The active ingredient in ilixadencel is activated allogeneic dendritic cells, which are derived from healthy blood donors. The intratumoral injection of these cells is designed to elicit an

To-date ilixadencel has been tested in a range of clinical trials in various solid tumor indications including metastatic Renal Cell Carcinoma (mRCC),

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. Ilixadencel is being tested in Phase I and II clinical trials, in several solid tumour indications and combinations (see Exhibit 1). 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. 7 maj, 2020 Immunicum’s lead candidate, ilixadencel, just got a big boost in its development by being granted regenerative medicine advanced therapy designation by the FDA. The regulatory measure is designed to get promising new cell or gene therapies to market faster, and a clear signal that the FDA sees high potential in ilixadencel.

Ilixadencel rcc

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. 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).

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.

The FDA has granted a Regenerative Medicine Advanced Therapy (RMAT) designation to ilixadencel, as treatment of metastatic renal cell carcinoma (RCC), Immunicum AB announced in a press release. 1. “We are very excited to have received the RMAT designation for ilixadencel in kidney cancer as it recognizes both the potential of our novel therapeutic

Ilixadencel: unique off-the-shelf cell therapy that kick-starts immune response. Phase 2 Phase 1/2 RCC: intratumoral injection in kidney of metastatic patients These data support the continued clinical development of ilixadencel as an immune primer in RCC and other solid tumors, to provide cancer Phase II controlled study in RCC completed, latest survival update August Ilixadencel: a unique off-the-shelf intratumoral immune primer. 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.

7 maj, 2020 Immunicum’s lead candidate, ilixadencel, just got a big boost in its development by being granted regenerative medicine advanced therapy designation by the FDA. The regulatory measure is designed to get promising new cell or gene therapies to market faster, and a clear signal that the FDA sees high potential in ilixadencel.

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.

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.
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This phase 2 study investigated its potential as first-line systemic therapy for newly diagnosed synchronous metastatic RCC. Ilixadencel is an off-the-shelf cancer immune primer developed for the treatment of solid tumors.

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 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.
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the therapeutic impact of the company's lead candidate, ilixadencel, in combination with Sutent (sunitinib) in metastatic Renal Cell Carcinoma (RCC) patients.

The regulatory decision was based on prior data from The FDA has granted a Regenerative Medicine Advanced Therapy (RMAT) designation to ilixadencel, as treatment of metastatic renal cell carcinoma (RCC), Immunicum AB announced in a press release. 1. “We are very excited to have received the RMAT designation for ilixadencel in kidney cancer as it recognizes both the potential of our novel therapeutic The addition of the off-the-shelf cancer immune primer ilixadencel to sunitinib (Sutent) trended toward a benefit in overall survival (OS) compared with sunitinib alone as a first-line treatment for patients with newly diagnosed metastatic renal cell carcinoma (RCC), according to updated results of the phase II MERECA trial (NCT02432846) presented during the 2020 ASCO-SITC Clinical Immuno-Oncology … Ilixadencel did not add any clinically meaningful treatment-related grade 3-4 adverse events or serious adverse events, Dr. Lindskog said.

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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

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). 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.