Immunicum AB publ erhåller särläkemedelsstatus, ODD, från

IMMUNICUM: RESULTAT I FAS 1/2 VID GIST PUBLICERADE

BioStock har pratat med bolagets interim-vd, Alex Karlsson-Parra, för att få GIST patients also tested with ilixadencel/TKI combo. MERECA is not the only study being run with ilixadencel in combination with TKIs. Immunicum is also evaluating the efficacy of such a combination in Gastrointestinal Stromal Tumors (GIST) and liver cancer. Immunicum AB (publ) announces publication of phase I/II clinical trial results of ilixadencel in gastrointestinal stromal tumors (GIST) in Cancer Immunology, Immunotherapy. News … “We continue to build recognition for ilixadencel’s potential and are pleased to announce that in addition to designations for ilixadencel in renal cell carcinoma and hepatocellular carcinoma, we have now received Orphan Drug Designation by the FDA for the treatment of soft tissue sarcoma, which includes GIST,” said Sven Rohmann, MD, PhD, CEO, Immunicum AB, in a statement. 2020-12-07 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).

19 February 2021. Immunicum AB (publ) Receives Orphan Drug Designation from EMA for Ilixadencel as Treatment for Gastrointestinal Stromal Tumors (GIST) Immunicum AB (publ) Receives Orphan Drug Designation from EMA for Ilixadencel as Treatment for Gastrointestinal Stromal Tumors (GIST) Publicerad: 2021-02-19 (GlobeNewswire) Immunicum AB (publ) erhåller särläkemedelsstatus, ODD, från EMA för ilixadencel för behandling av gastrointestinal stromacellstumör (GIST) (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 January 26, 2021 - 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. Immunicum AB (publ) erhåller särläkemedelsstatus, ODD, från EMA för ilixadencel för behandling av gastrointestinal stromacellstumör (GIST) 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. ilixadencel ännu inte uppnåtts, då data i denna grupp fort-farande är omogna. Den 7 december 2020 meddelade Immunicum dessutom att ilixadencel vid behandling av gastrointestinal stroma-cellstumör (GIST) erhållit Fast Track Designation från FDA. ••• cancer i bukspottkörteln Forskningschefen Alex Karlsson-Parra grundade Immunicum AB GIST-studierna uppvisar tydliga och lovande kliniska resultat för ilixadencel i kombination med tyrosinkinashämmare* samtidigt som ilixadencels fördelaktiga säkerhets-och tolerabilitetsprofil upprätthållits.

IMMUNICUM: RESULTAT I FAS 1/2 VID GIST PUBLICERADE

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. 7 december 2020.

Immunicum AB publ meddelar att abstrakten inför ASCO

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 .

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.
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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). 2020-06-13 För Immunicum var 2019 ett år fyllt med viktiga kliniska framsteg med huvudkandidaten ilixadencel. Kandidaten visade lovande potential i både MERECA och GIST-studierna från vilka man tillkännagav topline resultat under fjolåret.

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.
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Immunicum AB publ erhåller särläkemedelsstatus, ODD, från

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. 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.

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Immunicum - Cision News

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. 1. 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. 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).