of the Exchange, Immunicum AB (publ) Receives Orphan Drug Designation from EMA for Ilixadencel as Treatment for Gastrointestinal Stromal Tumors (GIST) .

Han syftar på den kliniska Fas I/II-studien med Immunicums huvudprodukt ilixadencel. Med utgångspunkt i de positiva resultaten hos den första

BioStock was able to get in touch with the new CEO and ask him about his plans for the company. 2 hours ago 2021-04-09 Immunicum AB (publ) today announced updated survival data from the Company’s randomized Phase II MERECA trial evaluating its off-the-shelf immune primer, ilixadencel, in combination with Immunicum AB (publ; IMMU.ST) tillkännager idag att bolaget har erhållit särläkemedelsstatus (Orphan Drug Designation, ODD) från den amerikanska läkemedelsmyndigheten, FDA, för bolagets ledande kandidat ilixadencel, en cellbaserad och lagringsbar immunaktiverare, för behandling av … EVELYN PESIKAN, ilixadencel, Immunicum, MERECA ATMP (Advanced Therapy Medicinal Products) är förkortningen för det många anser kommer att utgöra en viktig del i framtidens cancerläkemedel. Den internationella konkurrensen är stenhård inom detta område men Sverige hoppas så småningom kunna bli världsledande när det gäller utveckling och användning av dessa avancerade terapier. Köp aktien Immunicum AB (IMMU). Hos Nordnet kan du handla från 0 kr i courtage.

Immunicum AB (publ; IMMU.ST) has received and FDA Regenerative Medicine Advanced Therapy (RMAT) designation for the Company’s lead product candidate, ilixadencel, a cell-based, off-the-shelf immune primer for the treatment of metastatic Renal Cell Carcinoma (mRCC). Immunicum is advancing a novel immuno-oncology approach to treat solid tumors through its lead program ilixadencel Immunicum is listed on NASDAQ Stockholm under the ticker IMMU Tweets by @Immunicum Press Release 26 January 2021 Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment of Soft Tissue Sarcoma (STS) Immunicum AB (publ; IMMU.ST) announced today that Immunicum AB (publ; IMMU.ST) announced today that it has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for the Company’s lead About ilixadencelIlixadencel is an off-the-shelf cell-based cancer immunotherapy developed for the treatment of solid tumors. Its active ingredient is activated allogeneic dendritic cells, derived In December 2020, Immunicum announced that it received Fast Track Designation from the FDA for ilixadencel in Gastrointestinal Stromal Tumors (GIST) and Orphan Drug Designation by the FDA for ilixadencel in hepatocellular carcinomas. In January of this year, the company announced FDA Orphan Drug Designation for ilixadencel in STS. 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 pro-inflammatory allogeneic dendritic cell vaccine, being developed by Immunicum, for the treatment of cancer. The vaccine, called INTUVAX®, Immunicum’s clinical program DCP-001 is generated by transforming a proprietary leukemic cell, DCOne®, into a cell-based cancer vaccine. The company most recently presented comprehensive pre-clinical results showing that this transformation leads to an immunogenic shift.

Ilixadencel is an off-the-shelf cell-based cancer immunotherapy developed for the treatment of solid tumors. Its active ingredient is activated allogeneic dendritic cells, derived from healthy

Its active ingredient is activated allogeneic dendritic cells, derived from healthy Intratumoral administration of an immune primer is a therapeutic vaccine strategy aimed to trigger dendritic cell (DC)-mediated cross-presentation of cell-associated tumor antigens to cytotoxic CD8 + T cells without the need for tumor antigen characterization. Ilixadencel is an off-the-shelf cell-based cancer immunotherapy developed for the treatment of solid tumors. Its active ingredient is activated allogeneic dendritic cells, derived from healthy Ilixadencel is the 43rd FDA RMAT to be announced. Immunicum AB (publ; IMMU.ST) has received and FDA Regenerative Medicine Advanced Therapy (RMAT) designation for the Company’s lead product candidate, ilixadencel, a cell-based, off-the-shelf immune primer for the treatment of metastatic Renal Cell Carcinoma (mRCC).

Immunicum AB (publ) today announced updated survival data from the Company’s randomized Phase II MERECA trial evaluating its off-the-shelf immune primer, ilixadencel, in combination with

New CEO shares vision for Immunicum. With such deal making experience, Sven Rohmann is a welcome addition to the Immunicum team as the company moves forward with ilixadencel in clinical trials and continues its plans for partnering. BioStock was able to get in touch with the new CEO and ask him about his plans for the company. 2 hours ago 2021-04-09 Immunicum AB (publ) today announced updated survival data from the Company’s randomized Phase II MERECA trial evaluating its off-the-shelf immune primer, ilixadencel, in combination with Immunicum AB (publ; IMMU.ST) tillkännager idag att bolaget har erhållit särläkemedelsstatus (Orphan Drug Designation, ODD) från den amerikanska läkemedelsmyndigheten, FDA, för bolagets ledande kandidat ilixadencel, en cellbaserad och lagringsbar immunaktiverare, för behandling av … EVELYN PESIKAN, ilixadencel, Immunicum, MERECA ATMP (Advanced Therapy Medicinal Products) är förkortningen för det många anser kommer att utgöra en viktig del i framtidens cancerläkemedel.

2 feb 2021. EVELYN PESIKAN, ilixadencel, Immunicum, MERECA. ATMP (Advanced Therapy 21 Dec 2020 Immunicum has evaluated ilixadencel in several clinical trials including the recently completed exploratory Phase II MERECA study in kidney Pressmeddelande 31 december 2020 Immunicum AB (publ) erhåller särläkemedelsstatus, ODD, från FDA för ilixadencel för behandling av Pressmeddelande 7 december 2020 Immunicum AB (publ) erhåller Fast Track Designation från FDA för ilixadencel för behandling av GIST In addition to ilixadencel, these applications will allow the company to pursue or benefit from leading immuno-oncology trends in the biopharmaceutical industry.
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7 Jun 2018 Ilixadencel is an immune primer that uses activated DCs. It should not be confused with a DC therapy or DC vaccines.

The Stockholm-based immuno-oncology (IO) company […] Immunicum presented the updated results at the ASCO-SITC conference in Orlando, Florida, USA. Based on the MERECA results, Immunicum submitted an application to FDA, who decided to grant Immunicum Regenerative Medicine Advanced Therapy designation for ilixadencel is in metastatic RCC. Immunicum meddelar lovande resultat avseende överlevnad i fas II-studien MERECA med ilixadencel i njurcancer - Medianöverlevnad för patientgruppen som behandlades med ilixadencel i kombination med sunitinib har uppnåtts efter 35,6 månader, jämfört med 25,3 månader för kontrollgruppen med sunitinib, vilket indikerar en fördel vad gäller överlevnad för patienter i 2021-02-19 Immunicum AB (publ) Presents Preclinical Data on Ilixadencel in Combination with Cancer Therapies and Immunotherapies at the 2020 Virtual ESMO Congress. Publicerad: 2020-09-17 (GlobeNewswire) Immunicum AB (publ) presenterar prekliniska data för ilixadencel i kombination med cancerbehandlingar och immunterapier på årets ESMO-kongress Ilixadencel - an Allogeneic Cell-Based Anticancer Immune Primer for Intratumoral Administration Pharm Res. 2018 Jun 14 3 Immunicum AB, Grafiska Vägen 2, 412 63, Gothenburg, Sweden.
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Med hela tre pågående kliniska studier inväntar rapportaktuella Immunicum nya resultat för huvudkandidaten ilixadencel. Bolaget med vd Carlo de Sousa i spetsen ser fram emot att under året ytterligare validera potentialen hos läkemedelskandidaten. Trots tydliga tecken på framsteg inom onkologifältet är cancer fortfarande högt på listan av sjukdomar som människor världen över

BioStock reached out to Immunicum’s COO Sijme Zeilemaker to learn more. The Stockholm-based immuno-oncology (IO) company […] Immunicum presented the updated results at the ASCO-SITC conference in Orlando, Florida, USA. Based on the MERECA results, Immunicum submitted an application to FDA, who decided to grant Immunicum Regenerative Medicine Advanced Therapy designation for ilixadencel is in metastatic RCC. Immunicum meddelar lovande resultat avseende överlevnad i fas II-studien MERECA med ilixadencel i njurcancer - Medianöverlevnad för patientgruppen som behandlades med ilixadencel i kombination med sunitinib har uppnåtts efter 35,6 månader, jämfört med 25,3 månader för kontrollgruppen med sunitinib, vilket indikerar en fördel vad gäller överlevnad för patienter i 2021-02-19 Immunicum AB (publ) Presents Preclinical Data on Ilixadencel in Combination with Cancer Therapies and Immunotherapies at the 2020 Virtual ESMO Congress. Publicerad: 2020-09-17 (GlobeNewswire) Immunicum AB (publ) presenterar prekliniska data för ilixadencel i kombination med cancerbehandlingar och immunterapier på årets ESMO-kongress Ilixadencel - an Allogeneic Cell-Based Anticancer Immune Primer for Intratumoral Administration Pharm Res. 2018 Jun 14 3 Immunicum AB, Grafiska Vägen 2, 412 63, Gothenburg, Sweden. PMID: 29904904 PMCID: PMC6002422 DOI: 10.1007/s11095-018-2438-x Abstract 2020-09-17 To date Immunicum has established clinical proof of concept for its lead program, ilixadencel, which has been tested in a range of solid tumors. DCprime has produced equally encouraging clinical results for blood-borne tumors including interim data from its ongoing Phase II … Immunicum has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the company’s lead candidate, ilixadencel. Ilixadencel is a cell-based, off-the-shelf immune primer, for the treatment of the orphan indication, Gastrointestinal Stromal Tumors (GIST). Ilixadencel is a pro-inflammatory allogeneic dendritic cell vaccine, being developed by Immunicum, for the treatment of cancer.