The primary objectives of this study are to determine the safety of single agent Selinexor given with commercial bispecific antibody therapy in patients with Relapsed/Refractory Multiple Myeloma (RRMM) and to determine the MRD negativity rate at 10-5 at 12 months post bispecific antibody therapy.
The investigators will enroll 27 patients with RRMM who are receiving commercial bispecific antibody therapy. Patients will be on treatment for 12 months or until disease progression, and will be followed for 24 months. Study assessments include completing a drug diary, having a safety check in call, and have history, clinical assessments, and labs taken.
Twenty-seven patients will provide 80% power in a one-sample chi square test for a proportion assuming that the rate of negative MRD at 10-5 at 12 months post bispecific antibody therapy is 25% in historical control and 50% in the SEL+bispecific antibody experimental treatment group, under a one-sided 5% significance level.

开始日期2025-05-01

申办/合作机构

Duke University

NCT06813079

/ Not yet recruiting临床2期IIT

ADOPT: Adaptive Organoid-Based Precision Therapy Study in Pancreatic Cancer - A Prospective Single-Arm Phase II Trial

The purpose of this study is to see if using Patient Derived Organoids (PDO) to choose a drug for the treatment of pancreatic cancer individually for each patient is useful. The study will look at the number of participants who have a response to their assigned drug.

开始日期2025-02-17

申办/合作机构

University Health Network

ChiCTR2500096268

/ Recruiting临床4期IIT

Real-World Research:The application of selinexor in the total therapy of newly diagnosed high-risk multiple myeloma

开始日期2025-02-06

申办/合作机构

四川大学华西医院（四川省国际医院）

100 项与塞利尼索相关的临床结果

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100 项与塞利尼索相关的转化医学

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100 项与塞利尼索相关的专利（医药）

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706

项与塞利尼索相关的文献（医药）

2025-12-01·MOLECULAR BIOLOGY REPORTS

Prognostic and functional role of the nuclear export receptor 1 (XPO1) in gastrointestinal cancers: a potential novel target?

Review

作者: Günther, Michael ; Ormanns, Steffen ; Pichler, Renate ; Neureiter, Daniel ; Amann, Arno ; Sokolova, Viktorija ; Gruber, Rebecca ; Pammer, Lorenz M ; Seeber, Andreas ; Klieser, Eckhard ; Kocher, Florian

In the last decades the survival of metastatic gastrointestinal (GI) cancer patients could have been significantly extended due to the introduction of targeted- and immunotherapy. However, only the minority of patients will experience long-lasting survival. Hence, novel therapeutics are clearly necessary for GI cancer patients. Molecular high-throughput profiling techniques have revealed potential novel targetable molecular alterations, emphasizing the necessity for tailored therapeutic approaches. Nuclear export proteins, particularly Exportin-1 (XPO1), have emerged as promising targets in cancer therapy due to their crucial role in cellular homeostasis and regulation of key cellular functions. Dysregulation of XPO1-mediated nuclear export leads to the functional loss of tumor suppressors and pro-apoptotic factors, facilitating cancer progression. Selinexor, a XPO1 inhibitor, has shown promising activity in preclinical and clinical studies, particularly in hematological malignancies. However, its efficacy in GI cancers remains underexplored. This review aims to elucidate the functional and pathophysiological role of XPO1 in GI cancers. Despite the potential of XPO1 inhibitors in suppressing cell proliferation and inducing apoptosis, comprehensive molecular landscape data and validation of selective inhibitors in GI cancers are lacking. Targeting XPO1 presents a significant therapeutic potential for the treatment of GI cancer patients. Further research is necessary to fully elucidate the molecular landscape according to XPO1 expression in GI tumors and to validate the efficacy of selective XPO1 inhibitors. These efforts are expected to contribute to the development of more effective and personalized therapeutic strategies for GI cancer patients.

2025-03-01·CANCER LETTERS

Atovaquone and selinexor as a novel combination treatment option in acute myeloid leukemia

Article

作者: Weiss, Stefanie ; Podar, Klaus ; Witalisz-Siepracka, Agnieszka ; Stoiber, Dagmar ; Zdársky, Bernhard ; Heindl, Kerstin ; Holzer, Anja ; Casanova, Emilio ; Edtmayer, Sophie

Acute myeloid leukemia (AML) is the most common acute leukemia and is predominantly affecting the elderly. It is a heterogenous disease, showing a broad spectrum of genomic alterations and mutations that influence the clinical outcome and treatment options. The expression of the signal transducer and activator of transcription 3 (STAT3) is often dysregulated in AML and its constitutive activation is associated with poor outcome. Thus, STAT3 became an attractive therapeutic target but until now drugs targeting STAT3 only had moderate efficacy. This phenomenon might be related to the expression ratio of the two alternatively spliced isoforms: the full-length isoform STAT3α and the truncated version STAT3β, which play opposite roles in AML. In this study, we investigated the potential of selected, well-established drugs to impact the STAT3β/α ratio, as a higher STAT3β/α ratio is associated with better disease outcome. Atovaquone and selinexor independently elevated the STAT3β/α ratio and led to an upregulation of the STAT3β target gene SELL (CD62L). The combined treatment with atovaquone and selinexor entailed synergistic killing of AML cells in vitro and impaired the leukemic cell infiltration in vivo. Moreover, CD62L overexpression in a human AML cell line resulted in significantly prolonged survival in a xenograft mouse model. We propose that targeting the STAT3β/α ratio could be a promising new strategy for treating patients with AML and that the combination of selinexor and atovaquone could offer enhanced treatment outcomes.

2025-02-17·CLINICAL CANCER RESEARCH

Phase I/II Trial of Exportin 1 Inhibitor Selinexor plus Docetaxel in Previously Treated, Advanced KRAS-Mutant Non–Small Cell Lung Cancer

Article

作者: Eaton, Keith D. ; Nadeem, Urooba ; Burns, Timothy F. ; Fattah, Farjana ; Horn, Leora ; Kyle, Kelly ; Dowell, Jonathan E. ; Camidge, D. Ross ; Mu-Mosley, Hong ; Liu, Jialiang ; Gupta, Arjun ; York, Sally J. ; Gao, Ang ; Zhang, Song ; Gerber, David E. ; von Itzstein, Mitchell S.

Abstract:

Purpose::

Patients with Kirsten rat sarcoma viral oncogene (KRAS)–mutant non–small cell lung cancer (NSCLC) have limited therapeutic options. Based on the activity of nuclear export inhibition in preclinical models, we evaluated this strategy in previously treated, advanced KRAS-mutant NSCLC.

Patients and Methods::

The primary outcomes of this multicenter phase I/II dose-escalation trial of selinexor plus docetaxel were safety and tolerability. Selinexor was started 1 week before docetaxel to permit monotherapy pharmacodynamic assessment.

Results::

Among 40 enrolled patients, the median age was 66 years, 55% were female, and 85% were White. The MTD was selinexor 60 mg orally weekly plus docetaxel 75 mg/m2 every 3 weeks. The most common adverse events were nausea (73%, 8% grade ≥3), fatigue (70%, 5% grade ≥3), neutropenia (65%, 60% grade ≥3), and diarrhea (58%, 10% grade ≥3). Of 32 efficacy-evaluable patients, 7 (22%) had partial responses and 18 (56%) had stable disease. Outcomes were not associated with KRAS mutation type but were significantly better in cases with wild-type TP53 (42%), including response and disease control rates (27% and 80% vs. 9% and 27%, respectively; P = 0.03) and progression-free survival (median 7.4 vs. 1.8 months; HR, 0.2; 95% confidence interval, 0.07–0.67; P = 0.003). After selinexor initiation and prior to docetaxel administration, serum lactate dehydrogenase levels increased an average of 51 U/L in TP53-altered cases and decreased an average of 48 U/L in TP53 wild-type cases (P = 0.06).

Conclusions::

Selinexor plus docetaxel was relatively well tolerated in patients with advanced KRAS-mutant NSCLC. The regimen has promising efficacy in TP53 wild-type cases, in which selinexor monotherapy may also have activity.

434

项与塞利尼索相关的新闻（医药）

2025-02-13

·德琪医药

德琪医药希维奥®正式纳入台湾市场“全民健康保险”，惠及更多多发性骨髓瘤患者

// ▶ 希维奥®是首款在台湾市场获批纳入全民健康保险，用于治疗复发/难治性多发性骨髓瘤（R/R MM）成人患者的XPO1抑制剂。 ▶ 这是继中国大陆、韩国、澳大利亚和新加坡之后，公司在第五个亚太市场实现对于希维奥®的医保覆盖。 ▶ 公司预计希维奥®将在亚太地区的更多市场获得医保收录。中国上海和香港，2025年2月13日–致力于研发，生产和销售同类首款及/或同类最优血液及实体肿瘤疗法的商业化阶段领先创新生物制药公司–德琪医药有限公司（简称“德琪医药”，香港交易所股票代码：6996.HK）今日宣布，希维奥®（中文通用名：塞利尼索，台湾市场注册商品名：保必欧®）在台湾市场获批纳入全民健康保险，联合硼替佐米 (bortezomib) 和地塞米松 (dexamethasone) (XVd方案) 用于治疗接受过至少两种既往治疗的复发/难治性多发性骨髓瘤（R/R MM）成人患者。希维奥®将于2025年3月1日起正式纳入台湾市场《全民健康保险用药品项表》。希维奥®是全球首个全新机制的口服选择性XPO1抑制剂，已在亚太市场的9个国家和地区获批用于治疗多项适应症，并在其中5个市场（中国大陆、台湾市场、澳大利亚、新加坡和韩国）实现医保收录。公司预计希维奥®将在亚太地区的更多市场获得医保收录。多发性骨髓瘤（MM）是一种克隆浆细胞异常增殖导致的恶性疾病。研究报告显示，在台湾市场，MM是血液系统第二大常见的恶性肿瘤，每年新增约700至800例MM患者及400例相关死亡。1多数患者都面临着易复发、生存期短、治疗选择有限的困境。此次希维奥®成功在台湾市场获得医保报销批准，将进一步减轻患者经济负担，惠及更多患者及其家庭。在持续推进亚太市场布局的同时，公司也正努力扩充希维奥®的适应症范围。基于其独特的作用机制，公司正在开发希维奥®在骨髓纤维化（MF）和子宫内膜癌等不同疾病领域的多种联合疗法。关于希维奥®（塞利尼索）希维奥®是全球首个全新机制的口服选择性核输出蛋白（XPO1）抑制剂，具有“全新机制、协同增效、快速起效、持久缓解”四大特点。通过抑制核输出蛋白XPO1，希维奥®可促使肿瘤抑制蛋白和其他生长调节蛋白的核内储留和活化，并下调细胞浆内多种致癌蛋白水平。希维奥®发挥抗肿瘤作用机制的三条通路为：1）使抑癌蛋白在细胞核中明显聚集，再激活发挥抗肿瘤作用；2）使致癌基因mRNA滞留在细胞核，降低胞浆内致癌蛋白水平；3）激活糖皮质激素受体（GR）通路，恢复激素敏感性。基于其独特的作用机制，希维奥®在不同疾病领域的多种联合疗法正在进行开发。目前，德琪医药正在中国大陆地区开展多项（其中三项全球临床试验由德琪医药与Karyopharm Therapeutics Inc.[纳斯达克交易所股票代码：KPTI] 共同开展）针对复发/难治性血液及实体肿瘤的临床研究。关于德琪医药德琪医药有限公司（简称“德琪医药”，香港交易所股票代码：6996.HK）是一家以研发为驱动，并已进入商业化阶段的生物制药领先企业，以“医者无疆，创新永续”为愿景，德琪医药专注于血液及实体肿瘤领域的同类首款和同类最优疗法的早期研发、临床研究、药物生产及商业化，致力于通过提供突破性疗法，改善全球患者生活质量。自2017年以来，德琪医药现已建立起一条拥有9款从临床延展至商业化阶段的肿瘤药物资产研发管线，其中，6款产品具有全球权益，3款产品具有亚太权益。公司已在美国及多个亚太市场获得31个临床批件（IND），并递交了10个新药上市申请（NDA）。目前，希维奥®（塞利尼索片）已获得中国大陆、中国台湾、中国香港、中国澳门、韩国、新加坡、马来西亚、泰国和澳大利亚的新药上市批准。前瞻性陈述本文所作出的前瞻性陈述仅与本文作出该陈述当日的事件或资料有关。除法律规定外，于作出前瞻性陈述当日之后，无论是否出现新资料、未来事件或其他情况，我们并无责任更新或公开修改任何前瞻性陈述及预料之外的事件。请细阅本文，并理解我们的实际未来业绩或表现可能与预期有重大差异。本文内有关任何董事或本公司意向的陈述或提述乃于本文刊发日期作出。任何该等意向均可能因未来发展而出现变动。有关这些因素和其他可能导致未来业绩与任何前瞻性声明存在重大差异的因素的进一步讨论，请参阅我们截至2023年12月31日的公司年报中描述的其他风险和不确定性，以及之后向香港证券交易所提交的文件。参考文献 1. 2019 Cancer Registry Annual Report, Health Promotion Administration of Taiwan Ministry of Health and Welfare Antengene Announces XPOVIO® Approved for Public Health Insurance Coverage in Taiwan Market, Benefiting More Patients with R/R MM in the Region - XPOVIO® is the first XPO1 inhibitor approved in Taiwan for the treatment of adult patients with relapsed/refractory multiple myeloma (R/R MM). - After the mainland of China, South Korea, Australia and Singapore, Taiwan market is the fifth APAC market in which XPOVIO® has been approved for public health insurance coverage. - XPOVIO® is expected to extend public health insurance coverage across APAC markets. Shanghai and Hong Kong, PRC, February 13, 2025 — Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, today announced that XPOVIO® (selinexor) in combination with bortezomib and dexamethasone (XVd) for the treatment of adult patients with relapsed/refractory multiple myeloma (R/R MM) who have received at least two prior therapies, has been approved for reimbursement in Taiwan. Starting from March 1, 2025, XPOVIO® will be officially included in the NHI drug reimbursement scheme. With a novel mechanism of action, XPOVIO® is the world’s first approved orally-available, selective XPO1 inhibitor, which has already been approved in nine countries and regions in APAC, and included in the public insurance schemes in five of those markets (the mainland of China, Taiwan market, Australia, Singapore and South Korea). Moving forward, XPOVIO® is expected to extend public health insurance coverage across APAC markets. Multiple myeloma (MM) is a malignancy caused by the dysregulated proliferation of plasma cells. According to epidemiology data, MM is the second most prevalent hematologic malignancy in Taiwan market, accounting for approximately 700 to 800 newly diagnosed cases and around 400 relevant deaths each year.1 Most patients with MM have to face a range of challenges in treatment, including high propensity to relapse, short period of survival, and limited treatment options. The inclusion of XPOVIO® for reimbursement coverage in Taiwan market, will further reduce the financial burden on many patients, benefiting more patients and their families. While bringing XPOVIO® to more APAC markets, Antengene is also striving to expand the indications of XPOVIO®. Leveraging the drug’s novel mechanism of action, XPOVIO® is currently being developed with multiple combination regimens for the treatment of various additional indications including myelofibrosis (MF) and endometrial cancer. About XPOVIO® (selinexor) XPOVIO® is the world’s first approved orally-available, selective inhibitor of the nuclear export protein XPO1. It offers a novel mechanism of action, synergistic effects in combination regimens, fast onset of action, and durable responses. By blocking the nuclear export protein XPO1, XPOVIO® can promote the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins, and down-regulate the levels of multiple oncogenic proteins. XPOVIO® delivers its antitumor effects through three mechanistic pathways: 1) exerting antitumor effects by inducing the intranuclear accumulation of tumor suppressor proteins; 2) reducing the level of oncogenic proteins in the cytoplasm by inducing the intranuclear accumulation of oncogenic mRNAs; 3) restoring hormone sensitivity by activating the glucocorticoid receptors (GR) pathway. To utilize its unique mechanism of actions, XPOVIO® is being evaluated for use in multiple combination regimens in a range of indications. At present, Antengene is conducting multiple clinical studies of XPOVIO® in the mainland of China for the treatment of relapsed/refractory hematologic malignancies and solid tumors (3 of these studies are being jointly conducted by Antengene and Karyopharm Therapeutics Inc. [Nasdaq:KPTI]). About Antengene Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of “Treating Patients Beyond Borders”. Since 2017, Antengene has built a pipeline of 9 oncology assets at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. To date, Antengene has obtained 31 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 10 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO® (selinexor) already approved in Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia, Thailand and Australia. Forward-looking statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company’s Annual Report for the year ended December 31, 2023, and the documents subsequently submitted to the Hong Kong Stock Exchange. Reference 1. 2019 Cancer Registry Annual Report, Health Promotion Administration of Taiwan Ministry of Health and Welfare

信使RNA上市批准申请上市

2025-02-13

·PRNewswire

Antengene Announces XPOVIO® Approved for Public Health Insurance Coverage in Taiwan Market, Benefiting More Patients with R/R MM in the Region

XPOVIO® is the first XPO1 inhibitor approved in Taiwan for the treatment of adult patients with relapsed/refractory multiple myeloma (R/R MM). After the mainland of China, South Korea, Australia and Singapore, Taiwan market is the fifth APAC market in which XPOVIO® has been approved for public health insurance coverage. XPOVIO® is expected to extend public health insurance coverage across APAC markets. SHANGHAI and HONG KONG, Feb. 13, 2025 /PRNewswire/ -- Antengene Corporation Limited (" Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, today announced that XPOVIO® (selinexor) in combination with bortezomib and dexamethasone (XVd) for the treatment of adult patients with relapsed/refractory multiple myeloma (R/R MM) who have received at least two prior therapies, has been approved for reimbursement in Taiwan. Starting from March 1, 2025, XPOVIO® will be officially included in the NHI drug reimbursement scheme. With a novel mechanism of action, XPOVIO® is the world's first approved orally-available, selective XPO1 inhibitor, which has already been approved in nine countries and regions in APAC, and included in the public insurance schemes in five of those markets (the mainland of China, Taiwan market, Australia, Singapore and South Korea). Moving forward, XPOVIO® is expected to extend public health insurance coverage across APAC markets. Multiple myeloma (MM) is a malignancy caused by the dysregulated proliferation of plasma cells. According to epidemiology data, MM is the second most prevalent hematologic malignancy in Taiwan market, accounting for approximately 700 to 800 newly diagnosed cases and around 400 relevant deaths each year.[1] Most patients with MM have to face a range of challenges in treatment, including high propensity to relapse, short period of survival, and limited treatment options. The inclusion of XPOVIO® for reimbursement coverage in Taiwan market, will further reduce the financial burden on many patients, benefiting more patients and their families. While bringing XPOVIO® to more APAC markets, Antengene is also striving to expand the indications of XPOVIO®. Leveraging the drug's novel mechanism of action, XPOVIO® is currently being developed with multiple combination regimens for the treatment of various additional indications including myelofibrosis (MF) and endometrial cancer. About XPOVIO® (selinexor) XPOVIO® is the world's first approved orally-available, selective inhibitor of the nuclear export protein XPO1. It offers a novel mechanism of action, synergistic effects in combination regimens, fast onset of action, and durable responses. By blocking the nuclear export protein XPO1, XPOVIO® can promote the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins, and down-regulate the levels of multiple oncogenic proteins. XPOVIO® delivers its antitumor effects through three mechanistic pathways: 1) exerting antitumor effects by inducing the intranuclear accumulation of tumor suppressor proteins; 2) reducing the level of oncogenic proteins in the cytoplasm by inducing the intranuclear accumulation of oncogenic mRNAs; 3) restoring hormone sensitivity by activating the glucocorticoid receptors (GR) pathway. To utilize its unique mechanism of actions, XPOVIO® is being evaluated for use in multiple combination regimens in a range of indications. At present, Antengene is conducting multiple clinical studies of XPOVIO® in the mainland of China for the treatment of relapsed/refractory hematologic malignancies and solid tumors (3 of these studies are being jointly conducted by Antengene and Karyopharm Therapeutics Inc. [Nasdaq:KPTI]). About Antengene Antengene Corporation Limited ( "Antengene", SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of "Treating Patients Beyond Borders". Since 2017, Antengene has built a pipeline of 9 oncology assets at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. To date, Antengene has obtained 31 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 10 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO® (selinexor) already approved in Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia, Thailand and Australia. Forward-looking statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company's Annual Report for the year ended December 31, 2023, and the documents subsequently submitted to the Hong Kong Stock Exchange. Reference 2019 Cancer Registry Annual Report, Health Promotion Administration of Taiwan Ministry of Health and Welfare For more information, please contact: Investor Contacts: Donald Lung E-mail: [email protected] Mobile: +86 18420672158 PR Contacts: Peter Qian E-mail: [email protected] Mobile: +86 13062747000 SOURCE Antengene Corporation Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准

2025-01-11

·药时代

5.5亿美元！英矽智能与美纳里尼再次达成合作

（限时福利直播）如何借助AI使用PASS和R软件计算样本量英矽智能与美纳里尼二次合作，5.5亿美元对外授权AI辅助发现的临床前抗肿瘤管线。这是美纳里尼从英矽智能处授权引进的第二款候选药物，该药物是通过英矽智能生成式AI平台Chemistry42辅助发现的。一年前，美纳里尼从英矽智能处授权引进了临床前候选药物KAT6抑制剂（MEN2312），这个项目目前已经进入了临床阶段。根据协议，美纳里尼将获得该候选药物后续的全球独家开发和商业化的权力。合作交易总额逾5.5亿美元，包括 2000 万美元的首付款，以及后续开发、监管和商业里程碑。此外，英矽智能还将有资格获得净销售额的分级版税。国际领先的制药和诊断公司美纳里尼集团（"美纳里尼"）与其全资子公司 Stemline Therapeutics，和由人工智能（AI）驱动的临床阶段生物科技公司英矽智能达成一项授权许可协议。Stemline将获得英矽智能一款临床前候选药物的全球独家开发和商业化的权力，这款药物有望满足肿瘤领域未被满足的大量临床需求。该候选药物由英矽智能顶尖的药物研发团队利用公司自有的生成化学引擎Chemistry42辅助开发，是一款高选择性、潜在同类最佳（best-in-class）小分子抑制剂，有望用于多种实体瘤癌症的治疗。在临床前研究中，该分子在选定的多个癌种模型中显示出广泛的抗肿瘤活性，目前已被提名为项目的临床前候选药物，正在IND-enabling开发阶段。美纳里尼集团首席执行官Elcin Barker Ergun表示， “ 我们很高兴能与生成式AI领域的领跑者英矽智能开展二次合作，开发一种有望用于多种癌症的高选择性、潜在的同类最佳小分子抑制剂。这项资产将帮助我们进入存在大量未被满足需求的抗肿瘤领域，扩大我们用突破性疗法帮助癌症患者的能力。 ” 英矽智能创始人兼首席执行官Alex Zhavoronkov 博士表示， “ 此前与美纳里尼合作的经验证明，我们的合作伙伴高效、敏捷、具有战略眼光，致力于快速为癌症患者提供最佳的创新治疗方案，并最大限度地提高项目的成功率。美纳里尼集团卓有远见的管理层正在迅速重塑肿瘤治疗领域，我们非常高兴能参与到他们延长全球患者生命的探索中来。 ” 根据协议，该合作交易总额逾5.5亿美元，Stemline 将向英矽智能支付2000万美元的首付款，以及后续开发、监管和商业里程碑付款。此外，英矽智能还将有资格获得净销售额的分级版税。在此之前，美纳里尼与英矽智能于 2024 年 1 月签订了 MEN2312的独家许可协议，这是一种用于乳腺癌治疗和其他肿瘤适应症的创新小分子药物。关于MEN2312 MEN2312由英矽智能的研发团队在其端到端生成AI药物发现平台的帮助下设计而成，可抑制KAT6A并在转录水平阻断ERα表达，使其有潜力克服因ESR1突变带来的内分泌疗法耐药问题。在临床前研究中，该分子已在多个细胞系移植瘤模型(CDX)和人源异种移植模型(PDX)中显示出对KAT6A的强效抑制作用，体现了卓越的疗效和良好的安全性。关于英矽智能英矽智能是一家由生成式人工智能（AI）驱动的临床阶段药物研发公司，通过下一代人工智能系统连接生物学、化学和临床试验分析，利用深度生成模型、强化学习、转换模型等现代机器学习技术，构建强大且高效的人工智能药物研发平台，识别全新靶点并生成具有特定属性分子结构的候选药物。英矽智能聚焦癌症、纤维化、免疫、中枢神经系统疾病、衰老相关疾病等未被满足医疗需求领域，推进并加速创新药物研发。更多信息，请访问网站www.insilico.com 媒体垂询，请联系media@insilico.com 关于美纳里尼集团美纳里尼集团(Menarini Group)是一家领先的国际制药和诊断公司，营业额超过44亿美元，拥有17000多名员工。美纳里尼专注于需求亟待满足的治疗领域，产品包括心脏病学、肿瘤学、肺病学、胃肠病学、传染病学、糖尿病学、炎症和镇痛学。美纳里尼拥有18个生产基地和9个研发中心，产品销往全球140个国家/地区。如需了解更多信息，请访问www.menarini.com。关于Stemline Therapeutics Inc. Stemline Therapeutics, Inc.（下称"Stemline"）是美纳里尼集团的全资子公司，是一家商业阶段的生物制药公司，专注于创新肿瘤疗法的开发和商业化。在美国和欧盟，Stemline实现了ORSERDU®（elacestrant，艾拉司群）的商业化，这是一种口服内分泌疗法，获批用于治疗局部晚期或转移性乳腺癌的绝经后女性或者成年男性，患者具有ER+/HER2-和ESR1突变，并且接受了至少一种内分泌治疗后病情出现进展。Stemline同时推进了ELZONRIS®（tagraxofusp-erzs）商业化，这是一种靶向CD123的新型治疗药物，获批用于一种侵袭性癌症母细胞浆细胞样树突状细胞肿瘤（BPDCN）患者治疗，这也是迄今为止美国和欧盟唯一批准的治疗BPDCN的疗法。在欧洲Stemline还实现了NEXPOVIO®的商业化，这是一种治疗多发性骨髓瘤的XPO1抑制剂。此外，Stemline拥有广泛的处于不同临床阶段的小分子和生物制剂管线，用于治疗多种实体肿瘤和血液肿瘤。封面图来源：网络点击查看更多精彩！

引进/卖出临床申请突破性疗法

100 项与塞利尼索相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11222	塞利尼索	L01XX66	DB11942

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
难治性多发性骨髓瘤	中国澳门	德琪医药有限公司	2023-12-06
复发性多发性骨髓瘤	中国澳门	德琪医药有限公司	2023-12-06
复发性弥漫性大B细胞淋巴瘤	以色列	Karyopharm Therapeutics, Inc.	2021-02-04
难治性弥漫性大 B 细胞淋巴瘤	以色列	Karyopharm Therapeutics, Inc.	2021-02-04
弥漫性大B细胞淋巴瘤	美国	Karyopharm Therapeutics, Inc.	2020-06-22
多发性骨髓瘤	美国	Karyopharm Therapeutics, Inc.	2019-07-03

未上市

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
难治性急性髓细胞白血病	临床3期	中国	德琪医药有限公司	2023-01-29
复发性急性髓细胞白血病	临床3期	中国	德琪医药有限公司	2023-01-29
子宫内膜癌	临床3期	中国	德琪医药有限公司	2021-10-27
子宫内膜癌	临床3期	中国	Karyopharm Therapeutics, Inc.	2021-10-27
骨髓纤维化	临床3期	美国	Karyopharm Therapeutics, Inc.	2021-03-11
骨髓纤维化	临床3期	比利时	Karyopharm Therapeutics, Inc.	2021-03-11
骨髓纤维化	临床3期	保加利亚	Karyopharm Therapeutics, Inc.	2021-03-11
骨髓纤维化	临床3期	加拿大	Karyopharm Therapeutics, Inc.	2021-03-11
骨髓纤维化	临床3期	捷克	Karyopharm Therapeutics, Inc.	2021-03-11
骨髓纤维化	临床3期	丹麦	Karyopharm Therapeutics, Inc.	2021-03-11

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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


NCT03992339 (SEARCH study \| SEARCH, CTgov)	临床2期	弥漫性大B细胞淋巴瘤	60	ATG-010 60 mg, orally, twice weekly, each 4 week (28-day) a cycle	繭獵衊窪範艱夢壓餘鬱(膚膚廠鹽艱鑰願願艱製) = 憲繭鏇簾淵淵襯鬱齋鏇鏇鏇壓糧齋壓積範範膚 (範窪襯鏇顧憲憲構醖築, 餘積齋製網鑰繭製齋淵 ~ 夢齋衊淵醖壓餘齋獵窪) 更多	-	2025-02-07
NCT02419495 (Pubmed \| J Immunother Precis Oncol)	临床1期	葡萄膜黑色素瘤	10	Selinexor 60 mg PO twice weekly + Pembrolizumab	窪觸憲蓋糧積範願餘製(遞選網網蓋網簾膚顧膚) = 構簾糧簾艱築醖觸衊構範壓製觸鬱鏇壓衊積築 (構顧膚遞醖獵築衊簾餘, 4 ~ notreached) 更多	积极	2025-02-01
				Selinexor 60 mg PO once weekly + Nivolumab and Ipilimumab	窪觸憲蓋糧積範願餘製(遞選網網蓋網簾膚顧膚) = 糧觸壓憲夢鑰網鑰襯齋範壓製觸鬱鏇壓衊積築 (構顧膚遞醖獵築衊簾餘, 7 ~ notreached) 更多
NCT04421378 (XPORT-GBM-029 \| CTNI-18, CTgov)	临床1/2期	多形性胶质母细胞瘤 \| 复发性胶质母细胞瘤	74	Selinexor (Arms A+B+C+D+E: Selinexor)	觸餘網繭繭鑰鑰遞鏇襯(鏇遞選齋鹹膚窪壓鹹襯) = 廠鬱顧網選廠獵鹹鬱淵願淵獵醖廠鏇壓範遞築 (獵廠膚鏇壓網繭網蓋鹹, 鏇範醖蓋憲觸簾艱積膚 ~ 襯願顧齋選膚艱願憲窪)	-	2024-12-16
				Selinexor (Arm A: Selinexor + Radiation Therapy)	壓糧窪選蓋鹹鬱襯蓋鏇(鏇窪鏇糧構願鏇淵廠遞) = 製積鬱衊鹽糧顧積積製蓋鑰鬱糧廠窪餘積齋艱 (築構夢鑰網鏇鬱艱廠顧, 夢鬱淵構夢選鹹鬱蓋憲 ~ 鹽獵憲選積艱構衊廠膚) 更多
NCT04425070 (TOUCH, ASH2024) 人工标引	临床1/2期	结外NK-T细胞淋巴瘤	17	Selinexor + Tislelizumab	糧構憲夢壓夢築範齋齋(窪壓壓觸蓋鑰獵鹽製餘) = 膚構憲鹹襯齋積膚製窪廠積鏇選鬱廠淵製鏇夢 (襯簾積構襯壓鹹衊遞範 ) 更多	积极	2024-12-09
				Selinexor + Tislelizumab (CPIs exposed pts)	糧構憲夢壓夢築範齋齋(窪壓壓觸蓋鑰獵鹽製餘) = 壓憲鏇獵鬱願獵網積遞廠積鏇選鬱廠淵製鏇夢 (襯簾積構襯壓鹹衊遞範 ) 更多
NCT04939142 (BENCH, ASH2024) 人工标引	临床3期	多发性骨髓瘤	154	Selinexor + Bortezomib + Dexamethasone	淵蓋憲鏇顧壓鑰糧網築(齋範願製齋壓廠糧襯齋) = 壓範繭醖構襯淵醖夢壓餘範鬱廠遞夢鹹選艱築 (餘膚築積簾觸糧壓範鬱 ) 更多	积极	2024-12-09
				Bortezomib + Dexamethasone	淵蓋憲鏇顧壓鑰糧網築(齋範願製齋壓廠糧襯齋) = 網窪醖範願鹽鹹簾簾壓餘範鬱廠遞夢鹹選艱築 (餘膚築積簾觸糧壓範鬱 ) 更多
ASH2024 人工标引	临床2期	骨髓纤维化	40	Selinexor + Ruxolitinib	簾願憲糧醖製鏇糧襯襯(範築齋構壓艱製艱餘衊) = 餘獵選淵衊艱鏇簾構築艱鑰糧鹽廠艱窪壓壓積 (鑰餘範糧選齋窪夢觸網 ) 更多	积极	2024-12-09
ASH2024	N/A	多发性骨髓瘤	-	Selinexor/dexamethasone/pomalidomide	齋繭製艱醖願襯膚願鏇(獵艱築網積鏇範鏇網遞) = Toxicity and tolerability were consistent with previous selinexor trials and generally manageable, with 11% of patients discontinuing treatment early due to adverse events. 齋衊顧範獵膚觸選顧顧 (蓋餘獵壓顧範鬱製憲糧 )	-	2024-12-08
ASH2024	N/A	多发性骨髓瘤	-	Selinexor 60 mg QW	選夢齋鹹積衊簾鹽範憲(襯構艱齋範糧顧繭齋鹹) = Entire cohort: 54.3%/33.3%, SPd60: 65.0%/25.0%, SPd40: 31.3%/18.8% 糧範顧鏇遞選獵夢鬱糧 (鏇網範網鹽築淵願糧遞 ) 更多	-	2024-12-07
				Selinexor 40 mg QW
ASH2024	N/A	多发性骨髓瘤	-	Selinexor 40 mg QW + Lenalidomide 25mg + Dexamethasone 20mg	艱醖築醖鹹醖獵積選遞(構構範壓膚選網鹹積蓋) = Grade 3 events included: Anxiety (N=1) 製衊淵鬱構蓋獵鹹鏇艱 (鏇顧衊簾醖積鏇簾壓範 ) 更多	-	2024-12-07
ChiCTR2200055486 (NEWS) 人工标引	早期临床1期	多发性骨髓瘤	19	塞利尼索+硼替佐米+沙利度胺+地塞米松	築夢獵構選範築蓋繭鹽(遞觸網遞鹹觸膚鏇觸憲) = 顧願膚艱憲夢範選醖範遞襯選觸獵鹽鹽遞構顧 (蓋選願糧鬱窪憲鑰憲糧 ) 更多	积极	2024-11-11