更新于：2024-12-26

Roginolisib

更新于：2024-12-26

概要

研发状态

概要

基本信息

药物类型

小分子化药

别名

[6-Fluoro-1-(4-morpholin-4-ylmethyl-phenyl)-5,5-dioxo-4,5-dihydro-1H-5Lambda6-thiochromeno[4,3-c]pyrazol-3-yl]-morpholin-4-yl-methanone hemi-fumarate、Roginolisob、IOA 244

+ [3]

靶点

PI3Kδ

作用机制

PI3Kδ抑制剂(磷脂酰肌醇-3激酶δ抑制剂)

治疗领域

肿瘤血液及淋巴系统疾病免疫系统疾病+ [4]

在研适应症

葡萄膜黑色素瘤慢性淋巴细胞白血病非小细胞肺癌+ [6]

非在研适应症-

原研机构

iOnctura SA初创企业

在研机构

iOnctura SA初创企业

非在研机构-

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评孤儿药 (欧盟)、孤儿药 (美国)

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结构

分子式C26H27FN4O5S

InChIKeyNFHSJYKXENYICE-UHFFFAOYSA-N

CAS号1305267-37-1

关联

项与 Roginolisib 相关的临床试验

NCT06644183 / Not yet recruiting临床1/2期IIT

A Phase 1/2, Open Label, Study of Roginolisib (IOA-244), an Orally Bioavailable, Selective PI3Kδ Inhibitor in Patients With Refractory/Relapsed Chronic Lymphocytic Leukemia (CLL) in Combination With Venetoclax and Rituximab

This research study will test the safety and anticancer activity of the combination of three drugs (Roginolisib, Venetoclax, and Rituximab) for participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL).
The names of the study drugs involved in this study are:
* Roginolisib (a novel type of PI3-kinase delta inhibitor)
* Venetoclax (a type of B-cell lymphoma 2 inhibitor)
* Rituximab (a type of monoclonal antibody)

开始日期2025-04-01

申办/合作机构

Dana-Farber Cancer Institute, Inc.

[+1]

ISRCTN28449692 / Recruiting临床2期

A phase II, multi-centre, open-label, randomised study to evaluate the anti-tumour activity of roginolisib in patients with advanced/metastatic ocular/uveal melanoma

开始日期2024-12-02

申办/合作机构

iOnctura SA初创企业

NCT06717126 / Not yet recruiting临床2期

A Phase II, Multi-centre, Open Label, Randomised Study to Evaluate the Anti-tumour Activity of Roginolisib in Patients with Advanced/Metastatic Ocular/Uveal Melanoma

The goal of this clinical trial is to learn how roginolisib works in comparison to standard treatment in adulty patients with uveal/ocular melanoma. The main questions it aims to answer are:
Does roginolisib extend overall survival compared to standard treatment? How does dosing of roginolisib impact quality of life compared to standard treatment?

开始日期2024-12-01

申办/合作机构

iOnctura SA初创企业

100 项与 Roginolisib 相关的临床结果

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100 项与 Roginolisib 相关的转化医学

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100 项与 Roginolisib 相关的专利（医药）

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项与 Roginolisib 相关的文献（医药）

2024-05-01·Translational oncology

The highly selective and oral phosphoinositide 3-kinase delta (PI3K-δ) inhibitor roginolisib induces apoptosis in mesothelioma cells and increases immune effector cell composition

Article

作者: Falkenstern-Ge, Roger ; Conza, Giusy Di ; Lahn, Michael ; Kalla, Claudia ; Riganti, Chiara ; Niewola-Staszkowska, Karolina ; Finotello, Francesca ; Ott, German ; van der Veen, Lars ; Schüler, Julia ; Kopecka, Joanna

2023-12-01·Journal of Taibah University Medical Sciences

Molecular properties and In silico bioactivity evaluation of (4-fluorophenyl)[5)-3-phen-(4-nitrophenyl yl-4,5-dihydro-1H-pyrazol-1-yl]methanone derivatives: DFT and molecular docking approaches

Article

作者: Ayobami, Odunola O ; Banjo, Semire ; Felix, Latona D ; Kolawole, Oyebamiji A ; Omotayo, Ibrahim A ; Olasegun, Abdulsalami I ; Emmanuel, Oladuji T ; Dasola, Adeoye M ; Dele, Owonikoko A

2023-12-01·International journal of toxicology

Non-Clinical Toxicology Evaluation of the Novel Non-ATP Competitive Oral PI3 Kinase Delta Inhibitor Roginolisib

Article

作者: Deken, Marcel A. ; Lahn, Michael ; van der Veen, Lars ; Schmitt, Michael

项与 Roginolisib 相关的新闻（医药）

2024-12-11

·PRNewswire

iOnctura reaches new clinical milestones in uveal melanoma

Completed Phase I DIONE-01 study demonstrates clinical activity and long-term safety of roginolisib, a unique allosteric modulator of PI3Kδ Patients with uveal melanoma showed a doubling of overall survival compared to historical controls Site activation ongoing for randomized Phase II OCULE-01 study in uveal melanoma GENEVA and AMSTERDAM, Dec. 11, 2024 /PRNewswire/ -- iOnctura, a clinical-stage biopharmaceutical company combating neglected and hard-to-treat cancers, today provides a clinical update on its lead asset, roginolisib. Results from the completed Phase I DIONE-01 study are due to be presented at the European Society for Medical Oncology Immuno-Oncology (ESMO-IO) annual congress tomorrow, 12 December at 12:30 CET (presentation 164P). Allosteric modulator of PI3Kδ, roginolisib, has a unique chemical structure and binding mechanism which makes it highly specific for PI3Kδ, giving it an advantageous pharmacology profile and an unprecedented safety profile compared to previous generations of PI3Kδ inhibitors. Roginolisib is being investigated in solid and hematological malignancies including uveal melanoma (UM), a rare cancer of the eye. Eye melanoma is a rapidly growing market which is projected to be worth USD 9.56B by 2032[1]. The two-part Phase I study DIONE-01, firstly evaluated continuous daily dosing of roginolisib [at 10, 20, 40 and 80 mg] in 24 patients with pretreated solid tumors and follicular lymphoma (FL), and secondly evaluated a dose confirmation cohort in 20 UM patients. Results from DIONE-01 show: Study met its primary objective to determine the safety of the anticipated optimal biologically effective dose (BED): Roginolisib was well tolerated at the recommended Phase II dose (RP2D) of 80mg, with <7% Grade 3/4 treatment-emergent adverse events (TEAEs) considered to be related to roginolisib. TEAEs did not result in immune-related toxicity, or dose-limiting toxicity, in either solid tumor or hematological patients. In contrast to prior PI3Kδ inhibitors, roginolisib dosing did not require dose modifications. Roginolisib is well tolerated over long periods of treatment, up to 4.5 years. Median overall survival (OS) was 16 months for the 29 patients with UM treated with roginolisib, who had previously received a median of two prior therapies. This exceeds the median OS of 7 months observed in historical controls in patients receiving immunotherapies as second line treatment[2]. Median progression free survival (PFS) was 5 months for patients treated with roginolisib versus less than 3 months for historical controls2. Clinical findings validate the mechanism of action of roginolisib: roginolisib reduces immune-suppressive immune cells and chemokines, UM-related tumor clones (ctDNA) and PI3K-related signaling indicating a rebalancing of the immune system. Catherine Pickering, Chief Executive Officer of iOnctura, said: "The Phase I DIONE-01 data highlight the benefits of roginolisib for patients with uveal melanoma and advanced cancers. Roginolisib's unique allosteric binding mechanism has translated into a differentiated beneficial clinical profile, including a doubling of overall survival compared to historical controls in uveal melanoma. We are delighted to announce these data support progression of roginolisib into a randomized Phase II study." Professor Michele Maio, University of Siena and Principal Investigator of the roginolisib studies, added: "Being able to continue to investigate roginolisib in a randomized Phase II study is a positive step to understand more about this already well tolerated molecule. Roginolisib has given prolonged disease stabilization to patients with uveal melanoma who have exhausted all other therapeutic options. So far, these patients have maintained a good quality of life without major limitations. I'm looking forward to seeing what the Phase II trial delivers over the coming months." Activation of trial sites for the Phase II OCULE-01 study (NCT06717126) investigating roginolisib versus investigator's choice in the second-line+ treatment of uveal melanoma is ongoing. About iOnctura iOnctura is a clinical-stage biopharmaceutical company combating neglected and hard-to-treat cancers with precision oral small molecules that target cancers in novel ways. The bold new treatments extend lives and improve healthspans, changing the outlook for patients and their families. Two therapeutic candidates have progressed into mid-stage clinical development: roginolisib is the first allosteric modulator of PI3Kδ; and cambritaxestat is the only autotaxin inhibitor in clinical development to treat cancer. iOnctura BV is headquartered in Amsterdam, The Netherlands with its wholly owned Swiss subsidiary, iOnctura SA, located in Geneva, Switzerland. iOnctura is backed by specialist institutional investors including Syncona, EIC Fund, M Ventures, Inkef Capital, VI Partners and Schroders Capital. About roginolisib Roginolisib is an allosteric modulator of PI3Kδ with a unique chemical structure and binding mode. The PI3K signaling pathway is one of the most commonly dysregulated pathways in cancer and the precise targeting of the PI3Kδ isoform delivers substantial anti-tumor effects with a low-toxicity profile. Clinical data have demonstrated roginolisib's excellent safety profile and sustained clinical activity in uveal melanoma (UM), a rare eye cancer with few available treatments. Site activation for the randomized Phase II OCULE-01 study in uveal melanoma is ongoing, and Phase II studies in other cancers, including non-small cell lung cancer and myelofibrosis, are in planning. [1] Emergen Research, Jan 2024 [2] Rantala et al., Melanoma Res., 2019 Dec 29(6):561-568 SOURCE iOnctura WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床1期临床2期临床结果免疫疗法

2024-11-28

·PRNewswire

Follicular Lymphoma Clinical Trial Pipeline Appears Robust With 50+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight

Advances in immunotherapy have ushered in a new era of treatment for follicular lymphoma (FL), particularly for patients who have experienced relapse after conventional chemotherapy regimens. This paradigm shift is characterized by the emergence of innovative therapies like CAR T-cell therapy and bispecific antibodies, which have demonstrated remarkable efficacy in targeting and eradicating lymphoma cells. CAR T-cell therapy represents a groundbreaking approach where a patient's own T-cells are genetically engineered to recognize and attack cancer cells. This personalized treatment has shown significant promise, especially for individuals who have undergone extensive previous therapies. One notable example is Axicabtagene ciloleucel (Yescarta), a CAR T-cell therapy approved for use in patients with relapsed or refractory follicular lymphoma. Clinical trials have highlighted its ability to induce durable remissions, with some patients experiencing long-term remission even after multiple prior therapies. LAS VEGAS, Nov. 28, 2024 /PRNewswire/ -- DelveInsight's ' Follicular Lymphoma Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline follicular lymphoma therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the follicular lymphoma pipeline domain. Key Takeaways from the Follicular Lymphoma Pipeline Report DelveInsight's follicular lymphoma pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline therapies for follicular lymphoma treatment. Key follicular lymphoma companies such as Chia Tai Tianqing Pharmaceutical Group, Incyte Corporation, Mabworks, Johnson & Johnson Innovative Medicine, Nektar Therapeutics, Xynomic Pharmaceuticals, Merck Sharp & Dohme, Jiangsu HengRui Medicine Co., Ltd., ADC Therapeutics, Bristol-Myers Squibb, Swedish Orphan Biovitrum, Zhejiang DTRM Biopharma, Immpact Bio, Galapagos, Immunitas Therapeutics, Enterome, CRISPR Therapeutics, CHO Pharma, Shanghai Blueray Biopharma, BeiGene, AstraZeneca, AVM Biotechnology, Mustang Bio, Merck, Pell Bio-Med Technology, Schrodinger Inc., Sana Biotechnology, Poseida Therapeutics, OncoNano Medicine, Inc., Nurix Therapeutics, Inc., NovalGen, Pfizer, Xencor, Wellington Zhaotai Therapies, MEI Pharma, Sutro Biopharma, Synthekine, Verismo Therapeutics, Vincerx Pharma, Novartis, Century Therapeutics, Newave Pharmaceuticals, Bio-Path Holdings, Affimed GmbH, Iksuda Therapeutics, Allogene Therapeutics, Adicet Bio, Carna Biosciences, Inc., BeiGene, Boryung Pharmaceutical, Accutar Biotechnology, Atara Biotherapeutics, AbbVie, InnoCare Pharma, NeoImmuneTech, and others are evaluating new follicular lymphoma drugs to improve the treatment landscape. Promising follicular lymphoma pipeline therapies such as Parsaclisib, TQ-B3525, Tafasitamab, MIL62, Ibrutinib, AZD0486, NKTR-255, Abexinostat, Acalabrutinib, Zilovertamab vedotin, SHR2554, Nivolumab, Loncastuximab tesirine, Golcadomide, Emapalumab, DTRM-555, Capivasertib, IMPT 314, GLPG5101, IMT-009, EO2463, CTX112, CHO-H01, BR1733, BGB-16673, BGB-10188, AZD5492, AVM0703, MB106, MK-1026, PL001, SGR-1505, SC291, SC262, P-CD19CD20-ALLO1, ONM 501, NX-5948, NX 2127, NVG-111, Mevrometostat, Plamotamab, WZTL-002, Voruciclib, STRO001, SYNCAR-001 + STK-009, SynKIR-310, VIP-152, VAY736, CNTY-101, LP-168, BP1002, IOA-244, IKS 03, ALLO-501, ADI-001, AS-1763, BGB-21447, BR101801, AC676, ATA3219, ABBV-319, ABBV-101, ICP-B02, ICP-B05, C-CAR039, Efineptakin Alfa, and others are under different phases of follicular lymphoma clinical trials. In August 2024, the company expects to file a supplemental Biologics License Application for tafasitamab for the treatment of patients with FL who have failed at least one prior systemic anti-CD20 immunotherapy or chemo-immunotherapy by the end of 2024 based on the positive Phase III results. In June 2024, a consortium of Eugene Private Equity and Korea Development Bank Private Equity announced that they would acquire 80% of South Korean vaccine maker Boryung Biopharma Co. for 320 billion won (USD 231 million). In February 2024, Incyte announced that it had entered into an asset purchase agreement with MorphoSys AG, which gives Incyte exclusive global rights for tafasitamab. Incyte will now recognize revenue and cost for all US commercialization and clinical development and MorphoSys will no longer be eligible to receive future milestone, profit split and royalty payments. In September 2023, OncoNano Medicine, Inc. announced a clinical trial supply agreement with Regeneron for the use of Libtayo (cemiplimab), a PD-1 inhibitor, in the combination stage of the first human trial of ONM-501, a dual-activating STING (STimulator of INterferon Genes) agonist and lead therapeutic development candidate. The ONM-501 first-in-human trial is a multicenter Phase Ia/b dose escalation and dose expansion study of intratumoral ONM-501 as monotherapy and in combination with Libtayo in patients with advanced solid tumors and lymphomas. OncoNano is the sponsor of the clinical trial, and Regeneron will supply cemiplimab. In May 2023, Janssen Pharmaceutical Companies of Johnson & Johnson announced that it had entered into a worldwide collaboration and license agreement with Cellular Biomedicine Group Inc. (CBMG) to develop, manufacture, and commercialize next-generation chimeric antigen receptor (CAR) T-cell therapies for the treatment of B-cell malignancies. Under the terms of the agreement, CBMG will grant Janssen a worldwide license to develop and commercialize the CAR-T assets, except in Greater China. Janssen and CBMG will negotiate an option for Janssen to commercialize the products in the Chinese territory. Janssen will make an upfront payment of USD 245 million that will be accounted for in the second quarter as a research and development expense. Additional future payments will be based upon achieving certain development, regulatory, and sales milestones, as well as tiered royalty payments on worldwide net trade sales, excluding Greater China. Request a sample and discover the recent advances in follicular lymphoma treatment drugs @ Follicular Lymphoma Pipeline Report The follicular lymphoma pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage follicular lymphoma drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the follicular lymphoma clinical trial landscape. Follicular Lymphoma Overview Follicular lymphoma is a common type of non-Hodgkin lymphoma (NHL) that originates from B-cells, a kind of white blood cell responsible for producing antibodies. This cancer is characterized by the growth of abnormal lymphoid follicles, which can disrupt normal lymphatic function. While the exact causes of follicular lymphoma are not fully understood, certain factors may increase the risk, including age (most commonly affecting adults over 60), a family history of lymphoma, and potential environmental factors such as exposure to pesticides or chemicals. Symptoms of follicular lymphoma can vary widely but may include painless swelling of lymph nodes in the neck, armpit, or groin, unexplained weight loss, night sweats, fatigue, and fever. Some patients may remain asymptomatic for extended periods, as this type of lymphoma can progress slowly. Diagnosis typically involves a combination of physical examinations, blood tests, imaging studies (like CT scans), and a biopsy of affected lymph nodes. The biopsy helps determine the subtype and stage of the lymphoma, which is crucial for planning treatment. Treatment for follicular lymphoma depends on the stage of the disease and the patient's overall health. Options may include watchful waiting for asymptomatic cases, chemotherapy, immunotherapy (such as monoclonal antibodies), and targeted therapies. In some cases, stem cell transplants may be considered for patients with more aggressive forms or those who do not respond to initial treatments. Given the indolent nature of follicular lymphoma, ongoing management, and regular monitoring are vital for achieving the best possible outcomes. Find out more about follicular lymphoma treatment drugs @ Drugs for Follicular Lymphoma Treatment A snapshot of the Follicular Lymphoma Pipeline Drugs mentioned in the report: Learn more about the emerging follicular lymphoma pipeline therapies @ Follicular Lymphoma Clinical Trials Follicular Lymphoma Therapeutics Assessment The follicular lymphoma pipeline report proffers an integral view of the follicular lymphoma emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Follicular Lymphoma Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Intra-articular, Intraocular, Intrathecal, Intravenous, Oral, Parenteral, Subcutaneous, Topical, Transdermal Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule Therapeutics Assessment By Mechanism of Action: Phosphatidylinositol 3 kinase delta inhibitors, Phosphatidylinositol 3 kinase gamma inhibitors, Emt protein-tyrosine kinase inhibitors, Interleukin 15 receptor agonists, Histone deacetylase inhibitors, Rad51 recombinase inhibitors, Agammaglobulinaemia tyrosine kinase inhibitors, Apoptosis stimulants, Cell cycle inhibitors, Tubulin inhibitors, Tubulin polymerisation inhibitors, Enhancer of zeste homolog 2 protein inhibitors, Antibody-dependent cell cytotoxicity, Programmed cell death 1 receptor antagonists, T lymphocyte stimulants, Alkylating agents, DNA cross-linking agents Key Follicular Lymphoma Companies: Chia Tai Tianqing Pharmaceutical Group, Incyte Corporation, Mabworks, Johnson & Johnson Innovative Medicine, Nektar Therapeutics, Xynomic Pharmaceuticals, Merck Sharp & Dohme, Jiangsu HengRui Medicine Co., Ltd., ADC Therapeutics, Bristol-Myers Squibb, Swedish Orphan Biovitrum, Zhejiang DTRM Biopharma, Immpact Bio, Galapagos, Immunitas Therapeutics, Enterome, CRISPR Therapeutics, CHO Pharma, Shanghai Blueray Biopharma, BeiGene, AstraZeneca, AVM Biotechnology, Mustang Bio, Merck, Pell Bio-Med Technology, Schrodinger Inc., Sana Biotechnology, Poseida Therapeutics, OncoNano Medicine, Inc., Nurix Therapeutics, Inc., NovalGen, Pfizer, Xencor, Wellington Zhaotai Therapies, MEI Pharma, Sutro Biopharma, Synthekine, Verismo Therapeutics, Vincerx Pharma, Novartis, Century Therapeutics, Newave Pharmaceuticals, Bio-Path Holdings, Affimed GmbH, Iksuda Therapeutics, Allogene Therapeutics, Adicet Bio, Carna Biosciences, Inc., BeiGene, Boryung Pharmaceutical, Accutar Biotechnology, Atara Biotherapeutics, AbbVie, InnoCare Pharma, NeoImmuneTech, and others. Key Follicular Lymphoma Pipeline Therapies: Parsaclisib, TQ-B3525, Tafasitamab, MIL62, Ibrutinib, AZD0486, NKTR-255, Abexinostat, Acalabrutinib, Zilovertamab vedotin, SHR2554, Nivolumab, Loncastuximab tesirine, Golcadomide, Emapalumab, DTRM-555, Capivasertib, IMPT 314, GLPG5101, IMT-009, EO2463, CTX112, CHO-H01, BR1733, BGB-16673, BGB-10188, AZD5492, AVM0703, MB106, MK-1026, PL001, SGR-1505, SC291, SC262, P-CD19CD20-ALLO1, ONM 501, NX-5948, NX 2127, NVG-111, Mevrometostat, Plamotamab, WZTL-002, Voruciclib, STRO001, SYNCAR-001 + STK-009, SynKIR-310, VIP-152, VAY736, CNTY-101, LP-168, BP1002, IOA-244, IKS 03, ALLO-501, ADI-001, AS-1763, BGB-21447, BR101801, AC676, ATA3219, ABBV-319, ABBV-101, ICP-B02, ICP-B05, C-CAR039, Efineptakin Alfa, and others. Dive deep into rich insights for new drugs for follicular lymphoma treatment, visit @ Follicular Lymphoma Drugs Table of Contents For further information on the follicular lymphoma pipeline therapeutics, reach out @ Follicular Lymphoma Treatment Drugs Related Reports Follicular Lymphoma Market Follicular Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key follicular lymphoma companies including Epizyme, Eisai, Bayer Healthcare Pharmaceuticals, Verastem Oncology, Gilead Sciences, TG Therapeutics, Bristol-Myers-Squibb, Roche, Incyte Corporation, Bristol Myers Squibb, ADC Therapeutics, MorphoSys, Nordic Nanovector, AbbVie, Regeneron Pharmaceuticals, Janssen Research & Development, Novartis, MEI Pharma, and BeiGene, among others. Non-Hodgkin Lymphoma Market Non-Hodgkin Lymphoma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key Non-Hodgkin lymphoma companies, including Roche, Pfizer, Amgen, Novartis, Teva Pharmaceuticals, Genentech, ACD Therapeutics, among others. Non-Hodgkin Lymphoma Pipeline Non-Hodgkin Lymphoma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Non-Hodgkin lymphoma companies, including Novartis, AstraZeneca, Genentech, BioInvent, Genmab, SystImmune, Nordic Nanovector, Pacylex Pharmaceuticals, Artiva Biotherapeutics, Inc., Chipscreen Biosciences, Ltd., Timmune Biotech Inc., Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Gilead Sciences, Acerta Pharma BV, Adagene Inc, Conjupro Biotherapeutics, Inc., Rhizen Pharmaceuticals, Juventas Cell Therapy Ltd., Incyte Corporation, HUYA Bioscience International, SecuraBio, Genor Biopharma Co., Ltd., Kyowa Kirin Co., Ltd., Antengene Therapeutics Limited, Regeneron Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., Xynomic Pharmaceuticals, Inc., BioTheryX, Inc., UWELL Biopharma, Kronos Bio, Bio-Thera Solutions, Spectrum Pharmaceuticals, Inc., Aptose Biosciences Inc., Miltenyi Biomedicine GmbH, Precision BioSciences, Inc., Teneobio, Inc., TCR2 Therapeutics, IGM Biosciences, Inc, among others. Diffuse Large B-cell Lymphoma Market Diffuse Large B-cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key DLBCL companies, including AbbVie, Genmab, Merck, Roche, Xencor, Janssen, Denovo Biopharma, Calithera Biosciences IMV, Biogen, Autolus Therapeutics, Allogene Therapeutics, Novartis, Miltenyi Biomedicine, Regeneron Pharmaceuticals, Debiopharm, Seagen, Takeda, AstraZeneca, Gilead Sciences, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

免疫疗法引进/卖出临床3期疫苗细胞疗法

2024-08-09

·创鉴汇

上半年101家欧洲创新药公司获融资

▎药明康德内容团队编辑欧洲是全球重要医药市场之一，兼具发展成熟、规模庞大、发展稳定及创新驱动等特点。欧洲不仅拥有如拜耳（Bayer）、罗氏（Roche）、阿斯利康（AstraZeneca）等一众知名药企，同时较高的科技创新驱动力使欧洲的新锐创新药企持续获得全球投资者的关注。2024年上半年，至少有101家位于欧洲的创新药公司获得融资，披露融资总额超21亿美元。值得关注的亮点包括：英国、瑞士、德国占融资主导：英国获融资公司数最多，达38家，瑞士和德国分别有15家和12家公司获得融资。偶联药物公司势头迅猛：多家偶联药物研发公司获大额融资，如拥有3大技术平台的抗体偶联药物（ADC）研发公司Tubulis获高达1.28亿欧元的B2轮融资、开发下一代ADC的Pheon Therapeutics完成1.2亿美元B轮融资。癌症疾病领域为关注重点：其中52家获融资公司研发癌症领域新药，值得关注的公司有癌症疫苗研发公司Nouscom、免疫偶联药物研发公司Bright Peak Therapeutics和新型肿瘤免疫抑制剂研发公司iOnctura等。 ITM获1.88亿欧元融资 Isotope Technologies Munich（ITM）是一家放射性药物研发公司，致力于为难治性肿瘤提供新型放射性分子精准治疗和诊断。公司将放射性同位素与能够治疗一系列肿瘤的靶向分子相结合，研发精准肿瘤学产品管线。目前，ITM公司已有多条放射性核素疗法（TRT）进入临床阶段。其中，核心管线ITM-11（edotreotide）是一种肽类药物，能特异性地靶向神经内分泌肿瘤受体，其使用无载体添加 (no carrier added, nca) 的镥-177进行标记。目前ITM-11已经进入临床3期试验阶段，治疗胃肠胰神经内分泌肿瘤（GEP-NETs）。 6月6日，ITM宣布完成1.88亿欧元融资，旨在推动创新放射性药物管线研发，并为公司用于治疗胃肠胰神经内分泌肿瘤的3期候选药物ITM-11做好商业准备。此外，ITM还将利用这笔资金提高其Lutetium-177和Actinium-225的生产能力，扩大其医用放射性同位素的产线，为其全球供应网络提供备受需要的放射性同位素资源。 Tubulis完成1.28亿欧元B2轮融资 Tubulis成立于2019年，致力于通过在抗体偶联药物（ADC）开发的所有方面进行创新，解决该领域的主要瓶颈，以最大化ADCs的整体性能。公司拥有三大技术平台——P5偶联技术平台、Tubutecan（topo-I payload platform）平台以及Tub-tag平台。其技术平台允许使用传统有效载荷之外的载荷类别，并通过新型化学基团，扩展抗体和载荷之间的偶联选择，从而实现稳定的高药物-抗体比（DAR）。基于三大技术平台，Tubulis已经开发出了一系列项目，其中进展最快的是Napi2b ADC药物TUB-040，目前处于临床1期，此外还有两个项目公布了靶点，为5T4 ADC药物TUB-030，CD30 ADC药物TUB-010。 3月14日，Tubulis宣布完成1.28亿欧元B2轮融资，资金将主要支持公司下一代ADC管线临床评估的进展，并帮助实现主要候选药物TUB-040和TUB-030的临床概念验证。 Pheon Therapeutics完成1.2亿美元B轮融资 Pheon Therapeutics专注于开发用于治疗广泛难以治疗的癌症的下一代ADCs。目前公司拥有三款ADC核心项目，这三款ADC所靶向的是一种未公开的新靶点，该靶点在多种实体肿瘤中高度表达。其中一款ADC（PHN-010）使用拓扑异构酶-1抑制剂作为有效载荷，DAR达到8。另外两款ADC则利用其他连接子与有效载荷技术，进一步探索该靶点的治疗潜力。 5月21日，Pheon Therapeutics宣布完成1.2亿美元B轮融资，融资所获得款项将用于开发其三款差异化、潜在“first-in-class”抗体偶联药物以及扩展Pheon的内部技术平台套件以进一步优化其旗下ADC的构成。 Bright Peak Therapeutics完成9000万美元C轮融资 Bright Peak Therapeutics是一家生物技术公司，致力于推进治疗癌症和其他疾病的多功能免疫疗法组合。公司利用蛋白质工程能力和专有的化学蛋白质合成和偶联平台来发现和开发新型蛋白质疗法。其管线主要基于细胞因子IL-2和IL-18开展，药物类型包括增强型细胞因子，抗体-细胞因子偶联物等。以细胞因子为“载荷”，与PD-1单抗偶联，Bright Peak创建了一类新型双靶向生物制剂——Bright Peak Immunoconjugates。其中，核心药物管线BPT567是一种潜在“first-in-class” PD1-IL18免疫偶联物，旨在同时阻断PD（L）-1检查点通路并靶向递送IL-18信号转导。在临床前模型中，BPT567通过阻断PD-1，并特异性靶向IL-18介导的信号，表现出显著的协同抗肿瘤活性。 6月11日，Bright Peak Therapeutics宣布在C轮融资中筹集了9000万美元，所得资金将用于推动该公司的核心管线BPT567进入临床试验，并加速开发该公司一系列下一代免疫疗法。 iOnctura完成8000万欧元B轮融资 iOnctura是一家致力于发展提高癌症免疫疗法疗效的生物制药公司，正在开发一系列口服小分子，目前已将两种候选疗法推进到中期临床开发阶段。其中核心管线roginolisib是一款PI3Kδ别构调节剂，具有独特的化学结构和结合模式。在一项1b期临床试验中，roginolisib在葡萄膜黑色素瘤（UM）中表现出长期安全性和可喜的疗效，且在数月内持续保持临床活性。 6月20日，iOnctura宣布已完成8000万欧元B轮融资，新一轮资金将被用于加速其主导药物roginolisib对罕见眼部癌症——葡萄膜黑色素瘤的治疗研发。 Nouscom完成7580万欧元C轮融资 Nouscom是来自瑞士的一家处于临床阶段的免疫肿瘤学公司，致力于开发以新抗原为靶点、基于病毒载体的现货型和个体化癌症疫苗，旗下主要产品包括针对209个共有新抗原的现货型癌症疫苗NOUS-209以及个体化癌症免疫疗法NOUS-PEV。NOUS-209目前正在随机2期临床试验中进行测试，与帕博利珠单抗联合用于治疗错配修复缺陷/微卫星不稳定（dMMR/MSI）转移性结直肠癌（mCRC）。此外，Nouscom公司已经完成评估NOUS-PEV与检查点抑制剂联合治疗晚期黑色素瘤患者的1b期临床研究，并开展针对具有高度未竟医疗需求适应症的随机2期临床试验。 3月21日，Nouscom公司宣布完成7580万欧元的超额认购的C轮融资，所得资金将用于继续推进和扩大自有临床产品线。 Calluna Pharma完成7500万欧元A轮融资 Calluna Pharma是由Oxitope Pharma和Arxx Therapeutics两家公司合并组成。Oxitope致力于发现和开发治疗氧化应激引起的炎症和心血管疾病药物，主要产品是一款处于临床前阶段的、用于急性冠状动脉综合征（ACS）引起的心肌梗死（MI）再灌注损伤的抗体疗法。Arxx主要开发用于罕见纤维化疾病的疾病修饰疗法，2023年8月，其首款产品抗S100A4单克隆抗体AX-202开始双盲安慰剂对照试验。Calluna将基于损伤相关分子模式（DAMP）的先天免疫领域的专业知识与一系列针对炎症和纤维化适应症的选择性抗体相结合，旨在满足由急性或慢性炎症和非溶解性组织纤维化引起的各种疾病的临床需求。目前公司有四款潜力候选药物管线，包括处于临床1期的靶向S100A4的单克隆抗体CAL101和处于临床前研究的可中和氧化磷脂的单克隆抗体CAL102。 1月23日，合并组成的Calluna Pharma已经于A轮融资中筹募到7500万欧元，此次融资得到了Oxitope和Arxx现有主要投资者Forbion、Sarsia、p53和Investinor的支持。 SynOx Therapeutics完成7500万美元B轮融资 SynOx Therapeutics是一家临床阶段生物制药公司，从Celleron Therapeutics分拆出来。根据与罗氏签订的许可协议，SynOx获得了emactuzumab的全球独家临床开发、生产和商业化的权利。Emactuzumab是一款人源化靶向CSF-1受体（CSF-1R）的潜在“best-in-class”抗体疗法，设计用于靶向和消耗肿瘤组织中的巨噬细胞。Emactuzumab通过抑制CSF-1受体介导的信号通路，促进T细胞浸润和抗癌免疫反应。此前的临床试验数据显示，emactuzumab达到71%的客观缓解率（ORR），可快速缩小肿瘤并且疗效持久，显著改善患者功能性指标。 4月22日，公司宣布完成7500万美元的B轮融资，获得的资金将用于推动emactuzumab的3期临床试验和后续开发，用于治疗腱鞘巨细胞瘤（TGCT）。读者们请星标⭐创鉴汇，第一时间收到推送免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文由药明康德内容团队根据公开资料整理编辑，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转发/复制至其他平台。转发授权请在「创鉴汇」微信公众号留言联系我们。更多数据内容推荐点击“在看”，分享创鉴汇健康新动态

抗体药物偶联物临床3期放射疗法疫苗临床结果

100 项与 Roginolisib 相关的药物交易

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研发状态

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
葡萄膜黑色素瘤	临床2期	-	iOnctura SA初创企业	2024-12-01
血液肿瘤	临床2期	-	iOnctura SA初创企业	2023-05-31
慢性淋巴细胞白血病	临床2期	英国	iOnctura SA初创企业	-
非小细胞肺癌	临床2期	英国	iOnctura SA初创企业	-
外周T细胞淋巴瘤	临床2期	英国	iOnctura SA初创企业	-
原发性骨髓纤维化	临床2期	英国	iOnctura SA初创企业	-
霍奇金淋巴瘤	临床1期	意大利	iOnctura SA初创企业	2020-02-25
霍奇金淋巴瘤	临床1期	英国	iOnctura SA初创企业	2020-02-25
骨髓纤维化	临床1期	意大利	iOnctura SA初创企业	2020-02-25
骨髓纤维化	临床1期	英国	iOnctura SA初创企业	2020-02-25

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临床结果

适应症

分期

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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


NCT04328844 (DIONE-01, ESMO_IO2024)	临床1期	葡萄膜黑色素瘤 PI3K/mTOR-associated protein \| GPCR-related genes \| GNAQ/GNA11 mutations ... 更多	29	Roginolisib 80 mg QD	鏇願艱醖鹹觸構範衊廠(構構鬱憲齋膚醖壓餘觸) = 觸繭鑰構製鑰廠壓製齋艱醖鏇艱築顧壓構簾繭 (憲觸鑰餘齋觸齋醖壓膚 ) 更多	积极	2024-12-12
				Placebo	鏇願艱醖鹹觸構範衊廠(構構鬱憲齋膚醖壓餘觸) = 構範願觸壓襯範簾襯憲艱醖鏇艱築顧壓構簾繭 (憲觸鑰餘齋觸齋醖壓膚 )
ESMO_IO2023	N/A	-	-	Roginolisib 80 mg	壓夢淵餘廠範膚繭鬱壓(製蓋製艱獵獵鬱鏇醖鏇) = 艱膚製鬱顧積鹹廠獵顧窪鑰齋鬱築糧簾齋鹹鬱 (憲餘淵淵淵鹹構糧鏇獵 )	-	2023-12-07
NCT04328844 (FiH dose escalation study, ICML2023)	临床2期	滤泡性淋巴瘤	8	Roginolisib 80 mg QD	醖遞醖艱構餘餘衊夢築(壓襯壓壓壓齋願膚壓窪) = 廠衊選壓蓋選鹽膚繭艱鬱積醖蓋簾糧壓餘築餘 (廠範構膚蓋鹽繭觸鬱範 ) 更多	积极	2023-06-09
EHA2023	N/A	难治性滤泡性淋巴瘤	8	Roginolisib 20 mg QD	糧淵鬱壓鹽繭鑰窪觸齋(艱醖鑰顧鏇鑰淵構憲艱) = AST/ALT elevation (G3) were observed in 2/8 pts 壓製艱獵衊築製膚襯鏇 (膚蓋糧鬱夢繭糧鑰簾願 ) 更多	-	2023-06-08
				Roginolisib 80 mg QD
NCT04328844 (DIONE-01, ASCO 12023 \| ASCO 22023) 人工标引	临床1期	葡萄膜黑色素瘤 \| 晚期癌症	24	Roginolisib (Part A: pts with solid tumours and Follicular Lymphoma)	夢膚顧齋網築鹹衊簾夢(鹹鑰夢糧醖顧鬱獵築鹽) = roginolisib 80 mg QD 鹹鑰齋鹹鏇餘繭遞餘顧 (餘鹽鏇膚築願淵窪鬱艱 ) 更多	积极	2023-05-26
				Roginolisib (Part A(dose escalation): UM pts)
NCT04328844 (ASCO2022) 人工标引	临床1期	晚期癌症	23	IOA-244 (Part A Solid Tumor (completed))	鑰糧簾窪願鹽餘憲蓋築(獵積願窪製糧糧鏇餘糧) = 願窪選鹽觸積範齋鹹鑰壓鑰遞構願鏇餘蓋壓鏇 (鑰壓簾窪糧築願鏇簾築 )	积极	2022-06-02
				IOA-244 (Uveal Melanoma Pts (progressed ≥1 line prior therapy))	廠顧餘製觸憲簾憲遞構(鏇顧夢網夢積積鬱製繭) = 餘積範醖醖餘範衊鹽蓋築鏇膚簾衊憲鹹糧遞蓋 (醖範壓醖觸鹹顧襯積憲 ) 更多