Acquisition builds on Phase 3 STELLAR study results showing clinically meaningful improvements in overall and progression-free survival in the subgroup of patients with recurrent IDH-mutant Grade 3 astrocytoma

此次收购基于第三期 STELLAR 研究的结果，该研究显示，在复发性 IDH 突变型 3 级星形细胞瘤患者亚组中，总生存期和无进展生存期均具有临床意义的改善。

LOUISVILLE, Ky. and MENLO PARK, Calif.

肯塔基州路易斯维尔市和加利福尼亚州门洛帕克市

,

，

Oct. 27, 2026

2026年10月27日

/PRNewswire/ -- US WorldMeds Ventures, LLC and Orbus Therapeutics, Inc. today announced a definitive merger agreement under which US WorldMeds has acquired Orbus, a privately held pharmaceutical company developing investigational eflornithine for rare and serious brain tumors. The transaction adds Orbus' late-stage program in recurrent Grade 3 astrocytoma to US WorldMeds' rare-disease portfolio.

/美通社/ -- US WorldMeds Ventures, LLC 与 Orbus Therapeutics, Inc. 今日宣布达成最终合并协议，根据该协议，US WorldMeds 已收购 Orbus。Orbus 是一家私营制药公司，正在开发用于罕见且严重脑肿瘤的研究性药物依氟鸟氨酸（eflornithine）。此次交易将 Orbus 针对复发性3级星形细胞瘤的后期研发项目纳入 US WorldMeds 的罕见病产品组合。

US WorldMeds made an undisclosed upfront payment to Orbus, which will also be eligible for development, regulatory, and sales-based milestone payments, plus tiered royalties on net sales in the U.S. Orbus is now a wholly owned subsidiary of US WorldMeds..

US WorldMeds向Orbus支付了一笔未公开的前期款项，Orbus还有资格获得基于开发、监管和销售里程碑的付款，以及在美国净销售额上的分级特许权使用费。Orbus现在是US WorldMeds的全资子公司。

Eflornithine, also called DFMO, inhibits ornithine decarboxylase, or ODC, an enzyme involved in cellular division and proliferation that is known to become upregulated in certain cancers.  Orbus advanced oral eflornithine through the Phase 3 STELLAR study as a late-stage investigational therapy for recurrent Grade 3 astrocytoma, a rare and serious malignant glioma, and FDA granted the program Breakthrough Therapy designation for the treatment of anaplastic astrocytoma..

依氟鸟氨酸（又称DFMO）可抑制鸟氨酸脱羧酶（ODC），该酶参与细胞分裂和增殖，已知在某些癌症中表达上调。Orbus公司通过三期STELLAR研究推进了其先进口服依氟鸟氨酸的研发，作为复发性3级星形细胞瘤（一种罕见且严重的恶性胶质瘤）的后期 investigational 疗法；美国食品药品监督管理局（FDA）已授予该项目突破性疗法认定，用于治疗间变性星形细胞瘤。

US WorldMeds currently commercializes IWILFIN® (eflornithine 192 mg tablets) for a separate rare oncology indication, providing established experience with the molecule and with therapies for underserved patient populations. This complementary experience positions US WorldMeds to build on Orbus' scientific and clinical work..

US WorldMeds 目前正将 IWILFIN®（盐酸依氟鸟氨酸 192 mg 片剂）商业化，用于另一项罕见的肿瘤学适应症，从而在分子层面以及针对医疗服务不足患者群体的治疗方面积累了成熟经验。这种互补性经验使 US WorldMeds 能够在 Orbus 的科学与临床工作基础上进一步发展。

'The science and clinical results supporting eflornithine make this an especially exciting opportunity for US WorldMeds,' said P. Breckinridge Jones, Chief Executive Officer of US WorldMeds. 'We have built our company around bringing meaningful therapies to patients affected by difficult-to-treat and underserved diseases.

“支持依氟鸟氨酸的科学依据和临床结果使这成为美国世界医药公司（US WorldMeds）一个尤其令人振奋的机遇，”美国世界医药公司首席执行官P. Breckinridge Jones表示。“我们公司的创立宗旨，就是为受难以治疗且医疗资源不足疾病影响的患者带来有意义的疗法。”

The STELLAR study results provide a compelling foundation to build upon, and we believe our development and commercialization capabilities can help advance the program toward its next chapter.'.

STELLAR 研究结果提供了令人信实的坚实基础，我们相信我们的开发和商业化能力能够推动该项目迈向下一个阶段。

Building on Phase 3 STELLAR Study results

基于第三期STELLAR研究结果

The Phase 3 STELLAR study (n=343) evaluated eflornithine in combination with lomustine compared with lomustine alone in patients with recurrent Grade 3 astrocytoma based on the 2016 WHO classification. Although the study did not demonstrate a difference in overall survival between treatment arms in the overall intent-to-treat (ITT) study population, the study's primary endpoint, a subset analysis was planned to evaluate treatment effects in patients meeting the newly defined Grade 3 astrocytoma criteria per the 2021 WHO reclassification of brain tumors.

三期STELLAR研究（n=343）评估了依氟鸟氨酸联合洛莫司汀与单用洛莫司汀在复发性WHO 2016分级3级星形细胞瘤患者中的疗效。尽管该研究在总体意向治疗（ITT）人群中未显示各治疗组之间总生存期的差异（即主要终点），但计划进行亚组分析，以评估符合2021年WHO脑肿瘤重新分类中新定义的3级星形细胞瘤标准的患者的治疗效果。

The subset analysis, defined before unblinding, included patients with isocitrate dehydrogenase (IDH)-mutant, Grade 3 astrocytoma (n=196) and showed clinically meaningful improvements in overall survival and progression-free survival in the eflornithine plus lomustine arm versus lomustine alone. No benefit was observed in patients with Grade 4 tumors as defined by the updated 2021 classification..

在揭盲前定义的亚组分析纳入了异柠檬酸脱氢酶（IDH）突变型3级星形细胞瘤患者（n=196），结果显示，与单用洛莫司汀相比，依氟鸟氨酸联合洛莫司汀治疗组的总生存期和无进展生存期均具有临床意义的改善。根据2021年更新分类定义的4级肿瘤患者未观察到获益。

In the IDH-mutant Grade 3 astrocytoma subset analysis:

在IDH突变型3级星形细胞瘤的亚组分析中：

Median overall survival was 34.9 months for patients receiving eflornithine plus lomustine compared with 23.5 months for those receiving lomustine alone (hazard ratio of 0.64).

接受依氟鸟氨酸联合洛莫司汀治疗的患者的中位总生存期为34.9个月，而仅接受洛莫司汀治疗的患者为23.5个月（风险比为0.64）。

Median progression-free survival more than doubled as determined by investigator assessment, reaching 15.8 months versus 7.2 months with lomustine alone (hazard ratio of 0.57).

根据研究者评估，中位无进展生存期增加了一倍以上，达到15.8个月，而单用洛莫司汀组为7.2个月（风险比为0.57）。

Grade 3 or higher treatment-emergent adverse events of note included myelosuppression (42% vs. 29%) and hearing impairment (24% vs. 0%).

值得关注的3级或以上治疗期不良事件包括骨髓抑制（42% vs. 29%）和听力损害（24% vs. 0%）。

The STELLAR study findings were subsequently published in the

STELLAR 研究的结果随后发表在

Journal of Clinical Oncology

临床肿瘤学杂志

(Colman et al., 2026), adding peer-reviewed context to the observed survival outcomes in patients with recurrent IDH-mutant Grade 3 astrocytoma.

（Colman 等，2026），为复发性 IDH 突变型 3 级星形细胞瘤患者的观察生存结局增添了经同行评审的背景信息。

'Orbus has built a strong scientific and clinical foundation for eflornithine,' said Jason Levin, former President and Chief Executive Officer of Orbus. 'US WorldMeds brings the development expertise, commercial infrastructure and commitment to patients needed to advance the program.'

“Orbus 为依氟鸟氨酸奠定了坚实的科学和临床基础，”Orbus 前总裁兼首席执行官 Jason Levin 表示。“US WorldMeds 带来了推进该研发项目所需的专业开发能力、商业化基础设施以及对患者的承诺。”

Advancing the next chapter of eflornithine in gliomas

推进依氟鸟氨酸在胶质瘤治疗中的新篇章

US WorldMeds intends to build on Orbus' scientific and clinical work by evaluating the development and regulatory path for eflornithine in recurrent IDH-mutant Grade 3 astrocytoma and other potential opportunities in adult malignant glioma.

US WorldMeds 计划通过评估依氟鸟氨酸在复发性 IDH 突变型 3 级星形细胞瘤中的开发与监管路径，以及在成人恶性胶质瘤中的其他潜在机遇，来推进 Orbus 的科学和临床工作。

'This transaction is an opportunity to build on Orbus' work and responsibly evaluate eflornithine's potential in adult malignant glioma,' said Jones. 'It reflects our continued commitment to pursuing medicines that may meaningfully improve outcomes for patients with serious diseases. We look forward to engaging with FDA about the best path to advance this program for patients living with this rare and challenging to treat disease.'.

“此次交易是在Orbus公司工作基础上进一步推进，并负责任地评估依氟鸟氨酸在成人恶性胶质瘤中的潜力的良机，”Jones表示。“这反映了我们持续致力于开发可能显著改善严重疾病患者预后的药物。我们期待与美国食品药品监督管理局（FDA）就推进这一针对患有这种罕见且治疗困难疾病的患者的项目的最佳路径进行沟通。”

About Eflornithine

关于依氟鸟氨酸

Eflornithine, also called DFMO, irreversibly inhibits ornithine decarboxylase (ODC), the rate-limiting enzyme in polyamine synthesis. Cancer cells, including glioma cells, depend on elevated polyamine levels to sustain rapid growth, which makes ODC a rational therapeutic target.

依氟鸟氨酸（也称为DFMO）不可逆地抑制鸟氨酸脱羧酶（ODC），该酶是多胺合成中的限速酶。包括胶质瘤细胞在内的癌细胞依赖升高的多胺水平来维持快速生长，这使得ODC成为一个合理的治疗靶点。

US WorldMeds markets eflornithine 192 mg tablets as IWILFIN® for a separate rare oncology use.   Orbus's STELLAR trial results were achieved with an eflornithine oral solution which it has been developing for the treatment of recurrent Grade 3 astrocytoma.

美国WorldMeds公司将依氟鸟氨酸192毫克片剂作为IWILFIN®进行营销，用于一种独立的罕见肿瘤适应症。Orbus公司的STELLAR试验结果是通过其正在开发的用于治疗复发性3级星形细胞瘤的依氟鸟氨酸口服溶液取得的。

Eflornithine is investigational for use in the treatment of gliomas, including astrocytoma; its safety and efficacy for the treatment of glioma have not been established, and it is not approved by FDA or any other regulatory authority for this use.

依氟鸟氨酸用于治疗胶质瘤（包括星形细胞瘤）尚处于研究阶段；其治疗胶质瘤的安全性和有效性尚未确立，且未获得美国食品药品监督管理局（FDA）或任何其他监管机构的批准用于此适应症。

WHAT IS IWILFIN?

什么是 IWILFIN？

IWILFIN is a prescription medicine used to reduce the risk of relapse in adults and children with high-risk neuroblastoma (HRNB) who have had at least a partial response to certain prior therapies.

IWILFIN 是一种处方药，用于降低对某些既往疗法至少达到部分缓解的高危神经母细胞瘤（HRNB）成人和儿童患者的复发风险。

IMPORTANT SAFETY INFORMATION

重要安全信息

Before you take IWILFIN, tell your healthcare provider about your medical conditions, including if you have hearing problems, if you are pregnant or may become pregnant, or if you are breastfeeding.

在服用 IWILFIN 之前，请告知您的医疗保健提供者您的健康状况，包括是否有听力问题、是否怀孕或可能怀孕，以及是否正在哺乳。

If you or your partner are able to become pregnant, use effective birth control during treatment with IWILFIN and for 1 week after the last dose. Tell your healthcare provider right away if you or your partner become pregnant during treatment. Do not breastfeed during treatment with IWILFIN and for 1 week after the last dose..

如果您或您的伴侣有怀孕可能，在接受 IWILFIN 治疗期间以及末次给药后 1 周内，请采取有效的避孕措施。如果在治疗期间您或您的伴侣怀孕，请立即告知您的医疗保健提供者。在接受 IWILFIN 治疗期间以及末次给药后 1 周内，请勿母乳喂养。

IWILFIN can cause low blood cell counts. Tell your healthcare provider right away if you develop symptoms of low blood cell counts, including fever, easy bruising or bleeding, blood in your urine or stool, feeling unusually tired or weak, shortness of breath, or chills or shivering.

IWILFIN 可能导致血细胞计数降低。如果您出现血细胞计数降低的症状，包括发热、容易瘀伤或出血、尿液或粪便中带血、异常疲劳或虚弱、呼吸急促、寒战或颤抖，请立即告知您的医疗保健提供者。

IWILFIN can cause liver problems. Tell your healthcare provider right away if you develop symptoms of liver problems, including your skin or white of your eyes turning yellow; dark urine; light-colored stools; nausea or vomiting; easy bruising or bleeding; loss of appetite; or pain, aching, or tenderness on the right side of your abdomen..

IWILFIN 可能导致肝脏问题。如果您出现肝脏问题的症状，包括皮肤或眼白发黄、尿液颜色变深、粪便颜色变浅、恶心或呕吐、容易瘀伤或出血、食欲减退，或腹部右侧疼痛、酸痛或压痛，请立即告知您的医疗保健提供者。

Hearing loss is common during treatment with IWILFIN and can be serious. Some people have needed to use hearing aids. Tell your healthcare provider right away if you get ringing in your ears or any new or worsening hearing loss.

在使用 IWILFIN 治疗期间，听力损失较为常见，且可能较为严重。部分患者需要使用助听器。如果您出现耳鸣或任何新发或加重的听力损失，请立即告知您的医疗保健提供者。

What are the possible side effects of IWILFIN?

IWILFIN 的可能副作用有哪些？

The most common side effects of IWILFIN in Study 3b included ear infection; diarrhea; cough; sinus infection; pneumonia; upper respiratory tract infection; pink eye; vomiting; stuffy, runny, itchy nose or sneezing; fever; skin infection; and urinary tract infection.

在研究3b中，IWILFIN最常见的副作用包括耳部感染、腹泻、咳嗽、鼻窦感染、肺炎、上呼吸道感染、结膜炎、呕吐、鼻塞、流涕、鼻痒或打喷嚏、发热、皮肤感染以及尿路感染。

These are not all the possible side effects of IWILFIN. Contact your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

以上并非 IWILFIN 所有可能的副作用。如有任何关于副作用的医疗建议，请联系您的医疗保健提供者。您可以拨打 1-800-FDA-1088 向美国食品药品监督管理局（FDA）报告副作用。

About US WorldMeds

关于美国世界医药公司

US WorldMeds is a U.S.-based specialty pharmaceutical company that develops and commercializes therapies for patients with rare and underserved conditions. The company's portfolio spans oncology and other specialty areas, with a focus on bringing meaningful treatment options to patients with significant unmet needs..

US WorldMeds 是一家总部位于美国的特色制药公司，致力于开发和商业化针对罕见病及医疗资源不足疾病患者的疗法。公司的产品组合涵盖肿瘤学及其他特色治疗领域，专注于为存在重大未满足医疗需求的患者提供具有临床意义的治疗选择。

About Orbus Therapeutics

关于奥博思治疗公司

Orbus Therapeutics is a private pharmaceutical company founded by Bob Myers and Jason Levin based on the clinical work pioneered by Victor Levin, MD, Emeritus Professor of Neuro-Oncology. The company has been financially supported by leading healthcare institutional investors, including Longitude Capital, H.I.G.

Orbus Therapeutics 是一家由 Bob Myers 和 Jason Levin 创立的私营制药公司，其基础是神经肿瘤学名誉教授 Victor Levin 博士开创的临床工作。该公司获得了领先医疗保健机构投资者的资金支持，包括 Longitude Capital 和 H.I.G.。

HealthBridge, Abingworth, Adams Street Partners and Agent Capital and other investors. Orbus focused on the development of therapies for rare diseases. Its lead product candidate is oral eflornithine, which has been studied in malignant glioma, including in the Phase 3 STELLAR study..

HealthBridge、Abingworth、Adams Street Partners、Agent Capital 及其他投资者。Orbus 专注于罕见病疗法的开发。其核心候选产品为口服依氟鸟氨酸，该药物已在恶性胶质瘤中开展研究，包括在 III 期 STELLAR 研究中进行了评估。

Forward-Looking Statements

前瞻性陈述

This press release contains forward-looking statements, including statements regarding the development and regulatory path for eflornithine and the potential benefits of the transaction. These statements are based on current expectations and are subject to risks and uncertainties, including the outcome of discussions with FDA and other regulators and the results of any future clinical studies.

本新闻稿包含前瞻性陈述，包括有关依氟鸟氨酸的开发和监管路径以及交易潜在益处的陈述。这些陈述基于当前预期，并受风险和不确定性的影响，包括与美国食品药品监督管理局（FDA）及其他监管机构讨论的结果以及任何未来临床研究的结果。

Actual results may differ materially. US WorldMeds and Orbus undertake no obligation to update these statements except as required by law..

实际结果可能存在重大差异。US WorldMeds 和 Orbus 除法律要求外，不承担更新这些声明的义务。

References

参考文献

Colman, H., Lombardi, G., Wong, E. T., et al. (2026). STELLAR: Phase III, randomized, open-label study of eflornithine plus lomustine versus lomustine alone in patients with recurrent grade 3 astrocytoma.

Colman, H., Lombardi, G., Wong, E. T., 等 (2026). STELLAR：一项针对复发性3级星形细胞瘤患者的III期、随机、开放标签研究，比较依氟鸟氨酸联合洛莫司汀与单用洛莫司汀的疗效。

Journal of Clinical Oncology, 44

《临床肿瘤学杂志》，第44卷

(8), 641–652.

(8), 641–652。

https://doi.org/10.1200/JCO-25-01204

https://doi.org/10.1200/JCO-25-01204

Media Contact

媒体联系人

Name: Jessica Tracy

姓名：杰西卡·特雷西

Email:

电子邮件：

[email protected]

[email protected]

1-866-750-8796

1-866-750-8796

SOURCE US WorldMeds

来源：美国 WorldMeds