An Open Label, Phase 1b Safety, Dose-finding, Brain Tumor Delivery, and Pharmacokinetics Study of Intranasal NEO100 in Patients with Pediatric-type Select Brain Tumors

This is an open label, Phase 1b safety, dose-finding, brain tumor delivery, and pharmacokinetics study of intranasal NEO100 in patients with pediatric-type diffuse high grade gliomas. Patients will receive IN NEO100 that will follow a dose titration design, followed by a standard dose escalation design to establish safety. Brain tumor delivery of NEO100 will be confirmed in each disease sub-type by surgical resection/needle biopsy only if clinically indicated and scheduled for clinical purposes and testing with residual tissue for NEO100 and the major metabolite of NEO100 (Perillic Acid).

开始日期2024-12-01

申办/合作机构

NeOnc Technologies, Inc.

KCT0009442 / RecruitingN/AIIT

A human study to evaluate safety and effectiveness of Perilla oil on blood flow

开始日期2024-01-20

申办/合作机构

Seoul National University of Science & Technology

NCT05023018 / Recruiting临床2期

An Open-Label, Phase 2 Study of NEO100 in Participants with Residual, Progressive or Recurrent High-Grade Meningioma

This multi-site, Phase 2 clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO100 (perillyl alcohol) for the treatment of patients with residual high-grade meningioma following resection surgery, radiographically-confirmed progression of high-grade meningioma or recurrent high-grade meningioma. There will be up to 30 patients enrolled in this study to have 29 evaluable patients. NEO100 will be self-administered four times daily on a 28-day treatment cycle until disease progression, death or patient withdraw from study for any reason, whichever occurs first.

开始日期2022-07-01

申办/合作机构

NeOnc Technologies, Inc.

100 项与紫苏醇相关的临床结果

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100 项与紫苏醇相关的转化医学

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100 项与紫苏醇相关的专利（医药）

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项与紫苏醇相关的文献（医药）

2025-03-01·Comparative Biochemistry and Physiology D-Genomics & Proteomics

Molecular insights into oocyte development and sperm storage in black rockfish (Sebastes schlegelii): Proteomic changes across reproductive stages

Article

作者: Chen, Ying ; Ali, Wajid ; Qi, Jie ; Cai, Wenxiu ; Li, Zibin ; Men, Yu ; Yan, Kai ; He, Yan

Sperm storage in females is widespread among vertebrates and insects, and the expression of proteins in the female reproductive tract is influenced by the presence of sperm, allowing for adaptation to this phenomenon. Through histological observation, we confirmed that sperm were stored in the isthmic fossa outside the oocyte during the post-mating (POM) stage, and closer to the epithelial cells during the pre-fertilization (PRF) stage. In addition, we observed asynchronous ovarian development in black rockfish, where oocytes at various stages could be identified during the PRF phase. This study investigated the ovarian protein expression changes in black rockfish (Sebastes schlegelii) during key reproductive stages: pre-mating (PRM), POM, unmated control (POM-CT), and PRF. A total of 5012 proteins were identified, with notable fluctuations in protein expression observed at the PRF stage. Specifically, 140 proteins were upregulated and 615 downregulated when compared to the PRM stage, while 101 proteins were upregulated and 531 downregulated in comparison to the POM stage. The functional enrichment analysis of differentially expressed proteins (DEPs) revealed distinct pathways: POM vs. PRM showed involvement in vesicle sorting and hormone signaling; PRF vs. POM indicated pathways related to chromatin remodeling and gene expression regulation; and POM vs. POM-CT highlighted pathways associated with immune response. These findings suggested that these signaling pathways may play a crucial role in oocyte development and sperm storage. The majority of DEPs were localized in the nucleus, with key interactions involving proteins such as GSK3B and MED1. These findings enhance our understanding of the molecular mechanisms underlying oocyte maturation and sperm storage, providing insights relevant to reproductive biology and aquaculture practices.

2024-12-31·REDOX REPORT

Activation of the Nrf2/Keap1 signaling pathway mediates the neuroprotective effect of Perillyl alcohol against cerebral hypoxic-ischemic damage in neonatal rats

Article

作者: Wu, Yiqing ; Lin, Wei ; Lin, Zhenlang ; Tao, Xiaoyue ; Pang, Mengdan ; Gao, Qiqi ; Fang, Yu ; Zheng, Yihui ; Hu, Yingying ; Feng, Xiaoli

Neonatal hypoxic-ischemic encephalopathy (HIE) is a severe disease with a poor prognosis, whose clinical treatment is still limited to therapeutic hypothermia with limited efficacy. Perillyl alcohol (POH), a natural monoterpene found in various plant essential oils, has shown neuroprotective properties, though its effects on HIE are not well understood. This study investigates the neuroprotective effects of POH on HIE both in vitro and in vivo. We established an in vitro model using glucose deprivation and hypoxia/reperfusion (OGD/R) in PC12 cells, alongside an in vivo model via the modified Rice-Vannucci method. Results indicated that POH acted as an indirect antioxidant, reducing inducible nitric oxide synthase and malondialdehyde production, maintaining content of antioxidant molecules and enzymes in OGD/R-induced PC12 cells. In vivo, POH remarkably lessened infarct volume, reduced cerebral edema, accelerated tissue regeneration, and blocked reactive astrogliosis after hypoxic-ischemic brain injury. POH exerted antiapoptotic activities through both the intrinsic and extrinsic apoptotic pathways. Mechanistically, POH activated Nrf2 and inactivated its negative regulator Keap1. The use of ML385, a Nrf2 inhibitor, reversed these effects. Overall, POH mitigates neuronal damage in HIE by combating oxidative stress, reducing inflammation, and inhibiting apoptosis via the Nrf2/Keap1 pathway, suggesting its potential for HIE treatment.

2024-12-01·Current medicinal chemistry

Perillyl Alcohol Promotes Relaxation in Human Umbilical Artery

Article

作者: Batista, Paulo Ricardo ; de Menezes Dantas, Débora ; Gomes, Maria Franciele Lima ; Pereira-de-Morais, Luis ; de Alencar Silva, Andressa ; de Menezes, Irwin Rose Alencar ; de Araújo Delmondes, Gyllyandeson ; de Sena Bastos, Carla Mikevely ; da Silva, Renata Evaristo Rodrigues ; Barbosa, Roseli

Background::

Perillyl alcohol (POH) is a monoterpenoid found in plant essential oils and has been shown to relax murine vessels, but its effect on human vessels remains poorly studied.

Objective::

The study aimed to characterize the effect of POH on human umbilical arteries (HUA).

Methods::

Rings of HUA were obtained from uncomplicated patients and suspended in an organ bath for isometric recording. The vasorelaxant effect of POH in HUA was evaluated on basal tone and electromechanical or pharmacomechanical contractions, and possible mechanisms of action were also investigated.

Results::

POH (1-1000 μM) altered the basal tone of HUA and completely relaxed HUA rings precontracted with KCl (60 mM) or 5-HT (10 μM), obtaining greater potency in the pharmacomechanical pathway (EC50 110.1 μM), suggesting a complex interference in the mobilization of extra- and intracellular Ca2+. POH (1000 μM) inhibited contractions induced by BaCl2 (0.1-30 mM) in a similar way to nifedipine (10 μM), indicating a possible blockade of L-type VOCC. In the presence of potassium channel blockers, tetraethylammonium (1 mM), 4-aminopyridine (1 mM), or glibenclamide (10 μM), an increase in the EC50 value of the POH was observed, suggesting a modulation of the activity of BKCa, KV, and KATP channels.

Conclusion::

The data from this study suggest that POH modulates Ca2+ and K+ ion channels to induce a relaxant response in HUA.

项与紫苏醇相关的新闻（医药）

2024-10-22

·凯莱英Asymchem

【技术】凯莱英合成生物学崭露头角：大肠杆菌从头合成红景天苷确保稳定可持续供应

合成生物学近年来呈现出蓬勃发展的态势，在全球范围内掀起一股热潮。在科研领域，技术的不断创新和突破为大宗廉价工业品的绿色制造、高附加值化合物的可持续生产、昂贵医疗产品的平价替代、未来食品和生物基材料的超前部署带来了前所未有的机会。工业和医药等领域对合成生物学的投资和研发，进一步促进了该领域的繁荣，为廉价生产各种生物制品和化学品提供了无限可能，推动了技术和商业模式的变革。这股热潮不仅加速了合成生物学产品在商业领域的落地，也促使更多企业投身于这个充满潜力和机遇的领域。国内大批企业也纷纷押注于这一赛道，竞相利用合成生物技术开发各类产品，取代传统的化学合成和植物提取方法。近日，天津凯莱英生物科技有限公司在合成生物学领域取得了突破性进展。通过对大肠杆菌进行改造，成功解决了微生物合成红景天苷的难题，该成果近期已申请多个国家专利，部分专利已授权（如授权号CN118389391B，专利名称《基因工程菌、其制备方法及其在从头合成红景天苷中的应用》）。其微生物细胞工厂团队成功将大肠杆菌从头合成红景天苷的产量提高至47.67g/L，创下了微生物合成红景天苷的最高产量。这一技术利用大肠杆菌作为底盘菌株，无需添加任何前体。相较于行业内广泛使用的酵母底盘，该技术具有更短的发酵周期、更高的生产强度和更低的生产成本，更适合产业化应用。 2024年初，红景天苷项目已顺利完成了500L中试发酵并打通至后处理纯化的放大生产完整链条。最近，公司进一步完成了5000L规模的放大生产，单批次可生产超100公斤的高纯度产品SAL-98，发酵指标和产品质量均处于国际领先水平，能够满足医药、化妆品和保健品等领域的需求。这一技术突破为凯莱英在合成生物学领域的战略布局奠定了技术基础，并展现了公司在该领域良好的发展潜力。图1. 微生物法高效生产红景天苷红景天苷是珍贵的传统中药材红景天的一种生物活性成分，具有抗缺氧、抗疲劳、抗炎、抗抑郁、抗癌、心脏保护、抗氧化、防晒、抗皱、抗衰等多重功效。红景天是一种生长在高寒、缺氧、紫外线强、昼夜温差大的高海拔地区的植物，被多部中医药典籍如《神农本草经》《本草纲目》等所记载，具备多种药理活性，被誉为“高原人参”。红景天于2002年被列入我国卫生部颁布的“可用于保健食品的物品”名单，并于2021年被收录于药监局发布的《已使用化妆品原料目录》。随着人们对其药理作用认识的不断深入，红景天苷的需求量与日俱增。据公开资料，在保健品领域每年有约15~20亿元的销售额，在化妆品市场每年有约1亿元的销售额。 2021年，国内红景天提取物的产量在1100吨左右，其中红景天苷的需求量近250吨。然而，由于过度开采和出于生态保护的考虑，红景天已于2021年被列入我国Ⅱ级《国家重点保护野生植物名录》。图2. 红景天苷介绍凯莱英采用合成生物法生产的高纯度红景天苷SAL-98，能够确保其稳定的可持续供应，是植物来源红景天的有效替代品。科学研究数据已证实了生物法生产的高纯度红景天苷的安全性，一些临床结果也支持其提高氧摄入和抗疲劳等功效。红景天苷已被开发成为保健品，并被多家企业利用其防晒、抗皱、抗衰、抗氧化等性能用于化妆品的产品开发中。图3. 凯莱英开发的合成生物技术平台除红景天苷外，凯莱英还利用搭建的合成生物学平台布局了多个产品管线的开发，包括芳香族类、萜烯类、抗生素类等产品，并已成功开发出合成白藜芦醇、羟基酪醇和香紫苏醇等产品的高产菌株。目前，天津凯莱英生物科技有限公司开发了一系列自主创新的菌株改造技术和高通量筛选技术，结合公司的酶进化和AI技术等核心优势，具备利用大肠杆菌、酿酒酵母、解脂耶氏酵母、放线菌等多种微生物进行产品开发的能力。同时，公司具有规模化的发酵生产及后处理提取工艺能力，可为客户提供定制化方案，确保项目的顺利进行和产品的成功落地。凯莱英期待未来看到更多合成生物学的创新成果，为医药、食品、农业、保健品和化妆品等领域的可持续发展创造更多机遇。

上市批准微生物疗法

2024-09-08

·MedCity News

A Biotech Going Through the Nose to Treat the Brain Plots Alternative Path to Public Markets - MedCity News

Whether a brain cancer drug enters the body through a needle in the arm or swallowed by mouth, the blood-brain barrier stands as a formidable last obstacle on the therapy’s journey to its destination. NeOnc Technologies navigates around this protective barrier using drugs inhaled through the nose. With a lead program in mid-stage clinical testing, NeOnc is now preparing to take itself public. Though some recent signs point to improving IPO conditions, the IPO window has been mostly closed to biotech companies the past two years, which NeOnc knows firsthand. After laying groundwork for a traditional IPO earlier this year, the Westlake Village, California-based firm withdrew its registration statement amid lukewarm investor interest. NeOnc is changing course. Just as its drug takes an alternate path to the brain, the company is pursuing an alternate way of going public: a direct listing. Executives say they expect to file new securities paperwork this month. NeOnc is seeking investor buy-in for its novel approach to treating aggressive brain cancers, such as glioblastoma. The standard of care includes surgery, chemotherapy, and radiation. If the cancer advances, the standard drug treatment is temozolomide, brand name Temodar, a Merck chemotherapy in oral and injectable formulations that was initially approved in 1999. According to NeOnc CEO Thomas Chen, a neurosurgeon and professor of neurological surgery at the University of Southern California’s Keck School of Medicine, the challenge for the Merck drug is getting enough of it through the blood-brain barrier to reach tumors. presented by Health Tech What’s Keeping Healthcare CIOs Up at Night: How to Improve Patient Satisfaction by Handling Calls More Efficiently Health systems have spent billions on portals while investments in modernizing the voice channel — the dominant preference of healthcare consumers — have taken a backseat. By Stephanie Baum There’s precedent for intranasal drug delivery to hit central nervous system targets. Some migraine drugs work this way. NeOnc’s drug, NEO100, leverages cranial nerves in the brain, Chen said. While these nerves play a role in our senses, including smell and taste, they can also transport drugs across the blood brain barrier. “We want our drug to get to the target, but instead of trying to open up or break through the blood-brain barrier, we’re trying to bypass it,” Chen said. The Idea for Intranasal Drug Delivery to the Brain The active pharmaceutical ingredient in NEO100 is perillyl alcohol (POH), a naturally occurring compound isolated from essential oils of certain plants. While POH is an ingredient in common consumer items such as cosmetics and cleaning products, lab tests have also shown it interferes with the replication of dividing cancer cells, Chen said. However, academic research testing oral POH found not enough of the compound reached the bloodstream to confer a therapeutic effect. Increasing the dose led to intolerable gastrointestinal side effects. sponsored content 5 Health Reasons to Ditch Concrete Jungles for Countryside In an increasingly urbanized world, the allure of countryside living is growing stronger, especially when it comes to health and well-being. By Impact Brands Chen said the idea for delivering POH through the nose came from a NeOnc co-founder, a neurosurgeon who had success testing intranasal delivery of the compound in Brazil. NeOnc’s intellectual property is technology licensed from USC that enables the company to make ultra-pure, pharmaceutical-grade POH. The drug is administered with a commercially available nebulizer. In NeOnc’s Phase 1 dose-escalation study testing NEO100 in 12 glioblastoma patients, published results showed the drug was safe and well tolerated. This trial was not powered to demonstrate efficacy, but Chen noted three patients lived more than three years and one is still alive. For context, glioblastoma patients whose disease has returned after one or more rounds of standard treatment live an average of six months. A genomic analysis of tumors found better responses in those with a specific genetic signature, a mutation to IDH1 enzymes. IDH1 has validation with the recent FDA approval of the first systemic brain cancer therapy for that target, a pill from Servier Pharmaceuticals. NeOnc’s ongoing Phase 2a test is recruiting patients with IDH1 mutations. When NeOnc set preliminary IPO terms this past winter, it aimed to raise about $75 million. NeOnc’s largest shareholder is AFH, a biotech-focused family office. Amir Heshmatpour, managing director of AFH and executive chairman of NeOnc’s board of directors, said institutional investors did not warm to NeOnc, telling him they prefer companies be in late-stage testing or at least have Phase 2 data. “Institutional investors have pulled back in the last five years,” Heshmatpour said. “They want you to de-risk the lead asset as fast as possible with as little money as possible.” A Rare Path to the Public Markets NeOnc withdrew its registration statement in June, then raised $18.5 million, a combination of equity financing and the conversion of debt into equity. The company also stated its intention to go public via a direct listing. Whereas an IPO raises new capital by issuing new shares sold to the public, a direct listing involves no new shares and raises no new money, said Taylor Wirth, a partner at Barnes & Thornburg who specializes in securities transactions. Instead, company insiders sell their shares to the public without involving underwriters, explained Wirth, who has no connection to NeOnc. With no new shares offered, existing shareholders experience no dilution. Going public this way is also cheaper than an IPO because a company avoids paying underwriting fees. Music-streaming company Spotify, which went public in 2018, might be the most prominent direct listing example. The direct listing trend peaked in 2021, when six U.S. companies went public this way, according to PitchBook. From 2018 to mid-2023, the most recent figures available from PitchBook, 14 U.S. companies went public via a direct listing — none in the life sciences. There’s been at least one biotech direct listing this year. FibroBiologics, a regenerative medicine company in early-stage clinical development, completed its direct listing in January. Direct listings are particularly rare for biotech, Wirth said. One reason is that drug development is R&D intensive and companies in this sector need substantial sums of new money to finance that work. The benefits of a direct listing are clearer for well-capitalized companies that do not need extra cash, Wirth said. “I think the original thinking around the direct listing is you could cut out the middle man, cut out the underwriter, and democratize the process of going public,” he said. “But people found services of underwriters are extremely helpful marketing shares, placing them with investors. Going public is a complex legal and business process. Underwriters are helpful navigating those waters.” The biotech IPO market is showing new signs of life. BioAge Labs, a metabolic diseases-focused company collaborating with Eli Lilly, filed its registration statement last week. Two clinical-stage developers of bispecific antibody drugs, Zenas Biopharma and Bicara Therapeutics, have each set financial terms for IPOs expected to price this week. If NeOnc is able to join those companies on the public markets, it aims to continue work on other programs that use NEO100 as a way to deliver other therapies into the brain. NEO212 is comprised of NEO100 conjugated to Merck’s glioblastoma drug. The company also has preclinical research testing NEO100 as a way to deliver the Parkinson’s disease drug levadopa to the brain. But NeOnc’s near-term focus is glioblastoma. Chen expects the Phase 2a test of NEO100 will reach its targeted enrollment of 25 patients by the end of 2024; preliminary data could come in mid-2025. Image: Jolygon, Getty Images

临床结果临床1期上市批准临床2期IPO

2024-07-29

·药明康德

使97%患者症状获一致改善的ASO疗法；多款阿尔茨海默病疗法获积极早期进展…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. 治疗天使综合征（Angelman syndrome，AS）的在研反义寡核苷酸（ASO）疗法ION582在一项早期临床试验中使高达97%接受中、高剂量患者的整体AS症状获得缓解。 2. 希望之城（City of Hope）开发的用于治疗转移性去势抵抗性前列腺癌（mCRPC）的嵌合抗原受体（CAR）T细胞疗法在1期临床试验中使1例患者的前列腺特异性抗原（PSA）水平下降＞90%。 3. 多款治疗阿尔茨海默病的创新疗法获积极早期结果。药明康德内容团队整理 ION582：布1/2a期临床试验数据 Ionis Pharmaceuticals公司宣布，其在研ASO疗法ION582治疗天使综合征的1/2a期研究HALOS已完成多次剂量递增（MAD）部分，并取得积极成果。ION582是一款通过脊椎穿刺鞘内给药的在研ASO疗法，旨在抑制UBE3A反义转录本（UBE3A-ATS）的表达，并激活来自父体的UBE3A等位基因以增加患者大脑中UBE3A蛋白的产生，为天使综合征的潜在疗法。临床前研究显示，ION582能够显著增加动物的学习和记忆功能，以及其大脑中UBE3A蛋白的表达。美国FDA在2022年授予ION582孤儿药资格和罕见儿科疾病资格。 ▲在HALOS试验中，绝大部分患者在各个临床指标中皆获得改善（图片来源：参考资料[2]）此次公布的结果显示，ION582持续改善了患者的沟通、认知和运动功能，高达97%接受中、高剂量患者的整体AS症状获得缓解。根据此积极结果，Ionis计划与监管单位进行讨论，并于2025年上半年启动关键3期研究。 PSCA-CAR-T Cells：公布1期临床试验数据《自然-医学》（Nature Medicine）杂志发表了一项由希望之城开展的单中心1期临床试验的积极结果。该研究旨在评估前列腺干细胞抗原（PSCA）靶向CAR-T细胞疗法治疗转移性去势抵抗性前列腺癌的效果。该细胞疗法是在希望之城的GMP工厂制造的，只提供给参加试验的患者。此次公布的结果显示，该CAR-T细胞扩增和持续至输注后28天，3个剂量队列分别有1例、3例和3例患者的PSA水平下降，14例患者中有4例患者的PSA降幅＞30%。其中，队列2中有1例患者在输注CAR-T细胞后的首个28天内，PSA降幅＞90%。三个队列的疾病控制率分别为0%、67%和60%，6个月生存率分别为33%、67%和40%。该临床研究结果表明PSCA-CAR-T细胞疗法治疗mCRPC是安全的，有望成为mCRPC患者治疗新选择。 PMN310：公布1a期临床试验数据 ProMIS Neurosciences公司宣布，其用于治疗阿尔茨海默病的新型单克隆抗体PMN310在健康受试者中进行的1a期临床试验的前四个队列均获得了积极结果。PMN310能够高选择性地靶向被认为是阿尔茨海默病主要驱动因素的β淀粉样蛋白（Aβ）寡聚体。在临床前研究中，PMN310与其他靶向Aβ的抗体相比，对Aβ寡聚体表现出更强大的体外靶向作用。此外，PMN310未观察到与斑块的结合，可能会降低使用斑块结合抗体引起的淀粉样蛋白相关成像异常（ARIA）的风险。这些数据支持该疗法具有潜在的差异化临床特征。该初步研究的结果表明，在健康受试者中，四种递增剂量水平的PMN310的安全性和耐受性良好，患者脑脊液中的PMN310抗体水平与剂量有关，这表明该抗体有可能成为阿尔茨海默病患者的靶向药物。 VG-3927：公布1期临床试验的中期数据 Vigil Neuroscience公司公布了其阿尔茨海默病疗法VG-3927在健康受试者中进行的1期临床试验的中期数据。VG-3927是一种新型小分子TREM2激动剂，用于治疗与小胶质细胞功能障碍相关的常见神经退行性疾病，最初主要针对阿尔茨海默病患者，包括一些携带TREM2和其他疾病相关突变体的患者。此次公布的结果显示，VG-3927的安全性、耐受性、药代动力学和药效学特征支持将其作为治疗阿尔茨海默病的潜在每日一次口服疗法继续进行开发。此外，VG-3927能显著降低患者脑脊液中的可溶性TREM2，证明其具有临床靶向性。VG-3927重复给药后，骨桥蛋白/分泌磷蛋白1（SPP1）增加，这是一种与神经保护性小胶质细胞相关的生物标志物。该公司计划在2025年第一季度报告完整的1期临床数据。 NEO212：1期临床试验开始招募第三个队列的患者 NeOnc Technologies公司宣布，其用于治疗原发性和继发性恶性脑肿瘤的新型混合药物NEO212的1期临床试验已开始招募第三个队列的患者。NEO212是该公司的主要候选药物NEO100和替莫唑胺（TMZ）的生物偶联物。相比于将NEO100和TMZ简单混合，共价键合的NEO212有望提供更有效的脑癌治疗。临床前动物研究表明，与TMZ相比，NEO212的毒性可能较小，有望以三倍的效率穿透血脑屏障，并发挥十倍的效力。 ▲NEO212的分子式（图片来源：参考资料[9]） OST-HER2：公布1期临床试验数据 OS Therapies公司宣布，其生物治疗候选药物OST-HER2在HER2表达实体瘤（乳腺癌和其他癌症）患者中的1期临床试验数据良好。OST-HER2是一种以单核细胞增生李斯特氏菌（Listeria monocytogenes，Lm）为载体的现货型免疫治疗疫苗，旨在预防骨肉瘤和其他实体瘤患者的转移、延缓复发并提高总生存率。 OST-HER2的作用机制是通过激活抗原呈递细胞生成靶向HER2的特异性T细胞，这些T细胞增殖后定位、渗透并直接攻击肿瘤病灶，杀死肿瘤细胞并暴露出更多抗原。随后，免疫系统会根据新抗原生成更多的T细胞。该机制通过循环产生和激活T细胞，以持续延长抗肿瘤效果。此次公布的数据显示，OST-HER2在表达HER2的实体瘤患者中是安全的，并且耐受性良好。 Lomab-ACT：IND申请获得FDA许可 Actinium Pharmaceuticals公司宣布，FDA批准了其用于镰状细胞病患者在骨髓移植（BMT）前进行靶向调理的候选疗法Iomab-ACT的IND申请。这项试验旨在评估Iomab-ACT在接受同种异体BMT的镰状细胞病患者中的安全性。Lomab-ACT是一种靶向CD45的抗体偶联放射物（ARC），旨在取代目前在细胞和基因疗法之前用于调理患者的非靶向化疗和全身放射治疗，从而使镰状细胞病患者能够更广泛地获得有望治愈疾病的同种异体BMT或基因治疗。 NKX019：启动1期临床试验 Nkarta公司宣布，哥伦比亚大学Irving医学中心（CUIMC）的研究人员已经启动了一项由研究者发起的试验，旨在评估Nkarta的同种异体CD19靶向CAR自然杀伤（NK）细胞疗法NKX019在系统性红斑狼疮患者中的应用。NKX019是一种异体、低温保存、现货型候选免疫疗法，它使用从健康成人供体外周血中提取的NK细胞。NKX019采用人源化的CD19靶向CAR进行设计，增强了细胞的靶向性，并采用专有的膜结合型白细胞介素-15（IL-15），在没有外源细胞因子支持的情况下提高了持久性和活性。 Allocetra：启动1期临床试验 Enlivex Therapeutics公司宣布，以色列卫生部已批准启动一项1期临床试验，旨在评估Allocetra治疗银屑病关节炎患者的安全性和耐受性。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。 ▲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] Ionis announces positive detailed results from the HALOS Study of ION582 in people with Angelman syndrome. Retrieved July 22, 2024 from https://ir.ionis.com/news-releases/news-release-details/ionis-announces-positive-detailed-results-halos-study-ion582 [2] Angelman Syndrome Webcast. Retrieved July 22, 2024 from https://ir.ionis.com/static-files/3be48746-13cb-473c-8c43-18fa0717c2c0 [3] NKARTA ANNOUNCES INITIATION OF INVESTIGATOR-SPONSORED CLINICAL TRIAL EVALUATING NKX019 FOR SYSTEMIC LUPUS ERYTHEMATOSUS. Retrieved July 24, 2024 from https://ir.nkartatx.com/news-releases/news-release-details/nkarta-announces-initiation-investigator-sponsored-clinical [4] Dorff TB, Blanchard MS, Adkins LN, Luebbert L, Leggett N, Shishido SN, Macias A, Del Real MM, Dhapola G, Egelston C, Murad JP, Rosa R, Paul J, Chaudhry A, Martirosyan H, Gerdts E, Wagner JR, Stiller T, Tilakawardane D, Pal S, Martinez C, Reiter RE, Budde LE, D'Apuzzo M, Kuhn P, Pachter L, Forman SJ, Priceman SJ. PSCA-CAR T cell therapy in metastatic castration-resistant prostate cancer: a phase 1 trial. Nat Med. 2024 Jun;30(6):1636-1644. doi: 10.1038/s41591-024-02979-8. Epub 2024 Jun 12. PMID: 38867077; PMCID: PMC11186768. [5] Enlivex Receives Regulatory Authorization For The Initiation Of A Phase I Clinical Trial To Evaluate Allocetra In Patients With Psoriatic Arthritis. Retrieved July 24, 2024 from https://www.globenewswire.com/news-release/2024/07/23/2917164/0/en/Enlivex-Receives-Regulatory-Authorization-For-The-Initiation-Of-A-Phase-I-Clinical-Trial-To-Evaluate-Allocetra-In-Patients-With-Psoriatic-Arthritis.html [6] OS Therapies Announces Positive Safety Data from Phase 1 Clinical Trial of OST-HER2 in HER2-Expressing Breast Cancer and in Preclinical Efficacy in Models of Breast Cancer. Retrieved July 24, 2024 from https://www.businesswire.com/news/home/20240724194701/en [7] Vigil Neuroscience Announces Interim Data from its Ongoing Phase 1 Clinical Trial Evaluating VG-3927 in Healthy Volunteers Supporting Continued Development in Alzheimer’s Disease. Retrieved July 24, 2024 from https://www.globenewswire.com/news-release/2024/07/24/2917876/0/en/Vigil-Neuroscience-Announces-Interim-Data-from-its-Ongoing-Phase-1-Clinical-Trial-Evaluating-VG-3927-in-Healthy-Volunteers-Supporting-Continued-Development-in-Alzheimer-s-Disease.html [8] Actinium Announces FDA Clearance of Iomab-ACT Targeted Conditioning IND Application for Sickle Cell Disease Patients Undergoing Bone Marrow Transplant in Collaboration with Columbia University. Retrieved July 25, 2024 from https://www.prnewswire.com/news-releases/actinium-announces-fda-clearance-of-iomab-act-targeted-conditioning-ind-application-for-sickle-cell-disease-patients-undergoing-bone-marrow-transplant-in-collaboration-with-columbia-university-302206540.html [9] NeOnc Initiates Cohort 3 in Phase 1 Clinical Trial of NEO212™, a Patented Novel Hybrid Drug Designed to Deliver ‘Double Punch’ Against Malignant Brain Tumors. Retrieved July 25, 2024 from https://www.globenewswire.com/news-release/2024/07/24/2918220/0/en/NeOnc-Initiates-Cohort-3-in-Phase-1-Clinical-Trial-of-NEO212-a-Patented-Novel-Hybrid-Drug-Designed-to-Deliver-Double-Punch-Against-Malignant-Brain-Tumors.html [10] ProMIS Neurosciences Reports Positive Top-Line Data from its Phase 1a Alzheimer's Trial. Retrieved July 25, 2024 from https://www.globenewswire.com/news-release/2024/07/26/2919566/0/en/ProMIS-Neurosciences-Reports-Positive-Top-Line-Data-from-its-Phase-1a-Alzheimer-s-Trial.html [11] OCUGEN, INC. ANNOUNCES COMPLETION OF DOSING IN SUBJECTS WITH GEOGRAPHIC ATROPHY SECONDARY TO DAMD IN HIGH-DOSE COHORT OF PHASE 1/2 ARMADA CLINICAL TRIAL OF OCU410—A NOVEL MODIFIER GENE THERAPY. Retrieved July 25, 2024 from https://ir.ocugen.com/news-releases/news-release-details/ocugen-inc-announces-completion-dosing-subjects-geographic [12] Zymeworks Announces FDA Clearance of Investigational New Drug Application for ZW191, a Novel Folate Receptor-⍺ Targeted Topoisomerase I Inhibitor Antibody-Drug Conjugate. Retrieved July 25, 2024 from https://www.globenewswire.com/news-release/2024/07/22/2916373/0/en/Zymeworks-Announces-FDA-Clearance-of-Investigational-New-Drug-Application-for-ZW191-a-Novel-Folate-Receptor-Targeted-Topoisomerase-I-Inhibitor-Antibody-Drug-Conjugate.html [13] INIMMUNE ANNOUNCES FIRST CANCER PATIENT DOSED IN PHASE 1 CLINICAL STUDY USING THE IMMUNOTHERAPEUTIC INI-4001, A NOVEL TLR7/8 AGONIST. Retrieved July 25, 2024 from https://www.prnewswire.com/news-releases/inimmune-announces-first-cancer-patient-dosed-in-phase-1-clinical-study-using-the-immunotherapeutic-ini-4001-a-novel-tlr78-agonist-302204890.html [14] Cytoki Pharma Announces Positive Phase 1 Data Showing Potential of CK-0045 to Improve Cardiometabolic Risk Factors. Retrieved July 25, 2024 from https://www.prnewswire.com/news-releases/cytoki-pharma-announces-positive-phase-1-data-showing-potential-of-ck-0045-to-improve-cardiometabolic-risk-factors-302201481.html [15] Sonnet BioTherapeutics Reports Encouraging Data from Phase 1b/2a Clinical Trial of SON-080 in Chemotherapy-Induced Peripheral Neuropathy (CIPN) That Support Advancement into Phase 2 Study. Retrieved July 25, 2024 from https://www.globenewswire.com/news-release/2024/07/24/2917996/0/en/Sonnet-BioTherapeutics-Reports-Encouraging-Data-from-Phase-1b-2a-Clinical-Trial-of-SON-080-in-Chemotherapy-Induced-Peripheral-Neuropathy-CIPN-That-Support-Advancement-into-Phase-2-.html [16] Kaerus Bioscience Announces Initiation of Phase 1 Clinical Trial for its Novel BK Channel Modulator KER-0193 being developed for Fragile X Syndrome. Retrieved July 25, 2024 from https://www.globenewswire.com/news-release/2024/07/25/2918613/0/en/Kaerus-Bioscience-Announces-Initiation-of-Phase-1-Clinical-Trial-for-its-Novel-BK-Channel-Modulator-KER-0193-being-developed-for-Fragile-X-Syndrome.html 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

细胞疗法临床结果临床1期孤儿药免疫疗法

100 项与紫苏醇相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	紫苏醇	-	DB15289

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
复发性间变性（恶性）脑膜瘤	临床2期	美国	NeOnc Technologies, Inc.	2022-07-01
多形性胶质母细胞瘤	临床2期	美国	NeOnc Technologies, Inc.	2017-08-01
IDH1突变胶质瘤	临床2期	美国	NeOnc Technologies, Inc.	2017-08-01
胶质母细胞瘤	临床2期	美国	NeOnc Technologies, Inc.	2016-04-08
多发性骨髓瘤	临床2期	美国	Oncotherapeutics, Inc.	2014-08-01
光化性汗孔角化症	临床2期	美国	University of Arizona	2004-05-01
光化性角化病	临床2期	-	The University of Arizona Health Network	-
光化性角化病	临床2期	-	NeOnc Technologies, Inc.	-
儿童中枢神经系统肿瘤	临床1期	-	NeOnc Technologies, Inc.	2024-12-01
脉络丛癌	临床1期	-	NeOnc Technologies, Inc.	2024-12-01

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临床结果

适应症

分期

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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


NCT00608634 (CTgov)	临床2期	光化性汗孔角化症 \| 光化性角化病	89	placebo (Placebo)	醖選築襯顧醖蓋築襯鏇(鑰衊築壓鏇選觸選積襯) = 衊積艱蓋艱鹹鬱艱構憲窪範觸窪顧遞蓋築衊憲 (獵憲膚壓廠衊糧鹽醖觸, 蓋鏇鬱鑰願顧簾範艱遞 ~ 廠觸糧選膚餘範衊鑰醖) 更多	-	2015-04-01
NCT00608634 (CTgov)	临床2期	光化性汗孔角化症 \| 光化性角化病	89	perillyl alcohol (Low Dose POH 0.30%)	醖選築襯顧醖蓋築襯鏇(鑰衊築壓鏇選觸選積襯) = 鏇襯淵糧選製淵夢淵蓋窪範觸窪顧遞蓋築衊憲 (獵憲膚壓廠衊糧鹽醖觸, 壓範遞糧選鹹齋醖觸製 ~ 鏇膚築築網顧憲簾積醖)	-	2015-04-01
ASCO2010	临床1/2期	脑癌	89	Intranasal administration of perillyl alcohol (POH)	範糧鏇選鹽蓋顧廠壓艱(憲範願餘廠範範繭夢顧) = 獵廠願淵夢餘鹽鹽鹹壓願淵遞築膚鑰壓繭簾鏇 (齋廠繭淵廠蓋艱襯壓繭 )	积极	2010-05-20
ASCO2008	临床1/2期	复发性胶质瘤	-	Perillyl alcohol	鹽構選膚顧窪鏇繭壓繭(淵築顧遞廠憲範襯壓構) = 觸齋範獵餘鹽齋淵鏇餘蓋選積窪願鏇獵襯製蓋 (繭衊糧夢淵憲觸憲製繭 ) 更多	积极	2008-05-20