排名前五的靶点	数量

5-HT1A receptor(5-羟色胺1A受体)	2
BRAF(丝氨酸/苏氨酸蛋白激酶B-raf)	1
β-adrenoceptors(β-肾上腺素能受体家族)	1
c-Met(肝细胞生长因子受体)	1
β3-adrenergic receptor(β3-肾上腺素能受体)	1

关联

项与 Pierre Fabre SA 相关的药物

Vibegron

维贝格龙

靶点

β3-adrenergic receptor

作用机制

β3-adrenergic receptor激动剂

在研机构

Urovant Sciences Ltd. [+8]

原研机构

Merck & Co., Inc.

在研适应症

膀胱过度活动症综合征 [+5]

非在研适应症

内分泌系统疾病 [+3]

最高研发阶段批准上市

首次获批国家/地区

日本

首次获批日期2018-09-21

Encorafenib

恩可非尼

靶点

BRAF

作用机制

BRAF抑制剂

在研机构

Pfizer Inc. [+9]

原研机构

Array BioPharma, Inc.

在研适应症

BRAF突变的甲状腺未分化癌 [+24]

非在研适应症

BRAF V600 突变胶质母细胞瘤 [+5]

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2018-06-27

Binimetinib

贝美替尼

靶点

MEK1 x MEK2

作用机制

MEK1抑制剂 [+1]

在研机构

Pierre Fabre Médicament SAS [+10]

原研机构

Array BioPharma, Inc.

在研适应症

BRAF突变的甲状腺未分化癌 [+32]

非在研适应症

急性髓性白血病 [+33]

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2018-06-27

127

项与 Pierre Fabre SA 相关的临床试验

EUCTR2006-006947-30-FR / Not yet recruiting临床3期

EFFICACY STUDY OF THE ANTIHISTAMINE V0114 CP 2.5MG TABLETIN THE TREATMENT OF SEASONAL ALLERGIC RHINITIS. A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

开始日期2077-04-05

申办/合作机构

Pierre Fabre Médicament SAS

NCT06578559 / Recruiting临床2期IIT

Single Arm Phase II Study of ctDNA-guided Encorafenib Plus Cetuximab Retreatment in Patients With BRAF V600E Mutated mCRC (BRICKET)

The aim of this study is to evaluate the activity, in terms of best response according to RECIST criteria 1.1 as assessed by the local investigator, of the ctDNA-guided retreatment with encorafenib plus cetuximab in BRAFV600E mutated mCRC patients experiencing benefit from previous exposure to encorafenib plus cetuximab (+/- chemotherapy) and with BRAFV600E mutated, KRAS, NRAS and MAP2K1 wild-type and MET not amplified status on ctDNA at the time of study entry.

开始日期2024-07-23

申办/合作机构

Gruppo Oncologico del Nord-Ovest

[+2]

NCT05810740 / Completed临床1期

A Randomized, Single-center, Open-label, Single Dose, Two-period, Crossover Pivotal Bioequivalence Study Comparing Binimetinib 3 x 15 mg and 45 mg Tablets in Healthy Participants

The current commercially available MEKTOVI® (binimetinib) 15 mg tablets are provided as immediate release film-coated tablets for oral administration. For the treatment of adult patients with unresectable or metastatic melanoma with BRAF V600 mutation, the recommended dosing regimen is 45 mg twice daily (bis in die, BID). No food effect with the commercial formulation of 15 mg was demonstrated. In order to reduce the patient's burden, a new strength tablet containing 45 mg of binimetinib as active ingredient is being developed. As a result, the number of tablets to be taken by the patients will be reduced from 6 tablets (6 x 15 mg) to 2 tablets (2 x 45 mg) per day. The evaluation of the bioequivalence between one 45 mg tablet and three 15 mg tablets is therefore required.

开始日期2022-08-31

申办/合作机构

Pierre Fabre Médicament SAS

[+1]

100 项与 Pierre Fabre SA 相关的临床结果

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0 项与 Pierre Fabre SA 相关的专利（医药）

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116

项与 Pierre Fabre SA 相关的文献（医药）

2024-05-02·Cancer Research

Abstract PO4-17-01: Patient Perception and Decision-Making in HER2+ Early Breast Cancer Management: Insights from the ASKHER2 European Survey

作者: Berjonneau, Erwan ; Krone, Eugenia ; Brice, Miriam ; Matos, Soraia ; Jackisch, Christian ; Dialla, Olivia ; Guéroult-Accolas, Laure ; D’Antona, Rosanna ; Fontes-Sousa, Mário ; Ruz, Marcelo ; Lambertini, Matteo ; Vidal, Maria ; Valachis, Antonios ; Trédan, Olivier

AbstractBackgroundBreast cancer remains the most prevalent cancer in women globally, with Human Epidermal Growth Factor Receptor 2 positivity (HER2+) observed in 15-30% of initial breast cancer cases. Adjuvant treatment for HER2+ early breast cancer has notably reduced mortality and recurrence rates. However, the heterogeneity of the disease and in conveying risk information by healthcare providers (HCPs) leaves many women uncertain about their individual risk of recurrence and potential treatment (tx) options. Evidence shows that fear of recurrence, uncertainty about prognosis, and inadequate risk/benefit information can affect patients' decisions during their tx phase. Therefore, it is important to better understand the perceptions, attitudes, and behaviors regarding the risk of recurrence in women with HER2+ early breast cancer.MethodsA protocol-driven, direct-to-patient online survey (30 questions total) was administered in France, Germany, Italy, Portugal, Spain, and Sweden via patient advocacy groups and panels. Women aged 18 years and above with either early-stage (eBC) (stages I-III) or metastatic (mBC) (stage IV) as the result of recurrence from an initial diagnosis of locally advanced HER2+ breast cancer were eligible to participate. The implementation of soft quotas ensured a representative sample size. This abstract presents the results of the survey.ResultsA total of 622 participants completed the survey between July 2022 and February 2023. Majority of participants (70%) were between 40 and 65 years of age. Almost 85% had eBC (N=527), 62% had been diagnosed with HER2+ eBC for ≥ 2 years, and 68% were undergoing breast cancer tx at the time of the survey.The main worries and concerns that were reported by participants when asked about their tx plan were risk of recurrence (27%), fear of dying (22%) and risk of tx failure (14%). Among eBC participants, 40% perceived their personal risk of recurrence to be moderate, 18% perceived it to be high, while 21% did not know their personal risk. Most eBC participants (72%) preferred short and simple explanations from the medical team about the risk of cancer recurrence, while 4% preferred not to receive this information. Overall, 30% of participants said they had fully discussed the risk of recurrence with their doctor, while 20% had no discussion. Almost all participants (97%) wanted to be involved in their tx decision, 49% completely and 48% partially. To reduce this risk of recurrence, participants with eBC were willing to change their diet habits (77%), exercise more frequently (74%), take additional tx (65%) or undergo surgery (60%). Most participants (69%) were willing to take additional tx even if it would reduce their risk of recurrence by less than 50%. Participants were most willing to tolerate fatigue (53%), followed by hot flashes (51%) and joint pain (44%), as the most acceptable side effects if they had to take additional treatments with the potential benefit of reducing risk of recurrence.ConclusionThe multinational large direct-to-patient ASKHER2 survey reflects participants’ experience and highlights concerns of patients with HER2+ breast cancer, notably on their recurrence risk. To mitigate this risk, patients exhibited a willingness to modify lifestyle habits and consider additional tx. A fraction of participants considered they had thoroughly discussed these risks with their HCPs, while the vast majority desired active involvement in their treatment decisions. These results underscore the ongoing need for HCPs to discuss the risk of recurrence in a clear way, addressing the full potential of treatment options in eBC and mBC, to enable patients to participate in this patient-centered approach of the decision-making process.Citation Format: Matteo Lambertini, Christian Jackisch, Olivier Trédan, Maria Vidal, Mário Fontes-Sousa, Antonios Valachis, Rosanna D’Antona, Marcelo Ruz, Eugenia Krone, Miriam Brice, Erwan Berjonneau, Soraia Matos, Olivia Dialla, Laure Guéroult-Accolas. Patient Perception and Decision-Making in HER2+ Early Breast Cancer Management: Insights from the ASKHER2 European Survey [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-17-01.

2023-12-31·mAbs

Effects of the COVID-19 pandemic: new approaches for accelerated delivery of gene to first-in-human CMC data for recombinant proteins

作者: Souquet, Jonathan ; Beck, Alain ; Broly, Hervé

2023-08-01·Proteomics

Advanced mass spectrometry workflows for accurate quantification of trace-level host cell proteins in drug products: Benefits of FAIMS separation and gas-phase fractionation DIA.

Article

作者: Carapito, Christine ; Hernandez-Alba, Oscar ; Beaumal, Corentin ; Beck, Alain

Therapeutic monoclonal antibodies (mAb) production relies on multiple purification steps before release as a drug product (DP). A few host cell proteins (HCPs) may co-purify with the mAb. Their monitoring is crucial due to the considerable risk they represent for mAb stability, integrity, and efficacy and their potential immunogenicity. Enzyme-linked immunosorbent assays (ELISA) commonly used for global HCP monitoring present limitations in terms of identification and quantification of individual HCPs. Therefore, liquid chromatography tandem mass spectrometry (LC-MS/MS) has emerged as a promising alternative. Challenging DP samples show an extreme dynamic range requiring high performing methods to detect and reliably quantify trace-level HCPs. Here, we investigated the benefits of adding high-field asymmetric ion mobility spectrometry (FAIMS) separation and gas phase fractionation (GPF) prior to data independent acquisition (DIA). FAIMS LC-MS/MS analysis allowed the identification of 221 HCPs among which 158 were reliably quantified for a global amount of 880 ng/mg of NIST mAb Reference Material. Our methods have also been successfully applied to two FDA/EMA approved DPs and allowed digging deeper into the HCP landscape with the identification and quantification of a few tens of HCPs with sensitivity down to the sub-ng/mg of mAb level.

项与 Pierre Fabre SA 相关的新闻（医药）

2024-10-26

·美通社

Pierre Fabre宣布在PFL-002/VERT-002的I/II期首次给药，这是一种MET改变的NSCLC靶向治疗

PFL-002/VERT-002是一种具有新型分化作用机制的单克隆抗体，可作为c-MET的降解剂，有可能成为由MET改变驱动的癌症的同类最佳治疗方法 2024年10月24日-- Pierre Fabre Laboratories今天宣布，在针对非小细胞肺癌(NSCLC)患者的I/II期首次剂量递增、剂量优化和剂量扩展试验中，首例患者已接受PFL-002/VERT-002给药，这是一种作为c-MET降解剂的单克隆抗体。 PFL-002/VERT-002 I/II期临床试验是一项开放标签、多中心研究，旨在评估PFL-002/VERT-002作为MET依赖性肿瘤患者单药治疗的安全性、耐受性、药代动力学、药效学和初步临床疗效，包括对其他治疗有获得性耐药的新发患者。非小细胞肺癌（ NSCLC ）是最常见的肺癌形式，约占新诊断肺癌病例的85 ％， MET （也称为肝细胞生长因子受体（ HGFR ））是NSCLC患者亚群中的癌基因驱动因素。 1-4 MET外显子14跳跃突变和MET扩增被发现是主要的致癌驱动因素， MET扩增是选定靶向治疗的耐药机制。 “PFL-002/VERT-002针对具有独特和差异化作用机制的临床验证致癌驱动因素，引发c-MET致癌基因的退化。因此，它为测试MET驱动肿瘤患者的新型治疗方法提供了机会。我们期待与参与首次人体试验的研究人员合作，评估这种新药的安全性和有效性。” Pierre Fabre Laboratories医疗研发开发主管 Francesco Hofmann说。内容来源于网络，如有侵权，请联系删除。

临床研究

2024-10-24

·PipelineReview

Pierre Fabre announce 1st Patient Dosed in Phase I/II of PFL-002/VERT-002, a targeted therapy in NSCLC with MET Alterations

PFL-002/VERT-002 is a monoclonal antibody with a novel and differentiated mechanism of action, acting as a degrader of c-MET, with the potential to be a best-in-class treatment for cancer driven by MET alterations CASTRES, France I October 24, 2024 I Pierre Fabre Laboratories announced today that the first patient has been dosed with PFL-002/VERT-002, a monoclonal antibody acting as a degrader of c-MET, in a phase I/II first-in-human dose-escalation, dose-optimization and dose-expansion trial, for patients with Non-Small Cell Lung Cancer (NSCLC) harbouring MET alterations. Pierre Fabre Laboratories Announce First Patient Dosed in Phase I/II Clinical Trial of PFL-002/VERT-002, an Innovative Targeted Therapy Intended to Treat NonSmall Cell Lung Cancer with MET Alterations The PFL-002/VERT-002 phase I/II trial is an open label, multi-centre study that aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of PFL-002/VERT-002, as a monotherapy for patients with MET-dependent tumors, including those emerging with acquired resistance to other treatments. Non-small cell lung cancer (NSCLC) is the most prevalent form of lung cancer, accounting for approximately 85% of newly diagnosed lung cancer cases, and MET, also known as hepatocyte growth factor receptor (HGFR), is an oncogene driver in subsets of patients suffering from NSCLC. 1-4 MET exon 14 skipping mutation and MET amplification are found as primary oncogenic drivers and MET amplification as a resistance mechanism to selected targeted therapies. “PFL-002/VERT-002 targets a clinically validated oncogenic driver with a unique and differentiated mechanism of action, triggering the degradation of the c-MET oncogene. Thus, it provides the opportunity to test a novel therapeutic approach for patients with MET driven tumors. We are looking forward to collaborating with the investigators participating in the first-in-human trial to assess the safety and efficacy of this new agent.” said Francesco Hofmann, Head of Research and Development for Medical Care at Pierre Fabre Laboratories. SOURCE: Pierre Fabre

临床研究

2024-10-09

·美通社

Pierre Fabre Laboratories和Scorpion Therapeutics宣布，在针对局部晚期或转移性非小细胞肺癌的突变选择性抑制剂PFL-241/STX-241的I/II期临床试验中，首位患者已接受给药

PFL-241/STX-241是一种高选择性的第四代表皮生长因子受体（EGFR）抑制剂，有潜力成为同类产品中的佼佼者这是Scorpion Therapeutics正在开发的两个EGFR项目之一法国卡斯特尔和波士顿 2024年10月9日 /美通社/ -- 在肿瘤学领域具有全球影响力的Pierre Fabre Laboratories，以及致力于通过重新定义精准医学的前沿来改善癌症患者生活的创新临床阶段肿瘤学公司Scorpion Therapeutics, Inc.（简称“Scorpion”），今天宣布，在一项Ⅰ/Ⅱ期、首次人体剂量递增、剂量优化和剂量扩展试验中，首位患者已经开始接受给药。该临床试验评估了PFL-241/STX-241，这是一种高度分化、口服生物利用度高、高选择性的酪氨酸激酶抑制剂（TKI），靶向表皮生长因子受体（EGFR）外显子19或21突变以及共存的C797S突变，C797S是一种已知的对第三代EGFR抑制剂的耐药机制。 PFL-241/STX-241的Ⅰ/Ⅱ期临床试验是一项开放标签、多中心的研究，旨在评估PFL-241/STX-241作为单药治疗在局部晚期或转移性非小细胞肺癌（NSCLC）患者中的安全性、耐受性、药代动力学（PK）、药效学（PD）以及初步的临床疗效，这些患者带有EGFR外显子19或21的突变，并且存在共发的C797S突变。 NSCLC是最常见的肺癌形式，EGFR突变是其最常见的疾病驱动因素之一，其发生率可高达38%，具体取决于地理位置 1、2、3 。 “我们非常期待开始对PFL-241/STX-241进行临床评估，这是我们的突变选择性第四代EGFR抑制剂，一个具有独特特性的分子，我们相信它有潜力成为对现有靶向治疗产生耐药性的患者的最佳治疗选择。” Pierre Fabre Laboratories医疗护理研究和开发部门负责人Francesco Hofmann表示。 “这项临床试验的启动彰显了我们团队与Scorpion Therapeutics之间坚实的合作伙伴关系，以及我们在其中的积极参与和执行力度。我们期待展示这种靶向治疗如何为患者带来潜在的益处。” PDF： https://mma.prnewswire.com/media/2525480/Pierre_Fabre_Laboratories.pdf Pierre Fabre Laboratories媒体联系人： Laure Bregeon-Sgandurra Pierre Fabre Laboratories Laure.sgandurra@pierre-fabre.com Scorpion Therapeutics联系人：媒体联系人： Ethan Metelenis Precision AQ ethan.metelenis@precisionaq.com 投资者联系人： Emiley Demick Precision AQ emiley.demick@precisionaq.com

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