Immunicum - IMMU - Sidan 13 - Flashback Forum

In May 2020, ilixadencel was granted a Regenerative Medicine Advanced Therapy designation from the FDA for use in patients with RCC. Immunicum’s positioning of ilixadencel is as a first-line treatment for advanced solid tumours in combination with standard treatments (for example in RCC, where sunitinib is the standard of care). Ilixadencel appears to be a typical neoadjuvant opportunity that could be applied to many solid tumours as it can be injected into any primary or secondary solid tumour above 2cm in diameter prior to surgical excision. 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).

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. Metastatic disease newly diagnosed RCC with metastatic disease. R n=58 n=30 ilixadencel. 2 weeks control – no ilixadencel injections.

Immunicum AB publ Delårsrapport Januari – september 2020

For the study, 88 newly-diagnosed, intermediate- and poor-prognosis patients with metastatic RCC were enrolled. 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.

Etablerar ett unikt immun-onkologiskt angreppssätt genom att

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. Ilixadencel-Sunitinib Combo Improves Response In Certain Patients With Metastatic RCC In Phase II Trial wb.md/38xBsq0 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 … 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 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).

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. “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 did not add any clinically meaningful treatment-related grade 3-4 adverse events or serious adverse events, Dr. Lindskog said. He noted that the most common ilixadencel-related adverse 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.
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A total of 88 patients have been randomised in the trial to meet requirements of the study design and validity of the protocol.

The decision was made based on the results from the MERECA trial [6]. Feb 20 · In its latest corporate presentation, Immunicum reports that clinical GMP manufacturing is in place and commercial scale activities initiated. 2017-06-23 The treatment appears to be well tolerated, with ilixadencel not appearing to cause any additional serious adverse events. Learn more by clicking here.
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Etablerar ett unikt immun-onkologiskt angreppssätt genom att

The vaccine, called INTUVAX®, 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.

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Immunicum AB publ Delårsrapport Januari – september 2020

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). Ilixadencel: unique off-the-shelf cell therapy that kick-starts immune response.

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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). 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 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. Ilixadencel-Sunitinib Combo Improves Response In Certain Patients With Metastatic RCC In Phase II Trial wb.md/38xBsq0 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 … 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 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).