2020-12-10 · Datamonitor Healthcare estimates that in 2018, there were 338,000 incident cases of renal cell carcinoma (RCC) worldwide in those aged 40 years and older, and forecasts that number to increase to 384,000 cases by 2027. The majority (75%) of RCC cases have a clear cell histology (ccRCC), to which most first-line treatment regimens are specialized.

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2019-09-25 · Ilixadencel, a cell therapy product, is an off-the-shelf cancer immune primer, developed for the treatment of solid tumors. Its active ingredient is activated allogeneic dendritic cells, derived

Jan 27, 2021 Ilixadencel Gets Orphan Drug Designation for Soft Tissue Sarcoma was conducted in patients with metastatic renal cell carcinoma (RCC). Sep 10, 2019 A combination therapy of ilixadencel plus sunitinib (Sutent) achieved complete tumor responses in patients with metastatic renal cell carcinoma  Aug 26, 2020 The combination of the off-the-shelf cancer immune primer Ilixadencel and sunitinib has demonstrated promising survival benefit when used as  Jun 20, 2017 At the time of inclusion, all 12 patients were assessed as RCC with at by ELISpot at baseline and 2 weeks after the second ilixadencel dose. To-date ilixadencel has been tested in a range of clinical trials in various solid tumor indications including metastatic Renal Cell Carcinoma (mRCC),  May 4, 2015 Condition or disease, Intervention/treatment, Phase. Renal Cell Carcinoma, Metastatic, Biological: Intuvax (ilixadencel) Drug: Sunitinib, Phase  Dec 20, 2019 in renal cell carcinoma in October. And Immunicum turned in disappointing data from a trial comparing its dendritic cell vaccine ilixadencel to  14 feb 2020 Addition of intratumoral ilixadencel to sunitinib improved responses in patients with newly diagnosed synchronous metastatic renal cell  18 feb 2021 för ilixadencel för behandling av gastrointestinal stromacellstumör (GIST) för behandling av patienter med metastaserad njurcancer (RCC). Cytoreductive nephrectomy for metastatic renal cell carcinoma, the ultimate urologic The proposed mechanism of action of CN rests on the principle that RCC A randomized phase II study with ilixadencel, a cell-based immune primer, Dec 2, 2019 The study evaluated the therapeutic impact of ilixadencel in combination with Sutent (sunitinib), a TKI, in metastatic renal cell carcinoma (RCC)  be overexpressed by cancers such as renal cell carcinoma (RCC) and glioma. Upon intratumoral injection of ilixadencel, the dendritic cells (DCs) release  Sep 17, 2020 advanced renal cell carcinoma (RCC) patients in the CheckMate-214 treated with the combination of ilixadencel and anti-CTLA4 showed a  2020年5月12日 ilixadencel的活性成分是来源于健康献血者的树突状细胞(DC),这些 支持了 ilixadencel作为一种免疫触发剂在肾细胞癌(RCC)和其他实体  In addition to MCC, UC and RCC, these cancers include breast, was with Immunicum to investigate avelumab in combination with ilixadencel, an off-the- shelf,  Nov 10, 2015 Clinical studies have used systemic administration of IL‐12 in patients with melanoma, RCC and colon cancer, unfortunately this approach was  There has been no clinically useful diagnostic or prognostic biomarker for renal cell carcinoma (RCC).

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According to the latest (July) follow-up update from the MERECA trial (ilixadencel in renal cell carcinoma; RCC), the mOS was reached at 25.3 months in the sunitinib (control) group, while in the ilixadencel plus sunitinib group the mOS has not been reached yet. In the ilixadencel group, 43% of patients were still alive, vs 33% in the control group. Ilixadencel According to their website, Ilixadencel, Immunicum AB’s lead development candidate, is an off-the-shelf cell-based cancer immunotherapy indicated for treatment of hepatocellular carcinoma, gastrointestinal stromal tumors and mRCC. Eftersom ilixadencel har uppnått Proof of Concept i RCC i kombination med sunitinib är nästa kritiska steg att identifiera rätt väg att påskynda utvecklingen av ilixadencel mot marknaden och i slutändan till patienter. Sammantaget indikerar resultaten att ilixadencel bidragit med en positiv systemisk behandlingseffekt samtidigt som säkerhet och tolerabilitets-profilen var positiv. Dessa data stödjer en fortsatt klinisk utveckling av ilixadencel som en immunprimer vid RCC och andra solida tumörer. All toxicities associated with ilixadencel were found to be transient and had resolved before the end of the trial.

Fas II (MERECA) pågår. I princip helt avgörande studie för ilixadencel. 90 patienter (60/30) nästan 30 studiecentra i  Produkt-lanseringar med ilixadencel, för RCC (njurcancer) och NSCLC (icke småcellig lungcancer) utgör 25 respektive 35 procent av värdet enligt Edison.

May 20 · FDA grants Regenerative Medicine Advanced Therapy (RMAT) designation to ilixadencel for the treatment of mRCC. The decision was made based on the results from the MERECA trial. Feb 20 · In its latest corporate presentation, Immunicum reports that clinical GMP manufacturing is in place and commercial scale activities initiated.

Ilixadencel has been tested in these cancers in combination with several standard-of-care cancer therapies like chemotherapy. 2018-06-07 The first half of the year for one of Sweden’s top immuno-oncology (IO) companies, Immunicum, has been one of continued progress for the company’s main project, MERECA, which is exploring the effects of their off-the-shelf IO candidate ilixadencel in combination with the tyrosine kinase inhibitor (TKI) sunitinib in metastatic Renal Cell Carcinoma (RCC) patients.

May 4, 2015 Condition or disease, Intervention/treatment, Phase. Renal Cell Carcinoma, Metastatic, Biological: Intuvax (ilixadencel) Drug: Sunitinib, Phase 

The decision was made based on the results from the MERECA trial. Feb 20 · In its latest corporate presentation, Immunicum reports that clinical GMP manufacturing is in place and commercial scale activities initiated.

Unlike other intelligence solutions, BCIQ exclusively supports the unique needs of the biopharma industry and Under 2020 beviljade den amerikanska läkemedelsmyndigheten FDA Immunicum Regenerative Medicine Advanced Therapy (RMAT) designation för njurcancer (RCC) och Fast Track Designation (FTD) för ilixadencel för behandling av den sällsynta sjukdomen gastrointestinal stromalcellstumör (GIST).
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The trial evaluated the efficacy and safety of ilixadencel combined with the targeted anticancer drug Sutent (common name: sunitinib, sunitinib; developed by Pfizer) in the first-line treatment of patients with newly diagnosed metastatic renal cell carcinoma (mRCC). It insists that the response rate data warrants the continued clinical development of ilixadencel in RCC – the most common form of kidney cancer – as well as “other solid tumour indications.” Ilixadencel is an off-the-shelf cell-based immunotherapy indicated for solid tumors like hepatocellular carcinoma, gastrointestinal stromal tumors, and mRCC. Ilixadencel has been tested in these cancers in combination with several standard-of-care cancer therapies like chemotherapy. 2018-06-07 The first half of the year for one of Sweden’s top immuno-oncology (IO) companies, Immunicum, has been one of continued progress for the company’s main project, MERECA, which is exploring the effects of their off-the-shelf IO candidate ilixadencel in combination with the tyrosine kinase inhibitor (TKI) sunitinib in metastatic Renal Cell Carcinoma (RCC) patients. According to the latest (July) follow-up update from the MERECA trial (ilixadencel in renal cell carcinoma; RCC), the mOS was reached at 25.3 months in the sunitinib (control) group, while in the ilixadencel plus sunitinib group the mOS has not been reached yet.

Under 2020 beviljade den amerikanska läkemedelsmyndigheten FDA Immunicum Regenerative Medicine Advanced Therapy (RMAT) designation för njurcancer (RCC) och Fast Track Designation (FTD) för ilixadencel för behandling av den sällsynta sjukdomen gastrointestinal stromalcellstumör (GIST). 2020-12-10 · Datamonitor Healthcare estimates that in 2018, there were 338,000 incident cases of renal cell carcinoma (RCC) worldwide in those aged 40 years and older, and forecasts that number to increase to 384,000 cases by 2027. The majority (75%) of RCC cases have a clear cell histology (ccRCC), to which most first-line treatment regimens are specialized. A phase 2 clinical trial with a new treatment called ilixadencel in combination with sunitinib has shown to improve overall survival in newly diagnosed patients with metastatic renal cell carcinoma (RCC).
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the Phase II MERECA trial with ilixadencel delivered a positive surprise. newly diagnosed and had metastatic renal cell carcinoma (RCC), 

That is a cancer that has spread from the kidneys to other parts of the body. The mechanism of action of ilixadencel is to induce recruitment and activation of endogenous immune cells, including NK cells that subsequently promotes cross-presentation of cell-associated tumor antigens by co-recruited DCs. Intratumoral administration of an immune primer is a therapeutic vaccine strategy aimed to trigger dendritic cell 7 maj, 2020. Immunicum’s lead candidate, ilixadencel, just got a big boost in its development by being granted regenerative medicine advanced therapy designation by the FDA. The regulatory measure is designed to get promising new cell or gene therapies to market faster, and a clear signal that the FDA sees high potential in ilixadencel. Ilixadencel is an off-the-shelf dendritic cell-based primer, designed to elicit an anticancer immune response when injected intratumorally.


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14 feb 2020 Addition of intratumoral ilixadencel to sunitinib improved responses in patients with newly diagnosed synchronous metastatic renal cell 

Feb 20 · In its latest corporate presentation, Immunicum reports that clinical GMP manufacturing is in place and commercial scale activities initiated. 2017-06-23 The treatment appears to be well tolerated, with ilixadencel not appearing to cause any additional serious adverse events.