Immunicum - Updated Phase II MERECA data positive Edison

Immunicum AB publ erhåller särläkemedelsstatus, ODD, från

To-date ilixadencel has been tested in a range of clinical trials in various solid tumor indications including metastatic Renal Cell Carcinoma (mRCC), hepatocellular carcinoma (HCC) and gastrointestinal stromal tumors (GIST) and in combination with several standard-of-care cancer therapies such as the tyrosine kinase inhibitors Sutent® (sunitinib) and Stivarga® (regorafenib), and the checkpoint inhibitor … 2020-05-11 To-date ilixadencel has been tested in a range of clinical trials in various solid tumor indications including metastatic Renal Cell Carcinoma (mRCC), hepatocellular carcinoma (HCC) and Press Release 31 December 2020 Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC) Immunicum AB (publ; IMMU.ST) announced today that it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the Company’s lead candidate, ilixadencel, a cell-based, off-the-shelf immune … Press Release 28 September 2017. Immunicum AB (publ) Announces Completion of HCC Phase I/II Clinical Study --Topline Safety and Immune Response Data Support Continued Development of Ilixadencel in Liver Cancer-- 2018-06-07 Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC) Immunicum AB (publ; IMMU.ST) announced today that … 31.12.2020 - Press Release 31 December 2020 Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC… Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC) Immunicum AB (publ; IMMU.ST) announced today that it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the Company’s lead candidate, ilixadencel, a cell-based, off-the-shelf immune primer, for the treatment of … Press Release. 28 September 2017. Immunicum AB (publ) Announces Completion of HCC Phase I/II Clinical Study Press Release 31 December 2020 Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC) Immunicum AB … Press Release 31 December 2020 Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC) Immunicum AB (publ; IMMU.ST) announced today that it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the Company’s lead candidate, ilixadencel, a cell-based, off-the-shelf immune … Ilixadencel is an off-the-shelf cell-based immunotherapy indicated for solid tumors like hepatocellular carcinoma, gastrointestinal stromal tumors, and mRCC. Ilixadencel has been tested in these cancers in combination with several standard-of-care cancer therapies like chemotherapy. To date, ilixadencel has been tested in a range of clinical trials for various solid tumor indications including mRCC, hepatocellular carcinoma (HCC), and gastrointestinal stromal tumors (GIST). We will review our rNPV model for ilixadencel in RCC once more details are known about the next stage of the development following the discussions with regulators and any potential partners.

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 To-date ilixadencel has been tested in a range of clinical trials in various solid tumor indications including metastatic Renal Cell Carcinoma (mRCC), hepatocellular carcinoma (HCC) and gastrointestinal stromal tumors (GIST) and in combination with several standard-of-care cancer therapies such as the tyrosine kinase inhibitors Sutent® (sunitinib) and Stivarga® (regorafenib), and the checkpoint inhibitor Keytruda® (pembrolizumab). Beyond the safety profile, the immunological data confirm our mechanism of action and support our plans to move ilixadencel forward in HCC, an important part of our clinical development strategy," said Carlos de Sousa, MD, CEO of Immunicum. 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 The development of alloantibodies (i.e., vaccine-specific) occurred in 50% of patients, which could be compared to previous studies of ilixadencel where 25% and 64%, in mRCC and HCC, respectively, developed alloantibodies [20, 21], indicative of a humoral immune response. However, this alloimmunization was not seen in patients with partial Ilixadencel is an immune primer that uses activated DCs. It should not be confused with a DC therapy or DC vaccines. Immunicum’s DCs are allogeneic (from healthy donors) and, as such, induce an anti-tumour response. 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.

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Of 17 HCC patients enrolled, 12 patients received ilixadencel at the dose of 10 x cell therapy, immunotherapy, allogeneic, dendritic cells, ilixadencel, sorafenib tyder på att ilixadencel skulle kunna bidra till att övervinna resistensen mot levercancer (Hepatocellular carcinoma; HCC) behandlats med ilixadencel. Endast Ilixadencel har hittills uppvisat en konsekvent säkerhetsprofil i studien hepatocellulärt karcinom (HCC), gastrointestinala stromala tumörer kombinerad behandling med ilixadencel leder till en nästan dubbelt så karcinom (HCC) och gastrointestinala stromala tumörer (GIST) samt i IMMUNICUM: SÄRLÄKEMEDELSSTATUS FÖR ILIXADENCEL MOT för bolagets kandidat ilixadencel för behandling av levercancer (HCC). the Phase II MERECA trial with ilixadencel delivered a positive surprise.

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We have shown that intratumoral injections of the immune primer ilixadencel (pro-inflammatory allogeneic dendritic cells) are safe in renal-cell carcinoma. Here, we assessed ilixadencel as a single agent and combined with sorafenib in advanced HCC. 2020-12-31 FDA:s beslut grundar sig på resultaten från en klinisk fas I/II-studie av ilixadencel hos patienter med tumörer som inte går att avlägsna kirurgiskt och/eller spridd (metastaserad) levercancer (HCC). Ilixadencel är en cellbaserad och lagringsbar immunaktiverare för behandling av solida tumörer. 2018-06-14 2021-01-04 2019-01-21 Hittills har ilixadencel testats i en rad kliniska prövningar i olika solida tumörindikationer inklusive metastaserande njurcancer (mRCC), hepatocellulärt karcinom (HCC), gastrointestinala stromala tumörer (GIST) och i kombination med flera standardbehandlingar av cancer som tyrosinkinashämmare Sutent® (sunitinib) och Stivarga® (regorafenib) och checkpointhämmaren Keytruda® (pembrolizumab).
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Hepatocellular carcinoma (HCC) accounts for 75%-85% of all primary liver NCT01974661, Completed, Phase I, COMBIG-DC vaccine (ilixadencel), 18 Pembrolizumab Monotherapy May Play Role in Treatment-Naive HCC Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC) Dec 31, 2020 Immunicum AB, of Stockholm Ilixadencel Cell-based, off-the-shelf immune primer Hepatocellular carcinoma (HCC) FDA granted orphan drug Aug 29, 2020 Hepatocellular carcinoma (HCC) was the 6th most diagnosed cancer It is therefore no surprise that research into immunotherapy in HCC has begun Phase 1 trial with the cell-based immune primer ilixadencel, alone, an Mar 12, 2020 Hepatocellular carcinoma (HCC) remains as one of the major causes of Ilixadencel (pro‐inflammatory allogeneic dendritic cells) in advanced Immunicum AB (publ) Announces Publication of Phase I/II Clinical Trial Results of Ilixadencel in Advanced Hepatocellular Carcinoma in Frontiers in Oncology. 在2020年12月，FDA授予ilixadencel治疗GIST的快速通道资格（FTD）、治疗肝细胞癌（HCC）的孤儿药资格（ODD）。 ilixadencel是一种同种异体树突状 2021年1月2日制药公司Immunicum近日宣布，美国食品药品监督管理局（FDA）已经授予 Ilixadencel治疗肝细胞癌（HCC）的“孤儿药称号”（ODD）。 ODD, från FDA för ilixadencel för behandling av levercancer Immunicum kirurgiskt och/eller spridd (metastaserad) levercancer (HCC). AB (publ) erhåller särläkemedelsstatus, ODD, från EMA för ilixadencel för för ilixadencel för behandling av hepatocellulärt carcinom (HCC). Positiva topline resultat från den slutförda fas I/II studien som undersökt säkerhet och tolerans av ilixadencel hos 18 patienter med avancerad of Phase I/II Clinical Trial Results of Ilixadencel in Advanced Hepatocellular Carcinoma in Frontiers in Oncology Immunicum AB (publ; IMMU.

Om levercancer (Hepatocellulärt Carcinom - HCC) Hepatocellulärt Carcinom (HCC) är en sällsynt sjukdom men trots det den vanligaste förekommande dödsorsaken för personer med levercirros.
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Phase 1 Trial With the Cell-Based Immune Primer Ilixadencel

Ilixadencel: an off-the-shelf May 11, 2020 Immunicum AB has won an FDA RMAT for ilixadencel, its allogeneic hepatocellular carcinoma (HCC) and gastrointestinal stromal tumors May 18, 2020 orally administered drug for patients with hepatocellular carcinoma. Regenerative Medicine Advanced Therapy Designation for Ilixadencel in Approval Status. Phase 2.

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Publicerad: 2020-12-31 (GlobeNewswire) Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC… To-date ilixadencel has been tested in a range of clinical trials in various solid tumor indications including metastatic Renal Cell Carcinoma (mRCC), hepatocellular carcinoma (HCC) and gastrointestinal stromal tumors (GIST) and in combination with several standard-of-care cancer therapies such as the tyrosine kinase inhibitors Sutent® (sunitinib) and Stivarga® (regorafenib), and the 2020-12-31 The combination of the off-the-shelf cancer immune primer Ilixadencel and sunitinib has demonstrated promising survival benefit when used as a frontline treatment for newly diagnosed patients with Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC) Immunicum AB (publ; IMMU.ST) announced today that it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the Company’s lead candidate, ilixadencel, a cell-based, off-the-shelf immune primer, for the treatment of … 5 February 2018. Immunicum (publ) Presents Case Study of One Patient from Phase I/II HCC Trial at Cholangiocarcinoma Foundation Annual Conference.

FDA:s beslut grundar sig på resultaten från en klinisk fas I/II-studie av ilixadencel hos patienter med tumörer som inte går att avlägsna kirurgiskt och/eller spridd (metastaserad) levercancer (HCC). Ilixadencel är en cellbaserad och lagringsbar immunaktiverare för behandling av solida tumörer. Ilixadencel är på väg mot klinisk utveckling i sen fas. Om levercancer (Hepatocellulärt Carcinom - HCC) Hepatocellulärt Carcinom (HCC) är en sällsynt sjukdom men trots det den vanligaste förekommande dödsorsaken för personer med levercirros.