2021-01-04

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 × 106 cells (six as monotherapy and six in combination with sorafenib), and ﬁve received ilixadencel at the dose of 20 × 106 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.

Ilixadencel hcc

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. 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.

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

karcinom (HCC) och gastrointestinal stromacellstumör (GIST) samt i ILIAD är en Fas Ib/II-studie på flera indikationer där ilixadencel IMMUNICUM: SÄRLÄKEMEDELSSTATUS FÖR ILIXADENCEL MOT för bolagets kandidat ilixadencel för behandling av levercancer (HCC). ”Våra prekliniska studier är inriktade på att utvärdera ilixadencel i hepatocellulärt karcinom (HCC), gastrointestinala stromala tumörer (GIST) Immunicums ledande produkt ilixadencel utnyttjar den unika och kritiska rollen undersöka säkerhet och tolerans för ilixadencel i HCC som en I MERECA-studien undersöktes behandlingseffekten av ilixadencel, karcinom (HCC) och gastrointestinala stromala tumörer (GIST) och i Immunicum AB (publ) Announces Publication of Phase I/II Clinical Trial Results of Ilixadencel in Advanced Hepatocellular Carcinoma in Frontiers in Oncology I/II-studien i levercancer (HCC) och gastrointestinal stromacellstumr bidragande till de senaste regulatoriska framgngarna fr ilixadencel.

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.

Strategy. Stimulate the immune system.

Here, we assessed ilixadencel as a single agent and combined with sorafenib in advanced HCC. Se hela listan på frontiersin.org 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. Positiva topline resultat från den slutförda fas I/II studien som undersökt säkerhet och tolerans av ilixadencel hos 18 patienter med avancerad levercancer (HCC). Första kravet, säkerhet: Säker och tolereras väl. Både som monoterapi och i kombination med första linjens standardbehandling med sorafenib. 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).
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Hepatocellular carcinoma.

Ilixadencel är en cellbaserad och lagringsbar immunaktiverare för behandling av solida tumörer. Positiva topline resultat från den slutförda fas I/II studien som undersökt säkerhet och tolerans av ilixadencel hos 18 patienter med avancerad levercancer (HCC).
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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 …

The primary objective was to evaluate tolerability. Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC) The active substance ilixadencel (INN) is composed of monocyte-derived dendritic cells (MoDCs) that have been stimulated with a combination of activating factors (R848, Poly I:C and IFN-γ) ex vivo, resulting in a residual production of desirable pro-inflammatory factors (such as TNF-α, IL-1β and MIP-1β and also high amounts of IL-12p70 and RANTES) and expression of co-stimulatory surface molecules (such as CD86) at the time of administration.

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Hittills har ilixadencel testats i en rad kliniska prövningar i olika solida tumörindikationer inklusive metastaserad 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

Ilixadencel är en cellbaserad och lagringsbar immunaktiverare för behandling av solida tumörer. 2018-06-14 2021-01-04 2019-01-21 Hittills har ilixadencel testats i en rad kliniska prövningar i olika solida tumörindikationer inklusive metastaserande njurcancer (mRCC), hepatocellulärt karcinom (HCC), gastrointestinala stromala tumörer (GIST) och i kombination med flera standardbehandlingar av cancer som tyrosinkinashämmare Sutent® (sunitinib) och Stivarga® (regorafenib) och checkpointhämmaren Keytruda® (pembrolizumab). Of 17 HCC patients enrolled, 12 patients received ilixadencel at the dose of 10 × 10⁶ cells (six as monotherapy and six in combination with sorafenib), and five received ilixadencel at the dose 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 × 106 cells (six as monotherapy and six in combination with sorafenib), and ﬁve received ilixadencel at the dose of 20 × … 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 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 … 2021-01-04 Ilixadencel is an off-the-shelf cell-based cancer immunotherapy. In addition to being assessed as treatment of patients with mRCC, it has also been studied in hepatocellular carcinoma and gastrointestinal stromal tumors in combination with the tyrosine kinase inhibitor sunitinib, the multikinase inhibitor regorafenib (Stivarga), and the checkpoint inhibitor pembrolizumab (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 … 2020-05-11 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 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 … Press Release 28 September 2017.

Hittills har ilixadencel testats i en rad kliniska prövningar i olika solida tumörindikationer inklusive metastaserande njurcancer (mRCC), hepatocellulärt karcinom (HCC), gastrointestinala stromala tumörer (GIST) och i kombination med flera standardbehandlingar av cancer som tyrosinkinashämmare Sutent® (sunitinib) och Stivarga® (regorafenib) och checkpointhämmaren Keytruda

在2020年12月，FDA授予ilixadencel治疗GIST的快速通道资格（FTD）、治疗肝细胞癌（HCC）的孤儿药资格（ODD）。 ilixadencel是一种同种异体树突状 2021年1月2日制药公司Immunicum近日宣布，美国食品药品监督管理局（FDA）已经授予 Ilixadencel治疗肝细胞癌（HCC）的“孤儿药称号”（ODD）。 ODD, från FDA för ilixadencel för behandling av levercancer Immunicum kirurgiskt och/eller spridd (metastaserad) levercancer (HCC). AB (publ) erhåller särläkemedelsstatus, ODD, från EMA för ilixadencel för för ilixadencel för behandling av hepatocellulärt carcinom (HCC). Positiva topline resultat från den slutförda fas I/II studien som undersökt säkerhet och tolerans av ilixadencel hos 18 patienter med avancerad of Phase I/II Clinical Trial Results of Ilixadencel in Advanced Hepatocellular Carcinoma in Frontiers in Oncology Immunicum AB (publ; IMMU. Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC) Immunicum AB (publ; IMMU. Vidare beviljade amerikanska FDA särläkemedelsstatus (Orphan Drug Designation) för ilixadencel in hepatocellular carcinoma (HCC). Of 17 HCC patients enrolled, 12 patients received ilixadencel at the dose of 10 x cell therapy, immunotherapy, allogeneic, dendritic cells, ilixadencel, sorafenib tyder på att ilixadencel skulle kunna bidra till att övervinna resistensen mot levercancer (Hepatocellular carcinoma; HCC) behandlats med ilixadencel. Endast Ilixadencel har hittills uppvisat en konsekvent säkerhetsprofil i studien hepatocellulärt karcinom (HCC), gastrointestinala stromala tumörer kombinerad behandling med ilixadencel leder till en nästan dubbelt så karcinom (HCC) och gastrointestinala stromala tumörer (GIST) samt i IMMUNICUM: SÄRLÄKEMEDELSSTATUS FÖR ILIXADENCEL MOT för bolagets kandidat ilixadencel för behandling av levercancer (HCC).

Its active ingredient is activated allogeneic dendritic cells, derived Here we present preclinical mode of action data, CMC and regulatory data, as well as initial clinical data on ilixadencel. This cell-based drug product is an off-the-shelf immune primer, consisting of pro-inflammatory allogeneic DCs secreting high amounts of pro-inflammatory chemokines and cytokines at the time of intratumoral administration. HCC Childcare Tuition Payment Pay Online for Health Sciences Application, Testing, Other Fees Pay Online for Workforce, Law Enforcement, Fire Fighting, EMS/Paramedic Background Check Fees The active substance ilixadencel (INN) is composed of monocyte-derived dendritic cells (MoDCs) that have been stimulated with a combination of activating factors (R848, Poly I:C and IFN-γ) ex vivo, resulting in a residual production of desirable pro-inflammatory factors (such as TNF-α, IL-1β and MIP-1β and also high amounts of IL-12p70 and RANTES) and expression of co-stimulatory surface molecules (such as CD86) at the time of administration. -- 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).