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.

Ilixadencel is an off-the-shelf dendritic cell-based primer, designed to elicit an anticancer immune response when injected intratumorally. This phase 2 study investigated its potential as first-line systemic therapy for newly diagnosed synchronous metastatic RCC.

In May 2020, ilixadencel was granted a Regenerative Medicine Advanced Therapy designation from the FDA for use in patients with RCC. A few months later, in December 2020, the agent received a fast track designation for use in the treatment of patients with GIST. The FDA awarded ilixadencel RMAT based on the results of the previously announced Phase II MERECA clinical trial. The trial evaluated the efficacy and safety of ilixadencel combined with the targeted anticancer drug Sutent (common name: sunitinib, sunitinib; developed by Pfizer) in the first-line treatment of patients with newly diagnosed metastatic renal cell carcinoma (mRCC). It insists that the response rate data warrants the continued clinical development of ilixadencel in RCC – the most common form of kidney cancer – as well as “other solid tumour indications.” Ilixadencel is an off-the-shelf cell-based immunotherapy indicated for solid tumors like hepatocellular carcinoma, gastrointestinal stromal tumors, and mRCC.

No dose reductions were required. In May 2020, ilixadencel was granted a Regenerative Medicine Advanced Therapy designation from the FDA for use in patients with RCC. Immunicum’s positioning of ilixadencel is as a first-line treatment for advanced solid tumours in combination with standard treatments (for example in RCC, where sunitinib is the standard of care). Ilixadencel appears to be a typical neoadjuvant opportunity that could be applied to many solid tumours as it can be injected into any primary or secondary solid tumour above 2cm in diameter prior to surgical excision. Se hela listan på frontiersin.org 2019-09-25 · 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 för njurcancer (RCC) och Fast Track 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 Om ilixadencel Cellterapiprodukten ilixadencel är en immunaktiverare som är lagringsbar (”off-the-shelf”) och som utvecklats för behandling av solida tumörer.

Cytoreductive nephrectomy for metastatic renal cell carcinoma, the ultimate urologic The proposed mechanism of action of CN rests on the principle that RCC A randomized phase II study with ilixadencel, a cell-based immune primer, Dec 2, 2019 The study evaluated the therapeutic impact of ilixadencel in combination with Sutent (sunitinib), a TKI, in metastatic renal cell carcinoma (RCC) be overexpressed by cancers such as renal cell carcinoma (RCC) and glioma.

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).

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2020年5月，美国FDA授予ilixadencel治疗转移性肾细胞癌（RCC）的再生医学先进疗法（RMAT）资格。在2020年12月，FDA授予ilixadencel治疗GIST的快速

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. Taken together, the results indicate that ilixadencel provided a systemic therapeutic benefit while maintaining a positive safety and tolerability profile. 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.

It insists that the response rate data warrants the continued clinical development of ilixadencel in RCC – the most common form of kidney cancer – as well as “other solid tumour indications.” Adding Ilixadencel Improved Outcomes in Metastatic RCC Adding Ilixadencel Improved Outcomes in Metastatic RCC Combining intratumoral injections of ilixadencel with sunitinib improved responses in patients with newly diagnosed synchronous metastatic renal cell carcinoma in the phase 2 MERECA trial.Medscape Medical News The FDA awarded ilixadencel RMAT based on the results of the previously announced Phase II MERECA clinical trial. The trial evaluated the efficacy and safety of ilixadencel combined with the targeted anticancer drug Sutent (common name: sunitinib, sunitinib; developed by Pfizer) in the first-line treatment of patients with newly diagnosed metastatic renal cell carcinoma (mRCC). 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 Njurcancer (RCC) - beprövad indikation, ny kombination Baserat på de nyligen förändrade riktlinjerna kring standardbehandling och våra lovande prekliniska data kring ilixadencel i kombination med anti-PD1 och anti-CTLA4, har vi beslutat att addera ilixadencel till etablerad kombinationsbehandling med anti-CTLA-4 (ipilimumab) Pressmeddelande. 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.
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To-date ilixadencel has been tested in a range of clinical trials in various solid tumor indications including metastatic Renal Cell Carcinoma (mRCC), May 4, 2015 Condition or disease, Intervention/treatment, Phase. Renal Cell Carcinoma, Metastatic, Biological: Intuvax (ilixadencel) Drug: Sunitinib, Phase Dec 20, 2019 in renal cell carcinoma in October. And Immunicum turned in disappointing data from a trial comparing its dendritic cell vaccine ilixadencel to 14 feb 2020 Addition of intratumoral ilixadencel to sunitinib improved responses in patients with newly diagnosed synchronous metastatic renal cell 18 feb 2021 för ilixadencel för behandling av gastrointestinal stromacellstumör (GIST) för behandling av patienter med metastaserad njurcancer (RCC).

The majority (75%) of RCC cases have a clear cell histology (ccRCC), to which most first-line treatment regimens are specialized. 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).
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Njurcancer (RCC) - beprövad indikation, ny kombination Baserat på de nyligen förändrade riktlinjerna kring standardbehandling och våra lovande prekliniska data kring ilixadencel i kombination med anti-PD1 och anti-CTLA4, har vi beslutat att addera ilixadencel till etablerad kombinationsbehandling med anti-CTLA-4 (ipilimumab)

The decision was made based on the results from the MERECA trial [6]. Feb 20 · In its latest corporate presentation, Immunicum reports that clinical GMP manufacturing is in place and commercial scale activities initiated.

Bernie Maddog har fått RCC, Immunicum AB, 20-02-06 12:32 Detta pga alla nya potentiella behandlingar så det är orimligt att Ilixadencel når

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. Taken together, the results indicate that ilixadencel provided a systemic therapeutic benefit while maintaining a positive safety and tolerability profile. 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.

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 is a pro-inflammatory allogeneic dendritic cell vaccine, being developed by Immunicum, for the treatment of cancer. The vaccine, called INTUVAX®, för njurcancer (RCC) och Fast Track 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 The combination of ilixadencel vaccination and Sutent elicited 11% complete response (CR) rate in patients with metastatic renal cell carcinoma (RCC), according to findings from the phase II MERECA trial: 5 out of 45 metastatic kidney cancer patients (11%) in contrast to 1 out of 25 in the sutent monotherapy control arm (4%). 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, | … 2019-12-20 In May 2020, ilixadencel was granted a Regenerative Medicine Advanced Therapy designation from the FDA for the treatment of patients with mRCC.

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).

2020年5月，美国FDA授予ilixadencel治疗转移性肾细胞癌（RCC）的再生医学 先进疗法（RMAT）资格。在2020年12月，FDA授予ilixadencel治疗GIST的快速

Bernie Maddog har fått RCC, Immunicum AB, 20-02-06 12:32 Detta pga alla nya potentiella behandlingar så det är orimligt att Ilixadencel når

2020年5月，美国FDA授予ilixadencel治疗转移性肾细胞癌（RCC）的再生医学先进疗法（RMAT）资格。在2020年12月，FDA授予ilixadencel治疗GIST的快速