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.

Start Date14 Jan 2019

Sponsor / Collaborator

Mendus AB

[+1]

NCT02686944

/ CompletedPhase 1

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 If further tumor progression TKI will be withdrawn but if stable disease or objective response the patient will continue with TKI until progress.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.

Start Date01 Jun 2016

Sponsor / Collaborator

Mendus AB

NCT02432846

/ CompletedPhase 2

An Open-label, Randomized, Controlled, Multicenter, Phase II Study Evaluating Safety and Efficacy of Intratumorally Administered Intuvax Pre-nephrectomy Followed by Sunitinib Post-nephrectomy, Compared to Sunitinib Post-nephrectomy in Metastatic Renal Cell Carcinoma Patients

The purpose of this study is to compare tumor response, progression free survival (PFS) and overall survival (OS) in newly diagnosed mRCC patients treated with Intuvax (INN: ilixadencel) pre-nephrectomy followed by Sunitinib post-nephrectomy vs Sunitinib post-nephrectomy patients.

Start Date01 Apr 2015

Sponsor / Collaborator

Mendus AB

[+2]

100 Clinical Results associated with Ilixadencel

100 Translational Medicine associated with Ilixadencel

100 Patents (Medical) associated with Ilixadencel

Literatures (Medical) associated with Ilixadencel

01 Jun 2025·ARCHIVES OF ORAL BIOLOGY

Effect of intratumor dendritic cell vaccination with and without chemoradiation in induced oral squamous cell carcinoma of hamsters

Article

Author: Abouzaid, Basant Hamdy ; Amr, Nouran Mohamed ; Shoshan, Mohamed Monai ; Salem, Mohamed Labib

OBJECTIVES:

Oral squamous cell carcinoma represents an important health problem since its increasing incidence and persistent high mortality rates. The traditional therapies remain surgery and chemoradiation which have shown limited success in treating recurrent and metastatic cancers with multiple complications. Immunotherapy using dendritic cell vaccination is a rather novel approach that, yet, showed limited therapeutic efficacy in eradicating oral squamous cell carcinoma since the latter is known for its immunosuppressive microenvironment. Hence, there is pressing demand for adopting new multimodality approaches that would augment the antitumor effect of dendritic cell vaccine with lesser side effects and no relapse.

DESIGN:

Chemically induced oral squamous cell carcinoma model of hamster buccal pouch using 7,12-Dimethylbenz[a]anthracene was established. The clinically evident tumor masses were then 75 % surgically debulked. Resected tumors were manipulated to prepare dendritic cell vaccine. Animals were divided into 3 groups and subsequently subjected to different treatment approaches.

RESULTS:

The combination therapy of debulking surgery, chemoradiation, and intratumor dendritic cell vaccination significantly delayed tumor growth with complete regression of induced tumors. Moreover, this modality was associated with the highest survival rate (89 %) with establishment of immunological memory.

CONCLUSIONS:

Our findings emphasize the importance of modifying post-surgical environment, via co-administration of adjuvant chemoradiation, in generating robust anti-tumor immunologic activity. Chemoradiation and dendritic cell vaccines are available for clinical use/trial which endows this approach the merit of potential clinical application.

01 Feb 2025·Small science

Dendritic Cell Vaccine Harboring Inactivated Mycobacteria Induces Immune Protection Against Tuberculosis in Murine Models and is Well Tolerated in Humans

Article

Author: Xu, Jinchuan ; Wang, Huiling ; Yang, Heng ; Chen, Zhenyan ; Wang, Jing ; Huang, Xuejiao ; Liu, Xuhui ; Lu, Shuihua ; Gu, Ling ; Xia, Lu ; Hu, Zhidong ; Fan, Xiao‐Yong

The limited success of tuberculosis (TB) control measures reflects the inadequacy of Bacille Calmette‐Guérin (BCG), the only licensed TB vaccine. There is a recent resurgence of interest in intravenous administration of BCG. However, direct injection of live BCG bacteria into the bloodstream of human beings is not likely to be practical due to safety concerns. In this study, it is showed that debris of BCG‐infected macrophages induces activation and maturation of dendritic cells (DCs) in vitro, and an intravenous DCs vaccine phagocytosing noninfective cell debris induces robust antigen‐specific T‐cell immune responses and immune protection against Mycobacterium tuberculosis infection in murine models. Further, an investigator‐initiated clinical trial shows the safety of a DCs vaccine harboring the noninfective Mycobacterium vaccae vaccine. Infusions of naive DCs and DCs harboring Mycobacterium vaccae are well tolerated and safe in six active TB patients. Tests of the peripheral blood mononuclear cells of a patient who receives two doses of DCs vaccine infusion show enhanced secretion of IFN‐γ, IL‐2, IL‐17, and TNF‐α in both CD4 and CD8 T cells. The study provides evidence that DC‐based vaccines harboring inactivated mycobacteria can expand T‐cell immune responses in TB‐infected mice and are well tolerated in patients with active TB disease.

31 Dec 2024·Future Science OA

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

Article

Author: 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.

News (Medical) associated with Ilixadencel

12 Feb 2025

·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

Clinical ResultPhase 1ImmunotherapyPhase 2Executive Change

17 Dec 2024

·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

Immunotherapy

07 Nov 2024

·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

ImmunotherapyClinical StudyClinical Result

100 Deals associated with Ilixadencel

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Renal Cell Carcinoma	Phase 2	United States	Mendus AB	05 Mar 2015
Gastrointestinal Stromal Tumors	Phase 2	-	Uppsala University Hospital	-
Head and Neck Neoplasms	Phase 2	-	Uppsala University Hospital	-
Hepatocellular Carcinoma	Phase 2	-	Uppsala University Hospital	-
Non-Small Cell Lung Cancer	Phase 2	-	Uppsala University Hospital	-
Solid tumor	Phase 2	Sweden	Mendus AB	-
Advanced cancer	Phase 1	United States	Mendus AB	14 Jan 2019
Gastroesophageal junction adenocarcinoma	Phase 1	United States	Mendus AB	14 Jan 2019
Squamous Cell Carcinoma of Head and Neck	Phase 1	United States	Mendus AB	14 Jan 2019
stomach adenocarcinoma	Phase 1	United States	Mendus AB	14 Jan 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02432846 (MERECA, Pubmed \| Cancer Immunol Immunother) Manual	Phase 1	Gastrointestinal Stromal Tumors	6	ilixadencel	bmwpzqqtff(yfivwbwioy) = hitvdnazhq swsykqkdvz (qtpggbbcoo ) View more	Positive	01 Nov 2020
MERECA (ESMO2020)	Phase 2	Neoplasms	-	Mouse-ilixadencel+anti-VEGF	ukxdmbfiyd(wcefoqwgpp) = cbjjcsieau xlxmspnjex (neamsdlgyv )	-	17 Sep 2020
				Mouse-ilixadencel+anti-PD-1	ukxdmbfiyd(wcefoqwgpp) = yncsatxcrd xlxmspnjex (neamsdlgyv )
NCT02686944 (ASCO_SITC2020)	Phase 1	Gastrointestinal Stromal Tumors	6	Ilixadencel	omvxeplukb(buapplphec) = No serious adverse events were found to be possibly or probably related to ilixadencel administrtion lmjoumbsow (zbwlxbvqwf ) View more	Positive	06 Feb 2020
NCT02432846 (MERECA, ASCO_SITC2020)	Phase 2	Metastatic Renal Cell Carcinoma First line	88	Ilixadencel plus sunitinib	vstovootxf(hgsthhafyo) = Treatment with ilixadencel did not add any treatment-related Grade 3-4 Adverse Events kqauaogfvq (gaxvurgcaf ) View more	Positive	06 Feb 2020
				Sunitinib
NCT02432846 (MERECA, PipelineReview) Manual	Phase 2	Metastatic Renal Cell Carcinoma First line	70	Sunitinib Malate+ilixadencel (two intratumoral doses of ilixadencel before nephrectomy and subsequent treatment with Sunitinib Malate)	dquiytirdg(ibrdiiojil) = Median overall survival has not yet been reached in either group cxlgcvuole (qeplqaskvi ) View more	Positive	29 Aug 2019
				Sunitinib Malate (Sunitinib Malate therapy alone post-nephrectomy)
NCT01974661 (Pubmed) Manual	Phase 1	Advanced Hepatocellular Carcinoma	17	ilixadencel	nlkmwabnbi(fgufakftjh) = lpntywohjf knzstvbgpa (idtbenkpdz )	Positive	21 Jan 2019
				sorafenib+ilixadencel	-
NCT01525017 (Pubmed \| J Immunother Cancer) Manual	Phase 1/2	Metastatic Renal Cell Carcinoma First line	12	INTUVAX	tssuksplof(vmnmuyzlbr) = tfnpujsokg xxjfqlcscl (vqhhkeefrm ) View more	Positive	20 Jun 2017
NCT01525017 (ASCO 12016 \| ASCO 22016) Manual	Phase 1/2	Metastatic Renal Cell Carcinoma	3	Sunitinib+Ilixadencel	gxpigxnjir(pqylfttzhe) = twvnqrrofp kueugiriul (vvvbuhdnjh )	Positive	03 Jun 2016

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