Immunicum AB publ erhåller särläkemedelsstatus, ODD, från

Immunicum AB publ Announces Publication of Phase I/II

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. Pipeline; Clinical Trial Information; Expanded Access / Compassionate Use Policy; Partnering; Investors.

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We will review our rNPV model for ilixadencel in RCC once more details are known about the next stage of the development following the discussions with regulators and any potential partners. Immunicum’s H120 operating loss was SEK59.0m vs SEK62.3m a year ago, slightly lower as the MERECA study ended in around mid-2019. 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 | … 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 … 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 … Immunicum AB (publ), First North Premier: (IMMU.ST), ett bioteknikbolag som utvecklar nya immunaktiverande cancerbehandlingar för ett antal solida tumörer, offentliggör idag positiva topline resultat från den slutförda fas I/II studien som undersökt säkerhet och tolerans av ilixadencel, Immunicums ledande läkemedelskandidat, hos 18 patienter med avancerad levercancer (HCC). Immunicum erhöll särläkemedelsstatus, Orphan Drug Designation, från FDA för ilixadencel för behandling av levercancer, specifikt hepatocellular carcinoma (HCC).

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.

Immunicum ilixadencel HCC I/II topline resultat

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.

Immunicum AB publ erhåller särläkemedelsstatus, ODD, från

The primary objective was to evaluate tolerability. Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC) The active substance ilixadencel (INN) is composed of monocyte-derived dendritic cells (MoDCs) that have been stimulated with a combination of activating factors (R848, Poly I:C and IFN-γ) ex vivo, resulting in a residual production of desirable pro-inflammatory factors (such as TNF-α, IL-1β and MIP-1β and also high amounts of IL-12p70 and RANTES) and expression of co-stimulatory surface molecules (such as CD86) at the time of administration. Ilixadencel, a cell therapy product, is an off-the-shelf cancer immune primer, developed for the treatment of solid tumors. Its active ingredient is activated allogeneic dendritic cells, derived Here we present preclinical mode of action data, CMC and regulatory data, as well as initial clinical data on ilixadencel. This cell-based drug product is an off-the-shelf immune primer, consisting of pro-inflammatory allogeneic DCs secreting high amounts of pro-inflammatory chemokines and cytokines at the time of intratumoral administration. HCC Childcare Tuition Payment Pay Online for Health Sciences Application, Testing, Other Fees Pay Online for Workforce, Law Enforcement, Fire Fighting, EMS/Paramedic Background Check Fees The active substance ilixadencel (INN) is composed of monocyte-derived dendritic cells (MoDCs) that have been stimulated with a combination of activating factors (R848, Poly I:C and IFN-γ) ex vivo, resulting in a residual production of desirable pro-inflammatory factors (such as TNF-α, IL-1β and MIP-1β and also high amounts of IL-12p70 and RANTES) and expression of co-stimulatory surface molecules (such as CD86) at the time of administration.

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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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. Immunicum AB (publ; IMMU.ST) a biopharmaceutical company advancing a novel, immune-priming cancer treatment against a variety of solid tumors, announced today the presentation of a case study on an individual patient included in the … 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. Se hela listan på frontiersin.org 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.

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. See the full announcement with  Klinisk Fas I/II-studie vid behandling av levercancer (HCC) inleds Immunicum säkerhet och tolerans för ilixadencel i HCC som en andra linjens behandling för  Tack vare ilixadencels användbarhet inom flera olika solida tumörformer, med avancerad levercancer (HCC) behandlats med ilixadencel. 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?
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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. The primary objective was to evaluate tolerability. Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC) The active substance ilixadencel (INN) is composed of monocyte-derived dendritic cells (MoDCs) that have been stimulated with a combination of activating factors (R848, Poly I:C and IFN-γ) ex vivo, resulting in a residual production of desirable pro-inflammatory factors (such as TNF-α, IL-1β and MIP-1β and also high amounts of IL-12p70 and RANTES) and expression of co-stimulatory surface molecules (such as CD86) at the time of administration. Ilixadencel, a cell therapy product, is an off-the-shelf cancer immune primer, developed for the treatment of solid tumors.

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.
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Hepatocellular carcinoma. Gastric adenocarcinoma. Non-small cell lung cancer. Gastrointestinal stromal tumors.