Immunicums studie bekräftar ilixadencels potential i solida

Immunicums ilixadencel får särläkemedelsstatus i EU

Press Release 19 February 2021 Immunicum AB (publ) Receives Orphan Drug Designation from EMA for Ilixadencel as Treatment for Gastrointestinal Stromal Tumors (GIST) Immunicum AB (publ; IMMU.ST) announced today that the European Medicines Agency Committee for Orphan Medicinal Products (COMP) has issued a positive opinion on the Company’s application for orphan designation status for … 2020-05-11 07.12.2020 - Press Release 7 December 2020 Immunicum AB (publ) Receives FDA Fast Track Designation for Ilixadencel in Gastrointestinal Stromal Tumors (GIST… 2020-12-07 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) Receives Orphan Drug Designation from EMA for Ilixadencel as Treatment for Gastrointestinal Stromal Tumors (GIST) 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 Ilixadencel is an off-the-shelf cell-based cancer immunotherapy with allogeneic dendritic cells as the active ingredient. The drug was developed for the treatment of solid tumors. In addition to GIST, Ilixadencel has also been tested in clinical trials for patients with metastatic renal cell carcinoma, hepatocellular carcinoma. Ilixadencel är en cellbaserad och lagringsbar immunaktiverare som för närvarande utvecklas i klinisk fas II som behandling av gastrointestinal stromacellstumör, gist. Särläkemedelskommitténs beslut grundades på resultaten från den kliniska fas I/II-studien med ilixadencel i gist, en sällsynt och svårbehandlad cancersjukdom som hör till cancergruppen mjukdelssarkom. Pressmeddelande 16 juni 2020 Immunicum AB (publ) meddelar att resultaten från fas I/II-studien med Ilixadencel vid gastrointestinala stromacellstumörer (GIST) publicerats i Cancer Immunology, Immunotherapy Immunicum AB (publ; IMMU.ST) meddelar idag att den slutliga dataanalysen från den kliniska studien av ilixadencel hos patienter med gastrointestinala stromacellstumörer (GIST) har 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). 2021-02-19 · Immunicums ilixadencel får särläkemedelsstatus i EU. Bioteknikbolaget Immunicum har fått särläkemedelsstatus den europeiska hälsovårdsmyndigheten EMA för ilixadencel för behandling av gastrointestinal stromacellstumör (GIST).

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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. o Ilixadencel is a safe product in patients with advanced GIST. 10 Feb 2020 Combining intratumoral injections of ilixadencel, an off-the-shelf dendritic cell– based primer, with sunitinib improved responses in patients with  I/II Clinical Trial Results of Ilixadencel in Gastrointestinal Stromal Tumors (GIST ) in Cancer Immunology, Immunotherapy, Biotechnology, News Release, View. “GIST 新时空”专栏| 凌家瑜医生：评估瘤内注射ilixadencel治疗晚期GIST的安全性 和疗效的Ⅰ期研究.

Immunicum AB Immunicum AB Releases XML Feed

Immunicum AB (publ) erhåller Fast Track Designation från FDA för ilixadencel för behandling av GIST. Immunicum.

Immunicum AB Immunicum AB Releases XML Feed

Immunicums ledande läkemedelskandidat, ilixadencel,.

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). Ilixadencel is a cell-based, off-the-shelf immune primer, for the treatment of Soft Tissue Sarcoma (STS).
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from the clinical study of ilixadencel in patients with Gastrointestinal Stromal Tumors (GIST) providing further validation of ilixadencel. 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 The study is a prospective single armed, open label phase I study. Patients with advanced or metastatic GIST and tumor progression despite ongoing treatment with second, third or fourth line TKI treatment, and with at least one measureable tumor lesion, will be eligible for the study. A maximum of 12 patients will be included in this study.

Gastrointestinal Stromal Tümörler (GİST) Neden Olur? Hastaların % 80-90'  15 May 2020 as a fourth-line treatment for advanced gastrointestinal stromal tumor (GIST), a type of tumor that originates in the gastrointestinal tract. GIST ler tüm gastrointestinal sistem tümörlerinin %1 den azını, gastrointestinal sistemden kaynaklanan mezenkimal tümörlerin ise %80'ini oluştururlar. Mide  21 feb 2021 överlevnad i fas II-studien MERECA med ilixadencel i njurcancer och gastrointestinal stromacellstumör (GIST) samt i kombination med  Immunicum AB (publ) erhåller särläkemedelsstatus, ODD, från EMA för ilixadencel för behandling av gastrointestinal stromacellstumör (GIST). ilixadencel, säkerhetprofil och effekt i kombination med TKI:er. De inkluderade patienterna hade icke-operabel eller metastaserad GIST som  Forskningsbolaget Immunicum har fått särläkemedelsstatus för ilixadencel för behandling av gastrointestinal stromacellstumör, gist. Ilixadencel  GIST är en sällsynt och svårbehandlad sjukdom och studien uppfyllde det primära effektmåttet för säkerhet som visade att ilixadencel i  Track Designation från FDA för ilixadencel för behandling av GIST fas I/II-studien i GIST, en sällsynt och svårbehandlad cancersjukdom  I december 2020 erhöll Immunicum Fast Track Designation från FDA för ilixadencel för behandling av gastrointestinal stromacellstumör (GIST).
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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.
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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.