Ilixadencel is an immune primer designed to increase the body’s defenses against cancer cells. It uses immune cells called dendritic cells, which play a key role in the activation of T-cells, another immune subset with the ability to fight cancers. The dendritic cells are collected from healthy donors.

Pressmeddelande. 7 december 2020. Immunicum AB (publ) erhåller Fast Track Designation från FDA för ilixadencel för behandling av GIST . Immunicum AB (publ) (IMMU.ST) tillkännager idag att bolaget har erhållit Fast Track Designation från den amerikanska läkemedelsmyndigheten, FDA, för bolagets ledande kandidat ilixadencel, en cellbaserad och lagringsbar immunaktiverare, för behandling

Den aktiva ingrediensen är aktiverade allogena dendritiska celler som tas från friska blodgivare. Edisons analysuppdatering i februari innebar ökat motiverat värde till 25.8 kr per där sannolikheten att ilixadencel marknadsgodkänns i njurcancer sat… 2017-06-23 · Ilixadencel proved safe, with no severe adverse effects. The article in the Journal for ImmunoTherapy for Cancer “represents the complete analysis of data from the Phase 1/2 trial, and we are pleased to have achieved peer-reviewed publication in a well-reputed international journal,” Alex Karlsson-Parra, chief scientific officer of Immunicum, said in a press release . Om Ilixadencel Cellterapiprodukten ilixadencel är en cancerimmunaktiverare som kan lagras "på hylla" ("off-the-shelf") och som utvecklats för behandling av solida tumörer. Den aktiva ingrediensen är aktiverade allogena dendritceller som tas från friska blodgivare.

Ilixadencel

Nov 20 · Immunicum announces that it is advancing to late-stage development for ilixadencel, and is preparing a clinical trial. 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. Here we present preclinical mode of action data, CMC and regulatory data, as well as initial clinical data on ilixadencel. This cell-based drug product is an off-the-shelf immune primer, consisting of pro-inflammatory allogeneic DCs secreting high amounts of pro-inflammatory chemokines and cytokines at the time of intratumoral administration.

kombinerad behandling med ilixadencel leder till en nästan dubbelt så stor andel patienter med bekräftad objektiv respons jämfört med

Injection A Study to Evaluate the Safety and Effectiveness of ILIxadencel Administered Into Tumors in Combination With Checkpoint Inhibitor (CPI) in Patients With ADvanced Cancer (ILIAD) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. -- Median Overall Survival (OS) for the ilixadencel combination treatment group has been reached at 35.6 months, as compared to 25.3 months for the sunitinib control group, indicating a potential Ilixadencel, which consists of monocyte-derived, allogeneic dendritic cells (DCs) that are stimulated with a combination of pro-inflammatory factors, can be administered by intratumoral injections and function as an immune primer (21, 22). Of 17 HCC patients enrolled, 12 patients received ilixadencel at the dose of 10 × 106 cells (six as monotherapy and six in combination with sorafenib), and five received ilixadencel at the dose of 20 × 106 cells as monotherapy. The primary objective was to evaluate tolerability.

Patients in the Phase 1b part of the study will be treated with ilixadencel at an increasing dose and frequency, in combination with standard doses and schedules

Ilixadencel is an investigational anti-cancer vaccine that uses dendritic cells, a type of immune cell, to instruct T-cells to attack and destroy cancer cells. After being isolated from healthy donors, dendritic cells undergo a procedure to become activated and produce certain substances that trigger strong immune responses. Nov 20 · Immunicum announces that it is advancing to late-stage development for ilixadencel, and is preparing a clinical trial. 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. Here we present preclinical mode of action data, CMC and regulatory data, as well as initial clinical data on ilixadencel. This cell-based drug product is an off-the-shelf immune primer, consisting of pro-inflammatory allogeneic DCs secreting high amounts of pro-inflammatory chemokines and cytokines at the time of intratumoral administration.

Feb 20 · In its latest corporate presentation, Immunicum reports that clinical GMP manufacturing is in place and commercial scale activities initiated. 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 a cell-based, off-the-shelf immune primer, for the treatment of Soft Tissue Sarcoma (STS). The designation recognizes results from the Phase I/II clinical trial in Gastrointestinal Stromal Tumors (GIST), a rare and difficult-to treat cancer indication belonging to the group of cancers referred to as Soft Tissue Sarcoma.
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26 Jan 2021 FDA Grants Orphan Drug Designation to Ilixadencel for Soft Tissue Sarcoma January 26, 2021 - The FDA has granted the cell-based, off-the-

Forskningsbolaget Immunicum meddelar att Immunicum AB (publ) erhåller särläkemedelsstatus, ODD, från FDA för ilixadencel för behandling av mjukdelssarkom, Soft Tissue Sarcoma Han syftar på den kliniska Fas I/II-studien med Immunicums huvudprodukt ilixadencel. Med utgångspunkt i de positiva resultaten hos den första Immunicum tillkännager positiva preliminära resultat från koncepttest på djur med en kombination av ilixadencel och checkpointhämmare. Nature-artikeln idag - stöd för ilixadencel : I abstractet förklaras att framgång i behandlingen med checkpointhämmare kräver optimalt primade CD8+ T-celler inn.

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The active ingredients of ilixadencel are dendritic cells (DC) derived from healthy blood donors. These cells are specially activated to produce a large number of powerful immune stimulating factors.

2021-01-26 The combination of ilixadencel plus sunitinib (Sutent) has evidenced favorable survival compared with sunitinib alone in patient with newly diagnosed metastatic synchronous renal cell carcinoma (mRCC), clinical sponsor Immunicum AB recently announced and will present at the 2020 American Society of Clinical Oncology-Society for Immunotherapy of Cancer Clinical Immuno-Oncology Symposium Immunicum AB (publ) announced today an update on survival data from the randomized Phase II MERECA trial evaluating its off-the-shelf immune primer, ilixadencel, in combination with Sutent (sunitinib) first-line treatment regimen in newly diagnosed patients with metastatic renal cell carcinoma (mRCC).. During the trial, 88 patients were randomly assigned in a two-to-one ratio to the Pressmeddelande 27 november 2017 Immunicum tillkännager positiva preliminära resultat från koncepttest på djur med en kombination av ilixadencel och checkpointh 2020-06-16 Ilixadencel. Targeting solid tumors with an off-the-shelf, cell-based immune primer. Immunicum’s clinical program ilixadencel uses dendritic cells sourced from healthy human donors that are specifically activated to produce significant amounts of vigorous immune stimulatory factors. By administration through intratumoral injection, these cells 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. Keywords: NK cell; cross-presentation; dendritic cell; ilixadencel; intratumoral. Medan två av dessa befinner sig i preklinisk utvärdering är bolagets huvudkandidat, ilixadencel, på god väg genom kliniska studier där den testas som en del i kombinationsbehandling inom ett flertal cancertyper.

2020-02-10

Phase I Trial Evaluating Safety and Efficacy of Intratumorally Administered Inflammatory Allogeneic Dendritic Cells (Ilixadencel) in Advanced Gastrointestinal Stromal Tumors Phase I Trial Evaluating Safety and Efficacy of Intratumorally Administered Inflammatory Allogeneic Dendritic Cells (Ilixadencel) in Advanced Gastrointestinal Stromal Tumors Ilixadencel is an immune primer designed to increase the body’s defenses against cancer cells.

For the study, 88 newly-diagnosed, intermediate- and poor-prognosis patients with metastatic RCC were enrolled. Ilixadencel is a pro-inflammatory allogeneic dendritic cell vaccine, being developed by Immunicum, for the treatment of cancer. The vaccine, called INTUVAX®, Ilixadencel is an off-the-shelf cell-based immunotherapy indicated for solid tumors like hepatocellular carcinoma, gastrointestinal stromal tumors, and mRCC.