Sammantaget indikerar resultaten att ilixadencel bidragit med en positiv systemisk behandlingseffekt samtidigt som säkerhet och tolerabilitets-profilen var positiv. Dessa data stödjer en fortsatt klinisk utveckling av ilixadencel som en immunprimer vid RCC och andra solida tumörer.

25 september 2019. Immunicum AB (publ) meddelar komplett analys av topline-data från fas II-studien MERECA --Överlevnad per juli 2019 var 57% (32 av 56) för patienter som As ilixadencel has achieved Proof of Concept in RCC in combination with sunitinib, the next critical step is to identify the right way to accelerate ilixadencel through development, towards the Immunicum AB (publ; IMMU.ST) tillkännager idag att den europeiska läkemedelsmyndighetens kommitté för särläkemedel (European Medicines Agency Committee for Orphan Medicinal Products, EMA COMP) har utfärdat en positiv rekommendation för bolagets ansökan avseende dess Fas II kliniska kandidat ilixadencel, en cellbaserad och lagringsbar immunaktiverare, för behandling av Anti-cancer vaccine ilixadencel plus sunitinib show promise for untreated metastatic kidney cancer - Kidney Cancer Support Network A phase 2 clinical trial with a new treatment called ilixadencel in combination with sunitinib has shown to improve overall survival in newly diagnosed patients with metastatic renal cell carcinoma (RCC). Proven Indication, Novel Combination Immunicum has identified the opportunity for the advancement of ilixadencel in kidney cancer to test our lead candidate in a triple combination - specifically, | February 17, 2021 Ilixadencel is a pro-inflammatory allogeneic dendritic cell vaccine, being developed by Immunicum, for the treatment of cancer. The vaccine, called INTUVAX®, Ilixadencel achieved proof-of-concept through the Phase II MERECA study and our aim is to accelerate ilixadencel’s development toward market approval in order to reach patients in need. By prioritizing the development of ilixadencel in Gastrointestinal Stromal Tumors (GIST) and sarcomas, our goal is to shorten the development pathway These results indicate that ilixadencel provided a systemic therapeutic benefit while maintaining a positive safety and tolerability profile. Overall the data supports the continued clinical development of ilixadencel as an immune primer in RCC and other solid tumors. Portions of this data were previously communicated on August 29, 2019.

Ilixadencel rcc

the therapeutic impact of the company's lead candidate, ilixadencel, in combination with Sutent (sunitinib) in metastatic Renal Cell Carcinoma (RCC) patients. (RCC) och Fast Track Designation (FTD) för ilixadencel för behandling av den sällsynta sjukdomen gastrointestinal stromalcellstumör (GIST). för njurcancer (RCC) och Fast Track. Designation (FTD) för ilixadencel för behandling av den sällsynta sjukdomen gastrointestinal stromalcellstumör. (GIST).

The most advanced programme is in RCC, where ilixadencel is being tested in Phase II (MERECA study) in combination with Pfizer’s approved TKI sunitinib. Recruitment in this trial was completed in early January 2018.

Ilixadencel is an off-the-shelf cancer immune primer developed for the treatment of solid tumors. The MERECA clinical trial evaluated the therapeutic impact of combining ilixadencel with sunitinib in advanced kidney cancer. For the study, 88 newly-diagnosed, intermediate- and poor-prognosis patients with metastatic RCC were enrolled.

Feb 1, 2021 Phase II study of ilixadencel + pre- and post-nephrectomy sunitinib then TG4010 + IFNα2a + IL2 in patients with MUC1-positive RCC (n = 37)

Beskrivning: Two Intuvax (ilixadencel) vaccinations (10 milj cells/vaccination) 14 days apart before nephrectomy, followed by Sunitinib treatment post-nephrectomy RMAT designation from the FDA for their top drug candidate ilixadencel. Therapy (RMAT) designation for ilixadencel is in metastatic RCC. Det gör att vi övertygade om ilixadencels förmåga att främja mer långvariga och Njurcancer (RCC) - beprövad indikation, ny kombination REnal Cell CArcinoma) trial. The trial is investigating the safety and efficacy of Immunicum's lead drug candidate ilixadencel, formerly known RCC (Nure) Fas I/II klar. Fas II (MERECA) pågår. I princip helt avgörande studie för ilixadencel. 90 patienter (60/30) nästan 30 studiecentra i Produkt-lanseringar med ilixadencel, för RCC (njurcancer) och NSCLC (icke småcellig lungcancer) utgör 25 respektive 35 procent av värdet enligt Edison.

Immunicum has announced an update on its corporate and clinical development strategy. “With the information presented today at the corporate update event, we aim to provide an overview of our position as a cell therapy company, discuss strategic opportunities we intend to leverage and confirm our long-term mission for Immunicum,” commented Sven Rohmann, CEO of Immunicum. Ilixadencel-Sunitinib Combo Improves Response In Certain Patients With Metastatic RCC In Phase II Trial wb.md/38xBsq0 Eftersom ilixadencel har uppnått Proof of Concept i RCC i kombination med sunitinib är nästa kritiska steg att identifiera rätt väg att påskynda utvecklingen av ilixadencel mot marknaden och i … For the biopharma industry investment, business development and competitive intelligence professionals who require information to support financing, partnering and licensing activities, BCIQ provides accurate information and context to support profitable and strategic decision making. Unlike other intelligence solutions, BCIQ exclusively supports the unique needs of the biopharma industry and Under 2020 beviljade den amerikanska läkemedelsmyndigheten FDA Immunicum Regenerative Medicine Advanced Therapy (RMAT) designation för njurcancer (RCC) och Fast Track Designation (FTD) för ilixadencel för behandling av den sällsynta sjukdomen gastrointestinal stromalcellstumör (GIST). Renal Cell Carcinoma (RCC) showed that five patients had complete response and data on survival benefit in all patients showed that a higher percentage of ilixadencel patients were alive as per data cut-off in July 2019.
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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 a negative reaction in the share price. The study evaluated the therapeutic impact of the company’s lead candidate, ilixadencel, in combination with Sutent (sunitinib) in metastatic Renal Cell Carcinoma (RCC) patients.

R n=58 n=30 ilixadencel. 2 weeks control – no ilixadencel injections. Jan 27, 2021 Ilixadencel Gets Orphan Drug Designation for Soft Tissue Sarcoma was conducted in patients with metastatic renal cell carcinoma (RCC).
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Ilixadencel achieved proof-of-concept through the Phase II MERECA study and our aim is to accelerate ilixadencel’s development toward market approval in order to reach patients in need. By prioritizing the development of ilixadencel in Gastrointestinal Stromal Tumors (GIST) and sarcomas, our goal is to shorten the development pathway

These data support the continued clinical development of ilixadencel as an immune primer in RCC and other solid tumors, to provide cancer patients with additional treatment alternatives. Ilixadencel According to their website, Ilixadencel, Immunicum AB’s lead development candidate, is an off-the-shelf cell-based cancer immunotherapy indicated for treatment of hepatocellular carcinoma, gastrointestinal stromal tumors and mRCC. Immunicum has announced an update on its corporate and clinical development strategy. “With the information presented today at the corporate update event, we aim to provide an overview of our position as a cell therapy company, discuss strategic opportunities we intend to leverage and confirm our long-term mission for Immunicum,” commented Sven Rohmann, CEO of Immunicum. Ilixadencel-Sunitinib Combo Improves Response In Certain Patients With Metastatic RCC In Phase II Trial wb.md/38xBsq0 Eftersom ilixadencel har uppnått Proof of Concept i RCC i kombination med sunitinib är nästa kritiska steg att identifiera rätt väg att påskynda utvecklingen av ilixadencel mot marknaden och i … For the biopharma industry investment, business development and competitive intelligence professionals who require information to support financing, partnering and licensing activities, BCIQ provides accurate information and context to support profitable and strategic decision making. Unlike other intelligence solutions, BCIQ exclusively supports the unique needs of the biopharma industry and Under 2020 beviljade den amerikanska läkemedelsmyndigheten FDA Immunicum Regenerative Medicine Advanced Therapy (RMAT) designation för njurcancer (RCC) och Fast Track Designation (FTD) för ilixadencel för behandling av den sällsynta sjukdomen gastrointestinal stromalcellstumör (GIST). Renal Cell Carcinoma (RCC) showed that five patients had complete response and data on survival benefit in all patients showed that a higher percentage of ilixadencel patients were alive as per data cut-off in July 2019.

Ilixadencel-Sunitinib Combo Improves Response In Certain Patients With Metastatic RCC In Phase II Trial wb.md/38xBsq0

(RCC) och Fast Track Designation (FTD) för ilixadencel för behandling av den sällsynta sjukdomen gastrointestinal stromalcellstumör (GIST). för njurcancer (RCC) och Fast Track. Designation (FTD) för ilixadencel för behandling av den sällsynta sjukdomen gastrointestinal stromalcellstumör. (GIST).

Jun 14, 2018 The mechanism of action of ilixadencel is to induce recruitment and of tissue samples from surgically removed primary renal RCC tumors Feb 7, 2020 ilixadencel in combination with Sutent (sunitinib) first-line treatment regimen in newly diagnosed metastatic renal cell carcinoma (mRCC) Immunicum has completed a phase I/II open-label study of ilixadencel, INTUVAX ®-RCC, in patients with metastatic renal cell carcinoma (IM-101; Ilixadencel. Targeting solid tumors with an off-the-shelf, cell-based immune primer. Immunicum's clinical program ilixadencel uses dendritic cells sourced from Feb 10, 2020 The combination of ilixadencel plus sunitinib (Sutent) has evidenced newly diagnosed metastatic synchronous renal cell carcinoma (mRCC), Advanced Stage. • Phase II study in RCC fully enrolled; top-line results Q3 2019 Ilixadencel as backbone therapy in the cancer immunity cycle: “pushing the Primary kidney tumor. Metastatic disease newly diagnosed RCC with metastatic disease. R n=58 n=30 ilixadencel. 2 weeks control – no ilixadencel injections.