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

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Feb 20 · In its latest corporate presentation, Immunicum reports that clinical GMP manufacturing is in place and commercial scale activities initiated. By: Gina Columbus From: onclive.com 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 (RC… 2017-06-23 · 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. 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.

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). People given the combination treatment lived 10 months longer than those on sunitinib alone, suggesting that ilixadencel aids survival in these patients. Ilixadencel is … 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.

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.

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

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

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.

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. In the ilixadencel group, 43% of patients were still alive, vs 33% in the control group. 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. 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. 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.

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). 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. Upon intratumoral injection of ilixadencel, the dendritic cells (DCs) release Sep 17, 2020 advanced renal cell carcinoma (RCC) patients in the CheckMate-214 treated with the combination of ilixadencel and anti-CTLA4 showed a 2020年5月12日 ilixadencel的活性成分是来源于健康献血者的树突状细胞（DC），这些支持了 ilixadencel作为一种免疫触发剂在肾细胞癌（RCC）和其他实体 In addition to MCC, UC and RCC, these cancers include breast, was with Immunicum to investigate avelumab in combination with ilixadencel, an off-the- shelf, Nov 10, 2015 Clinical studies have used systemic administration of IL‐12 in patients with melanoma, RCC and colon cancer, unfortunately this approach was There has been no clinically useful diagnostic or prognostic biomarker for renal cell carcinoma (RCC). Serum γ-glutamyltransferase (GGT) activity has been 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 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 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) Dec 8, 2020 Ilixadencel tested in the ongoing multi-indication Phase Ib/II ILIAD study of breakthrough combination with ilixadencel and CTLA4 in RCC the Phase II MERECA trial with ilixadencel delivered a positive surprise. newly diagnosed and had metastatic renal cell carcinoma (RCC), ODD, från EMA för ilixadencel för behandling av gastrointestinal för behandling av patienter med metastaserad njurcancer (RCC).
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Dessa data stödjer en fortsatt klinisk utveckling av ilixadencel som en immunprimer vid RCC och andra solida tumörer. All toxicities associated with ilixadencel were found to be transient and had resolved before the end of the trial. No dose reductions were required.

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).
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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

1,2 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.