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 …

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.

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. 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 hcc

We have shown that intratumoral injections of the immune primer ilixadencel (pro-inflammatory allogeneic dendritic cells) are safe in renal-cell carcinoma. Here, we assessed ilixadencel as a single agent and combined with sorafenib in advanced HCC. 2020-12-31 FDA:s beslut grundar sig på resultaten från en klinisk fas I/II-studie av ilixadencel hos patienter med tumörer som inte går att avlägsna kirurgiskt och/eller spridd (metastaserad) levercancer (HCC). Ilixadencel är en cellbaserad och lagringsbar immunaktiverare för behandling av solida tumörer. 2018-06-14 2021-01-04 2019-01-21 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).

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.

Ilixadencel har hittills uppvisat en konsekvent säkerhetsprofil i studien hepatocellulärt karcinom (HCC), gastrointestinala stromala tumörer

The co-primary survival endpoint at 18-months lacked positive signals, which led to The combination of ilixadencel plus sunitinib has demonstrated favorable survival compared with sunitinib alone in patients with newly diagnosed metastatic synchronous renal cell carcinoma, Immunicum AB announced in a press release. The research update presented at the 2020 American Society of Clinical Oncology-Society for Immunotherapy of Cancer Clinical Immuno-Oncology Symposium showed a Immunicum is a clinical-stage immuno-oncology company based in Stockholm, Sweden. 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).

Press Release 28 September 2017. Immunicum AB (publ) Announces Completion of HCC Phase I/II Clinical Study --Topline Safety and Immune Response Data Support Continued Development of Ilixadencel in Liver Cancer--

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 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 Immunicum AB (publ; IMMU.ST) tillkännager idag att bolaget har erhållit särläkemedelsstatus (Orphan Drug Designation, ODD) från den amerikanska läkemedelsmyndigheten, FDA, för bolagets ledande kandidat ilixadencel, en cellbaserad och lagringsbar immunaktiverare, för behandling av levercancer (HCC). Pressmeddelande 5 februari 2018 Immunicum AB (publ) presenterar fallstudie på en patient från Fas I/II HCC-studien vid Cholangiocarcinoma Foundation Annual Conference Immunicum AB (IMMU.ST), ett biot 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. 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 Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma Immunicum AB announced today that it has received | March 28, 2021 Ilixadencel; Development Programs; Publications; Pipeline.

Publicerad: 2020-12-31 (GlobeNewswire) Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC) Publicerad: 2020-12-31 (GlobeNewswire) Immunicum’s updated results from the Phase II MERECA trial with ilixadencel delivered a positive surprise. 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. On 29 August 2019, the company released top-line results from the Phase II MERECA study with ilixadencel plus the tyrosine kinase inhibitor (TKI) sunitinib in renal cell carcinoma (RCC).
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Är det tänkt att Ilixadencel och opdivo (HCC) skall testas i kombo? IMMUNICUM: ILIXADENCEL FÅR SÄRLÄKEMEDELSSTATUS ÄVEN I EU FDA för bolagets kandidat ilixadencel för behandling av levercancer (HCC).

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Non-small cell lung cancer. Gastrointestinal stromal tumors. Kinase inhibitors.

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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 …

Ilixadencel: an off-the-shelf May 11, 2020 Immunicum AB has won an FDA RMAT for ilixadencel, its allogeneic hepatocellular carcinoma (HCC) and gastrointestinal stromal tumors May 18, 2020 orally administered drug for patients with hepatocellular carcinoma. Regenerative Medicine Advanced Therapy Designation for Ilixadencel in Approval Status. Phase 2.