The goal of this clinical trial is to learn about treatment for a type of brain tumor called a meningioma. This study will enroll two groups of people. One group will be for people who will receive surgery to remove their brain tumor. The other group will be for people who have previously received treatment for their brain tumor but do not have any other available options for treatment.
The primary goals of this study are:
1. To measure how much of the study drug is present in tumor tissue taken from patients during surgery to remove their brain tumor
2. To measure the length of time between a study participant's first dose of study treatment until the time when their brain tumor gets worse or their death

开始日期2025-12-01

申办/合作机构

University of Nebraska

[+1]

NCT05630794

/ Not yet recruiting临床1期IIT

Phase 1 Trial of ONC201 for Chemoprevention of Colorectal Cancer

This phase I trial tests the safety, side effects, and best dose of Akt/ERK Inhibitor ONC201 (ONC201) in preventing colorectal cancer in patients with familial adenomatous polyposis (FAP) or a history of multiple polyps. ONC201 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

开始日期2025-03-30

申办/合作机构

National Cancer Institute

NCT04629209

/ Withdrawn临床2期IIT

A Phase II, Open Label Study of ONC201 in Adults With EGFR-low Glioblastoma

This is an open-label, two arm study. The trial will enroll a total of up to 36 patients. Arm A will enroll up to a total of 6 evaluable patients and Arm B will enroll up to a total of 30 evaluable patients. Arm A will explore the intra-tumoral ONC201 concentrations and pharmacodynamic activity in adult EGFR-low glioblastoma patients. Arm B will determine the radiographic efficacy of ONC201 in adult recurrent EGFR-low glioblastoma patients. All patients will be treated with oral ONC201 (625 mg) twice weekly, 2 consecutive days on and 5 days off per week schedule.

开始日期2024-06-28

申办/合作机构

University of Minnesota Masonic Cancer Center

[+1]

100 项与 Dordaviprone 相关的临床结果

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100 项与 Dordaviprone 相关的转化医学

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100 项与 Dordaviprone 相关的专利（医药）

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217

项与 Dordaviprone 相关的文献（医药）

2025-04-01·JOURNAL OF CLINICAL PHARMACOLOGY

Relative Bioavailability of Dordaviprone (ONC201) is Not Affected by Co‐Administration of the Proton‐Pump Inhibitor Rabeprazole

Article

作者: Mullin, Mark J. ; Morrison, Marion ; Faison, Shamia L. ; Batonga, Joelle ; Naderer, Odin ; Bartkus, Angela ; Arumugham, Thangam ; Tippin, Tim

Abstract:

Dordaviprone (ONC201) is a novel, orally administered, anti‐cancer, small molecule imipridone with demonstrated antitumor effects in patients with glioma. Dordaviprone in vitro solubility is significantly reduced at pH >4.5. Concomitant use of acid reducing agents (ARAs) may therefore impact dordaviprone solubility and bioavailability. This open‐label, single‐sequence, three‐period crossover study evaluated the effect of proton‐pump inhibitor rabeprazole on dordaviprone pharmacokinetics (PK). Periods were consecutive and comprised of period 1 (days 1‐3), period 2 (days 4‐9), and period 3 (days 10‐13). In period 1, participants received a single oral 625 mg dose of dordaviprone on day 1. In period 2, participants received six consecutive days of QD 20 mg rabeprazole alone. In period 3, patients received one oral dose of 20 mg rabeprazole (the seventh consecutive daily dose), followed 2 h later by a single 625 mg dordaviprone oral dose. PK blood samples were collected and analyzed from pre‐dose 72 h following dordaviprone administration in periods 1 and 3. Dordaviprone exposure PK parameters were similar following administration of dordaviprone alone or with rabeprazole. Geometric mean ratios and 90% CIs for dordaviprone exposure parameters with and without rabeprazole following dordaviprone administration fell within bioequivalence limits of 80.00%‐125.00% for Cmax (97.19% [86.43‐109.28]), AUClast (102.21% [95.19‐109.75]), and AUCinf (102.27% [95.21‐109.86]), indicating no effect of multiple oral doses of rabeprazole on dordaviprone relative bioavailability. Six of the 16 participants reported treatment‐emergent adverse events (TEAEs); dordaviprone‐related TEAEs were reported by three participants and were limited to mild nausea and dizziness. No dordaviprone dose adjustment or ARA treatment modification is warranted.

2025-03-27·Oncotarget

Imipridones ONC201/ONC206 + RT/TMZ triple (IRT) therapy reduces intracranial tumor burden, prolongs survival in orthotopic IDH-WT GBM mouse model, and suppresses MGMT

Article

作者: Wong, Eric T. ; Hahn, Marina ; El-Deiry, Wafik S. ; Wu, Laura Jinxuan ; Chen, Clark C. ; Zhou, Lanlan ; Zhang, Jun ; George, Andrew ; Zhang, Shengliang ; Seyhan, Attila A. ; Zhang, Leiqing ; Safran, Howard P.

Glioblastoma remains a lethal brain tumor in adults with limited therapeutic options. TIC10/ONC201, a first-in-class imipridone we discovered, achieved meaningful therapeutic effects in phase I/II trials in patients with diffuse gliomas (DG's) harboring H3K27M mutations, and currently the drug is in randomized phase III testing (ACTION trial; NCT05580562). ONC201 targets mitochondrial protease ClpP to disrupt oxidative phosphorylation and trigger the integrated stress response (ISR), TRAIL/DR5, and tumor cell death. While ONC201 and its analog ONC206 are undergoing clinical trials as single agents, there is limited information on their interactions with stand-of-care therapy. We show that ONC201 and ONC206 synergize with temozolomide (TMZ) and Radiotherapy (RT). ONC201 enhances TMZ- or RT-induced apoptosis, ISR and cytotoxicity. ClpP-silencing suppresses ONC201-induced cytotoxicity but not TMZ. Both ONC201 and ONC206 reduce expression of TMZ-resistance mediator MGMT observed in H3K27M-mutated DG cells following treatment with imipridones+TMZ. Cytokine profiling indicates distinct effects of ONC201 relative to TMZ treatment. These results suggest mechanisms underlying ONC201's anti-tumoral activity are distinct from those associated with TMZ or RT with potential for synergy between these three treatments. Triple ONC201+RT+TMZ (IRT) therapy prolonged median survival to 123 days with tail on survival curve (3-of-7 mice alive beyond 200-days) in orthotopic U251 GBM model versus ONC201 (44-days; p = 0.000197), RT (63-days; p = 0.0012), TMZ (78-days; p = 0.0354), ONC201+RT (55-days; p = 0.0004), ONC201+TMZ (80-days; p = 0.0041) and RT+TMZ (103-days; p > 0.05). By 231-days, the only surviving mice were in IRT group. Our results support investigation of ONC201/ONC206 in combination with RT/TMZ (IRT) in GBM or H3K27M mutated DG therapy.

2025-03-03·JOURNAL OF CLINICAL INVESTIGATION

TRAIL agonists rescue mice from radiation-induced lung, skin, or esophageal injury

Article

作者: De La Cruz, Arielle ; Srinivasan, Praveen ; Rounds, Sharon I ; De La Cruz, Payton ; Louie, Anna ; Hahn, Marina ; Hernandez Borrero, Liz ; Wazer, David E ; Seyhan, Attila A ; Yakirevich, Evgeny ; El-Deiry, Wafik S ; Abbas, Abbas E ; Koffer, Paul P ; Strandberg, Jillian ; DiPetrillo, Thomas A ; Lee, Seulki ; Azzoli, Christopher G ; Zhang, Leiqing ; Tavora, Fabio ; Huntington, Kelsey E ; George, Andrew ; Klein-Szanto, Andres J ; Zhou, Lanlan ; Graff, Stephanie L

Radiotherapy can be limited by pneumonitis, which is impacted by innate immunity, including pathways regulated by TRAIL death receptor DR5. We investigated whether DR5 agonists could rescue mice from toxic effects of radiation and found that 2 different agonists, parenteral PEGylated trimeric TRAIL (TLY012) and oral TRAIL-inducing compound (TIC10/ONC201), could reduce pneumonitis, alveolar wall thickness, and oxygen desaturation. Lung protection extended to late effects of radiation including less fibrosis at 22 weeks in TLY012-rescued survivors versus unrescued surviving irradiated mice. Wild-type orthotopic breast tumor-bearing mice receiving 20 Gy thoracic radiation were protected from pneumonitis with disappearance of tumors. At the molecular level, radioprotection appeared to be due to inhibition of CCL22, a macrophage-derived chemokine previously associated with radiation pneumonitis and pulmonary fibrosis. Treatment with anti-CCL22 reduced lung injury in vivo but less so than TLY012. Pneumonitis severity was worse in female versus male mice, and this was associated with increased expression of X-linked TLR7. Irradiated mice had reduced esophagitis characterized by reduced epithelial disruption and muscularis externa thickness following treatment with the ONC201 analog ONC212. The discovery that short-term treatment with TRAIL pathway agonists effectively rescues animals from pneumonitis, dermatitis, and esophagitis following high doses of thoracic radiation exposure has important translational implications.

138

项与 Dordaviprone 相关的新闻（医药）

2025-04-04

·PRNewswire

March Recap: 15 Top Health Press Releases

A roundup of the most newsworthy healthcare press releases from PR Newswire, including Novo Nordisk's affordable semaglutide initiative and the fifth anniversary of COVID-19. NEW YORK, April 4, 2025 /PRNewswire/ -- With thousands of press releases published each month, it can be difficult to keep up with everything on PR Newswire. To help healthcare journalists and consumers stay on top of the month's most popular releases and newsworthy trends, here's a recap of some of the past month's most read- and engaged-with stories. The list below includes the headline (with a link to the full text) and an excerpt from each story. Click on the press release headlines to access accompanying multimedia assets that are available for download. Continue Reading PR Newswire Monthly Health Press Release Roundup, March 2025. Photos provided by iHealth Labs, Inc., Garmin International, Inc. and Eggland's Best. Novo Nordisk introduces NovoCare® Pharmacy, lowering cost of all doses of FDA-approved Wegovy® (semaglutide) to $499 per month and offering easy home delivery for cash-paying patients Amidst the dangers of fake or illegitimate compounded "semaglutide," NovoCare® Pharmacy offers reliable access to authentic, FDA-approved Wegovy® in a once-weekly, single-dose pen. National Resident Matching Program® Releases the 2025 Main Residency Match® Results, Celebrates the Next Generation of Physicians A record number of 52,498 applicants registered for the Match (a 4.1% increase from 2024) to learn where they will begin their medical training. The Cigna Group Completes Sale of Medicare Businesses to HCSC The transaction is not expected to disrupt coverage or service for customers, clients, providers, or brokers of the Medicare or CareAllies businesses. Pleio Unveils OLLIE™: AI That Listens, Learns, and Guides To Elevate Human Connection in Patient Medication Journeys Powered by AI, OLLIE™ analyzes conversations to deliver critical information about patient sentiment, confidence levels, and emotional barriers that impact medication adherence — a challenge that contributes to up to 69% of all medication-related hospitalizations in the U.S. Capstan Medical Achieves Milestone: World's First Robotic Catheter Mitral Valve Replacements Successfully Completed The landmark completion is the first time a minimally invasive robotic structural heart platform has been used in clinical practice, successfully delivering a novel mitral valve into two human patients. Labcorp Announces Acquisition of Select Assets of BioReference Health's Innovative Oncology and Related Clinical Testing Services Businesses Labcorp will acquire BioReference Health's laboratory testing businesses focused on oncology and oncology-related clinical testing services across the United States. The assets that Labcorp will be acquiring currently generate approximately $85 million to $100 million in annual revenue. Ajax Health and KKR Form New Platform to Develop System for Treating Heart Failure The new entity, FlowMod, intends to accelerate the creation, clinical validation, and regulatory approval for a system treating heart failure, a condition that affects pumping action of the heart muscles and currently impacts 64 million people worldwide. Boston Scientific announces agreement to acquire SoniVie Ltd. The TIVUS™ system was developed by SoniVie to treat a variety of hypertensive disorders, including renal artery denervation (RDN) for hypertension, and is expected to further expand Boston Scientific's interventional portfolio. AbbVie and Gubra Announce License Agreement to Develop an Amylin Analog for the Treatment of Obesity The partnership marks AbbVie's entrance into the obesity field. Robert A. Michael, chief executive officer, AbbVie, said, "At AbbVie, we are focused on transforming the future of patient care in areas where significant unmet need persists." Mallinckrodt and Endo to Combine to Create a Global, Scaled, Diversified Pharmaceuticals Leader "The combination of Mallinckrodt and Endo brings together two essential pharmaceuticals organizations to accelerate value creation for our shareholders, customers, employees, the patients we serve and our other stakeholders," said Siggi Olafsson, President and Chief Executive Officer of Mallinckrodt. Abbott Receives CE Mark for its Volt™ Pulsed Field Ablation System to Treat Patients with Abnormal Heart Rhythms Pulsed field ablation (PFA) uses high energy electrical pulses for ablation procedures that may offer benefits to targeting and treating tissue in the heart. Designed to overcome limitations of existing systems, Abbott's Volt™ PFA System provides a new therapy option for people battling heart rhythm disorders. Sun Pharma to Acquire Checkpoint Therapeutics "We are excited to enter this transaction with Sun Pharma as the next step to bringing UNLOXCYT to cSCC [metastatic cutaneous squamous cell carcinoma] patients in need of a differentiated immunotherapy treatment option," said James Oliviero, President and Chief Executive Officer of Checkpoint. RamSoft Partners with Alpha Nodus to Automate Prior Authorizations Using AI This collaboration will provide RamSoft's over 750 global healthcare sites access to Alpha Nodus's AI-powered tools, including automated document processing, cost estimates, prior authorizations, and scheduling. Amgen and Kyowa Kirin Provide Top-Line Results from Rocatinlimab Phase 3 IGNITE Study in Adults with Moderate to Severe Atopic Dermatitis The IGNITE study, which evaluated two dose strengths of rocatinlimab, met its co-primary endpoints and all key secondary endpoints, achieving statistical significance for both rocatinlimab dose strengths versus placebo. Jazz Pharmaceuticals to Acquire Chimerix, Further Diversifying Oncology Portfolio "If approved, dordaviprone [Chimerix's lead clinical asset] has the potential to rapidly become a standard of care for a rare oncology disease and also contribute durable revenue beginning in the near-term," said Bruce Cozadd, chairman and chief executive officer, Jazz Pharmaceuticals. For more news like this, check out all of the latest health-related releases from PR Newswire. Trending Topics In addition to the newsworthy headlines above, the PR Newswire team identified several trends shaping health industry news in March: COVID-19 Five-Year Milestone: It may be five years since the pandemic's onset, but medical research shows no signs of slowing down when it comes to the treatment and prevention of COVID-19. Pharmaceutical companies like Soligenix and Inovio presented breakthrough findings showcasing their ongoing efforts to develop more effective booster treatments and monoclonal antibodies. Diving deeper into clinical impacts, CalciMedica reported critical data for severe COVID-19 pneumonia patients. Consumer health preparedness also remained a priority with iHealth's at-home testing making health monitoring easier than ever. World Sleep Day: Did you snooze your alarm on World Sleep Day, March 14? If so, catch up with these dream-worthy insights. The National Sleep Foundation shed light on the critical intersection of sleep health and overall well-being. New research also highlighted a concerning statistic: 31% of Americans diagnosed with sleep apnea are not receiving treatment. Brands like Garmin and Love to Dream leveraged the awareness day to promote innovative sleep solutions, showcasing that a good night's rest isn't just a luxury, it's a necessity. National Nutrition Month: From grocery carts to fitness apps, press releases in March were geared towards making healthy eating more accessible. Celebrating National Nutrition Month, the American Diabetes Association and Instacart simplified nutritious shopping, while MyFitnessPal revealed surprising nutritional blind spots and Eggland's Best partnered with Club Pilates. From CVS's innovative weight management program to GENYOUth's mission to secure student nutrition, we noticed nutrition awareness becoming increasingly personalized, making healthy eating less of a puzzle. Looking ahead: April is full of must-follow awareness initiatives including World Health Day (April 7) and National Minority Health Month. April 1 also marks the beginning of National Autism Awareness Month and National Stress Awareness Month. We anticipate significant wire activity around these initiatives, with releases likely spotlighting health equity, innovative medical technologies and mental health and wellness. Do you have a health press release to distribute? Sign up with PR Newswire to share your story with the audiences who matter most. Helping Journalists Stay Up to Date on Industry News These are just a few of the recent press releases that consumers and the media should know about. To be notified of releases relevant to their coverage area, journalists can set up a custom newsfeed with PR Newswire for Journalists. Once they're signed up, reporters, bloggers, and freelancers have access to the following free features: Customization: Users can create customized newsfeeds that will deliver relevant news right to their inbox. Newsfeed results can be targeted by keywords, industry, subject, geography, and more. Photos and Videos: Thousands of multimedia assets are available to download and include in a journalist or blogger's next story. Subject Matter Experts: Journalists will have access to ProfNet, a database of industry experts to connect with as sources or for quotes in their articles. Related Resources: Our journalist- and blogger-focused blog, Beyond Bylines, features regular media news roundups, writing tips, upcoming events, and more. About PR Newswire PR Newswire is the industry's leading press release distribution partner with an unparalleled global reach of more than 440,000 newsrooms, websites, direct feeds, journalists and influencers and is available in more than 170 countries and 40 languages. From our award-winning Content Services offerings, integrated media newsroom and microsite products, Investor Relations suite of services, paid placement and social sharing tools, PR Newswire has a comprehensive catalog of solutions to solve the modern-day challenges PR and communications teams face. For 70 years, PR Newswire has been the preferred destination for brands to share their most important news stories across the world. For questions, contact the team at [email protected]. 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临床结果临床3期并购免疫疗法

2025-04-02

·药事纵横

梳理：3月重磅药物交易最高达53亿

一方面，创新药企在资本寒冬中面临融资挑战，通过对外授权和产品的商业化，可以形成新的盈利驱动循环。另一方面，制药公司也希望通过收购获得更多的潜在重磅药物，以补充现有管线。2025年3月，发生多项重磅药物交易，以下是相关交易的梳理。或许可以帮助我们了解一些研发热点和资本青睐方向。3月25日默沙东与江苏恒瑞医药股份有限公司达成协议，恒瑞将脂蛋白（a）Lp(a)口服小分子项目（HRS-5346）有偿许可给默沙东。默沙东将获得HRS-5346在大中华地区以外的全球范围内开发、生产和商业化的独家权利。Lp(a)是一类独特的脂蛋白，含有低密度脂蛋白（LDL）样颗粒，具有促动脉粥样硬化、促炎、促钙化等作用。高Lp(a)是动脉粥样硬化性心血管疾病的独立危险因素，也是主动脉瓣狭窄的危险因素。因此靶向Lp(a)的降脂疗法成为心血管疾病防治的重要突破点之一。目前HRS-5346处于3期临床阶段。恒瑞将获得2亿美元首付款，如果该药物达到一定的开发、监管和商业里程碑，恒瑞可能再获得17.7亿美元的额外付款以及销售特许权使用费。3月24日诺和诺德和联邦制药联合对外宣布，诺和诺德与联邦制药附属公司联邦生物达成在研药物UBT251的独家许可协议。根据许可协议，诺和诺德将获得UBT251在除大中华区（中国大陆、香港、澳门和台湾地区）以外的全球范围内开发、生产和商业化的独家授权许可。联邦生物将获得2亿美元的预付款以及最高达18亿美元的潜在里程碑付款。UBT251是一款胰高血糖素样肽-1(GLP-1)、葡萄糖依赖性促胰岛素多肽(GIP)和胰高血糖素(GCG)受体三重激动剂，目前处于早期临床开发阶段，用于治疗肥胖症、2型糖尿病及其他疾病。截止目前，UBT251已在中国获批开展针对成人2型糖尿病、超重或肥胖、代谢相关脂肪性肝病(MAFLD)和慢性肾病(CKD)的临床试验；在美国获批开展针对成人2型糖尿病、超重或肥胖以及慢性肾病的临床试验。3月20日赛诺菲斥资6亿美元从DrenBio收购了一种针对自身免疫性疾病的双特异性抗体DR-0201。如果DR-0201成功实现开发目标，赛诺菲将向DrenBio 再支付13亿美元。赛诺菲此次出手的DR-0201，是一款潜在同类首创靶向CD20的双抗，可作用于特定的组织驻留和运输髓系细胞，通过靶向吞噬作用诱导深度B细胞耗竭，可用于治疗肿瘤和自免疾病，正在开展治疗B细胞非霍奇金淋巴瘤、干燥综合征、多发性肌炎等适应证的I期临床。赛诺菲表示：深度B细胞耗竭是治疗自免疾病的新前沿，使用髓系细胞衔接器DR-0201有望提升治疗效果，尤其是对现有治疗耐药的患者。DR-0201在多项非人类灵长类动物研究中表现出良好的临床前安全性，没有细胞因子释放综合征或神经毒性。这一安全性的突破，正源于DrenBio公司专有的双抗平台。该平台产生的双抗体经过特殊设计，仅在存在靶抗原的情况下才能实现受控的髓系细胞活化，与其他疗法相比，治疗指数更高且安全性更好。3月17日总部位于日本的Taiho Pharmaceuticals表示，将以4亿美元的预付款收购瑞士的Araris Biotech及其抗体-药物偶联技术。并可能额外支付高达7.4亿美元的里程碑款项。Araris拥有新颖的ADC连接子平台AraLinQ。该平台生成了高度均匀、稳定且有效的ADC治疗候选药物，在临床前研究中显示出比传统ADC更广泛的安全性和增强的抗肿瘤效果。Araris正在推进三种用于治疗血液和实体肿瘤的产品，这些产品是利用其独特的AraLinQ技术开发的，目前处于临床前阶段。预计这些产品将在2025年至2026年之间进入临床试验。3月17日阿斯利康（AstraZeneca）以4.25亿美元的预付款收购比利时初创公司 EsoBiotech。此外，如果Eso Biotech的项目达到开发和监管里程碑，该公司可能会获得高达5.75亿美元的额外付款。根据阿斯利康的说法，EsoBiotec的平台有增强免疫系统攻击癌症的能力，从而改变细胞疗法。它利用靶向病毒在人体内直接改造免疫细胞，有望将治疗时间从目前的数周缩短至几分钟。3月13日临床阶段基因治疗公司Meira GTx宣布与AI初创公司Hologen AI达成战略合作，旨在加速其帕金森病基因疗法AAV-GAD的开发。Meira GTx将支付2亿美元的预付款，并与Hologen共同成立名为Hologen Neuro AI Ltd的合资公司。该合资企业将获得额外的2.3亿美元资金支持，用于推进AAV-GAD项目的三期临床开发直至商业化。此外，Hologen还将收购Meira GTx制造子公司的部分股权，利用AI技术优化其专有制造工艺。Meira GTx的AAV-GAD项目是一种基于腺相关病毒(AAV)的基因疗法，通过在大脑中局部产生γ-氨基丁酸(GABA)来重塑功能失调的大脑回路，从而改善帕金森病患者的症状。此前，该疗法在一项小规模临床试验中已显示出积极结果，患者在统一帕金森病评分量表和生活质量指标方面均有显著改善。3月12日罗氏宣布与Zealand Pharma达成一项重磅合作，双方将共同开发和商业化胰淀素类似物petrelintide，用于治疗肥胖和超重患者。根据协议，罗氏将向Zealand Pharma支付最高达53亿美元的款项，包括16.5亿美元的预付款，以及开发和销售里程碑付款。Petrelintide是Zealand Pharma研发的胰淀素类似物，数据显示，其目前处于临床二期研究阶段，其在减重方面显示出良好的潜力，且具有提高耐受性、保留肌肉等优势。对于罗氏来说，petrelintide的引入进一步丰富了其在减重领域的药物产品线，与其现有的GLP-1R/GIPR双激动剂CT-388形成协同效应，为患者提供更全面的治疗方案。3月11日CAR-T细胞疗法公司2seventybio（由bluebirdbio拆分而来）宣布被百时美施贵宝（BMS）以每股5.00美元的价格收购其所有流通股份，股本总价值约为2.86亿美元。2seventybio管线中有多款CAR-T细胞疗法产品，其中Abecma由BMS合作开发和商业化，已在2021年获批上市应用于多发性骨髓瘤患者的治疗。据BMS财报，2024年Abecma销售额为4.06亿美元。3月5日Jazz Pharmaceuticals宣布将斥资9.35亿美元收购Chimerix和一种治疗脑癌神经胶质瘤物药物dordaviprone，该药物已提交加速批准申请用于患有H327M突变的神经胶质瘤患者。2014年的一项小型研究表明，这种突变在50岁以下被诊断患有神经胶质瘤的人群中很常见。28%的患者出现肿瘤缩小或阻止新肿瘤出现。目前，正在放射治疗后的神经胶质瘤患者中进行一项3期试验，将其与安慰剂进行比较。中期数据预计将于2025年第三季度公布。3月3日艾伯维（AbbVie）宣布与丹麦的Gubra达成交易开发胰岛淀粉样肽类似物的药物GUB014295，根据条款，艾伯维将向Gubra支付3.5亿美元的预付款，并提供高达19亿美元的额外付款，以达到开发和销售里程碑。艾伯维将负责商业化。GUB014295，可调节食欲和血糖水平。如果开发成功，可以作为Novo的Wegovy和Lilly的Zepbound等上市药物的替代品或联合使用，以增加体重减轻或减少副作用。该实验药物已在体重指数超重的男性中完成了1期给药试验。接受最高剂量的试验志愿者在6周内平均减轻了3%的体重。另一项剂量试验正在进行中，该研究的完整数据将于2025年底发布。参考文献：1.https://www.biopharmadive.com/topic/deals/2.各公司官网药事纵横投稿须知：稿费已上调，欢迎投稿

并购临床3期引进/卖出申请上市临床1期

2025-03-21

·FierceBiotech

Chimerix engaged with 7 other biopharmas before choosing Jazz\'s $935M deal—here\'s why it won

Chimerix engaged with numerous biopharmas—termed parties A through G—about potential strategic transactions related to its oncology candidate.\n Before Jazz Pharmaceuticals inked a $935 million deal for Chimerix earlier this month, the biotech had been in talks with six other pharmas and one biotech about several different potential offers.Ultimately, Chimerix’s board went with Jazz’s offer due to its cash payable nature and the recent downward trend in biopharma financial markets, plus a general volatility tied to escalating political and global trade tensions, according to Securities and Exchange Commission documents filed Friday. Buying Chimerix gives Jazz control of the brain cancer drug candidate dordaviprone, also known as ONC201, a small molecule designed to treat recurrent H3 K27M-mutant diffuse glioma.But Jazz wasn’t first on site. Since August 2023, Chimerix had been in discussions about potential licensing deals for ONC201 with a “global pharmaceutical company,” known as “party A” in the filings. Chimerix steadily entered discussions with more companies—termed parties B through G—about potential strategic transactions related to the oncology candidate, per the docs.Jazz was one of the last contenders to enter the scene, reaching out after Chimerix publicly announced on Dec. 9, 2024, its plan to submit a new drug application seeking accelerated approval for ONC201 before the year ended. On Dec. 18 and Dec. 19, Chimerix’s board reviewed its offers from several different companies, including a potential equity financing, a possible ex-U.S. licensing transaction for ONC201 and a potential acquisition. The board ultimately decided to move forward with multiple options at the same time. On the same day—Dec. 19—party A submitted a proposal to acquire ONC201 and related assets for an upfront payment of $350 million and a contingent payment of $100 million upon FDA approval. Chimerix management reached out to the pharma and said the proposal was insufficient.Less than a month later, party A tried again, submitting a new proposal to acquire Chimerix for an upfront payment of $6.50 per share and one contingent value right (CVR) per share, representing the right to receive a one-time payment of $1.50 upon FDA approval of ONC201 no later than June 2027, plus a one-time payment of $1.50 once ONC201 achieved yearly net sales in the U.S. above $700 million at a date before 2030.According to the filing, Chimerix’s board directed management to discuss transaction terms with party A in a way designed to increase the economic value and certainty of that proposal, with the view that alternative offers from other potential counterparties could be increased if they had a better nonbinding indication from party A.Meanwhile, bidders started dropping. Party F lost interest after Chimerix told the company that it had received a proposal with a higher value than party F’s offer of around $5 per share. And party G—a biotech—discontinued conversations regarding a potential acquisition on the belief that it wouldn’t be able to compete with other interested parties. On Jan. 26, party A came back again with a revised proposal to acquire Chimerix on the same terms as before but with the deadlines to hit the payment-triggering milestones removed.Chimerix management told party A on Jan. 30 that the revised offer was still not good enough.On Feb. 6, Jazz outlined an acquisition offer for an upfront payment of $5.50 per share and one CVR per share representing the right to receive one-time payments of $1 upon FDA approval, 25 cents upon receipt of pricing approval in at least three major European markets and $1.50 once global net sales of ONC201 were above $500 million in a calendar year.Chimerix told Jazz the offer was insufficient but that Chimerix would provide additional due diligence materials so Jazz could increase its offer.Ten days later, Chimerix publicly announced that the FDA had accepted its new drug application seeking accelerated approval, with the application receiving priority review and a decision expected by Aug. 18 of this year.On March 3, Jazz submitted its final proposal: $8.55 per share in all cash. On the same day, party A shared a proposal to acquire Chimerix for an upfront payment of $7.50 per share and one CVR per share representing the right to receive a one-time payment of $2, payable if ONC201 received full approval by the FDA before Aug. 31, 2032. The CVR would not be payable if the primary endpoint of Chimerix’s ongoing phase 3 study was not achieved or if Chimerix received a complete response letter.That night, the board met to review the two offers and determined Jazz to be the winning bidder. The next afternoon, Chimerix’s board unanimously decided that Jazz’s offer was in the best interests of its stockholders. The board took into account several different factors when reaching its recommendation that stockholders accept the proposal, according to the documents.One consideration was that Jazz’s offer price represented a 70% premium over Chimerix’s closing price per share on March 3 and an 89% premium over the weighted average price of shares during the preceding 30-day trading period.The biotech board also considered the fact that the offer was payable fully in cash, allowing stockholders to realize immediate value.Furthermore, they weighed the risks of remaining a standalone company and general risks tied to market conditions. Among the potential risks identified were “the challenges faced by the biopharmaceutical industry,” including potential competition; “complex regulatory and political regimes”; and an “evolving pricing environment,” particularly in light of “the increasing scrutiny of pharmaceutical pricing and proposals to address the perceived high cost of pharmaceuticals.”Another consideration was “the current state of the U.S. and global economies, including the recent downward trend in the biopharmaceutical financial markets, U.S. trade policies and tariffs.” The board also cited rising inflation and volatility resulting from escalating political and global trade tensions in its ultimate decision.

$Chimerix engaged with 7 other biopharmas before choosing Jazz\'s $935M deal—here\'s why it won$

并购临床3期优先审批引进/卖出

100 项与 Dordaviprone 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB14844

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
组蛋白H3中K27M点突变的弥漫性中线胶质瘤	申请上市	美国	Chimerix, Inc.	2024-12-30
弥漫内生性脑桥神经胶质瘤	临床3期	丹麦	Chimerix, Inc.	2022-09-29
弥漫内生性脑桥神经胶质瘤	临床3期	法国	Chimerix, Inc.	2022-09-29
弥漫内生性脑桥神经胶质瘤	临床3期	西班牙	Chimerix, Inc.	2022-09-29
弥漫内生性脑桥神经胶质瘤	临床3期	瑞典	Chimerix, Inc.	2022-09-29
脑膜瘤	临床2期	美国	Chimerix, Inc.	2025-12-01
复发性胶质瘤	临床2期	美国	National Institute of Neurological Disorders & Stroke	2021-10-20
复发性胶质瘤	临床2期	澳大利亚	National Institute of Neurological Disorders & Stroke	2021-10-20
复发性胶质瘤	临床2期	以色列	National Institute of Neurological Disorders & Stroke	2021-10-20
复发性胶质瘤	临床2期	荷兰	National Institute of Neurological Disorders & Stroke	2021-10-20

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临床结果

适应症

分期

评价

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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


NCT02525692 (PATH-25 \| ACTR-51, CTgov)	临床2期	组蛋白H3中K27M点突变的弥漫性中线胶质瘤 \| 基底神经节疾病 \| 复发性胶质母细胞瘤	84	Dordaviprone (Arm A)	築膚構糧壓淵鹹淵鹽夢 = 夢製積鏇顧範餘窪壓構夢觸窪鏇餘繭製廠構鹹 (構繭築鏇廠衊蓋憲醖簾, 簾鹽衊夢製鹹鑰醖醖襯 ~ 艱願衊艱積憲願構鬱顧) 更多	-	2024-12-24
				Dordaviprone (Arm B)	築膚構糧壓淵鹹淵鹽夢 = 夢廠廠鹽鏇願顧鑰夢築夢觸窪鏇餘繭製廠構鹹 (構繭築鏇廠衊蓋憲醖簾, 壓製選鑰衊網簾餘淵鏇 ~ 積醖簾膚願積醖構鬱壓) 更多
NCT03485729 (CTgov)	临床2期	复发性子宫内膜癌	27	Dordaviprone (Arm B)	觸獵簾範觸憲製蓋簾窪 = 積窪製憲憲鹹繭獵鹽遞淵窪夢顧鑰鹽餘積淵憲 (壓衊顧憲願鑰淵糧鬱壓, 憲範淵觸網願壓壓顧鏇 ~ 窪夢築積遞獵蓋夢繭鏇) 更多	-	2024-12-24
				Dordaviprone (Arm A)	獵鹹齋夢壓窪遞構顧觸(襯鹽鹽糧醖範積網齋網) = 鏇壓鬱構壓餘遞選艱鹹鬱鏇鹽簾簾願夢選構憲 (觸憲鏇製繭願鬱鹹鑰選, 衊艱蓋夢糧夢鹽網鏇餘 ~ 齋積遞製鏇遞襯顧醖衊) 更多
NCT03034200 (CTgov)	临床2期	神经内分泌肿瘤 \| 嗜铬细胞瘤	30	ONC201 (Arm A: Metastatic PC-PG)	鑰構衊獵鏇鹹遞艱夢網(齋艱製簾淵獵餘觸繭簾) = 醖積範積製窪範糧鑰遞積窪廠鏇築窪蓋簾獵製 (鏇淵願餘淵壓顧獵鬱觸, 繭壓夢鏇齋鹹積艱膚積 ~ 鹹憲夢築壓選蓋積積築) 更多	-	2024-11-26
				ONC201 (Arm B: Other NETs)	鑰構衊獵鏇鹹遞艱夢網(齋艱製簾淵獵餘觸繭簾) = 簾餘繭觸夢醖艱願築鬱積窪廠鏇築窪蓋簾獵製 (鏇淵願餘淵壓顧獵鬱觸, 願製廠夢膚繭簾繭壓鑰 ~ 鹽憲廠壓衊觸蓋獵顧廠) 更多
NCT05580562 (ACTION, ASTRO2024)	临床3期	组蛋白H3中K27M点突变的弥漫性中线胶质瘤	50	ONC201	壓淵襯衊簾選顧糧選壓(製壓糧觸繭築積壓醖簾) = 鏇選膚襯衊構顧網積廠壓衊壓艱糧齋鹽積獵鹽 (淵淵糧繭積襯鏇艱築製 )	积极	2024-10-01
				Standard Radiotherapy Dosing Regimens	壓淵襯衊簾選顧糧選壓(製壓糧觸繭築積壓醖簾) = 襯獵選築夢廠鑰蓋糧餘壓衊壓艱糧齋鹽積獵鹽 (淵淵糧繭積襯鏇艱築製 )
NCT02863991 (CTgov)	临床1/2期	复发性多发性骨髓瘤	17	ONC201+Dexamethasone (Phase 1: 375 mg ONC201 + 20 mg Dexamethasone)	顧淵鑰廠選糧顧蓋餘繭 = 網網築製選蓋鹹膚遞製鹽積範遞顧糧繭廠鬱蓋 (鑰夢鑰繭艱遞繭築醖選, 艱顧壓遞顧鑰鏇繭鏇廠 ~ 鹹夢醖網鑰糧選夢憲襯) 更多	-	2024-07-03
				ONC201+Dexamethasone (Phase 2: 625 mg ONC201 + 20 mg Dexamethasone)	顧淵鑰廠選糧顧蓋餘繭 = 積觸醖選衊廠繭願憲製鹽積範遞顧糧繭廠鬱蓋 (鑰夢鑰繭艱遞繭築醖選, 繭鹽齋觸鏇鹽鹽窪艱網 ~ 網鏇鹽範蓋衊齋淵憲衊) 更多
NCT05009992 (Biospace) 人工标引	临床2期	弥漫性中线胶质瘤一线	132	paxalisib in combination with ONC201 (Cohort 1)	鏇鬱網艱網艱積襯選網(顧範獵齋鹹襯鹹糧遞憲) = 鏇鏇積窪衊鹹簾積範構獵壓構壓鹽淵鏇醖夢鑰 (壓鬱襯獵艱顧窪簾襯窪 )	积极	2024-06-27
				paxalisib in combination with ONC201 (Cohort 2)	鏇鬱網艱網艱積襯選網(顧範獵齋鹹襯鹹糧遞憲) = 壓夢夢夢夢構衊鹽構鬱獵壓構壓鹽淵鏇醖夢鑰 (壓鬱襯獵艱顧窪簾襯窪 )
NCT05009992 (SNO2023) 人工标引	临床2期	弥漫性中线胶质瘤	68	ONC201+paxalisib	夢築蓋範糧衊築範憲積(簾選糧鏇餘艱壓鹽觸淵) = 膚鹹簾蓋齋襯艱鹽糧簾選壓窪築廠憲憲衊襯衊 (選夢鑰醖艱餘獵齋餘膚, lower 11.6) 更多	积极	2023-11-10
TMET-02 (SNO2023)	N/A	脑干胶质瘤 H3K27M-mutant	71	ONC201 monotherapy	憲遞襯獵鏇鹹網餘願衊(艱觸憲艱壓範蓋積鏇觸) = 繭糧壓醖醖築齋鑰醖鹽襯鹽襯築觸窪醖憲鏇鑰 (鬱範蓋壓壓廠憲選廠觸 ) 更多	积极	2023-11-10
NCT03394027 (Pubmed)	临床2期	转移性乳腺癌 \| 晚期子宫内膜癌	30	ONC201	鬱觸築鑰鑰淵遞願獵醖(鬱廠構繭夢餘壓窪壓觸) = all patients experienced 膚衊夢鏇構選製壓廠構 (積衊繭獵構選願蓋鑰獵 )	不佳	2023-06-05
NCT03416530 \| NCT03134131 (CTNI-61, SNO2022)	临床2期	脑干胶质瘤 EGFR mutation \| EGFR expression \| MAPK-pathway alterations ... 更多	75	ONC201	艱廠齋觸鑰鬱願願憲繭(網鏇繭鏇鬱網窪範艱壓) = high EGFR expression as a marker of resistance and improved response in tumors with MAPK-pathway alterations 願遞糧廠蓋構願願醖積 (淵蓋構憲鹹願糧糧襯鏇 ) 更多	积极	2022-11-14
				ONC201 (Historical Control)