排名前五的靶点	数量

EZH2(组蛋白赖氨酸甲基化酶EZH2)	4
KDM1A(赖氨酸特异性组蛋白脱甲基酶-1)	2
p300-CBP transcription factors(p300-CBP转录因子)	2
TLR3(Toll样受体3)	2
F11 x FXIa	1

关联

项与 MorphoSys AG 相关的药物

Tafasitamab-Cxix

坦昔妥单抗

靶点

CD19

作用机制

CD19抑制剂 [+2]

在研机构

原研机构

在研适应症

非在研适应症

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2020-07-31

Ruxolitinib Phosphate

磷酸芦可替尼

靶点

JAK1 x JAK2

作用机制

JAK1抑制剂 [+1]

在研机构

原研机构

在研适应症

非在研适应症

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2011-11-16

Lenalidomide

来那度胺

靶点

CK1α x CRBN x IFNγ x IKZF1 x IKZF3 x IL-2 x IL-6 x TNF-α

作用机制

CK1α抑制剂 [+7]

在研机构

Bristol-Myers Squibb Pharma EEIG [+31]

原研机构

Celgene Corp.

在研适应症

边缘区B细胞淋巴瘤 [+65]

非在研适应症

Aase Smith综合征II型 [+98]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2005-12-27

项与 MorphoSys AG 相关的临床试验

NCT06401356 / Recruiting临床3期

An Open-Label, Multicenter, Extension Study for Patients Previously Enrolled in Studies with Pelabresib

The purpose of this study is to provide continued access to treatment with pelabresib for patients who previously received pelabresib in a parent study and to continue collecting safety and efficacy information. By collecting efficacy information, the study team monitors if pelabresib helps the patient with their disease. Additionally, survival follow-up data will be collected. Survival follow-up collects information on the patient's leukemia-free survival and overall survival status (life span) during and after the treatment is ended. If a patient stopped pelabresib treatment on the parent study for any other reason than participation in this study, they will not receive further pelabresib treatment, but they can enter the study for survival-follow up only.

开始日期2024-08-13

申办/合作机构

Constellation Pharmaceuticals, Inc.

NCT06029309 / Recruiting临床1/2期IIT

A Phase 1/2 Study of Zanubrutinib and Tafasitamab in Mantle Cell Lymphoma

The main purpose of this study to find the ideal dose for the combination treatment of Zanubrutinib and Tafasitamab in patients with mantle cell lymphoma. Another purpose is to assess how well the combination treatment works in patients with the study disease.

开始日期2024-05-03

申办/合作机构

University of Miami

[+3]

NCT05942300 / Recruiting临床1期IIT

Phase I Trial of CPI-0209 in Combination With Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer

This is a clinical trial using CPI-0209 in combination with Carboplatin chemotherapy followed by CPI-0209 maintenance in patients with platinum sensitive, recurrent ovarian cancer.

开始日期2024-01-10

申办/合作机构

University of Pittsburgh

[+2]

100 项与 MorphoSys AG 相关的临床结果

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0 项与 MorphoSys AG 相关的专利（医药）

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145

项与 MorphoSys AG 相关的文献（医药）

2024-08-01·CANCER RESEARCH

Comprehensive Target Engagement by the EZH2 Inhibitor Tulmimetostat Allows for Targeting of ARID1A Mutant Cancers

Article

作者: Adams, Elizabeth J. ; Khanna, Avinash ; Sun, Kaiming ; Côté, Alexandre ; Meyer, Rosana ; Arora, Shilpi ; Taimi, Mohammed ; Truong, Jennifer ; Cui, Jike ; Stuckey, Jacob I. ; Lakhani, Nehal J. ; Cantone, Nico ; Cummings, Richard T. ; Levell, Julian ; Devitt, Michael ; Zhao, Feng ; Mertz, Jennifer A. ; Wang, Jing ; Chen, Zehua ; Duska, Linda ; Trojer, Patrick ; Keller, Patricia J. ; Gehling, Victor ; Rippley, Ronda ; Yu, Ziyang ; Wu, Rentian ; Rasco, Drew ; Gutierrez, Martin

Abstract:

Recurrent somatic mutations in the BRG1/BRM-associated factor (BAF) chromatin remodeling complex subunit ARID1A occur frequently in advanced urothelial, endometrial, and ovarian clear cell carcinomas, creating an alternative chromatin state that may be exploited therapeutically. The histone methyltransferase EZH2 has been previously identified as targetable vulnerability in the context of ARID1A mutations. In this study, we describe the discovery of tulmimetostat, an orally available, clinical stage EZH2 inhibitor, and it elucidates the aspects of its application potential in ARID1A mutant tumors. Tulmimetostat administration achieved efficacy in multiple ARID1A mutant bladder, ovarian, and endometrial tumor models and improved cisplatin response in chemotherapy-resistant models. Consistent with its comprehensive and durable level of target coverage, tulmimetostat demonstrated greater efficacy than other PRC2-targeted inhibitors at comparable or lower exposures in a bladder cancer xenograft mouse model. Tulmimetostat mediated extensive changes in gene expression, in addition to a profound reduction in global H3K27me3 levels in tumors. Phase I clinical pharmacokinetic and pharmacodynamic data indicated that tulmimetostat exhibits durable exposure and profound target engagement. Importantly, a tulmimetostat controlled gene expression signature identified in whole blood from a cohort of 32 patients with cancer correlated with tulmimetostat exposure, representing a pharmacodynamic marker for the assessment of target coverage for PRC2-targeted agents in the clinic. Collectively, these data suggest that tulmimetostat has the potential to achieve clinical benefit in solid tumors as a monotherapy but also in combination with chemotherapeutic agents, and may be beneficial in various indications with recurrent ARID1A mutations.Significance: The EZH2 inhibitor tulmimetostat achieves comprehensive target inhibition in ARID1A mutant solid tumor models and cancer patients that can be assessed with a pharmacodynamic gene signature in peripheral blood.

2024-03-20·Leukemia & lymphoma

Results from phase 1 of the MANIFEST clinical trial to evaluate the safety and tolerability of pelabresib in patients with myeloid malignancies

Article

作者: Fathi, Amir T. ; Colak, Gozde ; Fusco, Andrea ; Harb, Wael A. ; Stein, Eytan M. ; Mangan, James K.

Pelabresib (CPI-0610), a BET protein inhibitor, is in clinical development for hematologic malignancies, given its ability to target NF-κB gene expression. The MANIFEST phase 1 study assessed pelabresib in patients with acute leukemia, high-risk myelodysplastic (MDS) syndrome, or MDS/myeloproliferative neoplasms (MDS/MPNs) (NCT02158858). Forty-four patients received pelabresib orally once daily (QD) at various doses (24-400 mg capsule or 225-275 mg tablet) on cycles of 14 d on and 7 d off. The most frequent drug-related adverse events were nausea, decreased appetite, and fatigue. The maximum tolerated dose (MTD) was 225 mg tablet QD. One patient with chronic myelomonocytic leukemia (CMML) showed partial remission. In total, 25.8% of acute myeloid leukemia (AML) patients and 38.5% of high-risk MDS patients had stable disease. One AML patient and one CMML patient showed peripheral hematologic response. The favorable safety profile supports the ongoing pivotal study of pelabresib in patients with myelofibrosis using the recommended phase 2 dose of 125 mg tablet QD.CLINICAL TRIAL REGISTRATION: NCT02158858.

2023-10-19·Blood

Safety and efficacy of tafasitamab with or without lenalidomide added to first-line R-CHOP for DLBCL: the phase 1b First-MIND study.

Article

作者: Dirnberger-Hertweck, Maren ; Staber, Philipp B ; Burke, John M ; Stevens, Don ; Kopeckova, Katerina ; Pichler, Petra ; Trneny, Marek ; Belada, David ; Mukhopadhyay, Amitava ; Nowakowski, Grzegorz S ; Duell, Johannes ; Waldron-Lynch, Maeve ; Bergua Burgues, Juan Miguel ; Persona, Ernesto Perez ; André, Marc ; Wagner, Steve

Anti-CD19 immunotherapy tafasitamab is used in combination with lenalidomide in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant. Open-label, phase 1b, First-MIND study assessed safety and preliminary efficacy of tafasitamab + R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) ± lenalidomide as first-line therapy in patients with DLBCL. From December 2019 to August 2020, 83 adults with untreated DLBCL (International Prognostic Index 2-5) were screened and 66 were randomly assigned (33 per arm) to R-CHOP-tafasitamab (arm T) or R-CHOP-tafasitamab-lenalidomide (arm T/L) for 6 cycles. Primary end point was safety; secondary end points included end-of-treatment (EoT) overall response rate (ORR) and complete response (CR) rate. All patients had ≥1 treatment-emergent adverse event, mostly grade 1 or 2. Grade ≥3 neutropenia and thrombocytopenia occurred, respectively, in 57.6% and 12.1% (arm T) and 84.8% and 36.4% (arm T/L) of patients. Nonhematologic toxicities occurred at similar rates among arms. R-CHOP mean relative dose intensity was ≥89% in both arms. EoT ORR was 75.8% (CR 72.7%) in arm T and 81.8% (CR 66.7%) in arm T/L; best ORR across visits was 90.0% and 93.9%. Eighteen-month duration of response and of CR rates were 72.7% and 74.5% (arm T) and 78.7% and 86.5% (arm T/L); 24-month progression-free and overall survival rates were 72.7% and 90.3% (arm T) and 76.8% and 93.8% (arm T/L). Manageable safety and promising signals of efficacy were observed in both arms. Potential benefit of adding tafasitamab + lenalidomide to R-CHOP is being investigated in phase 3 frontMIND (NCT04824092). This study is registered at www.clinicaltrials.gov as #NCT04134936.

400

项与 MorphoSys AG 相关的新闻（医药）

2024-11-02

·药事纵横

减值8亿美元！诺华29亿美元收购药物受挫

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。 10月29日，诺华公布2024年第三季度业绩并披露其29亿美元收购MorphoSys的赌注遇到危机。财报概述诺华财报显示：前三季度总收入371.64亿美元，同比增长11%；净收入91.19亿美元，同比增长62%；核心业务收入146.35亿美元，同比增长20%；研发投入为71.80亿美元，同比下降19%。其中第三季度收入128.23亿美元，同比增长10%；净收入为31.85亿美元，同比增长121%；研发投入为23.92亿美元，同比下降40%。在核药领域，诺华同时拥有Lutathera和Pluvicto两款畅销产品并在持续拓展适应症。2024Q3 Lutathera收入1.9亿美元，同比增长19%；前三季度Pluvicto总收入5.34亿美元，同比增长17%。 2024Q3 Pluvicto收入3.86亿美元，同比增长50%；前三季度Pluvicto总收入10.41亿美元，同比增长47%。目前诺华已提交Pluvicto用于二线治疗PSMA阳性mCRPC的上市申请。该适应症获批后，Pluvicto的全年销售额有望突破新高。收购减值此外，诺华公司在其第三季度财报中表示，在完成对MorphoSys公司29亿美元的收购交易仅五个月后，公司记录了一笔8亿美元的收购减值。这项收购的重点是MorphoSys公司的骨髓纤维化药物候选物Pelabresib，收购基于MorphoSys公司的骨髓纤维化药物候选物pelabresib 3期临床试验MANIFEST-2的顶线结果达到了主要终点。但今年7月，Pelabresib在III期MANIFEST-2研究中的结果好坏参半，而且有未经证实的报道显示其存在潜在安全风险。早在今年4月，STAT news引用参与Pelabresib 3期研究的匿名人员信息，有“多例”患者在接受Pelabresib治疗后，从骨髓纤维化“迅速进展”为更具侵袭性的急性髓性白血病（AML）。3期研究中的212名患者中6名患者进展为AML，而对照组只有2名。MorphoSys已经向FDA通报了这些安全信号，监管机构正在监控情况，并已向参与该研究的医生发出警告。这使该公司为收购的pelabresib申请批准的计划推迟数年，因为它需要更长时间地跟踪患者以应对对于突发恶性肿瘤的担忧。该公司最初希望今年获得批准用于骨髓纤维化治疗。诺华周二还披露了三项二期研究计划：一种用于多发性骨髓瘤的BCMA细胞疗法，名为durcabtagene autoleucel；一种用于高血压和心力衰竭的候选药物 XXB750；一种用于肺肉瘤病的IL-17抑制剂，名为CMK389。目前公司共有105条研发管线。参考资料： [1]公司公告 [2]https://endpts.com -END- 2025CMC-CHINA药博会 • 展位火热预定中！

并购临床3期财报临床结果临床成功

2024-11-02

·Endpoints

How RFK Jr. might influence the FDA; Pharma's Q3 highlights; AbbVie's latest neuro buyout; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here . Earnings season is in full swing, and we’ve got recaps for you for all the Big Pharma companies that reported this week. Plus, news of an AbbVie neuro buyout, new semaglutide data in MASH and experts discuss what an RFK Jr.-led crusade against public health agencies would look like for biopharma. — Max Gelman Biotech and pharma leaders are grappling with Donald Trump’s embrace of Robert F. Kennedy Jr. , who has extensively criticized vaccines and the drug industry, routinely embraces many conspiracy theories, and has made threats to force out FDA staff. Zachary Brennan has the details here. Rounding up the biggest earnings news of the week, Eli Lilly lowered the top end of its full-year revenue guidance by $600 million on Wednesday, triggering a significant one-day drop in stock price. Lilly attributed the guidance to “investing heavily in increasing the supply of tirzepatide .” Meanwhile, Novartis has recorded an $800 million impairment after reviewing “certain clinical trial data” just five months after closing its $2.9 billion deal for MorphoSys . CEO Vas Narasimhan remains confident and touted the company’s overall M&A track record. And Pfizer made its first substantive comments on the activist investor pushing for changes at the company this week while talking up the strength of its other programs including its plans in obesity . AstraZeneca said its China president Leon Wang is under investigation in the country, though not much is known about the nature of the investigation. Throughout the year, AstraZeneca has reiterated how important China is to the overall health of its business, with $1.6 billion of its revenue (about 12%) coming from the country. Last week, it was reported that a BeiGene executive was under investigation in China for alleged ties to an insurance fraud case while she was at AstraZeneca. In its third acquisition of the year, AbbVie said it will pay $1.4 billion in cash to buy the Phase 1 Alzheimer’s and neuroscience biotech Aliada Therapeutics . The deal adds to AbbVie’s big bet on CNS medicines after spending $8.7 billion last year to acquire Cerevel Therapeutics . Aliada’s study is investigating intravenous (or under-the-skin) doses of the anti-pyroglutamate amyloid beta antibody. The startup delayed data for a psilocybin program that’s one of the leaders in psychedelic drug development, pushing one study back about six months and another roughly one year. CEO Kabir Nath told Max Bayer that there had been delays in accruing data in the earlier study, citing a “logistical complexity” like having to arrange for therapists to participate in sessions. The company will lay off 30% of its employees, and its chief communications officer and chief legal officer/general counsel will both depart. SPOTLIGHT Q&A: Jade CEO talks about reverse merger and IgAN drugs ‘Imitation is best form of flattery’: Regeneron CEO comments on Amgen’s Eylea biosimilar Atlas of tumors reveals in 3D how cells change into cancer MORE IN R&D MORE IN PHARMA MORE IN STARTUPS MORE IN DEALS MORE IN FDA+ MORE IN MANUFACTURING MORE IN HEALTH TECH

并购临床1期

2024-10-31

·生物制药小编

一个潜在安全信号，计提8亿美元减值

8个月时间里，一个潜在的安全事件信号，间接造成了8亿美元的减值损失。近日，诺华公布2024Q3财报，前第三季度公司总收入371.64亿美元，同比增长11%。单Q3季度收入128.23亿美元，同比增长10%。值得注意的是，在该份财报中，诺华为其一笔价值29亿美元的收购（MorphoSys）计提了8亿美元的减值损失，而这距离该笔交易过仅8个月时间。收购的重心 pelabresib是全球进展最快的一款BET抑制剂，也是促使诺华收购MorphoSys的主要原因。今年2月初，诺华出价29亿美元收购MorphoSys公司，获得了其核心管线pelabresib。 pelabresib最初由一家名为Constellations公司开发，是一种口服小分子BET抑制剂，旨在抑制MF相关基因的表达，研究表明，BET抑制可以针对多种骨髓纤维化的驱动机制，并且与JAK抑制剂联合治疗可以产生协同效果。2021年6月，MorphoSys以17亿美元收购Constellation公司获得了该管线。事实上，MorphoSys在收购Constellations公司后，也出现了一件有意思的事情，大约一年后，MorphoSys为这笔交易计提了2.5亿美元减值损失，并砍掉了在美国大量的研发工作。 MorphoSys被收购时，公司的管线中只剩下三个项目，分别是已上市的CD19单抗Monjuvi，和剩下两条在研管线pelabresib和tulmimetostat。就在该笔交易公布的同一天，MorphoSys也把Monjuvi的全球权益以2500万美元卖给了Incyte公司。相较于tulmimetostat，Pelabresib进展更快一些，已经推进到临床Ⅲ期阶段了。诺华下定决心收购MorphoSys，很大程度得益于Ⅲ期临床MANIFEST-2的大获成功。 2023年11月，该项临床达到了主要终点目标，即第24周时，66%的pelabresib+Ruxolitinib组MF患者达到SVR35（脾脏体积减少35%以上），约为Ruxolitinib单药组的（35%）近一倍。安全性与既往观察到的安全性一致；没有观察到新的安全性信号，另外，与Ruxolitinib相比，Pelabresib+Ruxolitinib报告的贫血不良事件更少。基于该临床结果，MorphoSys计划在2024年中期在美国和欧洲提交Pelabresib+Ruxolitinib作为MF患者一线治疗的上市申请。可能发展为AML？ Pelabresib被收购后并没有按照MorphoSys原先的上市计划推进，而是一再被推迟，这期间，Pelabresib还报告了一个令人不安的安全信号。今年4月，MANIFEST-2的Pelabresib+ruxolitinib组报告了6例发展为更具侵袭性的急性髓性白血病（AML），而对照组只有2例，随后，MorphoSys便向FDA通报了这些安全信号。根据诺华二季度财报披露，公司认为需要获得48周的随访数据，来确定pelabresib的最终上市计划。然而在获得48周的数据后，诺华又表示，需要更长的随访时间来确定pelabresib获批的监管路径，此外，公司还会根据随访情况，评估是否需要额外的临床试验以支持上市批准，这最终可能会pelabresib的整个上市申请计划推迟数年。关于诺华对MorphoSys的收购，之前还有一个关于未证实的消息，这笔交易似乎包含一个退出条款，即如果Pelabresib被FDA拒绝批准，那么诺华可以退出收购。

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药物(靶点)	适应症	全球最高研发状态

Pelabresib ( BET )	原发性骨髓纤维化更多	临床3期
Abelacimab ( F11 x FXIa )	心房颤动更多	临床3期
坦昔妥单抗 ( CD19 )	复发性弥漫性大B细胞淋巴瘤更多	临床2期
来那度胺 ( CK1α x CRBN x IFNγ x IKZF1 x IKZF3 x IL-2 x IL-6 x TNF-α )	复发性弥漫性大B细胞淋巴瘤更多	临床2期
Ianalumab ( BAFF-R )	干燥综合征更多	临床2期