更新于：2024-07-03

Farletuzumab Ecteribulin

更新于：2024-07-03

概要

研发状态

概要

基本信息

药物类型

ADC

别名

Eribulin/farletuzumab antibody drug conjugate、Farletuzumab/eribulin ADC、MORAB 202

+ [1]

靶点

FOLR1 x Tubulin

作用机制

FOLR1拮抗剂(叶酸受体α拮抗剂)、微管蛋白抑制剂

治疗领域

肿瘤

在研适应症

实体瘤

非在研适应症

转移性非小细胞肺癌卵巢癌铂耐药性输卵管癌+ [1]

原研机构

在研机构

非在研机构

Bristol Myers Squibb Co.

Morphotek, Inc.

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

结构

分子式C30H42N6O11

InChIKeyFPFZTWMOHOCTJK-NVQXNPDNSA-N

CAS号-

使用我们的XDC技术数据为新药研发加速。

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查看完整样例数据

序列信息

Sequence Code 4703059

来源: *****

Sequence Code 4703062

来源: *****

关联

项与 Farletuzumab Ecteribulin 相关的临床试验

NCT05613088 / Recruiting临床2期

A Phase 2 Open-label Randomized Study of Farletuzumab Ecteribulin (MORAb-202), a Folate Receptor Alpha-targeting Antibody-drug Conjugate, Versus Investigator's Choice Chemotherapy in Women With Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

The purpose of the study is to assess the safety, tolerability, and efficacy of farletuzumab ecteribulin (MORAb-202) and compare it to Investigator's choice (IC) chemotherapy in female participants with platinum-resistant HGS ovarian, primary peritoneal, or fallopian tube cancer.

开始日期2023-02-01

申办/合作机构

Bristol Myers Squibb Co.

[+1]

NCT05577715 / Recruiting临床2期

A Phase 2, Open-label, Randomized Study of MORAb-202 (Farletuzumab Ecteribulin), a Folate Receptor Alpha-targeting Antibody-Drug Conjugate, in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC) After Progression on Prior Therapies

The aim of this study is to characterize the safety and tolerability of MORAb-202, and to assess the objective response rate in participants with previously treated, metastatic NSCLC AC.

开始日期2022-11-14

申办/合作机构

Bristol Myers Squibb Co.

[+1]

NCT04300556 / Recruiting临床1/2期

A Multicenter, Open-Label Phase 1/2 Trial Evaluating the Safety, Tolerability, and Efficacy of MORAb-202, a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Subjects With Selected Tumor Types

The primary objectives of the study are: (1) in the dose-escalation part: to evaluate safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of farletuzumab ecteribulin (MORAb-202) in participants with selected tumor types (ovarian cancer [OC], endometrial cancer [EC], non-small cell lung carcinoma [NSCLC], triple-negative breast cancer [TNBC]), and (2) in dose-confirmation part: to evaluate preliminary efficacy measured by objective response rate (ORR) of farletuzumab ecteribulin (MORAb-202) in participants with OC and EC at selected doses and to further evaluate the safety and tolerability of farletuzumab ecteribulin (MORAb-202) and (3) dose-optimization part. (divided in two parts: Part A [OC and EC participants] and Part B [EC only]): Part A: to evaluate other farletuzumab ecteribulin (MORAb-202) treatment regimens for safety, tolerability and preliminary efficacy in participants with OC and EC; to evaluate the use of the addition of short course of oral corticosteroids following every dose of farletuzumab ecteribulin (MORAb-202) administered every 21 days, as mitigation strategy for interstitial lung disease (ILD); and to select treatment regimens with farletuzumab ecteribulin (MORAb-202) for further evaluation in Part B. Part B: to further evaluate the safety, tolerability and preliminary efficacy of 2 treatment regimens with farletuzumab ecteribulin (MORAb-202) in participants with advanced EC and to determine the recommended treatment regimen for further development of farletuzumab ecteribulin (MORAb-202).

开始日期2020-08-06

申办/合作机构

Eisai, Inc.

[+1]

100 项与 Farletuzumab Ecteribulin 相关的临床结果

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100 项与 Farletuzumab Ecteribulin 相关的转化医学

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100 项与 Farletuzumab Ecteribulin 相关的专利（医药）

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项与 Farletuzumab Ecteribulin 相关的文献（医药）

2021-07-15·Clinical cancer research : an official journal of the American Association for Cancer Research1区 · 医学

First-in-Human Phase 1 Study of MORAb-202, an Antibody–Drug Conjugate Comprising Farletuzumab Linked to Eribulin Mesylate, in Patients with Folate Receptor-α–Positive Advanced Solid Tumors

1区 · 医学

Article

作者: Shimizu, Toshio ; Koyama, Takafumi ; Yamamoto, Noboru ; Furuuchi, Keiji ; Fujiwara, Yutaka ; Miura, Takuma ; Tamura, Kenji ; Yonemori, Kan ; Ikezawa, Hiroki ; Shimomura, Akihiko ; Sato, Jun ; Nomoto, Maiko ; Nakajima, Ryo

Abstract:

Purpose::

MORAb-202, an antibody–drug conjugate containing farletuzumab and eribulin with a cathepsin-B cleavable linker, targets folate receptor α (FRα)–expressing tumor cells. The primary objective of this first-in-human study was to evaluate the safety and tolerability of MORAb-202 in patients with solid tumors.

Patients and Methods::

Patients ≥20 years with adequate organ function and FRα-positive solid tumors who failed to respond to standard therapy were eligible. Patients received MORAb-202 intravenously at doses of 0.3 to 1.2 mg/kg once every three weeks. Endpoints included dose-limiting toxicities, safety, tumor responses, pharmacokinetics, and pharmacodynamics. Trial registration number: NCT03386942 (ClinicalTrials.gov).

Results::

Between November 28, 2017 and June 4, 2019, 22 patients (median age, 58.0 years) with advanced solid tumors were enrolled. Treatment-emergent adverse events occurred in 21 (95%) patients, with leukopenia and neutropenia in 10 (45%) patients each. One patient (0.9 mg/kg cohort) experienced two grade 3 dose-limiting toxicities: serum alanine aminotransferase and γ-glutamyl transferase increases. Following review by an independent adjudication committee, grade 1/2 interstitial lung disease thought to be related to MORAb-202 was identified in five (23%) patients. Complete response, partial response, and stable disease were observed in one, nine, and eight patients, respectively. The normalized predose serum FRα tended to be positively correlated with the maximum tumor shrinkage (R2 = 0.2379; P = 0.0291).

Conclusions::

The MTD of MORAb-202 was not reached. MORAb-202 demonstrated promising antitumor activity in FRα-positive solid tumors and was generally well-tolerated at the tested doses. Further investigations are required to establish appropriate dosage and clinical utility of MORAb-202.

2021-06-01·Cancer science

Antibody‐drug conjugate MORAb‐202 exhibits long‐lasting antitumor efficacy in TNBC PDx models

Article

作者: Fernando, Shawn ; Moriyama, Tomoyuki ; Cheng, Xin ; Wilson, Kerrianne ; Furuuchi, Keiji ; Rybinski, Katherine ; Drozdowski, Brian ; Milinichik, Andrew ; Albone, Earl ; Tanaka, Keigo ; Dula, Mary Lou ; Uenaka, Toshimitsu ; Soto, Allis ; Fulmer, James

Abstract:

The antibody‐drug conjugate (ADC) MORAb‐202, consisting of farletuzumab paired with a cathepsin B–cleavable linker and eribulin, targets folate receptor alpha (FRA), which is frequently overexpressed in various tumor types. MORAb‐202 was highly cytotoxic to FRA‐positive cells in vitro, with limited off‐target killing of FRA‐negative cells. Furthermore, MORAb‐202 showed a clear in vitro bystander cytotoxic effect in coculture with FRA‐positive/negative cells. In vivo antitumor efficacy studies of MORAb‐202 were conducted with a single administration of MORAb‐202 in triple‐negative breast cancer (TNBC) patient–derived xenograft (PDx) models expressing low and high levels of FRA. MORAb‐202 exhibited durable efficacy proportional to tumor FRA expression. Toxicology studies (Q3Wx2) in nonhuman primates suggested that the major observed toxicity of MORAb‐202 is hematologic toxicity. Overall, these findings support the concept that MORAb‐202 represents a promising investigational ADC for the treatment of TNBC patients.

2021-06-01·Clinical and translational medicine2区 · 医学

Folate receptor α increases chemotherapy resistance through stabilizing MDM2 in cooperation with PHB2 that is overcome by MORAb‐202 in gastric cancer

2区 · 医学

ArticleOA

作者: Nakagawa, Kazuhiko ; Sakai, Hitomi ; Teramura, Takeshi ; Somers, Elizabeth ; Uenaka, Toshimitsu ; Kato, Ryoji ; Furuuchi, Keiji ; Kawakami, Hisato ; Onodera, Yuta

Abstract:

Background:

The main function of folate receptor α (FOLRα) has been considered to mediate intracellular folate uptake and induce tumor cell proliferation. Given the broad spectrum of expression among malignant tumors, including gastric cancer (GC) but not in normal tissue, FOLRα represents an attractive target for tumor‐selective drug delivery. However, the efficacy of anti‐FOLRα monoclonal antibodies (mAbs) has not been proved so far, with the reason for this failure remaining unclear, raising the need for a better understanding of FOLRα function.

Methods:

The distribution of FOLRα in GC cells was evaluated by immunohistochemistry. The impacts of FOLRα expression on the survival of GC patients and GC cell lines were examined with the Gene Expression Omnibus database and by siRNA of FOLRα. RNA‐sequencing and Microarray analysis was conducted to identify the function of FOLRα. Proteins that interact with FOLRα were identified with shotgun LC‐MS/MS. The antitumor efficacy of the anti‐FOLRα mAb farletuzumab as well as the antibody‐drug conjugate (ADC) consists of the farletuzumab and the tublin‐depolymerizing agent eribulin (MORAb‐202) was evaluated both in vitro and in vivo.

Results:

FOLRα was detected both at the cell membrane and in the cytoplasm. Shorter overall survival was associated with FOLRα expression in GC patients, whereas reduction of FOLRα attenuated cell proliferation without inducing cell death in GC cell lines. Transcriptomic and proteomic examinations revealed that the FOLRα‐expressing cancer cells possess a mechanism of chemotherapy resistance supported by MDM2, and FOLRα indirectly regulates it through a chaperone protein prohibitin2 (PHB2). Although reduction of FOLRα brought about vulnerability for oxaliplatin by diminishing MDM2 expression, farletuzumab did not suppress the MDM2‐mediated chemoresistance and cell proliferation in GC cells. On the other hand, MORAb‐202 showed significant antitumor efficacy.

Conclusions:

The ADC could be a more reasonable choice than mAb as a targeting agent for the FOLRα‐expressing tumor.

项与 Farletuzumab Ecteribulin 相关的新闻（医药）

2024-07-02

·同写意

31亿美元BD之死

同写意20周年大会：中国医药创新未来之路！“意”同创新，穿越周期，赢取未来。7月中旬，苏州金鸡湖畔，让我们与“新药写意人”一起为中国医药创新“同写意”！自2022年下半年以来，FRα ADC（叶酸受体α抗体药物偶联物）领域的好消息，接踵而至。当年11月15日，Immunogen公司长期研发的FRα ADC药物Elahere获得FDA的加速批准上市，这不仅为公司赢得了“首创新药”的荣誉，也标志着医药界又成功开发了一个可成药的靶点。 Elahere上市，也意味着FRα作为药物靶点的有效性得到了证实。紧随其后，Immunogen公司超出预期的财务报告进一步提升了市场对FRα ADC的期待值，销量增长极大地推动了Immunogen公司的股价，并最终促成了其被艾伯维以超过100亿美元的价格收购。这些积极因素共同作用，吸引了众多药企进入FRα领域。然而，尽管Elahere已经证明了FRα靶点的潜力并确立了其FIC身份，但其他后来者仍面临较大的不确定性。 2024年7月1日，卫材公司宣布，其FRα ADC药物MORAb-202被百时美施贵宝退回，此前双方达成的价值31亿美元的BD合作，突然终止。这不仅意味着，与Elahere齐名的“FRα ADC三剑客”中，除了Elahere，其他竞争者都遭遇了挫折。即历经几十年磨难，药企要想在FRα ADC领域取得成功仍然并非易事。同时，这也进一步提醒市场，科学的发展并非线性，成功不能被规划。在最乐观的市场预期下，潜在的不确定性与挑战也可能正在悄然酝酿。 1 一次“失败”的逆袭原本，在外界看来，MORAb-202会是一个逆袭者。从90年代开始，FRα被医学界逐步认识，并被视为理想的成药靶点。然而，此后的发展却是一波三折，经历重重挫折。单抗、小分子偶联药物研发纷纷折戟，让FRα被冠以“巨头绞肉机”的称号，卫材也在此倍尝败绩。 2013年，卫材开发靶向FRα的人源化单抗farletuzumab，在一项针对上皮性卵巢癌患者III期试验中，相比于化疗，farletuzumab没能达到主要终点。而后，在另一项针对肺癌患者的临床试验中，farletuzumab同样以失败告终。不过，卫材并没有放弃该抗体，而是尝试用ADC技术去做新的尝试。具体而言，卫材将其开发成ADC药物MORAb-202的弹头，毒素则采用艾日布林，二者之间通过可裂解连接子相连。看起来，这让MORAb-202重新具备了想象空间。毕竟，尽管farletuzumab铩羽而归，但其它选手也并未在FRα靶点领域彻底突围。在MORAb-202之前，进度领先的也仅有ImmunoGen的IMGN853。所以，百时美施贵宝伸出橄榄枝： 2021年6月，百时美施贵宝以6.5亿美元首付款（其中2亿美元为研发费用）、24.5亿美元里程碑，与卫材就MORAb-202的开发与商业化达成合作。只是，随着退货的发生，MORAb-202的逆袭故事也遭遇了挫折，其前景也蒙上了一层不确定的阴霾。 2 真相是什么？从卫材口径来看，退货是因为百时美施贵宝在全球战略协作中持续进行产品组合的优先级排序工作。换句话说，MORAb-202在百时美施贵宝眼中，可能并没有那么重要。这意味着，MORAb-202并非临床失败。的确，就目前信息来看，MORAb-202仍是一个潜力选手。 Elahere的bug之一是患者群体较窄，只对高度表达FRα的患者有效。而这类患者只占据卵巢癌人群的35-40%，对于更多的FRα中低表达患者，Elahere束手无策。此外，Elahere还存在安全性的bug。毒性问题是所有FRα药物的隐忧，Elahere也不例外。其中，眼毒性更是不能忽视的问题，一名患者因视力障碍而终止治疗。为了提醒人们注意这一副作用，FDA直接给Elahere打上了黑框警告。而根据MORAb-202在2022年ASCO会上公布的数据情况来看，其并不存在Elahere的缺点。一方面，MORAb-202对FRα表达低于50%的患者也有效，另一方面也没有眼毒性的问题。也正因此，虽然遭遇退货，卫材似乎仍对MORAb-202抱有期待，表示将以高优先级去推进研发。当然，MORAb-202也并非高枕无忧。从ASCO公布的数据来看，间质性肺病/肺炎是最常见的治疗相关不良事件，分别有37.5%和66.7%的较低和较高剂量组患者在任何严重程度上受到影响。虽然3/4级严重性级别的不良事件只有1例，但考虑到队列2的样本量只有21人，所有MORAb-202如何做剂量优化，达到益处/风险和风险的平衡，还是一个值得考量的事情。毕竟如果MORAb-202完全具备竞争力，百时美施贵宝必然不会主动退货。首先，在O药竞争力衰退的情况下，百时美施贵宝亟需新增长引擎。也正因此，近年来不管是在ADC领域，还是其它领域，百时美施贵宝都在大力布局。目前，包括辉瑞等药企表示，并购可能需要缓一缓，百时美施贵宝则表示，如果有好的标的，仍然准备继续并购。换句话说，为了增长，百时美施贵宝不会轻易放手一个潜力分子。其次，FRα ADC的市场潜力不容忽视。去年第三季度，在仅有卵巢癌突破的情况下，Elahere美国净销售额为1.052亿美元。而Elahere的前景，不只有卵巢癌，根据《Oncotarget》上的一篇文献数据，FRα在非小细胞肺癌、间皮瘤、子宫内膜癌、上皮性卵巢癌中过表达的比例分别约为14-74%、72-100%、20-50%、76-89%。在引进MORAb-202后，百时美施贵宝也在腹膜癌和小肠癌、非小细胞癌等适应症领域进行了探索。因此，在这一背景下，百时美施贵宝放弃MORAb-202，并不一定表示其临床失败，但却意味着百时美施贵宝认为其竞争力有限。 3 杀死你的不是绝望事实上，FRα ADC领域的故事与事故一直并存。此前，Elahere、MORAb-202以及Sutro的STRO-002被视为“FRα ADC三剑客”。Elahere在进度方面毫无悬念，MORAb-202、STRO-002则是作为潜在颠覆者的身份出现。但早在2023年初，STRO-002便率先出现了翻车的一幕。此前，STRO-002宣称自己的优势在于能够无论FRα表达水平如何都能有效，但实际却并非如此。 2023年1月9日，STRO-002公布的最新临床数据显示，41名卵巢癌患者中，在FRα中高表达（TPS > 25%）的患者中，客观缓解率达到38%，略高于IMGN853的32%。但在中位持续缓解时间上，STRO-002为5.5个月，略低于IMGN853的6.9个月。即便只看高表达（TPS>75%）患者，STRO-002的客观缓解率也只有40%，优势并不明显。在安全性方面，STRO-002虽没有出现眼毒性，但也有着属于自己的困扰。STRO-002与 70%的严重中性粒细胞减少症相关。随着Elahere的上岸，看起来没有太大优势的STRO-002，商业价值大打折扣。SUTRO的股价也较2021年最高点已经蒸发近90%。眼下，MORAb-202同样遭遇了变故。这进一步告诉市场，FRα ADC赛道逐渐起风是事实，但对于所有药企来说，这绝对不会是一次轻松的征程。这也进一步提醒市场，任何时候，药企都需要保持清醒的头脑，客观看待早期临床数据、理性看待重大BD交易，并做好充分的准备，以应对可能的困难和挑战。因为，有时候，杀死你的并不是绝望，而是盲目的乐观。更多优质内容，欢迎关注↓↓↓

引进/卖出抗体药物偶联物上市批准临床3期临床2期

2024-07-02

·GBIHealth

1亿美元！Supercede与复旦和华东师范达成ActRII抑制剂合作；BMS 与卫材终止叶酸受体αADC 的全球合作

药械追踪 No.1 / 赛诺菲替利珠单抗落地博鳌，延缓1型糖尿病发病 2024年7月1日，全球首个且唯一获美国FDA批准用于延缓1型糖尿病发病的创新靶向疗法Tzield（Teplizumab，中文拟命名：替利珠单抗）近日获批先行先试，作为临床急需的进口药品，落地海南博鳌乐城国际医疗旅游先行区。Teplizumab是赛诺菲在免疫介导领域及糖尿病领域的重要战略创新产品，适用于延缓成人和8岁及以上儿童1型糖尿病患者从2期进展为3期。 1型糖尿病是危害儿童健康的重大儿科内分泌疾病，自幼发病的儿童始终面临健康成长的重大威胁。作为一种CD3靶向的单克隆抗体，Teplizumab从病因上实现对胰岛β细胞的保护，进而延缓1型糖尿病发病近3年，填补了1型糖尿病领域疾病修饰疗法的治疗空白。以1型糖尿病患者每天至少接受4次胰岛素注射为例，3年累计高达4380次，Teplizumab延缓发病近3年，可延缓进入长期胰岛素的治疗阶段。 ->点击阅读原文，解锁完整双语新闻 No.2 / 1亿美元！Supercede与复旦和华东师范达成ActRII抑制剂合作近日，复旦大学和华东师范大学与生物制药公司Supercede Therapeutics（以下简称“Supercede”）就抗肿瘤恶病质与增肌领域的创新药物达成一项全球权益合作。基于本次合作，Supercede将获得复旦大学和华东师范大学共同研发的处于临床前的小分子抗肿瘤恶病质肌萎缩、肌少症和增肌创新药物全球开发和商业化权益，复旦大学和华东师范大学将有资格获得最高可达近1亿美元的首付款和开发、监管和商业化里程碑付款，以及未来基于全球年度销售净额的梯度特许权使用费。该药物是一种新型口服小分子Activin 受体II型（ActRII）抑制剂，用于治疗肥胖症，也是Supercede首个开发项目。该小分子药物具有优异的增肌效果，有希望解决肿瘤恶病质、肌少症等肌萎缩缺乏有效治疗药物这一临床难题，也可成为GLP-1药物的黄金搭档，缓解GLP-1药物治疗之后去脂体重的降低，在增肌的热潮中再添加充满潜力的小分子创新药。 Supercede Therapeutics成立于2023年，专注于小分子药物开发的生物初创公司，利用 AI/ML 生物信息学平台有效推进药物发现，其研发领域包括Bach1抑制剂/Nrf2激活剂、ActRIIB抑制剂等，目标是治疗肥胖、Friedreich共济失调等复杂疾病。 ->点击阅读原文，解锁完整双语新闻 No.3 / 第三个适应证！安可坦在华获批治疗转移性激素敏感性前列腺癌日本安斯泰来制药（TSE:4503）近日宣布，旗下安可坦（恩扎鲁胺）用于治疗转移性激素敏感性前列腺癌（mHSPC）的新适应证申请获得国家药监局批准。这是该药在中国获批的第三个适应证。这项批准基于全球III期ARCHES研究和中国ARCHES研究的积极结果。结果显示，与安慰剂联合雄激素剥夺治疗（ADT）相比，恩扎卢胺联合ADT显著降低了PSA进展风险87%。影像学无进展生存期（rPFS）、至去势抵抗时间（TTCR）和PSA不可测率等次要终点，恩扎卢胺联合ADT治疗组也优于安慰剂联合ADT组的治疗。这些研究发现再次显示出恩扎卢胺的积极结果，与全球III期ARCHES研究保持一致。中国ARCHES研究中，恩扎卢胺联合ADT治疗的安全性与已知的安全性一致。恩扎卢胺此前于2020年在中国被批准用于治疗非转移性去势抵抗性前列腺癌（nmCRPC），并于2019年获批用于之前接受ADT治疗的转移性去势抵抗性前列腺癌（mCRPC）。在中国，前列腺癌是男性泌尿生殖系统中最常见的癌症，也是发病率不断上升的癌症之一。转移性激素敏感性前列腺癌（mHSPC）男性患者开始接受ADT治疗后的中位生存期约为3-4年。 ->点击阅读原文，解锁完整双语新闻企业动态 No.1 / BMS 与卫材终止叶酸受体αADC 的全球合作日本卫材近日宣布，百时美施贵宝（BMS; NYSE: BMS）出于内部产品组合优先级排序的原因，决定终止与其就抗体偶联药物（ADC）farletuzumab-ecteribulin（FZEC；MORAb-202）达成的全球战略合作。 FZEC由卫材自主研发，是一款叶酸受体α（FRα）靶向ADC药物，目前正在进行三项临床试验，分别为：卫材开展的治疗实体瘤的I/II期试验（NCT04300556），以及BMS开展的用于卵巢癌、腹膜癌和输卵管癌的II期试验（NCT05613088）和治疗非小细胞肺癌的II期试验（NCT05577715）。根据协议，卫材现在拥有FZEC的所有权利，并将全权负责该药物的全球开发和商业化。卫材计划退还根据合作协议从BMS获得的2亿美元研发费用中未使用的部分，并将剩余部分记为其他收入。 2021年，卫材与BMS就FZEC达成全球开发和商业化合作协议。根据当时的协议，BMS向卫材支付6.5亿美元，其中2亿美元作为支付卫材的研发费用。卫材还有权获得潜在未来开发、监管和商业里程碑方面的高达24.5亿美元的收益。今年4月，BMS宣布计划在2025年底前通过大规模重组削减15亿美元成本，其中包括削减12个开发项目，并且裁员2200人。卫材表示，该制剂仍然是公司高度优先事项，将加快其开发的步伐。 ->点击阅读原文，解锁完整双语新闻 No.2 / 迈科康生物完成超3亿元C系列融资 2024年6月，成都迈科康生物科技有限公司（以下简称“迈科康生物”）宣布获超 3 亿元C+轮融资。本轮融资由IDG资本领投，汉康资本和前海方舟跟投。至此，迈科康生物在2024年半年内已完成了C轮、C+轮系列融资，总额超6亿元人民币。本轮所募资金将主要用于支持重组带状疱疹疫苗Ⅲ期临床试验、重组呼吸道合胞病毒疫苗临床Ⅰ期和Ⅱ期的研究，后续多个创新疫苗管线临床前研发和国际合作。迈科康生物专注于创新人用和兽用（含宠物）疫苗的研发、生产和商业化，基于国际领先的新型佐剂、重组蛋白平台及免疫评价平台，搭建了一系列重大创新疫苗品种管线。 ->点击阅读原文，解锁完整双语新闻行业政策 No.1 / CDE与7月1日起启动药品注册电子申报资料网络传输试行工作 2024年7月1日，国家药监局药审中心（CDE）发布《关于试行以网络传输方式提交药品注册电子申报资料的通知》，建立电子申报资料网络传输通道，在使用光盘提交电子申报资料的基础上，增加网络传输方式，为申请人提交电子申报资料提供多种选择，以提升申请人电子申报资料提交效率。自2024年7月1日起，启动药品注册电子申报资料网络传输试行工作，申请人可通过网络传输方式提交药品注册电子申报资料。试行期间，申请人可以选择网络传输或光盘形式递交申报资料，避免出现重复递交申报资料的情形。通过网络传输系统提交的电子申报资料总大小应小于10GB，超过10GB的电子申报资料仍采用光盘形式按照现行要求递交。 ->点击阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作 ▶ zhangxinyue13@baidu.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

临床2期临床3期引进/卖出临床结果申请上市

2024-07-01

·PipelineReview

Eisai announces move to solo development and commercialization of farletuzumab ecteribulin (Fzec) antibody drug conjugate (ADC)

Strategic collaboration with Bristol Myers Squibb ended TOKYO, Japan I July 01, 2024 I Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has agreed to end its global strategic collaboration with Bristol Myers Squibb for the co-development and co-commercialization of farletuzumab ecteribulin (FZEC), formerly known as MORAb-202, a folate receptor alpha (FRα)-targeting antibody drug conjugate (ADC) due to ongoing portfolio prioritization efforts within Bristol Myers Squibb. Based on the agreement, Eisai now owns all rights to FZEC and will solely conduct the global development and commercialization of the agent. Eisai will accelerate the development of the agent as a high priority with the hope to deliver it to patients as early as possible. Eisai plans to refund a part of the unused portion of the $200 million payment it received towards research and development expenses from Bristol Myers Squibb under the collaboration agreement and record the remaining as other income. FZEC is Eisai’s first ADC and is composed of Eisai’s in-house developed farletuzumab, a humanized IgG1 monoclonal antibody that binds to the FRα, and Eisai’s in-house developed anticancer agent eribulin, using an enzymatically cleavable linker. Currently, three clinical studies are ongoing: Eisai’s Phase 1/2 study for solid tumors (NCT04300556), and Bristol Myers Squibb’s Phase 2 studies for ovarian, peritoneal and fallopian tube cancers (NCT05613088) and non-small cell lung cancer (NCT05577715). Eisai positions oncology as a key franchise area and aims to contribute toward the cure of cancers by exploring the depths of human biology. FZEC development for refractory cancers is a testament of our dedication to addressing the unmet medical needs of patients with cancer. Eisai will make continuous efforts to increase the benefits provided to patients with cancer and their families. [Notes to editors] 1. Farletuzumab ecteribulin (FZEC, formerly known as MORAb-202) FZEC is Eisai’s first antibody drug conjugate (ADC) and that is composed of Eisai’s in-house developed farletuzumab, a humanized IgG1 monoclonal antibody that binds to the folate receptor alpha (FRα), and Eisai’s in-house developed anticancer agent eribulin, using an enzymatically cleavable linker. After FZEC enters the target FRα-positive cancer cells, it is thought that the linker is enzymatically cleaved, releasing eribulin from the antibody leading to its antitumor activity. When the anticancer agent and antibody components of an ADC are separated inside a targeted antigen-positive cancer cell, it is theorized that the released anticancer agent also has a bystander effect on neighboring antigen-negative cancer cells and the component cells of the tumor microenvironment. In pre-clinical studies, FZEC demonstrated a bystander effect*, with antitumor activity on the FRα-negative cancer cells surrounding the FRα-positive cancer cells. The payload eribulin was the first in the halichondrin class of microtubule dynamics inhibitor. Structurally, eribulin is a simplified and synthetically produced version of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai, and functions by inhibiting the growth phase of microtubule dynamics which prevents cell division. Eribulin has been approved in countries including Japan, the United States, China, in Europe and in Asia for use in the treatment of advanced breast cancer and liposarcoma (soft tissue sarcoma in Japan). *Bystander effect: When the anticancer agent and antibody parts of an ADC are separated inside a targeted antigen-positive cancer cell, the released anticancer agent also affects neighboring antigen-negative cancer cells and the component cells of the cancer microenvironment. SOURCE: Eisai

引进/卖出抗体药物偶联物临床2期上市批准临床1期

100 项与 Farletuzumab Ecteribulin 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
卵巢癌	临床2期	美国	Bristol Myers Squibb Co.	2023-02-01
卵巢癌	临床2期	日本	Bristol Myers Squibb Co.	2023-02-01
卵巢癌	临床2期	澳大利亚	Bristol Myers Squibb Co.	2023-02-01
卵巢癌	临床2期	比利时	Bristol Myers Squibb Co.	2023-02-01
卵巢癌	临床2期	智利	Bristol Myers Squibb Co.	2023-02-01
卵巢癌	临床2期	以色列	Bristol Myers Squibb Co.	2023-02-01
卵巢癌	临床2期	意大利	Bristol Myers Squibb Co.	2023-02-01
卵巢癌	临床2期	韩国	Bristol Myers Squibb Co.	2023-02-01
卵巢癌	临床2期	西班牙	Bristol Myers Squibb Co.	2023-02-01
铂耐药性输卵管癌	临床2期	美国	Bristol Myers Squibb Co.	2023-02-01

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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


NCT03386942 (ESMO_GCC2023)	临床1期	卵巢癌	82	MORAb-202 0.9 mg/kg	鏇積餘蓋衊製鑰製衊簾(餘積簾範膚鑰夢選鑰範) = Translocation of HMGB1 and enhanced HSP90 production as ICD biomarkers were observed in triplicate tumor samples treated with MORAb-202 and eribulin 憲獵衊顧觸鏇壓夢選範 (繭選鹹遞積窪觸築築壓 ) 更多	-	2023-02-23
				MORAb-202 1.2 mg/kg
2022-RA-680-ESGO (ESGO2022)	临床1期	铂耐药性卵巢癌 FRÎ±-expression levels	-	MORAb-202 0.9 mg/kg	鏇製齋淵遞願網觸鹽憲(壓製選蓋淵積衊餘願繭) = 顧蓋構製積鬱鏇製鹽願糧膚遞醖簾餘觸淵夢範 (遞壓遞膚獵繭願築蓋醖 )	-	2022-10-20
				MORAb-202 1.2 mg/kg	鏇製齋淵遞願網觸鹽憲(壓製選蓋淵積衊餘願繭) = 艱顧憲醖窪醖蓋鬱繭淵糧膚遞醖簾餘觸淵夢範 (遞壓遞膚獵繭願築蓋醖 )
NCT03386942 (ASCO2022)	临床1期	铂耐药性卵巢癌	45	MORAb-202 0.9 mg/kg	觸齋獵廠壓顧膚積網選(選築範遞選範範築觸願) = 夢築鬱餘範憲鏇網選廠淵鏇襯夢構簾願觸遞構 (蓋築鹹淵觸齋構簾築鑰 )	-	2022-06-02
				MORAb-202 1.2 mg/kg	觸齋獵廠壓顧膚積網選(選築範遞選範範築觸願) = 衊繭膚鑰鑰願繭遞夢壓淵鏇襯夢構簾願觸遞構 (蓋築鹹淵觸齋構簾築鑰 )
NCT03386942 (ASCO2022)	临床1期	实体瘤	82	MORAb-202 BSA-based dosing (33 mg/m2)	簾範憲齋衊鹹遞鹹夢膚(醖願築積窪鹹襯憲淵簾) = rates of all-grade interstitial lung disease (ILD), an adverse event of interest, were lower at the 0.9 mg/kg dose vs the 1.2 mg/kg dose 範襯窪繭窪壓鹹窪範壓 (衊襯願鬱鹽窪網鑰壓構 ) 更多	-	2022-06-02
				MORAb-202 BW-based dosing (0.9 mg/kg)
NCT03386942 (Pubmed \| Clin Cancer Res) 人工标引	临床1期	实体瘤 Folate Receptor-α-Positive	22	MORAb-202	簾鑰壓積艱築憲簾淵襯(醖齋構繭遞夢艱鬱簾醖) = 積選構觸窪鏇鹹鹽願積膚製襯襯鹽襯膚膚廠築 (積鹽網餘窪艱積淵鑰衊 ) 更多	积极	2021-07-15
NCT03386942 (ASCO2019)	临床1期	实体瘤	16	MORAb-202	膚淵顧選醖鏇願願衊簾(築襯醖鏇構壓遞淵鬱構) = The most common TEAEs were leukopenia and neutropenia (50% each) 襯築願顧壓淵壓蓋築築 (網範網齋鬱簾選顧壓淵 )	积极	2019-05-26
NCT00738699 (CTgov)	临床2期	复发性卵巢癌	415	MORAb-003 (Farletuzumab)+Paclitaxel (MORAb-003 (Farletuzumab) Plus Paclitaxel)	醖積簾觸簾糧鑰鹽鬱蓋(簾構築憲顧簾選遞選積) = 鹹襯構遞醖衊繭鹽壓衊築獵顧窪鑰廠糧獵憲範 (齋積廠鹽顧醖鑰糧鑰憲, 膚醖齋構窪鏇襯遞範顧 ~ 鬱觸鹽膚窪襯淵蓋壓鏇) 更多	-	2017-03-30
				Placebo+Paclitaxel (Placebo (Normal Saline) Plus Paclitaxel)	醖積簾觸簾糧鑰鹽鬱蓋(簾構築憲顧簾選遞選積) = 壓衊選齋願艱築願遞蓋築獵顧窪鑰廠糧獵憲範 (齋積廠鹽顧醖鑰糧鑰憲, 築窪糧淵願遞積鹹築壓 ~ 糧網壓鏇齋鹽襯齋夢繭) 更多