更新于：2024-11-21

Fibromun

更新于：2024-11-21

概要

研发状态

概要

基本信息

药物类型

抗体融合蛋白

别名

Daromun component l19tnf、Fibromun、Immunoglobulin, anti-(human fibronectin ed-b domain) (synthetic human clone l19 scfv fragment) fusion protein with human tumor necrosis factor .alpha., trimer

+ [7]

靶点

EDB-FN x TNF-α

作用机制

EDB-FN抑制剂(纤维连接蛋白B结构域抑制剂)、TNF-α调节剂(肿瘤坏死因子α调节剂)

治疗领域

肿瘤其他疾病神经系统疾病

在研适应症

转移性软组织肉瘤胶质母细胞瘤，IDH野生型脑恶性胶质瘤

非在研适应症

基底细胞癌乳腺癌女性生殖器官肿瘤+ [3]

原研机构

Philogen SpA

在研机构

Philogen SpA

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)

登录后查看时间轴

序列信息

Sequence Code 315640122

来源: *****

关联

项与 Fibromun 相关的临床试验

NCT06284590 / Recruiting临床2期

A Phase 2, Three-arm, Randomized Study of the Efficacy of Intratumorally Administered L19IL2 or L19TNF or L19IL2/L19TNF, All in Combination with Systemic Anti-PD1 Pembrolizumab, in Stage III and IV Unresectable Melanoma Patients with Resistance to or Progressing Upon Anti-PD1 Checkpoint Inhibitors and with Presence of Injectable Metastases

The trial aims to evaluate the efficacy of single agent L19IL2, single agent L19TNF, and combination L19IL2+L19TNF given concurrently with anti-PD1 therapy compared to historical control of anti-PD-1 re-challenge alone for anti-PD1 refractory unresectable stage III-IV melanoma.

开始日期2024-07-12

申办/合作机构

Philogen SpA

[+1]

NCT06336291 / Not yet recruiting临床2期

A Dose Optimization Study for L19TNF in Combination With Lomustine in Patients With Glioblastoma at Progression or Recurrence

The trial aims to collect safety, efficacy, exposure, dose- response, pharmacokinetic and pharmacodynamic information of the combination of L19TNF and lomustine at different dose levels in patients with Glioblastoma at progression or recurrence

开始日期2024-06-01

申办/合作机构

Philogen SpA

NCT05304663 / Withdrawn临床1期

A Study to Evaluate the Safety and Efficacy of Different Administration Sequences of L19TNF in Combination With Lomustine in Patients With Glioblastoma at First Progression

Open label phase I study in subjects with glioblastoma at first progression to explore two different administration schedules of lomustine for the combination with L19TNF (ARM 1 and ARM 2).
Patients will be assigned in an alternating fashion to ARM 1 "Fractionating lomustine" or ARM 2 "Priming with L19TNF" as long as both treatment arms are open. Should one treatment arm be stopped as more or equal to two dose limiting toxicities occur in this treatment arm, then all remaining patients will be assigned to the treatment arm that is still open until also this treatment arm will be stopped.

开始日期2022-06-01

申办/合作机构

Philogen SpA

100 项与 Fibromun 相关的临床结果

登录后查看更多信息

100 项与 Fibromun 相关的转化医学

登录后查看更多信息

100 项与 Fibromun 相关的专利（医药）

登录后查看更多信息

项与 Fibromun 相关的文献（医药）

2025-01-01·International Journal of Cancer

Tripokin: A multi‐specific immunocytokine for cancer immunotherapy

Article

作者: Neri, Dario ; Rotta, Giulia ; Corbellari, Riccardo ; De Luca, Roberto ; Catastini, Jacopo Elia ; Weller, Michael ; Ciambellotti, Silvia ; Prodi, Eleonora ; Weiss, Tobias ; Pellegrino, Christian ; Rappuoli, Marco ; Ghezzi, Lorenzo ; Manz, Markus G. ; Sakic, Irma

AbstractAntibodies that target the tumor microenvironment can be used to deliver pro‐inflammatory payloads, such as cytokines. Cytokines are small proteins able to modulate the activity of the immune system, and antibody–cytokine fusion proteins have been tested in preclinical and clinical settings. In this study, we describe Tripokin, a novel multi‐specific fusion protein that combines interleukin‐2 and a single amino acid mutant of tumor necrosis factor. The two pro‐inflammatory payloads were fused to the L19 antibody, a clinical‐grade antibody against the extradomain B of fibronectin. The human payloads were used for clinical applications, while the corresponding murine cytokines were used for preclinical studies. The resulting fusion proteins were produced in mammalian cells and purified to homogeneity. The murine Tripokin product was well tolerated in tumor‐bearing mice at three doses of 30 μg in a 2‐day interval and promoted rapid tumor eradication in murine models, more efficiently than single‐agent immunocytokines. Tripokin induced rapid tumor necrosis and stimulated a robust immune response, impacting innate and adaptive immune pathways. In addition, the combination with immune checkpoint inhibitors further boosted the therapeutic efficacy of our molecule. Tripokin represents a promising clinical candidate for the simultaneous delivery of interleukin‐2 and tumor necrosis factor to neoplastic sites.

2024-12-31·mAbs

Antibodies to watch in 2024

Article

作者: Kaplon, Hélène ; Reichert, Janice M. ; Crescioli, Silvia ; Chenoweth, Alicia ; Visweswaraiah, Jyothsna ; Wang, Lin

The 'Antibodies to Watch' article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi)). We briefly review 26 product candidates for which marketing applications are under consideration in at least one country or region, and 23 investigational antibody therapeutics that are forecast to enter regulatory review by the end of 2024 based on company disclosures. These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa). We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.

2023-05-24·Science Translational Medicine1区 · 医学

Targeted delivery of tumor necrosis factor in combination with CCNU induces a T cell–dependent regression of glioblastoma

1区 · 医学

Article

作者: Kirschenbaum, Daniel ; Becher, Burkhard ; Puca, Emanuele ; Neri, Dario ; Rindlisbacher, Lukas ; Roth, Patrick ; Hemmerle, Teresa ; Weiner, Assaf ; Look, Thomas ; Bühler, Marcel ; Di Nitto, Cesare ; Weller, Michael ; Katzenelenbogen, Yonatan ; Ravazza, Domenico ; Amit, Ido ; De Luca, Roberto ; Stucchi, Riccardo ; Weiss, Tobias

Glioblastoma is the most aggressive primary brain tumor with an unmet need for more effective therapies. Here, we investigated combination therapies based on L19TNF, an antibody-cytokine fusion protein based on tumor necrosis factor that selectively localizes to cancer neovasculature. Using immunocompetent orthotopic glioma mouse models, we identified strong anti-glioma activity of L19TNF in combination with the alkylating agent CCNU, which cured the majority of tumor-bearing mice, whereas monotherapies only had limited efficacy. In situ and ex vivo immunophenotypic and molecular profiling in the mouse models revealed that L19TNF and CCNU induced tumor DNA damage and treatment-associated tumor necrosis. In addition, this combination also up-regulated tumor endothelial cell adhesion molecules, promoted the infiltration of immune cells into the tumor, induced immunostimulatory pathways, and decreased immunosuppression pathways. MHC immunopeptidomics demonstrated that L19TNF and CCNU increased antigen presentation on MHC class I molecules. The antitumor activity was T cell dependent and completely abrogated in immunodeficient mouse models. On the basis of these encouraging results, we translated this treatment combination to patients with glioblastoma. The clinical translation is ongoing but already shows objective responses in three of five patients in the first recurrent glioblastoma patient cohort treated with L19TNF in combination with CCNU (NCT04573192).

项与 Fibromun 相关的新闻（医药）

2024-07-22

·药智网

「蛋白偶联」创新：细胞因子只是开始，PEG/mPEG修饰才是未来

有目共睹，ADC药物已是继PD-1单抗肿瘤药之后，肿瘤研发领域的最大热点。而随着越来越多ADC药物的持续上市，全球ADC市场规模也在快速增长。但是，ADC药物逐渐内卷的竞争趋势下，在价值百亿的ADC市场赛道中，如何跑出差异化，却成为每个玩家都迫切面临的难题。为此，有的企业选择在靶向分子上下功夫，避开抗体，以多肽、小分子等新的靶向载体为突破，诞生了PDC、SMDC等区别于ADC的技术类型；而另一些企业却将差异化目光放到了有效载荷之上，利用有效载荷的多样化来凸显差异化。比如以放射性核素、PROTAC分子作为有效载荷的新技术，以各种“药效蛋白”作为治疗性payload的大胆尝试。蛋白效应偶联物优势明显所谓蛋白效应偶联物，即将药效蛋白（细胞因子、蛋白毒素与免疫细胞）与靶向性分子链接在一起，在原来药效蛋白的基础上增加靶向性或其他，减少药效蛋白的系统性毒性，其原理上与熟知的ADC机理相似，在兼具了药效蛋白与偶联药物的特点的同时，也有其特殊优势：相较传统药效蛋白，蛋白效应偶联物理论上可以拥有更强的有效性、更低的毒副作用、更特异性的靶点与更高的效价，当其与化疗、放疗等其他抗肿瘤治疗方式结合时，抗肿瘤特性还会显著增强。而相较传统ADC，蛋白效应偶联物可以拥有更强的靶向毒性，更广的适应范围，可以应用于更多非肿瘤领域，如多数自免疾病。现在来看，靶向分子与药效蛋白发挥协同效应，明显可以产生1+1＞2的作用，达成更高效的治疗需求。但同时，由于药效蛋白与靶向分子的诸多链接限制，对于蛋白偶联物领域而言，也有不少值得进一步研究的内容。细胞因子药效蛋白偶联物的开始就现阶段而言，药效蛋白作为效应分子在偶联药物领域的例子并没有想象中那么多，近年来陆续出现的蛋白毒素、细胞因子与免疫细胞已是较为前沿的研究成果，而其中又以“细胞因子偶联物”的研究最具代表性。过去几十年，随着细胞因子的持续发现，其被广泛应用于抗肿瘤与抗感染方面，但与此同时，应用越广，其凸显出的局限性也越强，比如半衰期短，治疗窗口窄，毒副作用大等，这普遍存在于多数药效蛋白中。而抗体偶联细胞因子（immunocytokine），即通过特异性抗体将细胞因子引导至肿瘤微环境等疾病局部，再由细胞因子发挥其作用（如激活或者抑制免疫细胞），如此一来，可以有效降低肿瘤外毒性，以此扩大细胞因子的治疗窗口，因而，近年来也有越来越多的“抗体偶联细胞因子”相继进入临床阶段。品种原研单位许可单位靶点临床阶段 Nidlegy Philogen SpA 印度太阳药业有限公司 TNFA;EDB-FN;IL-2 注册申请 L19-TNF;Fibromun Philogen SpA - TNFA;EDB-FN 临床Ⅲ期 IBI-363 信达生物制药（苏州）有限公司 - IL-2;PD-1 临床Ⅱ期 RO6874281;simlukafusp alfa 罗氏制药 - AFAP1L2;FAP-alpha;IL-2 临床Ⅱ期 SAR-445877 赛诺菲 - IL15;PD-1 临床Ⅱ期 OXS-3550 University of Minnesota OXIS International Inc IL15;CD16;CD33 临床Ⅱ期 PF-06687234 Philogen SpA 辉瑞公司 IL10;CD29;EDA-FN 临床Ⅱ期 IBB-0979 盛禾（中国）生物制药有限公司 - IL10;CD276 临床Ⅱ期 SNG-2005 EMD Lexigen Research Center Corp;EMD Serono Inc Alopexx Oncology LLC CD20 临床Ⅱ期 APN-301 Apeiron Biologics GmbH;默克 - IL-2 临床Ⅱ期 ANV-419 Anaveon AG;University of Zurich - IL-2 临床Ⅱ期 TAK-573 武田药品工业株式会社 - IFN-alpha-2;CD38 临床Ⅱ期 Darleukin;L19-IL2 Philogen SpA Maastricht University Medical Center EDB-FN;IL-2 临床Ⅱ期 NHS-IL2-LT 默克 - IL-2;IL2R 临床Ⅱ期 STAR-0602 Marengo Therapeutics - TCRBV 临床Ⅱ期 RG-7835 罗氏制药 - CD25 临床Ⅱ期 IAE-0972 盛禾（中国）生物制药有限公司 - IL10;EGFR 临床Ⅱ期 F16IL2 PhiloGene Inc - IL-2;Tenascin 临床Ⅱ期 M-9241 默克 National Cancer Institute IL12R 临床Ⅱ期 PDS0301 PDS Biotechnology Corp - IL-12 临床Ⅱ期 IAP-0971 盛禾（中国）生物制药有限公司 - IL15;PD-1 临床Ⅱ期数据来源：药智数据截至目前，全球已有数十款在研的抗体偶联细胞因子药物，其有效载荷主要集中在IL-2，IFN-γ，EPO等类型。其中由Philogen开发的Nidlegy是抗体偶联细胞因子领域中进度最靠前的管线，目前已向欧洲药品管理局（EMA）提交了上市申请，一旦获批，或将成为第一款上市的抗体偶联细胞因子产品。而作为 Philogen 专有的生物制药产品，Nidlegy是专为治疗皮肤癌而设计。结构上由 L19IL2 和 L19TNF 组成，其中L19 抗体对纤连蛋白的额外结构域 B 具有特异性，其Ⅲ期PIVOTAL研究显示，治疗组复发或死亡风险降低了41%，中位RFS延长了一倍以上，且患者组实现病理学完全缓解（pCR）的比例为21%。而国内领域，研究进度较靠前的则是信达生物的一款PD-1/IL-2（IBI363），其采取非对称二聚体设计，IL-2经过改造保留CD25（IL2Rɑ）活性以最大化疗效和高选择性，同时减少对Rβγ 结合以降低系统毒性。既可以阻断PD-1/PD-L1免疫抑制通路，又可以通过IL-15激活免疫细胞；同时，PD-L1抗体还能将IL-15靶向到PD-L1+的肿瘤微环境，选择性激活肿瘤浸润CD8+T细胞和NK细胞，降低IL-15全身性副作用。综上可知，抗体偶联细胞因子的技术方向，因其强大的靶向肿瘤和延长细胞因子半衰期的能力，以及其对多个靶点的协同抗肿瘤作用，目前已经成为效应蛋白偶联物领域最具前景的疗法，成了创新biotech脱颖而出的重要资本。不过，尽管表面上看抗体偶联细胞因子领域似乎前景广阔，但对于“药效蛋白偶联物”领域而言，仍是成功的个别例子，占据极小的部分，放眼整个药效蛋白偶联领域，仍有大量药效蛋白缺乏有效的偶联方式。化学修饰+蛋白药效蛋白偶联物的未来就技术层面而言，如何想将任一蛋白进行修饰偶联，而不需要考虑药效蛋白的针对性与特殊性，是现阶段专家在研究中主要的思考方向。目前来看，通过化学偶联修饰方式与药效蛋白相结合是比较切实可行的方法。比如PEG/mPEG修饰、氨甲酰化修饰、硫酸化修饰与磷酸化修饰。 PEG/mPEG偶联蛋白所谓PEG，是一种被广泛应用于蛋白质和多肽等生物聚合物进行共价修饰的高分子材料；mPEG则是将PEG其中一端进行封端后的产物；而PEG/mPEG化修饰就是将其与药物共价结合，以改善药物的药代动力学、药效学和免疫学特性，从而增强其治疗效果的一种药物技术。通常情况下，PEG/mPEG由于提高水溶性、减少酶水解、降低毒性和免疫原性、延长体内半衰期、改变组织分布以及增加药物分子的靶向位点浓度等特点，被主要考虑用作生物分子偶联的起始材料。图片来源：西宝生物而在众多与PEG偶联的生物大分子中，脂类、蛋白质、小分子药物和其他疏水性聚合物已被广泛研究，并被用来制造用于药物输送和成像的纳米载体，对于蛋白质而言，其没有对蛋白种类的显示，简单来讲就是局限于细胞因子、免疫细胞等种类，理论上可以与所有蛋白质进行PEG偶联。在原理上，蛋白质的PEG修饰之所以有一系列优势，主要是由于蛋白质PEG修饰后，偶联物使原有蛋白质的分子量增大，空间结构发生改变，一方面可以是使其可以逃避肾小球滤过作用，在血液循环中停留更长的时间；另一方面修饰剂会使得蛋白质表面抗原决定簇掩盖起来，避开免疫系统识别；甚至修饰剂作用下，蛋白质药物还能不易被各种蛋白酶的攻击，降解速率明显降低。图注：聚乙二醇修饰蛋白示意图资料来源：键凯科技招股说明书从蛋白质PEG修饰到mPEG修饰，如今在该领域范围内，已经有了许多蛋白质的聚乙二醇化修饰物作为药物取得了较好的结果，可行性上得到了充分验证。 1991年，第一种经聚乙二醇化修饰的蛋白质类药物PEG-腺苷脱氨酶被FDA批准上市，用于治疗一种严重的儿童免疫缺陷症； 2001年，用聚乙二醇修饰的干扰素（PEG-INTRON）经FDA批准上市，用于治疗慢性丙型肝炎； 2010年，通过赖氨酸偶联进行聚乙二醇化的普瑞凯希Krystexxa（pegloticase）被FDA批准用于治疗痛风，实现每月一针的注射频率。 2024年，J.P. Morgan大会上，由 Ascendis Pharma 原研开发的一款在研 PTH 激素原药（TransCon PTH ）亮相，由母药 PTH(1-34) 和支链甲氧基聚乙二醇 (mPEG) 载体通过专有连接剂瞬时结合而成，正在开发用于治疗成人甲状旁腺功能减退症，可以实现24 小时的正常生理范围内提供稳定的 PTH 水平。并且，作为化学偶联修饰中最主要的存在，PEG/mPEG修饰还成功为化学修饰蛋白建立了良好的开端，也为后续企业更多在研化学修饰方法，提供了良好的模板，比如氨甲酰化、硫酸化、磷酸化等。小结总结来看，由于药效蛋白本身诸多优势，目前通过偶联方式将药效蛋白进行系列改装已成为了现实，最切实有用的方法可以参考“抗体+蛋白毒素、抗体+细胞因子”。但是，无论是细胞因子、蛋白毒素，还是免疫细胞，其都只能代表药效蛋白中较小部分，蛋白偶联仍存在明显的局限性与针对性，好在以PEG/mPEG为首的化学偶联修饰技术之下，研究者们似乎在寻找针对任何蛋白偶联方法上已经有了些许突破。未来，随着更多如PEG/mPEG化、氨甲酰化、硫酸化、磷酸化等化学偶联修饰方法的发现，整个药效蛋白市场或许也将发生巨大重构，我们拭目以待。来源 | 博药（药智网获取授权转载）撰稿 | 头孢责任编辑 | 八角声明：本文系药智网转载内容，图片、文字版权归原作者所有，转载目的在于传递更多信息，并不代表本平台观点。如涉及作品内容、版权和其它问题，请在本平台留言，我们将在第一时间删除。商务合作 | 王存星 19922864877（同微信）阅读原文，是受欢迎的文章哦

抗体药物偶联物多肽偶联药物蛋白降解靶向嵌合体

2024-07-05

·Pharmaceutical Technology

EMA validates Philogen and Sun Pharma’s MAA for melanoma

A total of 256 patients were enrolled across 22 clinical centres in Germany, Italy, France and Poland. Credit: Gorodenkoff / Shutterstock. The European Medicines Agency (EMA) has validated Philogen and Sun Pharmaceutical’s marketing authorisation application (MAA) for Nidlegy, a treatment for melanoma. Nidlegy is an investigational treatment for neoadjuvant (before surgical procedure) locally advanced fully resectable melanoma. The application, submitted on 4 June 2024, is based on data from the Phase III PIVOTAL study and a Phase II trial. The international, multicentre, randomised, comparator-controlled, parallel-group PIVOTAL trial assessed the efficacy and safety of Nidlegy as a neoadjuvant treatment in melanoma patients with locally advanced, fully resectable cutaneous, subcutaneous or nodal metastases accessible to intratumoural injection. A total of 256 patients were enrolled across 22 clinical centres in Italy, Germany, France and Poland. See Also: CAN-3110 by Candel Therapeutics for High-Grade Glioma: Likelihood of Approval ICTCAR-028 by Innovative Cellular Therapeutics for Hematological Tumor: Likelihood of Approval Results from the PIVOTAL trial showed that Nidlegy reduced the relapse or mortality risk by 41% versus the control arm, with a significant improvement in median recurrence-free survival and distant metastasis-free survival (DMFS). Nidlegy’s safety profile was characterised by mostly low-grade, local adverse events. No grade 3 or grade 4 immune-related adverse events or drug-related deaths were recorded. Nidlegy is a biopharmaceutical product of Philogen, designed to treat skin cancer through intralesional administration of two active ingredients, L19IL2 and L19TNF. These ingredients are pro-inflammatory cytokines with potent anti-tumour activity. Nidlegy is also being investigated in additional Phase III trials for locally advanced melanoma and Phase II trials for high-risk basal cell carcinoma and other non-melanoma skin cancers. Philogen CEO and chief scientific officer Dario Neri stated: “The validation of the dossier by the EMA represents the first important milestone for the MAA review process.” “Our group is committed to working with EMA throughout the review process to make Nidlegy available to patients in need.”

临床3期临床结果临床2期

2024-02-20

·GlobeNewswire-Health Care

Philogen provides update on pre-planned interim analysis of the Phase III FIBROSARC trial investigating Onfekafusp alfa (L19TNF) in patients with first-line advanced or metastatic Soft Tissue Sarcoma

FIBROSARC (NCT04650984) is a Phase III trial evaluating Onfekafusp alfa (L19TNF, also known as Fibromun) plus doxorubicin versus doxorubicin alone as front-line therapy for patients with advanced or metastatic Soft Tissue Sarcoma An Independent Data and Safety Monitoring Board reviewed safety and efficacy data of the pre-planned interim analysis and recommended continuing the study as planned by the protocol L19TNF is also currently studied in pivotal trials for the treatment of newly diagnosed and recurrent Glioblastoma, for which very encouraging data have recently been published SIENA, Italy, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Philogen S.p.A. (BIT:PHIL) is pleased to announce that the Phase III FIBROSARC trial (NCT04650984) will continue as planned by the protocol. The decision was made by an Independent Data and Safety Monitoring Board (DSMB) following the review of efficacy and safety data in the pre-planned interim analysis. FIBROSARC is a Phase III 1:1 randomized trial (NCT04650984) which studies L19TNF in combination with doxorubicin (Experimental Arm) versus doxorubicin alone (Control Arm) in 118 patients as first-line therapy for advanced or metastatic Soft Tissue Sarcoma (STS). The primary objective of the study is Progression Free Survival (PFS), with an estimated 45% reduction in the risk of progression in the Experimental Arm (Hazard Ratio 0.55). The pre-planned interim analysis was carried out at 50% of the expected events (i.e., one event corresponds to a disease progression or death) necessary for the primary outcome. The 46 events required to trigger the interim analysis were reached on 9th November 2023, and at the time of this Press Release the study has enrolled 97 out of 118 patients across 24 clinical centers in Germany, Italy, France, Poland, and Spain. The enrolment of 118 patients is expected to be completed in 2024. Prof. Dario Neri, co-founder, CEO and CSO of Philogen, commented: "We are very pleased with the recommendation of the DSMB to continue the study as planned by the protocol. The Phase III FIBROSARC trial was designed to demonstrate a significant clinical benefit of L19TNF plus doxorubicin compared to doxorubicin alone. If the final analysis is successful, the study is expected to provide an innovative treatment option for patients with advanced or metastatic STS, for whom no new paradigm-shifting therapies have been available in the last decades.” Alfredo Covelli, MD, Chief Medical Officer of Philogen, commented: "Advanced or metastatic STS are aggressive tumors still treated with chemotherapy-based regimens that were approved in the 1970s. Most innovative therapies, such as immune checkpoint inhibitors, failed to provide a significant benefit to this patient population. We are excited to record the outcome of the interim analysis of FIBROSARC and look forward to seeing the final analysis.” L19TNF is also being evaluated in (i) a Phase IIb randomized trial in first-line metastatic Leiomyosarcoma in the United States (NCT03420014), (ii) a Phase II randomized trial in pre-treated advanced or metastatic Soft Tissue Sarcoma in Europe (NCT04733183), (iii) a Phase II randomized trial in Glioblastoma at first progression in Europe (NCT04573192), and (iv) a Phase I/II/IIb trial in newly diagnosed Glioblastoma in Europe (NCT04443010). Philogen is currently launching a new Phase II study in Glioblastoma at first or later progression in the United States, based on the very encouraging preliminary data observed in the European study. These results have already been published in the journal Science Translational Medicine in 2023 (Look at al. Sci. Trans. Med. 2023, 15:eadf2281). For more information about Onfekafusp alfa (also known as Fibromun), FIBROSARC Phase III study (NCT04650984), Soft Tissue Sarcoma, and Philogen, please visit https://www.philogen.com/investors/press-releases/. FOR MORE INFORMATION: Philogen - Investor Relations IR@philogen.com - Emanuele Puca | Investor Relations

临床2期临床3期免疫疗法

100 项与 Fibromun 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16269

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
胶质母细胞瘤，IDH野生型	临床2期	瑞士	Philogen SpA	2019-05-31
脑恶性胶质瘤	临床2期	瑞士	Philogen SpA	2019-05-31
转移性软组织肉瘤	药物发现	西班牙	Philogen SpA	2021-08-09
平滑肌肉瘤	药物发现	美国	Philogen SpA	2021-02-10
胶质母细胞瘤	药物发现	-	Philogen SpA	2020-12-01
基底细胞癌	药物发现	瑞士	Philogen SpA	2020-09-02
黑色素瘤	药物发现	意大利	Philogen SpA	2016-07-01
黑色素瘤	药物发现	德国	Philogen SpA	2016-07-01
黑色素瘤	药物发现	波兰	Philogen SpA	2016-07-01
女性生殖器官肿瘤	药物发现	意大利	Philogen SpA	2013-01-14

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04650984 (ESMO2021)	临床3期	转移性软组织肉瘤一线	118	L19TNF + Doxorubicin	(鏇選衊繭構壓餘鏇鑰鹽) = 壓製齋膚製淵淵顧築憲觸鹹衊衊鹹廠鹽壓範夢 (憲襯鏇壓窪夢膚築醖範 )	-	2021-09-16