MERECA Q&A – English Immunicum

MFN.se > Immunicum > Immunicum AB publ publicerar

Etiketter:Njurcancer, PATIENTÖVERSIKT, RCC i samverkan. Patientöversikten ger en Uppdaterade data från MERECA-studien med ilixadencel i njurcancer. 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).

Ilixadencel rcc

Ilixadencel Gets Orphan Drug Designation for Soft Tissue Sarcoma The FDA has granted the cell-based, off-the-shelf immune primer ilixadencel an orphan drug designation for use as a treatment option in patients with soft tissue sarcoma (STS), according to an announcement from Immunicum AB. ORLANDO – Combining intratumoral injections of ilixadencel, an off-the-shelf dendritic cell–based primer, with sunitinib improved responses in patients with newly diagnosed synchronous metastatic renal cell carcinoma in the phase 2 MERECA trial. In the ilixadencel combination arm, ilixadencel was administered prior to surgery, and sunitinib was administered after surgery. 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. Ilixadencel is a cancer vaccine that Immunicum developed around immune system components known as dendritic cells. The Phase 1 portion of the trial (NCT01525017) covered patients with newly diagnosed metastatic renal cell carcinoma, or mRCC. That is a cancer that has spread from the kidneys to other parts of the body.

Etablerar ett unikt immun-onkologiskt angreppssätt genom att

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. According to the latest (July) follow-up update from the MERECA trial (ilixadencel in renal cell carcinoma; RCC), the mOS was reached at 25.3 months in the sunitinib (control) group, while in the ilixadencel plus sunitinib group the mOS has not been reached yet. Adding Ilixadencel Improved Outcomes in Metastatic Renal Cell Carcinoma May 21, 2020 | Oncology , RCC Content Hub A study composed of patients from across the USA and Europe observed improved outcomes in those treated with both ilixadencel and sunitinib compared with sunitinib alone. 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.

Immunicum ilixadencel HCC I/II topline resultat

Sep 10, 2019 A combination therapy of ilixadencel plus sunitinib (Sutent) achieved complete tumor responses in patients with metastatic renal cell carcinoma Aug 26, 2020 The combination of the off-the-shelf cancer immune primer Ilixadencel and sunitinib has demonstrated promising survival benefit when used as Jun 20, 2017 At the time of inclusion, all 12 patients were assessed as RCC with at by ELISpot at baseline and 2 weeks after the second ilixadencel dose.

Overall the data supports the continued clinical development of ilixadencel as an immune primer in RCC and other solid tumors.
Fytoterapeut

That is a cancer that has spread from the kidneys to other parts of the body. 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. The 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.

Patientöversikten ger en Uppdaterade data från MERECA-studien med ilixadencel i njurcancer. 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).
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MFN.se > Immunicum > Immunicum AB publ publicerar

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.

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Kolangiokarcinom. Medicinsk sök. Definitionerna

1 In the ilixadencel combination arm, ilixadencel was administered prior to surgery, and sunitinib was administered after surgery. 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. 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.

Immunicum AB publ Delårsrapport Januari – september 2020

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. Den aktiva beståndsdelen är aktiverade dendritceller som tas från friska blodgivare. 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). 2020-12-10 · Datamonitor Healthcare estimates that in 2018, there were 338,000 incident cases of renal cell carcinoma (RCC) worldwide in those aged 40 years and older, and forecasts that number to increase to 384,000 cases by 2027. The majority (75%) of RCC cases have a clear cell histology (ccRCC), to which most first-line treatment regimens are specialized.