“GIST är i hög grad resistent mot konventionell strål- och cellgiftsbehandling, och att vi nu har erhållit särläkemedelsstatus grundat på de positiva data från vår kliniska Fas I/II-studie skapar ytterligare momentum för vår pipeline och uppmuntrar oss i vår ambition att ta ilixadencel till patienterna så snabbt som möjligt”.
2019 var ett viktigt år för Immunicum. Resultaten från Mereca- och GIST-studierna uppvisar tydliga och lovande kliniska resultat för ilixadencel i
Pressmeddelande. 7 december 2020. Immunicum AB (publ) erhåller Fast Track Designation från FDA för ilixadencel för behandling av GIST . Immunicum AB (publ) (IMMU.ST) tillkännager idag att GIST/sarkom för sällsynta och svårbehandlade sjukdomar - beprövad indikation och kombination 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.
Pressmeddelande. 7 december 2020. In December 2020, Immunicum announced that it received Fast Track Designation from the FDA for ilixadencel in Gastrointestinal Stromal Tumors (GIST) and Orphan Drug Designation by the FDA for ilixadencel in hepatocellular carcinomas. In January of this year, the company announced FDA Orphan Drug Designation for ilixadencel in STS. Pressmeddelande 19 februari 2021 Immunicum AB (publ) erhåller särläkemedelsstatus, ODD, från EMA för ilixadencel för behandling av gastrointestinal stromacells Pressmeddelande. 19 februari 2021 . Immunicum AB (publ) erhåller särläkemedelsstatus, ODD, från EMA för ilixadencel för behandling av gastrointestinal stromacellstumör (GIST) 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® (pembrolizumab). Immunicum AB (publ) meddelar att resultaten från fas I/II-studien med Ilixadencel vid gastrointestinala stromacellstumörer (GIST) publicerats i Cancer Immunology, Immunotherapy 2020-12-07 · Immunicum announced positive topline results from the Phase I/II open-label, single arm clinical trial evaluating ilixadencel in combination with different TKIs in patients with GIST in June 2019.
15 May 2020 as a fourth-line treatment for advanced gastrointestinal stromal tumor (GIST), a type of tumor that originates in the gastrointestinal tract.
Covid-19 » To date, Immunicum has not experienced any major impact to its operations as a result of the COVID-19 pandemic but it is a risk that the recruitment of patients to the ongoing ILIAD trial will be delayed since it’s Press Release 26 January 2021 Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment of Soft Tissue Sarcoma (STS) Immunicum AB … GIST is a rare and difficult-to-treat disease and the trial showed that ilixadencel in combination with different tyrosine kinase inhibitors (TKIs) had a favorable safety profile and provided initial signals of clinical benefit, with two out of six patients showing tumor shrinkage despite previous tumor progression on the same TKI. Immunicum AB (publ) (IMMU.ST) tillkännager idag att bolaget har erhållit Fast Track Designation från den amerikanska läkemedelsmyndigheten, FDA, för bolagets ledande kandidat ilixadencel, en cellbaserad och lagringsbar immunaktiverare, för behandling av den sällsynta sjukdomen gastrointestinal stromacellstumör (GIST). Press Release 7 December 2020 Immunicum AB (publ) Receives FDA Fast Track Designation for Ilixadencel in Gastrointestinal Stromal Tumors (GIST) Immunicum AB (publ; IMMU.ST) announced today that it has received Fast Track Designation (FTD) 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 About the GIST study The GIST study, completed in June 2019, was a Phase I/II open-label, single arm clinical trial conducted at the Karolinska University Hospital in Stockholm that evaluated the safety and efficacy of ilixadencel in unresectable or metastatic GIST patients with tumor progression during ongoing second, third- or fourth-line treatment with TKI therapy.
2020-12-07
In addition to GIST, Ilixadencel has also been tested in clinical trials for patients with metastatic renal cell carcinoma, hepatocellular carcinoma. Phase I Trial Evaluating Safety and Efficacy of Intratumorally Administered Inflammatory Allogeneic Dendritic Cells (Ilixadencel) in Advanced Gastrointestinal Stromal Tumors Phase I Trial Evaluating Safety and Efficacy of Intratumorally Administered Inflammatory Allogeneic Dendritic Cells (Ilixadencel) in Advanced Gastrointestinal Stromal Tumors 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 15 Background: Ilixadencel is a cell-based, off-the-shelf product based on allogeneic monocyte-derived inflammatory cells aimed to prime an anti-cancer immune response when injected intratumorally. The present single arm Phase I trial (ClinicalTrials.gov Identifier: NCT02686944) assessed the safety and efficacy of ilixadencel in subjects with progressing advanced/metastatic GIST despite Immunicum AB (publ) Receives Orphan Drug Designation from EMA for Ilixadencel as Treatment for Gastrointestinal Stromal Tumors (GIST) In December 2020, Immunicum announced that it received Fast Track Designation from the FDA for ilixadencel in Gastrointestinal Stromal Tumors (GIST) and Orphan Drug Designation by the FDA for ilixadencel in hepatocellular carcinomas. In January of this year, the company announced FDA Orphan Drug Designation for ilixadencel in STS. Ilixadencel (allogeneic inflammatory dendritic cells) is a cell-based immune primer injected intratumorally that previously has been clinically investigated in metastatic renal cell carcinoma and hepatocellular carcinoma. Ilixadencel has been evaluated in clinical trials for a range of solid tumors, including a Phase II MERECA study in kidney cancer and Phase I/II studies in liver cancer and gastrointestinal stromal tumors (GIST).
Immediately before administration to the patient, the frozen vials were thawed and the cells were washed and resuspended in 0.15 M saline with 2% human serum albumin before administration. “Although the GIST study was a trial with few patients enrolled, they were all at an advanced disease stage, meaning that both the safety data and the signals of clinical efficacy are encouraging and support ilixadencel’s potential as a safe and effective cell-based cancer immune primer,” Alex Karlsson-Para, MD, PhD, CSO and interim CEO of Immunicum, stated in a press release. Pressmeddelande.
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Its active ingredient is activated allogeneic dendritic cells, derived from healthy 15 Background: Ilixadencel is a cell-based, off-the-shelf product based on allogeneic monocyte-derived inflammatory cells aimed to prime an anti-cancer immune response when injected intratumorally. The present single arm Phase I trial (ClinicalTrials.gov Identifier: NCT02686944) assessed the safety and efficacy of ilixadencel in subjects with progressing advanced/metastatic GIST despite Immunicum AB (publ) Receives Orphan Drug Designation from EMA for Ilixadencel as Treatment for Gastrointestinal Stromal Tumors (GIST) In December 2020, Immunicum announced that it received Fast Track Designation from the FDA for ilixadencel in Gastrointestinal Stromal Tumors (GIST) and Orphan Drug Designation by the FDA for ilixadencel in hepatocellular carcinomas. In January of this year, the company announced FDA Orphan Drug Designation for ilixadencel in STS. Ilixadencel (allogeneic inflammatory dendritic cells) is a cell-based immune primer injected intratumorally that previously has been clinically investigated in metastatic renal cell carcinoma and hepatocellular carcinoma. Ilixadencel has been evaluated in clinical trials for a range of solid tumors, including a Phase II MERECA study in kidney cancer and Phase I/II studies in liver cancer and gastrointestinal stromal tumors (GIST). The FDA has granted the cell-based, off-the-shelf immune primer ilixadencel an orphan drug designation for use as a treatment option in patients with soft tissue sarcoma (STS), according to an announcement from Immunicum AB. Patients with progressing advanced or metastatic GIST were administered ilixadencel intratumorally at a maximum dose of 10,000,000 allogeneic dendritic cells/mL per injection despite ongoing treatment with second- or later lines of tyrosine kinase inhibitors (TKIs).
References. 1. Ilixadencel är en cellbaserad och lagringsbar immunaktiverare som för närvarande utvecklas i klinisk fas II som behandling av gastrointestinal stromacellstumör, gist.
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I juni 2020 publicerades den slutliga dataanalysen från den kliniska studien av ilixadencel hos patienter med gastrointestinala stromacellstumörer (GIST) i den vetenskapliga tidskriften Cancer Immunology, Immunoterapi som innebar en ytterligare validering av ilixadencel. GIST är en sällsynt och svårbehandlad sjukdom och studien visade att ilixadencel i kombination med olika tyrosinkinashämmare (TKI) hade en gynnsam säkerhetsprofil och påvisade initiala tecken på klinisk effekt hos
Ilixadencel has been evaluated in clinical trials for a range of solid tumors, including a Phase II MERECA study in kidney cancer and Phase I/II studies in liver cancer and gastrointestinal stromal tumors (GIST). The FDA has granted the cell-based, off-the-shelf immune primer ilixadencel an orphan drug designation for use as a treatment option in patients with soft tissue sarcoma (STS), according to an announcement from Immunicum AB. Patients with progressing advanced or metastatic GIST were administered ilixadencel intratumorally at a maximum dose of 10,000,000 allogeneic dendritic cells/mL per injection despite ongoing treatment with second- or later lines of tyrosine kinase inhibitors (TKIs). 15 Background: Ilixadencel is a cell-based, off-the-shelf product based on allogeneic monocyte-derived inflammatory cells aimed to prime an anti-cancer immune response when injected intratumorally. The present single arm Phase I trial (ClinicalTrials.gov Identifier: NCT02686944) assessed the safety and efficacy of ilixadencel in subjects with progressing advanced/metastatic GIST despite Immunicum AB (publ; IMMU.ST) announced today that it has received Fast Track Designation (FTD) 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 the orphan indication, Gastrointestinal Stromal Tumors (GIST). 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 7 December 2020 Immunicum AB (publ) Receives FDA Fast Track Designation for Ilixadencel in Gastrointestinal Stromal Tumors (GIST) Immunicum AB (publ; IMMU.ST) announced today that it has received Fast Track Designation (FTD) 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 Immunicum AB (publ; IMMU.ST) announced today that it has received Fast Track Designation (FTD) 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 the orphan indication, Gastrointestinal Stromal Tumors (GIST). study of ilixadencel in patients with Gastrointestinal Stromal Tumors (GIST) has been published in the journal, Cancer Immunology, Immunotherapy. GIST is a rare and difficult-to-treat disease indication and the trial met the primary endpoint of safety showing that ilixadencel in combination Patients with progressing advanced or metastatic GIST were administered ilixadencel intratumorally at a maximum dose of 10,000,000 allogeneic dendritic cells/mL per injection despite ongoing treatment with second- or later lines of tyrosine kinase inhibitors (TKIs).
26 Feb 2021 overall survival that ilixadencel may achieve for [patients with kidney cancer] carcinoma (HCC), and gastrointestinal stromal tumors (GIST).
整理：肿瘤资讯 来源：肿瘤资讯. 伊马替 9 Nov 2018 of scientific review of ilixadencel approach in Pharmaceutical Research. Immunicum announced end of enrollment in Phase I/II GIST clinical resultat från en klinisk fas I/II-studie i GIST patienter. I studien undersöktes säkerhet och tolerabilitet för. Immunicums ledande läkemedelskandidat, ilixadencel,.
27 Jan 2021 off-the-shelf immune primer ilixadencel an orphan drug designation for the agent in patients with gastrointestinal stromal tumors (GIST). DESIGNATION FROM EMA FOR ILIXADENCEL AS TREATMENT FOR GASTROINTESTINAL STROMAL TUMORS (GIST).IMMUNICUM AB - COMP OPINION of the Exchange, Immunicum AB (publ) Receives Orphan Drug Designation from EMA for Ilixadencel as Treatment for Gastrointestinal Stromal Tumors (GIST) . 16 Jun 2020 Ilixadencel is an off-the-shelf cell-based cancer immunotherapy developed for the treatment of solid tumors. Its active ingredient is activated We have shown that intratumoral injections of the immune primer ilixadencel advanced gastrointestinal stromal tumor (GIST) develop resistance to imatinib, 13 Dec 2019 Gastrointestinal stromal tumor (GIST) is the most common human sarcoma.