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 If further tumor progression TKI will be withdrawn but if stable disease or objective response the patient will continue with TKI until progress.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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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: Laux, Douglas ; Rovers, Jeroen ; Bajor, David ; Karlsson-Parra, Alex ; Hamm, John ; Weiss, Jared ; Lockhart, Albert C.

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.

2023-01-01·Acta Radiologica4区 · 医学

Evaluation of response in patients with hepatocellular carcinoma treated with intratumoral dendritic cell vaccination using intravoxel incoherent motion (IVIM) MRI and histogram analysis

4区 · 医学

Article

作者: Jalnefjord, Oscar ; Rizell, Magnus ; Montelius, Mikael ; Sternby Eilard, Malin ; Andersson, Mats ; Ljungberg, Maria

Background Immunotherapy of hepatocellular carcinoma (HCC) is an emerging method with promising results. Immunotherapy can have an antitumor effect without affecting tumor size, calling for functional imaging methods for response evaluation. Purpose To evaluate the response to intratumoral injections with the immune primer ilixadencel in HCCs with diffusion-weighted magnetic resonance imaging (DW-MRI) using intravoxel incoherent motion (IVIM) and histogram analysis. Material and Methods A total of 17 patients with advanced HCC were treated with intratumoral injections with ilixadencel on three occasions 2–5 weeks apart. The patients were examined with IVIM before each injection as well as approximately three months after the first injection. Results The 10th percentile of perfusion-related parameter D* decreased significantly after the first and second intratumoral injections of ilixadencel compared to baseline ( P < 0.05). There was a non-significant trend of lower median region of interest f (perfusion fraction) before injection 2 compared to baseline ( P = 0.07). There were significant correlations between the 10th percentile and median of D at baseline and change in tumor size after three months ( r = 0.79, P < 0.01 and r = 0.72, P < 0.05, respectively). Conclusion DW-MRI with IVIM and histogram analysis revealed significant reductions of D* early after treatment as well as an association between D at baseline and smaller tumor growth at three months. The lower percentiles (10th and 50th) were found more important. Further research is needed to confirm our preliminary findings of reduced perfusion after ilixadencel vaccinations, suggesting a treatment effect on HCC.

2022-12-31·OncoImmunology

Intratumoral administration of pro-inflammatory allogeneic dendritic cells improved the anti-tumor response of systemic anti-CTLA-4 treatment via unleashing a T cell-dependent response

Article

作者: Iskantar, Alexandros ; Fotaki, Grammatiki ; Ali, Arwa ; Wang, Hai ; Yu, Di ; Jin, Chuan ; Essand, Magnus ; Karlsson-Parra, Alex

Immune checkpoint inhibitors (ICIs) have revolutionized the oncology field. However, a significant number of patients do not respond, at least partly due to the lack of preexisting anti-tumor T-cell immunity. Therefore, it is emergent to add an immune-priming step to improve efficacy. Here, we report a combined approach consisting of intratumoral administration of pro-inflammatory allogeneic dendritic cells (AlloDCs) and systemic treatment with αCTLA-4 that can drastically improve the anti-tumor efficacy compared to αCTLA-4 monotherapy. When evaluated in mice with large established CT-26 tumors, monotherapy with αCTLA-4 neither delayed tumor progression nor improved mice survival. However, combination treatment of AlloDCs and αCTLA-4 drastically improved the effectiveness, with 70% of mice being cured. This effect was T cell-dependent, and all survived mice rejected a subsequent tumor re-challenge. Further investigation revealed an immune-inflamed tumor microenvironment (TME) in the combination treatment group characterized by enhanced infiltration of activated antigen-presenting endogenous DCs and CD8⁺ T cells with a tissue-resident memory (T_RM) phenotype (CD49a⁺CD103⁺). This correlated with elevated levels of tumor-specific CD39⁺CD103⁺CD8⁺ T cells in the tumor and "tumor-matching" NKG2D⁺CD39⁺CX3CR1⁺CD8⁺ T cells in peripheral blood. Moreover, splenocytes from mice in the combination treatment group secreted significantly higher IFN-γ upon stimulation with the peptide from the endogenous CT-26 retroviral gp70 (model neoantigen), confirming the induction of a tumor-specific CD8⁺ T-cell response. Taken together, these data indicate a strong anti-tumor synergy between AlloDCs and αCTLA-4 that warrant further clinical investigation with the corresponding human AlloDC product (ilixadencel) for patients receiving αCTLA-4 therapy.

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	-	Uppsala University Hospital	-
胃肠道间质瘤	临床2期	-	Mendus AB	-
头颈部肿瘤	临床2期	-	Mendus AB	-
头颈部肿瘤	临床2期	-	Uppsala University Hospital	-
肝细胞癌	临床2期	-	Mendus AB	-
肝细胞癌	临床2期	-	Uppsala University Hospital	-
非小细胞肺癌	临床2期	-	Mendus AB	-
非小细胞肺癌	临床2期	-	Uppsala University Hospital	-
实体瘤	临床2期	瑞典	Mendus AB	-

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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


MERECA (ESMO2020)	临床2期	肿瘤	-	Mouse-ilixadencel+anti-VEGF	淵構夢醖壓顧膚網顧憲(餘鹽鹽鹽簾醖艱壓範窪) = 顧壓顧鬱鹽夢選襯艱鹹遞齋鹽壓築築餘艱艱淵 (膚廠顧製製遞願觸築襯 )	-	2020-09-17
MERECA (ESMO2020)	临床2期	肿瘤	-	Mouse-ilixadencel+anti-PD-1	淵構夢醖壓顧膚網顧憲(餘鹽鹽鹽簾醖艱壓範窪) = 鑰糧觸網膚遞糧網築鑰遞齋鹽壓築築餘艱艱淵 (膚廠顧製製遞願觸築襯 )	-	2020-09-17
NCT02686944 (ASCO_SITC2020)	临床1期	胃肠道间质瘤	6	Ilixadencel	遞構築糧網窪壓衊築齋(餘夢築膚糧衊鹽淵範簾) = No serious adverse events were found to be possibly or probably related to ilixadencel administrtion 鏇壓鹹選鑰鏇獵膚網鹽 (鏇構窪觸膚夢齋鬱繭築 ) 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	(鹹網繭艱築觸簾網鹽鏇) = 鏇積鏇鑰餘膚醖鏇鑰醖膚廠廠鑰淵積選顧製壓 (遞膚鏇鏇淵構獵鏇鹹膚 )	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	(鬱鏇艱鑰夢鑰憲獵簾淵) = 齋糧願築憲膚壓構艱鏇壓築淵選壓製襯選窪遞 (蓋構窪襯衊遞鏇鑰醖餘 ) 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	(積鹹膚襯壓網選築鑰衊) = 憲糧窪夢獵齋艱齋餘網顧範獵醖製選構簾壓鏇 (醖觸醖艱構鹹膚鏇艱築 )	积极	2016-06-03