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2024-05-01

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 for up to twelve cycles, until disease progression or death, whichever occurs first. Following the completion of cycle twelve, patients receiving benefit will be given the option to continue receiving compassionate use treatment with NEO100.

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）

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.

2024-08-01·JOURNAL OF INTERNATIONAL MEDICAL RESEARCH

Periorbital melanosis and its possible association with insulin resistance and vitamin D deficiency: A pilot case-control study

Article

作者: Hassan, Rasha Mohamad ; El-Bassiouny, Mahy ; Hamdy, Marwa ; Salem, Lamyaa ; Taha, Sara I. ; El-Mohamdy, Marwa Adham

Objective:

To investigate the possible association of periorbital melanosis (POM) with insulin resistance (IR) and vitamin D serum levels.

Methods:

In this pilot, case-control study, we included 100 adult patients with POM and 100 age- and sex-matched healthy control subjects. Vitamin D levels and IR indices (i.e., homeostatic model assessment-insulin resistance [HOMA-IR], triglycerides/high-density lipoprotein cholesterol (TG/HDL-c) ratio, adiponectin/leptin (A/L) ratio) were compared between cases and controls.

Results:

Compared with controls, POM cases had significantly higher values of HOMA-IR and TG/HDL-c ratio, and significantly lower values of A/L and vitamin D. HOMA-IR and TG/HDL-c ratio were statistically significantly positively correlated with POM severity while Vitamin D and A/L ratio were statistically significantly negatively correlated.

Conclusion:

POM was associated with indices of IR and vitamin D deficiency. However, the exact causal link among POM, IR, and vitamin D needs to be established. However, the results of this pilot study suggest that POM may have potential as a cutaneous non-invasive marker of these metabolic disorders which would assist in detecting and treating them at an early stage.

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）

2024-09-08

·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

2024-01-18

·FierceBiotech

CG Oncology aims for $209M IPO, as more biotechs eye path to public markets

If underwriters jump at the opportunity to buy a further 1.77 million shares then the haul would rise to $209 million. CG Oncology is hoping to raise $209 million from its upcoming IPO, blazing a trail to the public markets that seems to be enticing more biotechs in the first month of the year. Bladder cancer-focused CG kicked off 2024 by outlining plans to go public, although the company didn’t offer any figures at the time. Now, the biotech has said it is looking to sell 11.8 million shares at a price of between $16 and $18 apiece. Assuming that the final share price falls in the middle of this range, CG said it expects to rake in $181.1 million from the IPO. However, if underwriters jump at the opportunity to snap up a further 1.77 million shares then the haul would rise to $209 million, the biotech explained in a Jan. 18 SEC filing. California-based CG is focused on developing cretostimogene grenadenorepvec, an oncolytic adenovirus encoding immunohematopoietic cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF). The candidate is designed to infect and replicate in tumor cells, directly killing them while also causing the release of tumor-derived antigens and GM-CSF to stimulate an immune attack. CG has initially been developing the candidate as a treatment for non-muscle invasive bladder cancer. Despite an icy IPO market last year, CG made no secret of its ambition to go public as far back as August. The company was one of the few that opted for a pre-IPO crossover funding round last year, a financing model that proved popular during the biotech boom years. Since CG set out its IPO stall, Alto Neuroscience, gene-editing company Metagenomi, Arrivent Biopharma, and CAR-T developer Kyverna Therapeutics have all followed suit. ReCode Therapeutics CEO Shehnaaz Suliman, M.D., also told a Fierce Biotech event last week that her company was mulling going public in the second half of the year. Last Friday, NeOnc Technologies filed its own plans for a Nasdaq IPO. The brain cancer-focused company didn’t offer any estimates for its share price but said it intended to allocate $23.7 million of the proceeds towards its clinical trials, along with $11.4 million going to R&D and $35 million earmarked for general corporate purposes and working capital. A further $10 million would be used to pay off a short-term loan, Neonc explained in the Jan. 12 SEC filing. NeOnc’s lead candidate is NEO100, a purified form of perillyl acid that is administered to brain cancer patients intranasaly and is currently in a phase 2 trial. NEO212, a covalently conjugated molecule of the chemotherapy drug temozolomide and perillyl alcohol, is in a phase 1/2 trial for brain tumor patients.

IPO临床2期免疫疗法

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

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
脑膜瘤	临床2期	美国	NeOnc Technologies, Inc.	2022-07-01
胶质母细胞瘤	临床2期	美国	NeOnc Technologies, Inc.	2016-04-08
多形性胶质母细胞瘤	临床2期	美国	NeOnc Technologies, Inc.	2016-04-08
IDH1突变胶质瘤	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
光化性角化病	临床2期	美国	University of Arizona	2004-05-01
儿童中枢神经系统肿瘤	临床1期	-	NeOnc Technologies, Inc.	2024-05-01
脉络丛癌	临床1期	-	NeOnc Technologies, Inc.	2024-05-01
组蛋白H3中K27M点突变的弥漫性中线胶质瘤	临床1期	-	NeOnc Technologies, Inc.	2024-05-01
高级别胶质瘤	临床1期	-	NeOnc Technologies, Inc.	2024-05-01

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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	光化性角化病	89	placebo (Placebo)	窪選鹽鹹網膚廠鹹艱鏇(網夢網壓鹹構廠範繭壓) = 窪製範遞鬱網膚壓顧鑰蓋憲鑰襯願餘鑰餘範顧 (顧構餘繭膚構鏇淵糧醖, 網膚壓繭襯簾構構範醖 ~ 遞鑰憲繭膚簾鏇鹹鹽夢) 更多	-	2015-04-01
NCT00608634 (CTgov)	临床2期	光化性角化病	89	perillyl alcohol (Low Dose POH 0.30%)	窪選鹽鹹網膚廠鹹艱鏇(網夢網壓鹹構廠範繭壓) = 餘繭鏇構鹽構鹹憲製鑰蓋憲鑰襯願餘鑰餘範顧 (顧構餘繭膚構鏇淵糧醖, 衊蓋獵選獵壓願窪鹽鑰 ~ 鏇蓋淵膚鬱鏇夢糧蓋艱)	-	2015-04-01
ASCO2010	临床1/2期	脑癌	89	Intranasal administration of perillyl alcohol (POH)	糧遞製醖選遞鑰鏇糧顧(夢網淵觸鹽選網蓋醖願) = 艱艱鏇遞餘範糧蓋窪範願齋襯獵蓋鑰網淵觸築 (觸網獵餘觸襯鬱顧襯簾 )	积极	2010-05-20
NCT00003219 (Pubmed \| Cancer Chemother Pharmacol)	临床2期	转移性乳腺癌	14	Perillyl alcohol	淵簾蓋範襯選鏇網鑰齋(醖觸窪廠遞蓋艱壓齋鏇) = 窪壓衊衊憲願鑰顧獵鏇繭醖網繭積製襯構襯襯 (醖獵醖壓鹽糧積獵艱網 ) 更多	不佳	2008-06-01
ASCO2008	临床1/2期	复发性胶质瘤	-	Perillyl alcohol	夢願鏇夢蓋衊獵壓積糧(鬱網選製衊遞淵獵壓顧) = 願窪襯選構簾構糧製繭餘膚遞簾簾廠製餘顧鑰 (鬱鬱繭選網齋範壓製艱 ) 更多	积极	2008-05-20