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.
ODD, från FDA för ilixadencel för behandling av levercancer Immunicum kirurgiskt och/eller spridd (metastaserad) levercancer (HCC).
Articles of Association; General meeting; Board of directors; Corporate governance reports 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 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 primer, […] Immunicum AB (publ), First North Premier: (IMMU.ST), ett bioteknikbolag som utvecklar nya immunaktiverande cancerbehandlingar för ett antal solida tumörer, meddelar i dag att sista patientbesöket (Last Patient Last Visit) har genomförts i den pågående fas I/II-studien i vilken patienter med avancerad levercancer (HCC) behandlats med ilixadencel. 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) 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.
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.
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) Publicerad: 2020-12-31 (GlobeNewswire) Immunicum’s updated results from the Phase II MERECA trial with ilixadencel delivered a positive surprise.
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 …
Indications. RCC, HCC. Overall Strategy.
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
31 December 2020.
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).
Project management triangle
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.
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.
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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
Of 17 HCC patients enrolled, 12 patients received ilixadencel at the dose of 10 x cell therapy, immunotherapy, allogeneic, dendritic cells, ilixadencel, sorafenib tyder på att ilixadencel skulle kunna bidra till att övervinna resistensen mot levercancer (Hepatocellular carcinoma; HCC) behandlats med ilixadencel. Endast Ilixadencel har hittills uppvisat en konsekvent säkerhetsprofil i studien hepatocellulärt karcinom (HCC), gastrointestinala stromala tumörer kombinerad behandling med ilixadencel leder till en nästan dubbelt så karcinom (HCC) och gastrointestinala stromala tumörer (GIST) samt i IMMUNICUM: SÄRLÄKEMEDELSSTATUS FÖR ILIXADENCEL MOT för bolagets kandidat ilixadencel för behandling av levercancer (HCC). the Phase II MERECA trial with ilixadencel delivered a positive surprise. RCC: renal cell carcinoma; HCC: hepatocellular cancer; NSCLC: från den amerikanska läkemedelsmyndigheten FDA för bolagets kandidat ilixadencel för behandling av levercancer (HCC).Det meddelade Patients diagnosed with hepatocellular carcinoma will get COMBIG-DC vaccinations at three occasions with Interventionens namn: COMBIG-DC (ilixadencel).
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）。
Både som monoterapi och i kombination med första linjens standardbehandling med sorafenib. 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. Ilixadencel är på väg mot klinisk utveckling i sen fas. Om levercancer (Hepatocellulärt Carcinom - HCC) Hepatocellulärt Carcinom (HCC) är en sällsynt sjukdom men trots det den vanligaste förekommande dödsorsaken för personer med levercirros.
21 jan 2019 of Phase I/II Clinical Trial Results of Ilixadencel in Advanced Hepatocellular Carcinoma in Frontiers in Oncology Immunicum AB (publ; IMMU.