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 

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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).

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. By prioritizing the development of ilixadencel in Gastrointestinal Stromal Tumors (GIST) and sarcomas, our goal is to shorten the development pathway These results indicate that ilixadencel provided a systemic therapeutic benefit while maintaining a positive safety and tolerability profile. 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.

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Jun 14, 2018 The mechanism of action of ilixadencel is to induce recruitment and of tissue samples from surgically removed primary renal RCC tumors  Feb 7, 2020 ilixadencel in combination with Sutent (sunitinib) first-line treatment regimen in newly diagnosed metastatic renal cell carcinoma (mRCC)  Immunicum has completed a phase I/II open-label study of ilixadencel, INTUVAX ®-RCC, in patients with metastatic renal cell carcinoma (IM-101;  Ilixadencel. 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. • 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.

Ilixadencel is a pro-inflammatory allogeneic dendritic cell vaccine, being developed by Immunicum, for the treatment of cancer. The vaccine, called INTUVAX®,

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).

Ilixadencel rcc

Sep 10, 2019 A combination therapy of ilixadencel plus sunitinib (Sutent) achieved complete tumor responses in patients with metastatic renal cell carcinoma 

Ilixadencel rcc

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).

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.
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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.

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).
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May 4, 2015 Condition or disease, Intervention/treatment, Phase. Renal Cell Carcinoma, Metastatic, Biological: Intuvax (ilixadencel) Drug: Sunitinib, Phase 

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.


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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 …

All toxicities associated with ilixadencel were found to be transient and had resolved before the end of the trial.