A Randomized, Open-label, Multi-center, Phase 1b/2 Trial Evaluating the Safety and Efficacy of Intratumorally-administered Ilixadencel in Combination With Checkpoint Inhibitor (CPI) in Advanced Cancer Subjects Who Are Candidates for CPI Therapy

Patients in the Phase 1b part of the study will be treated with ilixadencel at an increasing dose and frequency, in combination with standard doses and schedules of checkpoint inhibitor (CPI) pembrolizumab. The Phase 1b study will determine the optimal dose and schedule of ilixadencel. Patients in the Phase 2 part of the study will be randomly assigned to receive either ilixadencel (at the dose determined in Phase 1b) combined with the CPI, or only the CPI.
Note: Recruitment to Phase 1b of the study has been completed.

开始日期2019-01-14

申办/合作机构

Mendus AB

[+1]

NCT02686944

/ Completed临床1期

A Phase I Open-label Study Evaluating Safety and Efficacy of Intratumorally Administered Intuvax in Patients With Progressing Gastrointestinal Stromal Tumors (GIST) During Ongoing Second, Third or Fourth Line Treatment With Tyrosine Kinase Inhibition Therapy. A Prospective Single Armed, Open Label Phase I Safety and Efficacy Study

The study is a prospective single armed, open label phase I study. Patients with advanced or metastatic GIST and tumor progression despite ongoing treatment with second, third or fourth line TKI treatment, and with at least one measureable tumor lesion, will be eligible for the study. A maximum of 12 patients will be included in this study. The patients will continue with TKI treatment until the 3 months follow up visit. If further tumor progression TKI will be withdrawn but if stable disease or objective response the patient will continue with TKI until progress. The investigational product Intuvax will be injected into a tumor lesion at two or three treatment occasions; day 1, 14 days (±3 days) after the first vaccination, and 28 days (±3 days) after the second vaccination (patient 7-12 only). Intuvax will be injected in a viable part of the tumor, using ultrasound-guided or CT technique for correct administration.

开始日期2016-06-01

申办/合作机构

Mendus AB

NCT01974661

/ Completed临床1期

A Phase I Open-label Study to Evaluate Safety and Immunologic Response of COMBIG-DC Administered Intra-tumorally in Patients With Hepatocellular Carcinoma

The primary objective of this study is to answer the question "Is it possible to inject the COMBIG-DC vaccine in a hepatic tumor without getting unacceptable side effects"?

开始日期2013-10-01

申办/合作机构

Mendus AB

[+1]

100 项与 Ilixadencel 相关的临床结果

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100 项与 Ilixadencel 相关的转化医学

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100 项与 Ilixadencel 相关的专利（医药）

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168

项与 Ilixadencel 相关的文献（医药）

2024-12-31·Future Science OA

Phase I study of allogeneic monocyte-derived inflammatory dendritic cells in combination with pembrolizumab

Article

作者: Hamm, John ; Weiss, Jared ; Lockhart, Albert C. ; Rovers, Jeroen ; Laux, Douglas ; Karlsson-Parra, Alex ; Bajor, David

PD-1 checkpoint inhibition has revolutionized the care of cancer. A small portion of patients with stage IV cancer achieve durable control. But, early progression is common and dramatic control is achieved for only a minority. We hypothesized that ilixadencel, an allogeneic monocyte-derived dendritic cell product could be injected into tumor to potentiate PD-1 response and thus conducted a phase I study of pembrolizumab plus ilixadencel. Twenty-one patients were accrued. The most common treatment emergent adverse events were fatigue, injection site pain, anemia, weight decreased and hyponatremia, mostly grade 1-2. No dose limiting toxicities were observed and the recommended phase II dose was established at 10 million cells administered twice. Two unconfirmed responses were observed, with no confirmed responses.

2023-12-01·Clinical cancer research : an official journal of the American Association for Cancer Research

Randomized Phase II Trial of Dendritic Cell/Myeloma Fusion Vaccine with Lenalidomide Maintenance after Upfront Autologous Hematopoietic Cell Transplantation for Multiple Myeloma: BMT CTN 1401

Article

作者: Malek, Ehsan ; Geller, Nancy ; Lazarus, Hillard M. ; Avigan, David ; Mendizabal, Adam ; Stroopinsky, Dina ; McKenna, David ; Wu, Juan ; Efebera, Yvonne ; Pasquini, Marcelo C. ; Dhakal, Binod ; Uhl, Lynne ; Waller, Edmund K. ; Howard, Alan ; Johnson, Bryon ; Shah, Nina ; Nooka, Ajay ; O'Donnell, Lynn ; Chodon, Thinle ; Cheloni, Giulia ; Rosenblatt, Jacalyn ; Bisharat, Lina ; Munshi, Nikhil ; Logan, Brent ; Holmberg, Leona ; Chung, David J. ; Reese, Jane ; McCarthy, Philip ; Somaiya Dutt, Poorvi ; Ghiasuddin, Haider ; Callander, Natalie ; Karagkouni, Dimitra ; Vlachos, Ioannis S. ; Anderson, Kenneth ; Rapoport, Aaron P. ; Hematti, Peiman ; Devine, Steve ; Soiffer, Robert ; Young, James W.

Abstract:

Purpose::

Vaccination with dendritic cell (DC)/multiple myeloma (MM) fusions has been shown to induce the expansion of circulating multiple myeloma–reactive lymphocytes and consolidation of clinical response following autologous hematopoietic cell transplant (auto-HCT).

Patients and Methods::

In this randomized phase II trial (NCT02728102), we assessed the effect of DC/MM fusion vaccination, GM-CSF, and lenalidomide maintenance as compared with control arms of GM-CSF and lenalidomide or lenalidomide maintenance alone on clinical response rates and induction of multiple myeloma–specific immunity at 1-year posttransplant.

Results::

The study enrolled 203 patients, with 140 randomized posttransplantation. Vaccine production was successful in 63 of 68 patients. At 1 year, rates of CR were 52.9% (vaccine) and 50% (control; P = 0.37, 80% CI 44.5%, 61.3%, and 41.6%, 58.4%, respectively), and rates of VGPR or better were 85.3% (vaccine) and 77.8% (control; P = 0.2). Conversion to CR at 1 year was 34.8% (vaccine) and 27.3% (control; P = 0.4). Vaccination induced a statistically significant expansion of multiple myeloma–reactive T cells at 1 year compared with before vaccination (P = 0.024) and in contrast to the nonvaccine arm (P = 0.026). Single-cell transcriptomics revealed clonotypic expansion of activated CD8 cells and shared dominant clonotypes between patients at 1-year posttransplant.

Conclusions::

DC/MM fusion vaccination with lenalidomide did not result in a statistically significant increase in CR rates at 1 year posttransplant but was associated with a significant increase in circulating multiple myeloma–reactive lymphocytes indicative of tumor-specific immunity. Site-specific production of a personalized cell therapy with centralized product characterization was effectively accomplished in the context of a multicenter cooperative group study.See related commentary by Qazilbash and Kwak, p. 4703

2023-10-03·Neuro-oncology

Dendritic cell vaccine trials in gliomas: Untangling the lines.

Review

作者: Khasraw, Mustafa ; Mohan, Aditya ; Hotchkiss, Kelly M ; Rahman, Rifaquat ; Piantadosi, Steven ; Batich, Kristen A

Glioblastoma is a deadly brain tumor without any significantly successful treatments to date. Tumor antigen-targeted immunotherapy platforms including peptide and dendritic cell (DC) vaccines, have extended survival in hematologic malignancies. The relatively "cold" tumor immune microenvironment and heterogenous nature of glioblastoma have proven to be major limitations to translational application and efficacy of DC vaccines. Furthermore, many DC vaccine trials in glioblastoma are difficult to interpret due to a lack of contemporaneous controls, absence of any control comparison, or inconsistent patient populations. Here we review glioblastoma immunobiology aspects that are relevant to DC vaccines, review the clinical experience with DC vaccines targeting glioblastoma, discuss challenges in clinical trial design, and summarize conclusions and directions for future research for the development of effective DC vaccines for patients.

项与 Ilixadencel 相关的新闻（医药）

2025-02-12

·mendus.com

Mendus AB Year-end Report 2024

Preparations for pivotal-stage readiness of vididencel in AML on trackThe hard work of the Mendus team to advance the company’s lead product vididencel in acute myeloid leukemia (AML) continued to pay off during the fourth quarter of 2024. In December, we presented positive updated survival data of the ongoing ADVANCE II Phase 2 trial at ASH, demonstrating that the majority of patients treated remained alive at 41.8 months median follow-up. Also in Q4, we received positive EMA and FDA feedback endorsing our registration trial preparations. We successfully advanced our manufacturing alliance for the large-scale production of vididencel. The progress realized during the quarter keeps us on track to achieve pivotal-stage readiness of vididencel in AML as our lead program in the second half of 2025. Erik Manting, Ph.D.Chief Executive Officer Significant events of Q4 2024 Net sales for the period amounted to KSEK – (-) Result for the period amounted to KSEK -31,515 (-41,165) Earnings and diluted earnings per share totalled SEK -0.63 (-0.95*) Cash runway extended until beginning of 2026 versus earlier guidance until Q4 2025 Mendus presented preclinical data supporting the combination of its intratumoral primer ilixadencel with the immune checkpoint inhibitor avelumab at the 39th annual meeting of the Society for Immunotherapy of Cancer (SITC). Mendus announced that the members of the Nomination Committee for the 2025 Annual General Meeting were appointed. The Nomination Committee consists of Erik Esveld, appointed by Van Herk Investments B.V, Karl Elmqvist, appointed by Flerie Invest AB, and Mats Andersson, appointed by Holger Blomstrands Byggnads AB. Mendus presented positive survival data from the ongoing ADVANCE II Phase 2 trial at the ASH 2024 conference. The data showed that the majority of AML patients treated with vididencel remain alive and disease-free in long-term follow-up, with a median follow-up of 41.8 months. Mendus also presented two preclinical abstracts during the ASH 2024 conference. The first abstract demonstrated synergies between vididencel and the combination of venetoclax and azacitidine, two backbone drugs in the treatment of AML, with venetoclax having a direct synergistic effect on vididencel’s mode of action. The second abstract supports the potential use of vididencel in the treatment of chronic myeloid leukemia (CML). Mendus reported positive topline data from the ALISON Phase 1 clinical trial with vididencel in ovarian cancer. The data confirmed that vididencel stimulates immune responses against ovarian cancer antigens, as a potential basis for an effective anti-tumor response, and the strong safety profile for vididencel. Mendus announced that Institut Bergonié was no longer in a position to study Mendus’ intratumoral immune primer ilixadencel in soft tissue sarcomas as part of the REGOMUNE trial, because third party funding for the trial had been terminated. Significant events after end of reporting period Mendus announced a summary of the feedback received from FDA and EMA in the fourth quarter of 2024. The feedback is supportive of the preparations for a registration trial with vididencel in AML. Financial summary * The comparative numbers recalculated taking into account the reverse split, 20:1 The full report is attached as PDF and is available on the company’s website: https://mendus.com/investors/financial-reports/ Webcast investor call, February 13, 08.30 CETThe company will host a live presentation and business update today at 08.30 CET. The presentation will be held in English and includes a Q&A session. If you wish to participate via webcast please use the link below.https://mendus.events.inderes.com/q4-report-2024/register If you wish to participate and ask questions via teleconference, please register on the link below. After registration you will be provided phone numbers and a conference ID to access the conference.https://conference.inderes.com/teleconference/?id=5004794 For more information, please contact:Erik MantingChief Executive OfficerE-mail: ir@mendus.com About Mendus AB (publ) Mendus is dedicated to changing the course of cancer treatment by addressing tumor recurrence and improving long-term survival for cancer patients, while preserving health and quality of life. We leverage our understanding of dendritic cell biology to develop an advanced clinical pipeline of immunotherapies which combine clinical efficacy with a benign safety profile. Based in Sweden and The Netherlands, Mendus is publicly traded on the Nasdaq Stockholm under the ticker IMMU.ST. https://www.mendus.com/ AttachmentsMendus Q4 2024 ENG 02 13 FinalMendus AB Year-end Report 2024

临床结果临床1期免疫疗法临床2期高管变更

2024-12-17

·mendus.com

Mendus to participate in upcoming industry conferences in September

Mendus AB ("Mendus" publ; IMMU. ST), a biopharmaceutical company focused on immunotherapies targeting tumor recurrence, announces that it will participate in the following upcoming industry and investor conferences in September: International Society for Cell & Gene Therapy Europe 2024 Regional MeetingGothenburg, Sweden, September 4-6, 2024Mendus will present the regulatory milestones of its clinical-stage programs vididencel and ilixadencel during a poster session held on September 4, 18.30–20.00 CEST. In addition, Mendus Head of Regulatory Affairs, Dr Anna Koptina Gültekin, will participate in a panel discussion held on September 5 about the importance of interactions with regulatory authorities during drug development.ISCT EU 2024 H.C. Wainwright 26th Annual Global Investment ConferenceNew York City, USA, September 9-11Mendus CEO Erik Manting will participate for investor meetings and a company presentation.HCW Events Nordic Life Science Days 2024Malmö, Sweden, September 18-19, 2024Mendus CEO Erik Manting will take part in a presentation hosted by the Dutch Government about the collaboration potential between Sweden and The Netherlands in the Life Sciences sector.NLSDays Pareto Securities' 15th Annual Healthcare ConferenceStockholm, Sweden, September 19, 2024Mendus CEO Erik Manting will participate for investor meetings and a company presentation.Pareto Securities' 15th Annual Healthcare Conference

免疫疗法

2024-11-07

·mendus.com

Mendus to present preclinical data supporting the combination potential of ilixadencel with the immune checkpoint inhibitor avelumab at SITC 2024

Press Release Stockholm, Sweden, November 7, 2024 Mendus AB ("Mendus" publ; IMMU. ST), a biopharmaceutical company focused on immunotherapies targeting tumor recurrence, announces that it will present preclinical data demonstrating immune priming synergies between the intratumoral primer ilixadencel and avelumab, an immune checkpoint inhibitor approved for multiple solid tumor indications, at the SITC 2024 conference. Mendus will present preclinical data demonstrating that ilixadencel and avelumab act synergistically in intratumoral priming of the immune system during the 39th annual meeting of the Society for Immunotherapy of Cancer (SITC), held November 6-10, 2024 (SITC 2024). Addition of avelumab leads to stronger natural killer cell activation by ilixadencel, enhances production of proinflammatory cytokines and chemokines in ilixadencel-stimulated peripheral blood mononuclear cells and leads to improved maturation of bystander dendritic cells. The presented data indicate that ilixadencel and avelumab act synergistically to promote a pro-inflammatory tumor microenvironment required for effective anti-tumor immune responses. The data will be presented by Mendus’ Director Research Dr Satwinder Kaur Singh on Friday, November 8, at 12.15 CST. Abstracts are available online on the SITC website Titles and Publications – SITC 2024 . Please find below the details of the abstract to be presented by Mendus: Abstract Number 761; Title: The intratumoral immune primer ilixadencel acts synergistically with the anti-PD-L1 antibody avelumab; Date: Friday, November 8, 2024; Presentation Time: 12.15-1.45 pm CST; Location poster session: Exhibit Halls A B, George R. Brown Convention Center, Houston, Texas, USA In July, Mendus announced a collaboration with Institut Bergonié, a leading cancer research centre based in Bordeaux, France, to study ilixadencel in soft tissue sarcomas as part of the REGOMUNE trial, a multicenter, prospective open-labeled phase 1/2 trial combining regorafenib, a tyrosine kinase inhibitor (TKI), and avelumab, an immune checkpoint inhibitor, in solid tumors. Mendus will support the REGOMUNE trial by supplying ilixadencel as study drug to treat up to 43 soft tissue sarcoma (STS) patients. Ilixadencel is an off-the-shelf intratumoral immune primer consisting of pro-inflammatory monocyte-derived dendritic cells (DCs) from allogeneic healthy donor material. Upon administration, ilixadencel promotes a local pro-inflammatory environment, activation of NK cells and cross-presentation of tumor antigens by recruited and activated endogenous DCs in the tumor microenvironment. In clinical trials, ilixadencel has demonstrated promising signs of efficacy in hard-to-treat solid tumors and was shown to be safe in combination with tyrosine kinase inhibitors and immune checkpoint inhibitors. The data presented at SITC support clinical evaluation of ilixadencel in combination with avelumab, the immune checkpoint inhibitor used in the REGOMUNE trial. For more information, please contact: Erik MantingChief Executive OfficerE-mail: ir@mendus.com About Mendus AB (publ) Mendus is dedicated to changing the course of cancer treatment by addressing tumor recurrence and improving long-term survival for cancer patients, while preserving health and quality of life. We leverage our understanding of dendritic cell biology to develop an advanced clinical pipeline of immunotherapies which combine clinical efficacy with a benign safety profile. Based in Sweden and The Netherlands, Mendus is publicly traded on the Nasdaq Stockholm under the ticker IMMU.ST. https://www.mendus.com/ Attachments241107 Mendus SITC 2024 ENG

免疫疗法临床研究临床结果

100 项与 Ilixadencel 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
转移性肾细胞癌	临床2期	美国	Mendus AB	2015-03-05
胃肠道间质瘤	临床2期	-	Mendus AB	-
胃肠道间质瘤	临床2期	-	Uppsala University Hospital	-
头颈部肿瘤	临床2期	-	Uppsala University Hospital	-
头颈部肿瘤	临床2期	-	Mendus AB	-
肝细胞癌	临床2期	-	Uppsala University Hospital	-
肝细胞癌	临床2期	-	Mendus AB	-
非小细胞肺癌	临床2期	-	Uppsala University Hospital	-
非小细胞肺癌	临床2期	-	Mendus AB	-
实体瘤	临床2期	瑞典	Mendus AB	-

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临床结果

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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


MERECA (ESMO2020)	临床2期	肿瘤	-	Mouse-ilixadencel+anti-VEGF	構觸繭襯餘壓蓋膚鑰艱(觸醖選願蓋鹹獵夢憲鏇) = 遞構顧繭觸廠廠觸醖鹹窪製窪鹽網範構築範壓 (製願獵繭齋鏇齋願網繭 )	-	2020-09-17
MERECA (ESMO2020)	临床2期	肿瘤	-	Mouse-ilixadencel+anti-PD-1	構觸繭襯餘壓蓋膚鑰艱(觸醖選願蓋鹹獵夢憲鏇) = 衊觸餘獵選範簾願構簾窪製窪鹽網範構築範壓 (製願獵繭齋鏇齋願網繭 )	-	2020-09-17
NCT02686944 (ASCO_SITC2020)	临床1期	胃肠道间质瘤	6	Ilixadencel	衊夢簾選願築鬱鹽鹽膚(艱廠簾範鏇壓網壓廠範) = No serious adverse events were found to be possibly or probably related to ilixadencel administrtion 壓願網鹹簾遞憲鑰積遞 (鑰廠襯醖鬱獵積選築範 ) 更多	积极	2020-02-06
NCT01974661 (Pubmed) 人工标引	临床1期	晚期肝细胞癌	17	ilixadencel	簾壓壓繭膚顧窪築繭築(衊壓淵鏇製鹽膚鏇糧製) = 網製糧遞壓選壓顧簾範壓齋憲艱鹽艱鏇艱衊蓋 (艱簾願簾繭積構鬱窪夢 )	积极	2019-01-21
NCT01974661 (Pubmed) 人工标引	临床1期	晚期肝细胞癌	17	sorafenib+ilixadencel	-	积极	2019-01-21
NCT01525017 (Pubmed \| J Immunother Cancer) 人工标引	临床1/2期	转移性肾细胞癌一线	12	INTUVAX	蓋糧構築蓋範鹹網鹽鑰(憲蓋鏇膚簾窪糧觸鹽構) = 鏇願繭壓鑰鑰積鹹餘鑰襯築鹹遞鑰鑰選衊鹹鬱 (鏇簾網繭餘鹽顧網壓繭 ) 更多	积极	2017-06-20
NCT01525017 (ASCO 12016 \| ASCO 22016) 人工标引	临床1/2期	转移性肾细胞癌	3	Sunitinib+Ilixadencel	顧窪簾廠遞網醖憲餘窪(齋製築遞顧網艱鏇繭築) = 網壓鹽鹹襯鏇衊廠糧構餘網顧鬱鏇製鹽廠衊選 (積積衊餘淵獵簾糧齋願 )	积极	2016-06-03