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]. Feb 20 · In its latest corporate presentation, Immunicum reports that clinical GMP manufacturing is in place and commercial scale activities initiated.

Adding Ilixadencel Improved Outcomes in Metastatic RCC Adding Ilixadencel Improved Outcomes in Metastatic RCC Combining intratumoral injections of ilixadencel with sunitinib improved responses in patients with newly diagnosed synchronous metastatic renal cell carcinoma in the phase 2 MERECA trial.Medscape Medical News

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.

Ilixadencel rcc

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. He noted that the most common ilixadencel-related adverse The combination of the off-the-shelf cancer immune primer ilixadencel and sunitinib (Sutent) elicited a 11% complete response (CR) rate in patients with metastatic renal cell carcinoma (RCC 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. 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… 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]. Feb 20 · In its latest corporate presentation, Immunicum reports that clinical GMP manufacturing is in place and commercial scale activities initiated.

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).

The first half of the year for one of Sweden’s top immuno-oncology (IO) companies, Immunicum, has been one of continued progress for the company’s main project, MERECA, which is exploring the effects of their off-the-shelf IO candidate ilixadencel in combination with the tyrosine kinase inhibitor (TKI) sunitinib in metastatic Renal Cell Carcinoma (RCC) patients.

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

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

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). Renal Cell Carcinoma (RCC) showed that five patients had complete response and 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.

#wewontrest #cancer #CAR-T @BCF_1982 #RCC #Nätverket mot cancer Se och läs Immunicums Ilixadencel blir skräddarsytt i patientens Immunicums ledande produkt ilixadencel utnyttjar den unika och kritiska mation om de pågående studierna inom RCC och GIST, se avsnittet De prekliniska resultaten visar hur ilixadencel genererar komplementära immunologiska Njurcancer (RCC) Rekryteringen har slutförts till den pågående Ilixadencel är en off-the shelf - produkt framtagen från friska allogena Fas II Fas III Ilixadencel IM-201 Njure (RCC) Ilixadencel IM-102 Lever (HCC) Ilixadencel Cancercentrum (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. 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.
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The MERECA clinical trial evaluated the therapeutic impact of combining ilixadencel with sunitinib in advanced kidney cancer.

Ilixadencel is an off-the-shelf cell-based immunotherapy indicated for solid tumors like hepatocellular carcinoma, gastrointestinal stromal tumors, and mRCC.
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The FDA awarded ilixadencel RMAT based on the results of the previously announced Phase II MERECA clinical trial. 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).

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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The FDA awarded ilixadencel RMAT based on the results of the previously announced Phase II MERECA clinical trial. 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).

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.