To-date ilixadencel has been tested in a range of clinical trials in various solid tumor indications including metastatic Renal Cell Carcinoma (mRCC), hepatocellular carcinoma (HCC) and gastrointestinal stromal tumors (GIST) and in combination with several standard-of-care cancer therapies such as the tyrosine kinase inhibitors Sutent® (sunitinib) and Stivarga® (regorafenib), and the

-- Median Overall Survival (OS) for the ilixadencel combination treatment group has been reached at 35.6 months, as compared to 25.3 months for the sunitinib control group, indicating a potential

To date, ilixadencel has been tested in a range of clinical trials for various solid tumor indications including mRCC, hepatocellular carcinoma (HCC), and gastrointestinal stromal tumors (GIST). We will review our rNPV model for ilixadencel in RCC once more details are known about the next stage of the development following the discussions with regulators and any potential partners. Immunicum’s H120 operating loss was SEK59.0m vs SEK62.3m a year ago, slightly lower as the MERECA study ended in around mid-2019. Press Release 31 December 2020 Immunicum AB Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma Immunicum AB announced today that it has received | … Hittills har ilixadencel testats i en rad kliniska prövningar i olika solida tumörindikationer inklusive metastaserande njurcancer (mRCC), hepatocellulärt carcinom (HCC) och gastrointestinal stromacellstumör (GIST) samt i kombination med olika typer av standardbehandling som tyrosinkinashämmarna Sutent® (sunitinib) och Stivarga® (regorafenib) och checkpointhämmaren … Press Release 31 December 2020Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC) 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 … Immunicum AB (publ), First North Premier: (IMMU.ST), ett bioteknikbolag som utvecklar nya immunaktiverande cancerbehandlingar för ett antal solida tumörer, offentliggör idag positiva topline resultat från den slutförda fas I/II studien som undersökt säkerhet och tolerans av ilixadencel, Immunicums ledande läkemedelskandidat, hos 18 patienter med avancerad levercancer (HCC). Immunicum erhöll särläkemedelsstatus, Orphan Drug Designation, från FDA för ilixadencel för behandling av levercancer, specifikt hepatocellular carcinoma (HCC).

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Here, we assessed ilixadencel as a single agent and combined with sorafenib in advanced HCC. Of 17 HCC patients enrolled, 12 patients received ilixadencel at the dose of 10 x 10 6 cells (six as monotherapy and six in combination with sorafenib), and five received ilixadencel at the dose of 20 x 10 6 cells as monotherapy. Immunicum erhöll särläkemedelsstatus, Orphan Drug Designation, från FDA för ilixadencel för behandling av levercancer, specifikt hepatocellular carcinoma (HCC). COVID-19 Immunicum har hittills inte haft någon väsentlig påverkan på verksamheten på grund av covid-19-pandemin. Designation (FTD) för ilixadencel för behandling av den sällsynta sjukdomen gastrointestinal stromalcellstumör (GIST). Vidare beviljade amerikanska FDA särläkemedelsstatus (Orphan Drug Designation) för ilixadencel in hepatocellular carcinoma (HCC). Vidare har ilixadencel utvecklats enligt plan i de pågående kliniska studierna. Hittills har ilixadencel testats i en rad kliniska prövningar i olika solida tumörindikationer inklusive metastaserande njurcancer (mRCC), hepatocellulärt carcinom (HCC) och gastrointestinal stromacellstumör (GIST) samt i kombination med olika typer av standardbehandling som tyrosinkinashämmarna Sutent® (sunitinib) och Stivarga® (regorafenib) och checkpointhämmaren Keytruda To-date ilixadencel has been tested in a range of clinical trials in various solid tumor indications including metastatic Renal Cell Carcinoma (mRCC), hepatocellular carcinoma (HCC) and gastrointestinal stromal tumors (GIST) and in combination with several standard-of-care cancer therapies such as the tyrosine kinase inhibitors Sutent® (sunitinib) and Stivarga® (regorafenib), and the checkpoint inhibitor Keytruda® (pembrolizumab).

Designation (FTD) för ilixadencel för behandling av den sällsynta sjukdomen gastrointestinal stromalcellstumör (GIST). Vidare beviljade amerikanska FDA särläkemedelsstatus (Orphan Drug Designation) för ilixadencel in hepatocellular carcinoma (HCC). Vidare har ilixadencel utvecklats enligt plan i de pågående kliniska studierna.

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

Press Release 31 December 2020 Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC) 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 … Designation for ilixadencel as a treatment for liver cancer, specifically Hepatocellular Carcinoma (HCC). Covid-19 » To date, Immunicum has not experienced any major impact to its operations owing to the Covid-19 pandemic. For further information, go to the risk section on … Several lines of evidence support immunotherapy in hepatocellular carcinoma (HCC).

FDA:s beslut grundar sig på resultaten från en klinisk fas I/II-studie av ilixadencel hos patienter med tumörer som inte går att avlägsna kirurgiskt och/eller spridd (metastaserad) levercancer (HCC). Ilixadencel är en cellbaserad och lagringsbar immunaktiverare för behandling av solida tumörer.

2020-12-31 · Ilixadencel is an off-the-shelf cell-based cancer immunotherapy developed for the treatment of solid tumors. Its active ingredient is activated allogeneic dendritic cells, derived from healthy Ilixadencel är en cell-baserad lagringsbar cancerimmunaktiverare som utvecklats för att aktivera patientens egna immunförsvar till att upptäcka och förstöra cancerceller, och därmed övervinna cancercellernas förmåga att undvika immunsystemets detektion och attack. Press Release 21 January 2019 Immunicum AB (publ) Announces Publication of Phase I/II Clinical Trial Results of Ilixadencel in Advanced Hepatocellular Carcinoma in Frontiers in Oncology 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 Ilixadencel är en cell-baserad lagringsbar cancerimmunaktiverare som utvecklats för att aktivera patientens egna immunförsvar till att upptäcka och förstöra cancerceller, och därmed övervinna cancercellernas förmåga att undvika immunsystemets detektion och attack. Here, we assessed ilixadencel as a single agent and combined with sorafenib in advanced HCC. Of 17 HCC patients enrolled, 12 patients received ilixadencel at the dose of 10 x 10 6 cells (six as monotherapy and six in combination with sorafenib), and five received ilixadencel at the dose of 20 x 10 6 cells as monotherapy.

Covid-19 » To date, Immunicum has not experienced any major impact to its operations owing to the Covid-19 pandemic. For further information, go to the risk section on … Several lines of evidence support immunotherapy in hepatocellular carcinoma (HCC). We have shown that intratumoral injections of the immune primer ilixadencel (pro-inflammatory allogeneic dendritic Immunicum AB (publ) erhåller särläkemedelsstatus, ODD, från FDA för ilixadencel för behandling av levercancer.
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The company was selected for an oral presentation at the ASCO-SITC Clinical Immuno-Oncology Symposium yesterday. The maturing data (24-month follow up) confirmed the separation of the Kaplan-Meier curves, which was projected in September 2019 at the time of the release of the final The last several weeks have been volatile for Immunicum and illustrate how complicated immunotherapy efficacy trials can be. On 29 August 2019, the company released top-line results from the Phase II MERECA study with ilixadencel plus the tyrosine kinase inhibitor (TKI) sunitinib in renal cell carcinoma (RCC). The co-primary survival endpoint at 18-months lacked positive signals, which led to The combination of ilixadencel plus sunitinib has demonstrated favorable survival compared with sunitinib alone in patients with newly diagnosed metastatic synchronous renal cell carcinoma, Immunicum AB announced in a press release.

FDA:s beslut grundar sig på resultaten från en klinisk fas I/II-studie av ilixadencel hos patienter med tumörer som inte går att avlägsna kirurgiskt och/eller spridd (metastaserad) levercancer (HCC). Ilixadencel är en cellbaserad och lagringsbar immunaktiverare för behandling av solida tumörer. Ilixadencel är på väg mot klinisk utveckling i sen fas.
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28 September 2017. Immunicum AB (publ) Announces Completion of HCC Phase I/II Clinical Study Press Release 31 December 2020 Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC) Immunicum AB … Press Release 31 December 2020 Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC) 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 … 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. To date, ilixadencel has been tested in a range of clinical trials for various solid tumor indications including mRCC, hepatocellular carcinoma (HCC), and gastrointestinal stromal tumors (GIST). We will review our rNPV model for ilixadencel in RCC once more details are known about the next stage of the development following the discussions with regulators and any potential partners.