，其第一代口服诺如病毒候选疫苗VXA-G1.1-NN在老年人群（55-80岁）中的1b期临床试验完整数据已发表在学术期刊Science Translational Medicine上。VXA-G1.1-NN是一种口服疫苗片剂，将表达诺如病毒GI.1主要衣壳蛋白VP1的非复制性腺病毒载体递送到小肠，旨在预防由诺如病毒引起的急性胃肠炎。该试验评估了VXA-G1.1-NN在55-65岁和66-80岁两个健康老年人群中的安全性和免疫原性。受试者以2：1的比例随机接受疫苗或安慰剂，并在第28天进行加强接种。63名志愿者完成了研究，安全性及免疫原性评估持续至第390天。免疫原性结果显示，与安慰剂相比，疫苗在所有三个剂量组中均诱导了强效且持久的血清抗体反应，第29天和第57天的血清抗VP1 IgA水平显著增加，且抗VP1 IgG水平也显著高于接种前水平，呈剂量依赖性增加。口服疫苗还刺激了唾液和鼻腔中强烈且持久的IgA反应。安全性方面，疫苗在老年人群中表现出良好的安全性和耐受性，未发生与疫苗相关的3级不良事件。最常见的不良反应为头痛（14%）和不适/疲劳（16%），与安慰剂组的发生率相似。 APG990：公布1期临床试验的中期数据 Apogee Therapeutics公司公布了其新型半衰期延长的OX40L单克隆抗体APG990的首个人体试验的积极中期结果。APG990是一种皮下注射疗法，靶向炎症通路中位于IL-13上游的OX40L，从而对1型、2型和3型炎症通路产生广泛影响。此次公布的结果显示，APG990的半衰期约为60天，可支持每3个月或6个月一次的维持给药方案。在所有5个剂量组（最高剂量为1200 mg）中，APG990均表现出良好的耐受性。Apogee公司还开发了APG279，即APG777（一种深度抑制2型炎症的药物）与APG990的联合制剂，旨在实现单次注射2 mL联合制剂，每年仅需给药2-4次的治疗方案，为患者提供更有效的治疗选择，同时最大限度地减少其他可用疗法的副作用。 BL-001：公布1期临床试验数据 Bloom Science公司公布了其在研口服疗法BL-001在一项涉及32名健康成年人（体重从正常到超重）的1期试验中的疗效和安全性结果。BL-001是一种潜在“first-in-class”、口服给药的活生物治疗产品（LBP），旨在模拟生酮饮食的治疗效果。临床前数据表明，BL-001在癫痫模型中复制了生酮饮食的治疗效果，并进一步展示了其对γ-氨基丁酸（GABA）和其他关键生物能途径的调节作用，以抑制癫痫发作的关键驱动因素——过度兴奋性。 BL-001在28天的治疗期内在体重减轻方面的整体治疗效果具有统计学显著性（p=0.0424）。超重组（BMI≥25）中接受BL-001治疗的受试者与所有接受安慰剂的受试者相比，体重的百分比变化具有统计学意义（p=0.0007）。此外，BL-001治疗的超重和正常体重个体之间的体重百分比变化也具有统计学意义（p=0.0003），体重减轻最高为4.9%。80%在BL-001治疗期间体重减轻的受试者在最后一次给药两周后仍保持体重减轻，其中接受最高剂量的所有超重受试者的体重继续下降，在两周随访期结束时体重减少了3.4%。此外，BL-001治疗组观察到了剂量依赖性的变化，包括尿酮、食欲降低和体重减轻，而安慰剂组未观察到这些变化。靶向生物标志物分析显示，与食欲控制、代谢调节和消化相关的关键代谢激素发生了具有统计学意义的变化。更大规模的代谢组学分析还揭示了循环酮体的统计学显著变化，这些发现进一步支持了BL-001的潜在生酮和减肥效果。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看） [1] Perfuse Therapeutics Announces Positive Visual, Structural and Safety Data from a Ph1/2a Trial of PER-001 in Glaucoma Patients at the American Glaucoma Society Meeting. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/perfuse-therapeutics-announces-positive-visual-structural-and-safety-data-from-a-ph12a-trial-of-per-001-in-glaucoma-patients-at-the-american-glaucoma-society-meeting-302387598.html [2] Sernova Biotherapeutics Receives FDA Clearance for IND Application for its Cell Pouch Bio-hybrid Organ with Autograft Thyroid Cells in Patients with Hypothyroidism. Retrieved March 7, 2025, from https://www.globenewswire.com/news-release/2025/03/03/3035709/0/en/Sernova-Biotherapeutics-Receives-FDA-Clearance-for-IND-Application-for-its-Cell-Pouch-Bio-hybrid-Organ-with-Autograft-Thyroid-Cells-in-Patients-with-Hypothyroidism.html [3] Enlivex Therapeutics Announces Investor Webinar to Discuss Positive Interim Data from Phase I/II Allocetra™ Trial in Knee Osteoarthritis. Retrieved March 7, 2025, from https://www.globenewswire.com/news-release/2025/03/04/3036995/0/en/Enlivex-Therapeutics-Announces-Investor-Webinar-to-Discuss-Positive-Interim-Data-from-Phase-I-II-Allocetra-Trial-in-Knee-Osteoarthritis.html [4] Bloom Science Reports Positive Data from Phase 1 Trial of BL-001 Demonstrating Statistically Significant, Durable Weight Loss in Overweight Individuals. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/bloom-science-reports-positive-data-from-phase-1-trial-of-bl-001-demonstrating-statistically-significant-durable-weight-loss-in-overweight-individuals-302391446.html [5] Bioheng Therapeutics Announces FDA Clearance of IND Application for CD7 UCAR T Cell Therapy in T-ALL/LBL. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/bioheng-therapeutics-announces-fda-clearance-of-ind-application-for-cd7-ucar-t-cell-therapy-in-t-alllbl-302392846.html [6] Neurocrine Biosciences Announces Initiation of Phase 1 Clinical Study Evaluating NBI-1140675, a Second-Generation VMAT2 Inhibitor, in Healthy Adults. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/neurocrine-biosciences-announces-initiation-of-phase-1-clinical-study-evaluating-nbi-1140675-a-second-generation-vmat2-inhibitor-in-healthy-adults-302392294.html [7] Biohaven Reports Positive Degrader Data Achieving > 80% Sustained Reductions in Total IgG with Potential First-in-Class BHV-1300. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/biohaven-reports-positive-degrader-data-achieving--80-sustained-reductions-in-total-igg-with-potential-first-in-class-bhv-1300-302389515.html [8] Adiso Therapeutics Announces Data Publication of Two Phase 1 Studies of First-in-Class Neutrophil Modulator ADS051 in the American Journal of Gastroenterology. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/adiso-therapeutics-announces-data-publication-of-two-phase-1-studies-of-first-in-class-neutrophil-modulator-ads051-in-the-american-journal-of-gastroenterology-302393958.html [9] Apogee Therapeutics Announces Positive Interim Phase 1 Results from the APG990 Healthy Volunteer Trial, Unlocking Potential Maintenance Dosing Every Three and Six Months for APG279 (APG777 + APG990). Retrieved March 7, 2025, from https://www.globenewswire.com/news-release/2025/03/03/3035377/0/en/Apogee-Therapeutics-Announces-Positive-Interim-Phase-1-Results-from-the-APG990-Healthy-Volunteer-Trial-Unlocking-Potential-Maintenance-Dosing-Every-Three-and-Six-Months-for-APG279-.html [10] Acadia Pharmaceuticals and Saniona Announce Initial Positive Results from ACP-711 (formerly SAN711) Phase 1 Study. Retrieved March 7, 2025, from https://acadia.com/en-us/media/news-releases/acadia-pharmaceuticals-and-saniona-announce-initial-positive [11] Actio Biosciences Announces First Participant Dosed in Phase 1 Clinical Trial of ABS-0871, a Novel TRPV4 Inhibitor, for the Treatment of Charcot Marie Tooth Disease 2C. Retrieved March 7, 2025, from https://actiobiosciences.com/actio-biosciences-announces-first-participant-dosed-in-phase-1-clinical-trial-of-abs-0871-a-novel-trpv4-inhibitor-for-the-treatment-of-charcot-marie-tooth-disease-2c/ [12] Contineum Therapeutics Initiates Patient Dosing in Phase 1b Positron Emission Tomography (PET) Trial of PIPE-791. Retrieved March 7, 2025, from https://www.businesswire.com/news/home/20241216396391/en/Contineum-Therapeutics-Initiates-Patient-Dosing-in-Phase-1b-Positron-Emission-Tomography-PET-Trial-of-PIPE-791 [13] Phio Pharmaceuticals Announces Completion of Enrollment in Third Safety Cohort in PH-762 Phase 1b Dose-Escalation Study. Retrieved March 7, 2025, from https://phiopharma.com/phio-pharmaceuticals-announces-completion-of-enrollment-in-third-safety-cohort-in-ph-762-phase-1b-dose-escalation-study/ [14] Bambusa Therapeutics Announces First Subject Dosed in Phase 1 Clinical Trial of BBT001, a Novel Multi-Targeting, Half-Life Extended Bispecific Antibody for the Treatment of Atopic Dermatitis and Other Inflammatory Skin Diseases. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/bambusa-therapeutics-announces-first-subject-dosed-in-phase-1-clinical-trial-of-bbt001-a-novel-multi-targeting-half-life-extended-bispecific-antibody-for-the-treatment-of-atopic-dermatitis-and-other-inflammatory-skin-diseases-302388661.html [15] Luxa Biotechnology Presents Clinical Data from First-in-Human Retinal Pigment Epithelium Cell Therapy Trial for Dry Age-Related Macular Degeneration at the 77th Annual Wills Eye Conference. Retrieved March 7, 2025, from https://www.businesswire.com/news/home/20250306998366/en/Luxa-Biotechnology-Presents-Clinical-Data-from-First-in-Human-Retinal-Pigment-Epithelium-Cell-Therapy-Trial-for-Dry-Age-Related-Macular-Degeneration-at-the-77th-Annual-Wills-Eye-Conference [16] ImmunoGenesis Doses First Patient in Phase 1/2 Clinical Trial of IMGS-101 in Combination With Balstilimab (anti-PD-1) and Zalifrelimab (anti-CTLA-4) in Relapsed or Refractory Advanced Prostate, Pancreatic, and HPV(-) Head & Neck Tumors. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/immunogenesis-doses-first-patient-in-phase-12-clinical-trial-of-imgs-101-in-combination-with-balstilimab-anti-pd-1-and-zalifrelimab-anti-ctla-4-in-relapsed-or-refractory-advanced-prostate-pancreatic-and-hpv--head--neck-t-302393719.html [17] Vaxart Announces Publication Demonstrating the Immunogenicity and Safety of its First-Generation Oral Pill Norovirus Vaccine Candidate in Elderly Adults. Retrieved March 7, 2025, from https://investors.vaxart.com/news-releases/news-release-details/vaxart-announces-publication-demonstrating-immunogenicity-and 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。版权说明：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「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床申请临床1期细胞疗法免疫疗法临床结果

2025-02-18

·GlobeNewswire-Health Care

Enlivex Issues Urgent Statement on Fraudulent News Dissemination

Ness-Ziona, Israel, Feb. 18, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq and TASE: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, alerts investors and the public that a completely false and misleading report regarding the Company was intentionally published this morning by the website Tipranks.com claiming that the Company has suspended its stock trading due to an internal investigation. These reports are completely unfounded and constitute fake news. The Company continues to operate normally, and its shares continue to trade regularly on the Tel Aviv Stock Exchange and NASDAQ Stock Exchange without any interruption. The Company unequivocally denies the claims made in this false report and urges investors to rely only on official communications from the Company, including press releases, filings with the U.S. Securities and Exchange Commission, and statements from verified Company channels. “This is a blatant attempt to manipulate public perception and mislead investors,” said Oren Hershkovitz, the Company’s CEO. “We take this matter very seriously and will pursue all available legal actions against the individuals responsible, including the publishers of the false report and the hosting service of Tipranks.com. We are continuing to execute our operating plan and are excited about the potential of AllocetraTM to offer treatment solutions to tens of millions of osteoarthritis patients, who have very poor treatment alternatives today.” Investors and stakeholders with concerns or questions are encouraged to contact Shachar Shlosberger, the Company’s CFO. ABOUT ENLIVEX Enlivex is a clinical stage macrophage reprogramming immunotherapy company developing Allocetra™, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening conditions. For more information, visit http://www.enlivex.com. Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “would”, “could,” “intends,” “estimates,” “suggests,” “has the potential to” and other words of similar meaning, including statements regarding expected cash balances, market opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRATM programs. All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex’s business and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRATM product line could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Enlivex’s filings with the Securities and Exchange Commission, including in the Company’s most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law. ENLIVEX CONTACTShachar Shlosberger, CFOEnlivex Therapeutics, Ltd.shachar@enlivexpharm.com INVESTOR RELATIONS CONTACTDave Gentry, CEORedChip Companies Inc.1-407-644-4256ENLV@redchip.com

免疫疗法细胞疗法

100 项与 Leukocyte cell therapy (Enlivex Therapeutics) 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
腹腔感染	临床2期	法国	Enlivex Therapeutics Ltd.	2020-11-30
多器官功能衰竭	临床2期	法国	Enlivex Therapeutics Ltd.	2020-11-30
多器官功能衰竭	临床2期	西班牙	Enlivex Therapeutics Ltd.	2020-11-30
多器官功能衰竭	临床2期	比利时	Enlivex Therapeutics Ltd.	2020-11-30
多器官功能衰竭	临床2期	荷兰	Enlivex Therapeutics Ltd.	2020-11-30
多器官功能衰竭	临床2期	以色列	Enlivex Therapeutics Ltd.	2020-11-30
新型冠状病毒感染	临床前	以色列	Hadassah University Hospital	2020-10-20
新型冠状病毒感染	临床前	以色列	Hadassah University Hospital	2020-10-20
终末器官损害	临床前	以色列	Hadassah University Hospital	2020-10-20
呼吸功能不全	临床前	以色列	Hadassah University Hospital	2020-10-20

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


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