Drugs / ilixadencel
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03735290 | Jan 2019 → Dec 2021 | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, head and neck squamous cell carcinoma, non-small cell lung carcinoma | Mendus | Terminated | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT02432846 | Apr 2015 → Jan 2021 | renal cell carcinoma | Mendus | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 35
| Date | Issuer | Release |
|---|---|---|
| 2024-11-07 | Mendus | Results Mendus to present preclinical data supporting the combination potential of ilixadencel with the immune checkpoint inhibitor avelumab at SITC 2024 mendus.com ↗ |
| 2023-12-22 | Mendus | Results Mendus announces clinical pipeline update mendus.com ↗
The final results of the MERECA trial confirm the decision not to pursue mRCC as a possible indication for ilixadencel. |
| 2023-08-16 | Mendus | Results Mendus publishes preclinical data demonstrating synergies of ilixadencel and 4-1BB-targeting immunotherapies mendus.com ↗
The data demonstrate the potential of proinflammatory allogeneic dendritic cells to significantly enhance the therapeutic efficacy of an anti-4-1BB antibody, delaying tumor growth and prolonging survival in murine colon carcinoma and melanoma models. |
| 2022-07-14 | Mendus | Results Mendus AB: Mendus Publishes Preclinical Data Demonstrating Significant Anti-Tumor Synergies of Intratumoral Immune Priming with CTLA-4 Inhibition mendus.com ↗
Intratumoral injection of allogeneic pro-inflammatory dendritic cells (“ilixadencel”) substantially and sustainably enhanced an otherwise ineffective systemic anti CTLA-4 treatment in an established in vivo cancer model |
| 2022-06-09 | Mendus | Regulatory Immunicum AB: Immunicum Received FDA Orphan Drug Designation for Ilixadencel as Treatment of Gastrointestinal Stromal Tumors (GIST) mendus.com ↗
Immunicum AB (“Immunicum” publ; IMMU.ST), a biopharmaceutical company focused on tumor recurrence and hard-to-treat established tumors, announced today that it has been granted an Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for ilixadencel in the treatment of Gastrointestinal Stromal Tumors (GIST). |
| 2022-04-28 | Mendus | Results Immunicum AB: Immunicum Publishes Phase II MERECA Trial Results of Ilixadencel in Kidney Cancer in European Urology Open Sciences mendus.com ↗
The MERECA study showed that the combination of ilixadencel with the tyrosine kinase inhibitor sunitinib was safe and associated with a positive trend for improved tumor response rate and overall survival, compared with sunitinib monotherapy (control group). |
| 2021-12-03 | Mendus | Results Immunicum Announces Completion of Phase Ib Portion and Early Closure of ILIAD Study mendus.com ↗
Responses to treatment were observed in patients previously treated with CPIs and not in CPI-naive patients. |
| 2021-07-26 | Mendus | Results Immunicum Announces Positive Review by Data Safety Monitoring Board for Phase Ib Part of ILIAD Study mendus.com ↗
The positive opinion by the DSMB was based on the absence of material safety issues during the trial and is the first confirmation of safety for the use of ilixadencel in combination with a checkpoint inhibitor. |
| 2021-05-03 | Mendus | Results Immunicum AB Presents Preclinical Data for Ilixadencel and DCP-001 at the 18th Cancer Immunotherapy Annual Meeting mendus.com ↗
The presentations cover updated preclinical data on the combination of ilixadencel with a checkpoint inhibitor targeting CTLA4 and new preclinical data on the mechanism of action of DCP-001 and its combination with the emerging immunotherapy target CD47. |
| 2021-02-22 | Mendus | Results Immunicum Announces Encouraging Signs of Survival Benefit in Phase II MERECA Trial of Ilixadencel in Kidney Cancer mendus.com ↗
As previously reported in August 2020, the co-primary endpoint of median OS was reached at 25.3 months in the sunitinib control group, while the median OS in the ilixadencel treatment group has now been reached at 35.6 months. |
| 2021-02-19 | Mendus | Regulatory Immunicum AB (publ) Receives Orphan Drug Designation from EMA for Ilixadencel as Treatment for Gastrointestinal Stromal Tumors (GIST) mendus.com ↗ |
| 2021-01-26 | Mendus | Regulatory Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment of Soft Tissue Sarcoma (STS) mendus.com ↗
Immunicum AB (publ; IMMU.ST) announced today that it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the Company’s lead candidate, ilixadencel, a cell-based, off-the-shelf immune primer, for the treatment of Soft Tissue Sarcoma (STS). |
| 2020-12-31 | Mendus | Regulatory Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC) mendus.com ↗
Immunicum AB (publ; IMMU.ST) announced today that it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the Company’s lead candidate, ilixadencel, a cell-based, off-the-shelf immune primer, for the treatment of Hepatocellular Carcinoma (HCC). |
| 2020-12-07 | Mendus | Regulatory Immunicum AB (publ) Receives FDA Fast Track Designation for Ilixadencel in Gastrointestinal Stromal Tumors (GIST) mendus.com ↗ |
| 2020-10-06 | Mendus | Results Immunicum AB (publ) Announces Next Safety and Enrollment Update for Phase Ib/II ILIAD Combination Trial mendus.com ↗
In addition, ilixadencel has maintained a consistent safety profile in the study to-date and the Dose Escalation Committee (DEC) confirmed there were no dose limiting toxicities. |
| 2020-09-17 | Mendus | Results Immunicum AB (publ) Presents Preclinical Data on Ilixadencel in Combination with Cancer Therapies and Immunotherapies at the 2020 Virtual ESMO Congress mendus.com ↗
Immunicum AB (publ: IMMU.ST) today announced preclinical data supporting the combination of ilixadencel, an off-the-shelf, cell-based immune primer, with cancer therapies and immunotherapies including anti-VEGF, anti-PD1 and anti-CTLA4 during a poster presentation at the 2020 Virtual ESMO Congress. |
| 2020-09-14 | Mendus | Results Immunicum AB (publ) Announces Publication of Abstract for the ESMO Virtual Congress 2020 mendus.com ↗
Intratumoral injection of allogeneic pro-inflammatory dendritic cells (ilixadencel) in combination with anti-CTLA-4 treatment induce complete tumor responses and anti-tumor immune memory in a mouse tumor model |
| 2020-08-18 | Mendus | Results Immunicum AB (publ) Announces Update on Survival Data from Phase II MERECA Trial of Ilixadencel in Kidney Cancer mendus.com ↗
Based on the updated survival data, the final median OS value was reached in the sunitinib control group, while the median OS has not yet been reached in the ilixadencel treatment group. |
| 2020-06-16 | Mendus | Results Immunicum AB (publ) Announces Publication of Phase I/II Clinical Trial Results of Ilixadencel in Gastrointestinal Stromal Tumors (GIST) in Cancer Immunology, Immunotherapy mendus.com ↗
The final data analysis showed that two out of six patients exhibited partial tumor responses, according to the Choi response criteria (i.e. 33% objective response rate). |
| 2020-06-15 | Mendus | Results Immunicum AB (publ) Announces Advancement to a Non-Staggered Inclusion Phase in the Phase Ib/II ILIAD Combination Trial mendus.com ↗
The Dose Escalation Committee (DEC) confirmed there were no dose limiting toxicities, therefore the study can move into the non-staggered inclusion phase. |
| 2020-05-06 | Mendus | Regulatory Immunicum AB (publ) Receives Regenerative Medicine Advanced Therapy Designation from FDA for Ilixadencel in Kidney Cancer mendus.com ↗
Immunicum AB (publ; IMMU.ST) announced today that it has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for the Company’s lead candidate, ilixadencel, a cell-based, off-the-shelf immune primer for the treatment of metastatic Renal Cell Carcinoma (mRCC). |
| 2020-02-06 | Mendus | Results Immunicum AB (publ) Presents Updated Data from Phase II MERECA Trial of Ilixadencel in Kidney Cancer at ASCO-SITC Clinical Immuno-Oncology Symposium mendus.com ↗
Immunicum AB (publ) announced today updated results from the randomized Phase II MERECA trial testing its off-the-shelf immune primer ilixadencel in combination with Sutent (sunitinib) first-line treatment regimen in newly diagnosed metastatic renal cell carcinoma (mRCC) patients. |
| 2019-10-21 | Mendus | Results Immunicum AB (publ) Announces Positive Preclinical Data on Ilixadencel in Combination with CTLA-4 Immune Checkpoint Inhibitor mendus.com ↗
Immunicum AB (publ) announced today results from a preclinical study examining ilixadencel, an off-the-shelf, cell-based immune primer, tested in combination with the immune checkpoint inhibitor CTLA-4. |
| 2019-10-01 | Mendus | Results Immunicum AB (publ) Announces Advancement to Next Dosage Group Level in Phase Ib/II ILIAD Combination Trial mendus.com ↗
The Company has received confirmation from the Dose Escalation Committee (DEC) that ilixadencel showed a favorable safety profile with no serious adverse events in combination with Keytruda® in three patients dosed with two intratumoral injections of 3 million cells. |
| 2019-09-25 | Mendus | Results Immunicum AB (publ) Announces Complete Topline Data Analysis from Phase II MERECA Trial mendus.com ↗
Immunicum AB (publ) announced today the complete analysis of the topline data from the exploratory Phase II MERECA clinical trial. |
| 2019-08-29 | Mendus | Results Immunicum AB (publ) Announces Positive Phase II MERECA Topline Results Including Complete Tumor Responses in Metastatic Renal Cell Carcinoma Patients mendus.com ↗ |
| 2019-06-12 | Mendus | Results Immunicum AB (publ) Announces Positive Topline Results from the Phase I/II Clinical Trial in GIST mendus.com ↗
Immunicum AB (publ) announced today the completion and positive topline results from its Phase I/II clinical trial examining the safety and tolerability of Immunicum’s lead candidate, ilixadencel, in combination with tyrosine kinase inhibitors (TKIs) in six patients with Gastrointestinal Stromal Tumors (GIST), a rare and difficult-to-treat disease indication. |
| 2019-01-21 | Mendus | Results Immunicum AB (publ) Announces Publication of Phase I/II Clinical Trial Results of Ilixadencel in Advanced Hepatocellular Carcinoma in Frontiers in Oncology mendus.com ↗
Immunicum AB (publ; IMMU.ST) announced today that the final data analysis from the exploratory clinical study of ilixadencel in patients with advanced hepatocellular carcinoma (HCC) has been published in the journal,Frontiers in Oncology. |
| 2018-10-22 | Mendus | Results Immunicum AB (publ) Presents Preclinical Results of Ilixadencel in Combination with Checkpoint Inhibitors and Immune Enhancers at ESMO 2018 mendus.com ↗
Immunicum AB (publ; IMMU.ST) announced today the presentation of preclinical results that showed anti-tumor synergy between its lead product ilixadencel and a checkpoint inhibitor or an immune enhancer in a poster at the European Society for Medical Oncology (ESMO) 2018 Congress. |
| 2018-07-23 | Mendus | Regulatory Immunicum AB (publ) Announces Protocol Approval by the FDA Enabling the Initiation of Expanded Multi-indication Phase Ib/II Combination Trial mendus.com ↗
Immunicum AB (publ; IMMU.ST) announced today that the U.S. Food and Drug Administration (FDA) has approved the clinical trial protocol for its planned Phase Ib/II trial to evaluate the safety and efficacy of intratumorally-administered ilixadencel in combination with checkpoint inhibitors (CPI). |
| 2018-04-03 | Mendus | Results Immunicum AB (publ) Provides Update on Ilixadencel Clinical Development Program mendus.com ↗
The final median overall survival for the patients is 48 months, which compares favorably with published historical data of 15-16 months overall survival for newly diagnosed mRCC patients treated with sunitinib alone. |
| 2018-03-20 | Mendus | Regulatory Immunicum AB: Immunicum AB (publ) Announces ATMP Certificate Granted by EMA to Ilixadencel for Manufacturing Quality and Non-clinical Data mendus.com ↗
Immunicum AB (publ; IMMU.ST) a biopharmaceutical company advancing a novel, immune-priming cancer treatment against a variety of solid tumors, announced today that its lead product candidate, ilixadencel, has been granted an Advanced Therapy Medicinal Product (ATMP) certificate following a review of manufacturing quality and non-clinical data by the European Medicines Agency (EMA). |
| 2017-11-10 | Mendus | Results Immunicum AB (publ) and Academic Collaborators Publish Preclinical Ilixadencel Mode of Action Data in Journal Oncoimmunology mendus.com ↗
The new data that now has been published, show the ability of ilixadencel, and corresponding allogeneic proinflammatory mouse dendritic cells, to stimulate several very important mechanisms to induce tumor-specific immune responses, |
| 2017-11-07 | Mendus | Results Immunicum AB (publ) Presents Further Preclinical Ilixadencel Mode of Action Data at Annual SITC Meeting mendus.com ↗
The preclinical results show how ilixadencel induces complementary immunological processes that are needed in order to prime the immune system to recognize and destroy cancer cells. |
| 2014-12-03 | Mendus | Results Immunicum reports continued promising survival data for INTUVAX-treated renal cancer patients mendus.com ↗
The median survival in the subgroup of five individuals who were initially classified as high-risk patients now stands at 19.8 months, compared with an expected median survival of nine months following current standard therapy. |
All press releases naming this drug 46 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ilixadencel | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03735290 ↗ |
| Known as | Intuvax | “Intuvax (INN: ilixadencel)” NCT02432846 ↗ |
| Modality | Cell therapy | “allogeneic, pro-inflammatory dendritic cells” NCT02432846 ↗ |
| Route | Other | “Intratumorally Administered Intuvax” NCT02432846 ↗ |