Approval Status. Phase 2. Indications. RCC, HCC. Overall Strategy. Immune system. Strategy. Stimulate the immune system. Drug Category. Immune stimulate 

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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.

2020-12-31 14:00:00 Immunicum Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma  Immunicum AB / Fortsatt sträckbänk / Ilixadencel + Opdivo=sant? 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). egenskaperna gällande säkerhet och tolerabilitet för ilixadencel, of ilixadencel in patients with advanced hepatocellular carcinoma HCC  Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC) Here, 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 × 10 6 cells (six as monotherapy and six in combination with sorafenib), and five received ilixadencel at the dose of 20 × 10 6 cells as monotherapy. 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. Here, 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 × 10 6 cells (six as monotherapy and six in combination with sorafenib), and five received ilixadencel at the dose of 20 × 10 6 cells as monotherapy.

Ilixadencel hcc

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Vidare har ilixadencel utvecklats enligt plan i de pågående kliniska studierna. 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 … Designation for ilixadencel as a treatment for liver cancer, specifically Hepatocellular Carcinoma (HCC). Covid-19 » To date, Immunicum has not experienced any major impact to its operations owing to the Covid-19 pandemic. For further information, go to the risk section on … 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 Immunicum AB (publ) erhåller särläkemedelsstatus, ODD, från FDA för ilixadencel för behandling av levercancer. Publicerad: 2020-12-31 (GlobeNewswire) Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC… 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 2020-12-31 The combination of the off-the-shelf cancer immune primer Ilixadencel and sunitinib has demonstrated promising survival benefit when used as a frontline treatment for newly diagnosed patients with 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 … 5 February 2018. Immunicum (publ) Presents Case Study of One Patient from Phase I/II HCC Trial at Cholangiocarcinoma Foundation Annual Conference.

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 Ilixadencel är en cell-baserad lagringsbar cancerimmunaktiverare som utvecklats för att aktivera patientens egna immunförsvar till att upptäcka och förstöra cancerceller, och därmed övervinna cancercellernas förmåga att undvika immunsystemets detektion och attack. Here, 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 x 10 6 cells (six as monotherapy and six in combination with sorafenib), and five received ilixadencel at the dose of 20 x 10 6 cells as monotherapy.

Press Release 31 December 2020Immunicum 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 …

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).

Ilixadencel hcc

To date, ilixadencel has been tested in a range of clinical trials for various solid tumor indications including mRCC, hepatocellular carcinoma (HCC), and gastrointestinal stromal tumors (GIST).

Ilixadencel hcc

Kinase inhibitors. Ilixadencel: an off-the-shelf  Immunicums fas II-studie MERECA, som testar ilixadencel i patienter med driver nu tre egna studier inom cancerindikationerna: mRCC, HCC och GIST. Längst  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. kombination med ilixadencel och PD-1-hämmare förlängde överlevnad på mössen Bolaget påbörjar en fas II-studien för ilixadencel inom HCC i slutet av 2019. Bolagets huvudkandidat, ilixadencel, har studerats i kombination med hepatocellulärt karcinom (HCC), gastrointestinala stromala tumörer  NeuroVive kunde idag meddela nya positiva cancerdata från bolagets sanglifehrin-baserade substanser inom hepatocellulär cancer (HCC) eller primär  Ilixadencel är på väg mot klinisk utveckling i sen fas.Om levercancer (Hepatocellulärt Carcinom – HCC) Hepatocellulärt Carcinom (HCC) är en  Vi fortstter att f bekrftelse p ilixadencels potential och r glada ver att kunna hepatocellulrt carcinom (HCC) och gastrointestinal stromacellstumr  Last Visit) har genomförts i den pågående fas I/II-studien i vilken patienter med avancerad levercancer (HCC) behandlats med ilixadencel.

Längst  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. kombination med ilixadencel och PD-1-hämmare förlängde överlevnad på mössen Bolaget påbörjar en fas II-studien för ilixadencel inom HCC i slutet av 2019. Bolagets huvudkandidat, ilixadencel, har studerats i kombination med hepatocellulärt karcinom (HCC), gastrointestinala stromala tumörer  NeuroVive kunde idag meddela nya positiva cancerdata från bolagets sanglifehrin-baserade substanser inom hepatocellulär cancer (HCC) eller primär  Ilixadencel är på väg mot klinisk utveckling i sen fas.Om levercancer (Hepatocellulärt Carcinom – HCC) Hepatocellulärt Carcinom (HCC) är en  Vi fortstter att f bekrftelse p ilixadencels potential och r glada ver att kunna hepatocellulrt carcinom (HCC) och gastrointestinal stromacellstumr  Last Visit) har genomförts i den pågående fas I/II-studien i vilken patienter med avancerad levercancer (HCC) behandlats med ilixadencel. karcinom (HCC) och gastrointestinal stromacellstumör (GIST) samt i ILIAD är en Fas Ib/II-studie på flera indikationer där ilixadencel  IMMUNICUM: SÄRLÄKEMEDELSSTATUS FÖR ILIXADENCEL MOT för bolagets kandidat ilixadencel för behandling av levercancer (HCC). ”Våra prekliniska studier är inriktade på att utvärdera ilixadencel i hepatocellulärt karcinom (HCC), gastrointestinala stromala tumörer (GIST)  Immunicums ledande produkt ilixadencel utnyttjar den unika och kritiska rollen undersöka säkerhet och tolerans för ilixadencel i HCC som en  I MERECA-studien undersöktes behandlingseffekten av ilixadencel, karcinom (HCC) och gastrointestinala stromala tumörer (GIST) och i  Immunicum AB (publ) Announces Publication of Phase I/II Clinical Trial Results of Ilixadencel in Advanced Hepatocellular Carcinoma in Frontiers in Oncology  I/II-studien i levercancer (HCC) och gastrointestinal stromacellstumr bidragande till de senaste regulatoriska framgngarna fr ilixadencel. Today we announced the publication of the Phase I/II clinical trial results of ilixadencel in advanced HCC in @FrontOncology.
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Ilixadencel hcc

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).

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Designation (FTD) för ilixadencel för behandling av den sällsynta sjukdomen gastrointestinal stromalcellstumör (GIST). Vidare beviljade amerikanska FDA särläkemedelsstatus (Orphan Drug Designation) för ilixadencel in hepatocellular carcinoma (HCC). Vidare har ilixadencel utvecklats enligt plan i de pågående kliniska studierna.

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). 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.

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 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.

在2020年12月,FDA授予ilixadencel治疗GIST的快速通道资格(FTD)、治疗肝 细胞癌(HCC)的孤儿药资格(ODD)。 ilixadencel是一种同种异体树突状  2021年1月2日 制药公司Immunicum近日宣布,美国食品药品监督管理局(FDA)已经授予 Ilixadencel治疗肝细胞癌(HCC)的“孤儿药称号”(ODD)。 ODD, från FDA för ilixadencel för behandling av levercancer Immunicum kirurgiskt och/eller spridd (metastaserad) levercancer (HCC). AB (publ) erhåller särläkemedelsstatus, ODD, från EMA för ilixadencel för för ilixadencel för behandling av hepatocellulärt carcinom (HCC). Positiva topline resultat från den slutförda fas I/II studien som undersökt säkerhet och tolerans av ilixadencel hos 18 patienter med avancerad  of Phase I/II Clinical Trial Results of Ilixadencel in Advanced Hepatocellular Carcinoma in Frontiers in Oncology Immunicum AB (publ; IMMU. Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC) Immunicum AB (publ; IMMU. Vidare beviljade amerikanska FDA särläkemedelsstatus (Orphan Drug Designation) för ilixadencel in hepatocellular carcinoma (HCC).