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.

BioStock: Immunicum's ilixadencel granted regenerative medicine advanced therapy designation from FDA. Read the full interview with Sijme

Placeringstips och råd om aktier, fonder, sparande och privatekonomi Tidigare i år erhöll ilixadencel en så kallad Regenerative Medicine Advanced Therapy-status (RMAT) från den amerikanska läkemedelsmyndigheten FDA baserat på tidigare kommunicerade resultat från fas II-studien Mereca. Ilixadencel avancerar i preklinisk studie. När det gäller ilixadencel-behandling i kombination med CPIer kunde bolaget presentera resultaten från en preklinisk studie där ilixadencel kombinerades med anti-CTLA-4. Syftet var att avgöra kandidatens potential att fungera i kombination med andra immunterapier. Om ilixadencel Cellterapiprodukten ilixadencel är en immunaktiverare som är lagringsbar (”off-the-shelf”) och som utvecklats för behandling av solida tumörer. Den aktiva beståndsdelen är aktiverade dendritceller som tas från friska blodgivare. 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

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. 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 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. According to Immunicum, the active ingredient of the off-the-shelf immunotherapy ilixadencel is activated allogeneic dendritic cells. These cells come from healthy blood donors and are injected into the patient’s tumor.

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 .

Det viktigaste fyndet i studien var att 5 patienter STOCKHOLM (Nyhetsbyrån Direkt) Forskningsbolaget Immunicum har fått läkemedelskandidaten ilixadencel vid behandling av mjukdelssarkom (soft tissue Immunicums ledande produkt, ilixadencel, har utvecklats med syftet att kunna Ilixadencel har genomgått kliniska studier i Fas I/II på njur- och Immunicum: Överlevnad 54 procent med ilixadencel i Mereca-studien. torsdag 6 februari 2020 kl. 22:24.

The mechanism of action of ilixadencel is to induce recruitment and activation of endogenous immune cells, including NK cells that subsequently promotes cross-

Om ilixadencel Cellterapiprodukten ilixadencel är en immunaktiverare som är lagringsbar (”off-the-shelf”) och som utvecklats för behandling av solida tumörer. Den aktiva beståndsdelen är aktiverade dendritceller som tas från friska blodgivare.

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 Pressmeddelande.
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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 är en cellbaserad och lagringsbar immunaktiverare för behandling av solida tumörer.

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. 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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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

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. 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. Ilixadencel is an immunotherapy developed for the treatment of solid tumors, with an active ingredient of activated allogeneic dendritic cells that are derived from healthy blood donors. 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).