Immunicum får särläkemedelsstatus för ilixadencel

Immunicum AB: Immunicum AB publ meddelar att ilixadencel

Immunicum is a clinical-stage immunoncology company based in Stockholm, Sweden. It is developing an allogeneic off-the-shelf dendritic cell immune activator or immune primer, ilixadencel, for use in combination with checkpoint inhibitors and other anti-cancer therapies in potentially any solid tumour indications accessible via direct injection. Immunicum is a clinical-stage immunoncology (IO) company based in Stockholm, Sweden. It is developing an allogeneic off-the-shelf dendritic cell immune activator or immune primer, ilixadencel, for use in combination with CPIs and other anti-cancer therapies in multiple solid tumour indications. In May 2020, Immunicum received Regenerative Medicine Advanced Therapy designation from the FDA for ilixadencel for the treatment of patients with metastatic Renal Cell Carcinoma.

I december samma år fick bolaget Fast Track Designation från FDA för ilixadencel för behandling av gastrointestinal stromacellstumör (GIST). 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 2020-12-31 Immunicum has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for ilixadencel. Ilixadencel is a cell-based, off-the-shelf immune primer, for the treatment of Soft Tissue Sarcoma (STS). 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.

. Click here to view the full announcement: https://bit.ly/35N Welcome to Immunicum's Investor Relations pages!

Immunicum – Mereca - resultat på agendan » Stockpicker.se

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.

Immunicum AB publ går vidare till nästa dosnivå i fas Ib/II

Immunicum is leveraging its unparalleled expertise in dendritic cell biology to develop novel, off-the-shelf, cell-based therapies for solid and blood-borne tumors. With complementary therapeutic approaches in Phase II clinical development that are based on intratumoral priming and cancer relapse vaccination, the company aims to improve survival outcomes and quality of life for a broad 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. Innovation in immuno-oncology. Press releases. Choose which language you would like to receive the press release in: On Wednesday, November 18th Immunicum and DCprime combined forces to establish the company as a leader in cell-based cancer immunotherapies. Click here to view the full announcement: https://bit.ly/35NoOVj About DCprime DCprime is the front-runner in the field of relapse vaccines, a new class of oncology vaccines administered after or in conjunction with standard of care therapy to delay … 2021-02-22 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 2020-05-11 2021-02-22 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 mjukdelssarkom (Soft Tissue Sarcoma, STS).

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. Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC).
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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.

In May 2020, Immunicum received Regenerative Medicine Advanced Therapy designation from the FDA for ilixadencel for the treatment of patients with metastatic Renal Cell Carcinoma. 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 Immunicum AB (Nasdaq Stockholm: https://t.co/flpMTI73nE) is a clinical stage # ilixadencel, +sunitinib for the treatment of #KidneyCancer, with an observed We look forward to Peter's continued insights on advancing ilixadencel and the pipeline in his role as clinical advisor to Immunicum.” Dr. Rovers joined DCprime Feb 19 (Reuters) - Immunicum AB ::REG-IMMUNICUM AB (PUBL) RECEIVES ORPHAN DRUG DESIGNATION FROM EMA FOR ILIXADENCEL The company's lead product ilixadencel, consisting of pro-inflammatory allogeneic dendritic cells, has the potential to become a backbone component of modern 3 Mar 2021 While the study was not designed to determine a statistical difference in survival outcomes, this finding suggests that Immunicum's ilixadencel 22 Feb 2021 In May 2020, Immunicum received Regenerative Medicine Advanced Therapy designation from the FDA for ilixadencel for the treatment of Company Name matching 'Immunicum AB' 17 Sep 2020, 8:00 am, GNW · Immunicum AB · Immunicum AB (publ) Presents Preclinical Data on Ilixadencel in 23 Nov 2020 BioStock Studio: Immunicum and DCprime enter immuno-oncology Immunicum's phase II MERECA study testing ilixadencel in kidney cancer of the Exchange, Immunicum AB (publ) Receives Orphan Drug Designation from EMA for Ilixadencel as Treatment for Gastrointestinal Stromal Tumors (GIST) .
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MFN.se > Immunicum > Immunicum AB publ Receives FDA

Publicerad: 2020-09-17 (GlobeNewswire) Immunicum AB (publ) presenterar prekliniska data för ilixadencel i kombination med cancerbehandlingar och immunterapier på årets ESMO-kongress 2020-05-11 2021-02-22 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 mjukdelssarkom (Soft Tissue Sarcoma, STS). I maj 2020 erhöll Immunicum så kallad Regenerative Medicine Advanced Therapy (RMAT) designation från FDA för ilixadencel för behandling av patienter med metastaserad njurcancer. I december samma år fick bolaget Fast Track Designation från FDA för ilixadencel för behandling av gastrointestinal stromacellstumör (GIST). Med hela tre pågående kliniska studier inväntar rapportaktuella Immunicum nya resultat för huvudkandidaten ilixadencel.

Immunicum AB publ erhåller särläkemedelsstatus, ODD, från

Den utvärderar ilixadencels säkerhet och effekt 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. 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 sunitinib 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 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 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.

Köp aktien Immunicum AB (IMMU).