Track Designation från FDA för ilixadencel för behandling av GIST fas I/II-studien i GIST, en sällsynt och svårbehandlad cancersjukdom

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

02月26日. 专家点评. 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,.

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Detta inkluderar utvärdering av ilixadencel i kombination med andra immuno-onkologiklasser inom särläkemedelsindikationer såsom gastrointestinal stromacellstumör (GIST), ett behov av partnerskap för att avancera Immunicums projekt samt planer på att expandera bortom ilixadencel till nästa generations cellterapier. Pressmeddelande 26 januari 2021 Immunicum AB (publ) erhåller särläkemedelsstatus, ODD, från FDA för ilixadencel för behandling av mjukdelssarkom, Soft Tissue Sarcoma (STS) Immunicum AB (publ; GlobeNewswire - 07 dec 20 kl. 08:00 Immunicum AB (publ) erhåller Fast Track Designation från FDA för ilixadencel för behandling av GIST. 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 bolaget har erhållit Fast Track Designation från den amerikanska 4 Feb 2020 Conclusions: Ilixadencel treatment presented an acceptable safety profile among advanced GIST patients who developed resistance to TKI. 26 Feb 2021 overall survival that ilixadencel may achieve for [patients with kidney cancer] carcinoma (HCC), and gastrointestinal stromal tumors (GIST). 22 Feb 2021 “The Orphan Drug Designations awarded by both the EMA and the FDA for ilixadencel in the GIST indication represent an important step Immunicum AB (publ) Announces Publication of Phase I/II Clinical Trial Results of Ilixadencel in Gastrointestinal Stromal Tumors (GIST) in Cancer Immunology, 18 Feb 2021 “The Orphan Drug Designations awarded by both the EMA and the FDA for ilixadencel in the GIST indication represent an important step 26 Jan 2021 "We continue to build recognition for ilixadencel's potential and are the U.S. FDA for ilixadencel in Gastrointestinal Stromal Tumors (GIST). 27 Jan 2021 off-the-shelf immune primer ilixadencel an orphan drug designation for the agent in patients with gastrointestinal stromal tumors (GIST).

Immunicum.

Immunicum AB (publ) Announces Publication of Phase I/II Clinical Trial Results of Ilixadencel in Gastrointestinal Stromal Tumors (GIST) in Cancer Immunology,

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.

2020-05-11

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.

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.
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Topline results - GIST trial. First results from the downsized Phase I/II trial with gastrointestinal stromal tumor. Ilixadencel is an off-the-shelf cell-based cancer immunotherapy with allogeneic dendritic cells as the active ingredient.

08:00 Immunicum AB (publ) erhåller Fast Track Designation från FDA för ilixadencel för behandling av GIST. 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 bolaget har erhållit Fast Track Designation från den amerikanska 4 Feb 2020 Conclusions: Ilixadencel treatment presented an acceptable safety profile among advanced GIST patients who developed resistance to TKI. 26 Feb 2021 overall survival that ilixadencel may achieve for [patients with kidney cancer] carcinoma (HCC), and gastrointestinal stromal tumors (GIST). 22 Feb 2021 “The Orphan Drug Designations awarded by both the EMA and the FDA for ilixadencel in the GIST indication represent an important step Immunicum AB (publ) Announces Publication of Phase I/II Clinical Trial Results of Ilixadencel in Gastrointestinal Stromal Tumors (GIST) in Cancer Immunology, 18 Feb 2021 “The Orphan Drug Designations awarded by both the EMA and the FDA for ilixadencel in the GIST indication represent an important step 26 Jan 2021 "We continue to build recognition for ilixadencel's potential and are the U.S. FDA for ilixadencel in Gastrointestinal Stromal Tumors (GIST). 27 Jan 2021 off-the-shelf immune primer ilixadencel an orphan drug designation for the agent in patients with gastrointestinal stromal tumors (GIST).
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GIST/sarkom - för sällsynta sjukdomar med stora medicinska behov För att skynda på ilixadencels utveckling mot marknadsgodkännande, prioriterar vi ilixadencels utveckling inom de sällsynta sjukdomarna gastrointestinala stromacellstumörer (GIST) och sarkom där ilixadencel redan visat kliniska signaler på effekt.

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. 2021-02-19 In May 2020, ilixadencel was granted a Regenerative Medicine Advanced Therapy designation from the FDA for use in patients with RCC. A few months later, in December 2020, the agent received a fast track designation for use in the treatment of patients with GIST. References.

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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

GIST är en mycket ovanlig och komplex sjukdom med enbart 200 fall som diagnostiseras i Sverige varje år. “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”. GIST/sarkom - för sällsynta sjukdomar med stora medicinska behov För att skynda på ilixadencels utveckling mot marknadsgodkännande, prioriterar vi ilixadencels utveckling inom de sällsynta sjukdomarna gastrointestinala stromacellstumörer (GIST) och sarkom där ilixadencel redan visat kliniska signaler på effekt. Detta inkluderar utvärdering av ilixadencel i kombination med andra immuno-onkologiklasser inom särläkemedelsindikationer såsom gastrointestinal stromacellstumör (GIST), ett behov av partnerskap för att avancera Immunicums projekt samt planer på att expandera bortom ilixadencel till nästa generations cellterapier. Pressmeddelande 26 januari 2021 Immunicum AB (publ) erhåller särläkemedelsstatus, ODD, från FDA för ilixadencel för behandling av mjukdelssarkom, Soft Tissue Sarcoma (STS) Immunicum AB (publ; GlobeNewswire - 07 dec 20 kl. 08:00 Immunicum AB (publ) erhåller Fast Track Designation från FDA för ilixadencel för behandling av GIST. 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 bolaget har erhållit Fast Track Designation från den amerikanska 4 Feb 2020 Conclusions: Ilixadencel treatment presented an acceptable safety profile among advanced GIST patients who developed resistance to TKI. 26 Feb 2021 overall survival that ilixadencel may achieve for [patients with kidney cancer] carcinoma (HCC), and gastrointestinal stromal tumors (GIST).

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

Catalyst types.

22 Feb 2021 “The Orphan Drug Designations awarded by both the EMA and the FDA for ilixadencel in the GIST indication represent an important step Immunicum AB (publ) Announces Publication of Phase I/II Clinical Trial Results of Ilixadencel in Gastrointestinal Stromal Tumors (GIST) in Cancer Immunology, 18 Feb 2021 “The Orphan Drug Designations awarded by both the EMA and the FDA for ilixadencel in the GIST indication represent an important step 26 Jan 2021 "We continue to build recognition for ilixadencel's potential and are the U.S. FDA for ilixadencel in Gastrointestinal Stromal Tumors (GIST). 27 Jan 2021 off-the-shelf immune primer ilixadencel an orphan drug designation for the agent in patients with gastrointestinal stromal tumors (GIST).