2018-06-07

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.

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 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. 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 cell-based immunotherapy indicated for solid tumors like hepatocellular carcinoma, gastrointestinal stromal tumors, and mRCC. Ilixadencel has been tested in these cancers in combination with several standard-of-care cancer therapies like chemotherapy.

Ilixadencel rcc

Follow-up on survival data in December 2019 demonstrated a separation in survival curves in favor of the ilixadencel group. GIST/sarkom för sällsynta och svårbehandlade sjukdomar - beprövad indikation och kombination 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 … 2020-12-10 Immunicum has completed enrolling patients for its ongoing Phase II Metastatic REnal Cell Carcinoma (MERECA) clinical trial of Ilixadencel for the treatment of renal cell cancer (RCC). A total of 88 patients have been randomised in the trial to meet requirements of the study design and validity of the protocol. 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.

Immunicum erhöll Fast Track Designation från FDA för ilixadencel för för njurcancer (RCC) och Fast Track Designation (FTD) för ilixadencel A randomized phase II study with ilixadencel, a cell-based immune primer, plus sunitinib versus sunitinib alone in synchronous metastatic renal cell carcinoma.

RMAT designation from the FDA for their top drug candidate ilixadencel. Therapy (RMAT) designation for ilixadencel is in metastatic RCC.

Du kan också I studierna hittills har ilixadencels säkerhetsprofil olika cancerformer där ilixadencel skulle kunna 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 Fas II delen av ILIAD, där man utvärderar effekt av ilixadencel i med BMS nivolumab + ipilimumab i RCC innan man tar ställning till fas III. Bolaget har även en pågående fas II-studie inom njurcancer (RCC) kallad Det intressantaste med verkningsmekanismen av ilixadencel är att att cancerimmunaktiveraren ilixadencel kombinerats med standardläkemedel Regionala cancercentrums (RCC) samverkansgrupp beslöt vid sitt möte 18 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 FDA Grants RMAT Designation to Ilixadencel in Metastatic RCC "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 approach as well as the clear need for viable therapies to address this difficult-to-treat disease." 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 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). Ilixadencel showed strong clinical activity with a potential overall survival (OS) benefit in patients with newly diagnosed metastatic renal cell carcinoma (RCC), according to data from the phase 2 MERECA trial reported by Immunicum, the developer of the off-the-shelf, cell-based immunotherapy.1 ORLANDO, Florida — Combining intratumoral injections of ilixadencel, an off-the-shelf dendritic cell–based primer, with sunitinib improved responses in patients with newly diagnosed synchronous May 20 · FDA grants Regenerative Medicine Advanced Therapy (RMAT) designation to ilixadencel for the treatment of mRCC.

2020-12-10

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 slutändan till patienter.

The decision was made based on the results from the MERECA trial. Feb 20 · In its latest corporate presentation, Immunicum reports that clinical GMP manufacturing is in place and commercial scale activities initiated. 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.
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1 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 May 20 · FDA grants Regenerative Medicine Advanced Therapy (RMAT) designation to ilixadencel for the treatment of mRCC. The decision was made based on the results from the MERECA trial [6].

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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Produkt-lanseringar med ilixadencel, för RCC (njurcancer) och NSCLC (icke småcellig lungcancer) utgör 25 respektive 35 procent av värdet enligt Edison.

Fas II (MERECA) pågår.

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

The mechanism of action of ilixadencel is to induce recruitment and activation of endogenous immune cells, including NK cells that subsequently promotes cross-presentation of cell-associated tumor antigens by co-recruited DCs. Intratumoral administration of an immune primer is a therapeutic vaccine strategy aimed to trigger dendritic cell 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 is an off-the-shelf dendritic cell-based primer, designed to elicit an anticancer immune response when injected intratumorally.

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%).