Uppdaterade data från MERECA-studien med ilixadencel i

3348

Immunicum AB publ erhåller särläkemedelsstatus, ODD, från

21 jan 2019 of Phase I/II Clinical Trial Results of Ilixadencel in Advanced Hepatocellular Carcinoma in Frontiers in Oncology Immunicum AB (publ; IMMU. Hepatocellular carcinoma (HCC) accounts for 75%-85% of all primary liver NCT01974661, Completed, Phase I, COMBIG-DC vaccine (ilixadencel), 18  Pembrolizumab Monotherapy May Play Role in Treatment-Naive HCC Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC)  Dec 31, 2020 Immunicum AB, of Stockholm Ilixadencel Cell-based, off-the-shelf immune primer Hepatocellular carcinoma (HCC) FDA granted orphan drug  Aug 29, 2020 Hepatocellular carcinoma (HCC) was the 6th most diagnosed cancer It is therefore no surprise that research into immunotherapy in HCC has begun Phase 1 trial with the cell-based immune primer ilixadencel, alone, an Mar 12, 2020 Hepatocellular carcinoma (HCC) remains as one of the major causes of Ilixadencel (pro‐inflammatory allogeneic dendritic cells) in advanced  Immunicum AB (publ) Announces Publication of Phase I/II Clinical Trial Results of Ilixadencel in Advanced Hepatocellular Carcinoma in Frontiers in Oncology. 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).

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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. 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.

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).

Klinisk prövning på Hepatocellular Carcinoma: COMBIG-DC

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. -- Median Overall Survival (OS) for the ilixadencel combination treatment group has been reached at 35.6 months, as compared to 25.3 months for the sunitinib control group, indicating a potential 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).

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Ilixadencel hcc

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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. 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).
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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).

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? 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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Nasdaq Stockholm av aktier i Immunicum AB publ

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.


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Immunicum - Cision News

Ilixadencel has been tested in these cancers in combination with several standard-of-care cancer therapies like chemotherapy.

Immunicum Immu.st - Redeye

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). 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.

Positiva topline resultat från den slutförda fas I/II studien som undersökt säkerhet och tolerans av ilixadencel hos 18 patienter med avancerad levercancer (HCC).