Pressmeddelande28 september 2017 Immunicum meddelar slutförandet av den kliniska fas I/II studien vid levercancer --Topline resultat gällande säkerhet och immunologiskt svar stödjer fortsatt utveckling av ilixadencel som behandling för leverc

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 …

It is developing an allogeneic off-the-shelf dendritic cell immune activator or immune primer ilixadencel for use in combination with checkpoint inhibitors and other anti-cancer therapies in potentially any solid tumour indications accessible via direct injection. Hepatocellular Carcinoma (HCC) is one of the most dreadful cancers and is known to be Ilixadencel is a cell-based cancer immunotherapy developed for the Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC). 31 December 2020 Read Feb 22, 2021 EMA for Ilixadencel as Treatment for Gastrointestinal Stromal Tumors hepatocellular carcinoma (HCC) and gastrointestinal stromal tumors Jan 20, 2021 the survival of people with inoperable hepatocellular carcinoma (HCC) — the for patients with inoperable HCC in more than 60 countries worldwide, Ilixadencel-Sutent Combo Shows 'Meaningful' Survival in Immunicum received Orphan Drug Designation from the US Food and Drug Administration (FDA) for ilixadencel in Hepatocellular Carcinoma (HCC). Hepatocellular carcinoma. Gastric adenocarcinoma.

Recruitment is now complete in both the phase I study in gastrointestinal stromal tumors (GIST) (IM-103) and the multicenter comparative phase II study in patients with newly diagnosed mRCC (IM-201). 2021-01-04 · Immunicum har fått särläkemedelsstatus från den amerikanska läkemedelsmyndigheten FDA för bolagets kandidat ilixadencel för behandling av levercancer (HCC).Det meddelade bolaget i ett pressmeddelande på nyårsafton. 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 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 primer, for the treatment of Hepatocellular Carcinoma (HCC). Hittills har ilixadencel testats i en rad kliniska prövningar i olika solida tumörindikationer inklusive metastaserande njurcancer (mRCC), hepatocellulärt carcinom (HCC) och gastrointestinal 2019-01-21 · About ilixadencel . Ilixadencel, a cell therapy product, is an off-the-shelf cancer immune primer, developed for the treatment of solid tumors.

Top-line data som nyligen presenterades för HCC- studien visar, inte helt överraskande, på bra säkerhet och tolerans av ilixadencel. Positivt och i linje med vad.

The company was selected for an oral presentation at the ASCO-SITC Clinical Immuno-Oncology Symposium yesterday. The maturing data (24-month follow up) confirmed the separation of the Kaplan-Meier curves, which was projected in September 2019 at the time of the release of the final The last several weeks have been volatile for Immunicum and illustrate how complicated immunotherapy efficacy trials can be.

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

Hepatocellular carcinoma.

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). The phase I open-label study, IM-102, tested ilixadencel alone and in combination with sorafenib in patients with advanced hepatocellular carcinoma (HCC). Recruitment is now complete in both the phase I study in gastrointestinal stromal tumors (GIST) (IM-103) and the multicenter comparative phase II study in patients with newly diagnosed mRCC (IM-201). 2021-01-04 · Immunicum har fått särläkemedelsstatus från den amerikanska läkemedelsmyndigheten FDA för bolagets kandidat ilixadencel för behandling av levercancer (HCC).Det meddelade bolaget i ett pressmeddelande på nyårsafton. 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.
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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 primer, for the treatment of Hepatocellular 2020-12-31 · Press Release . 31 December 2020.

Several lines of evidence support immunotherapy in hepatocellular carcinoma (HCC). We have shown that intratumoral injections of the immune primer ilixadencel (pro-inflammatory allogeneic dendritic cells) are safe in renal-cell carcinoma.
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Jan 2, 2021 IMMUNICUM AB (PUBL): Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC).

Indications. RCC, HCC. Overall Strategy. Immune system.

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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.

Vidare har ilixadencel utvecklats enligt plan i de pågående kliniska studierna. 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 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 Keytruda® (pembrolizumab). In the ilixadencel combination arm, ilixadencel was administered prior to surgery, and sunitinib was administered after surgery. In the monotherapy, treatment also occurred after surgery. 2 The co-primary end points of the MERECA study were OS and the overall 18-month survival rate from randomization in different subgroups of patients with metastatic RCC. 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 Frontline ilixadencel in combination with sunitinib as utilized in newly diagnosed patients with metastatic renal cell carcinoma in the phase 2 MERECA clinical trial has updated survival data, which indicates continued survival benefit with the combination over sunitinib alone. 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 primer, for the treatment of Hepatocellular 2020-12-31 · Press Release . 31 December 2020.