These results indicate that ilixadencel provided a systemic therapeutic benefit while maintaining a positive safety and tolerability profile. Overall the data supports the continued clinical development of ilixadencel as an immune primer in RCC and other solid tumors. Portions of this data were previously communicated on August 29, 2019.

The addition of the off-the-shelf cancer immune primer ilixadencel to sunitinib (Sutent) trended toward a benefit in overall survival (OS) compared with sunitinib alone as a first-line treatment for patients with newly diagnosed metastatic renal cell carcinoma (RCC), according to updated results of the phase II MERECA trial (NCT02432846) presented during the 2020 ASCO-SITC Clinical Immuno-Oncology …

Ilixadencel is an off-the-shelf immune primer for the treatment of solid tumours. The clinical trial assessed the effectiveness of combining ilixadencel with sunitinib in 88 untreated patients with intermediate- or poor 2020-02-10 A phase 2 clinical trial with a new treatment called ilixadencel in combination with sunitinib has shown to improve overall survival in newly diagnosed patients with metastatic renal cell carcinoma (RCC). People given the combination treatment lived 10 months longer than those on sunitinib alone, suggesting that ilixadencel aids survival in these patients. In May 2020, ilixadencel was granted a Regenerative Medicine Advanced Therapy designation from the FDA for use in patients with RCC. A few months later, in December 2020, the agent received a fast track designation for use in the treatment of patients with GIST. The FDA awarded ilixadencel RMAT based on the results of the previously announced Phase II MERECA clinical trial.

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The Phase 1 portion of the trial ( NCT01525017) covered patients with newly diagnosed metastatic renal cell carcinoma, or mRCC. That is a cancer that has spread from the kidneys to other parts of the body. 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. Intratumoral administration of an immune primer is a therapeutic vaccine strategy aimed to trigger dendritic cell 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 an off-the-shelf dendritic cell-based primer, designed to elicit an anticancer immune response when injected intratumorally. This phase 2 study investigated its potential as first-line systemic therapy for newly diagnosed synchronous metastatic RCC. Ilixadencel is an off-the-shelf cancer immune primer developed for the treatment of solid tumors.

Cytoreductive nephrectomy for metastatic renal cell carcinoma, the ultimate urologic The proposed mechanism of action of CN rests on the principle that RCC A randomized phase II study with ilixadencel, a cell-based immune primer,

The vaccine, called INTUVAX®, Ilixadencel achieved proof-of-concept through the Phase II MERECA study and our aim is to accelerate ilixadencel’s development toward market approval in order to reach patients in need. By prioritizing the development of ilixadencel in Gastrointestinal Stromal Tumors (GIST) and sarcomas, our goal is to shorten the development pathway These results indicate that ilixadencel provided a systemic therapeutic benefit while maintaining a positive safety and tolerability profile. Overall the data supports the continued clinical development of ilixadencel as an immune primer in RCC and other solid tumors. Portions of this data were previously communicated on August 29, 2019.

Proven Indication, Novel Combination Immunicum has identified the opportunity for the advancement of ilixadencel in kidney cancer to test our lead candidate in a triple combination - specifically, | …

The majority (75%) of RCC cases have a clear cell histology (ccRCC), to which most first-line treatment regimens are specialized. A phase 2 clinical trial with a new treatment called ilixadencel in combination with sunitinib has shown to improve overall survival in newly diagnosed patients with metastatic renal cell carcinoma (RCC). People given the combination treatment lived 10 months longer than those on sunitinib alone, suggesting that ilixadencel aids survival in these patients.

Designation (FTD) för ilixadencel för behandling av den sällsynta sjukdomen gastrointestinal stromalcellstumör.
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Unlike other intelligence solutions, BCIQ exclusively supports the unique needs of the biopharma industry and Njurcancer (RCC) - beprövad indikation, ny kombination Baserat på de nyligen förändrade riktlinjerna kring standardbehandling och våra lovande prekliniska data kring ilixadencel i kombination med anti-PD1 och anti-CTLA4, har vi beslutat att addera ilixadencel till etablerad kombinationsbehandling med anti-CTLA-4 (ipilimumab) Pressmeddelande. 25 september 2019. Immunicum AB (publ) meddelar komplett analys av topline-data från fas II-studien MERECA --Överlevnad per juli 2019 var 57% (32 av 56) för patienter som As ilixadencel has achieved Proof of Concept in RCC in combination with sunitinib, the next critical step is to identify the right way to accelerate ilixadencel through development, towards the Immunicum AB (publ; IMMU.ST) tillkännager idag att den europeiska läkemedelsmyndighetens kommitté för särläkemedel (European Medicines Agency Committee for Orphan Medicinal Products, EMA COMP) har utfärdat en positiv rekommendation för bolagets ansökan avseende dess Fas II kliniska kandidat ilixadencel, en cellbaserad och lagringsbar immunaktiverare, för behandling av Anti-cancer vaccine ilixadencel plus sunitinib show promise for untreated metastatic kidney cancer - Kidney Cancer Support Network A phase 2 clinical trial with a new treatment called ilixadencel in combination with sunitinib has shown to improve overall survival in newly diagnosed patients with metastatic renal cell carcinoma (RCC). Proven Indication, Novel Combination Immunicum has identified the opportunity for the advancement of ilixadencel in kidney cancer to test our lead candidate in a triple combination - specifically, | February 17, 2021 Ilixadencel is a pro-inflammatory allogeneic dendritic cell vaccine, being developed by Immunicum, for the treatment of cancer.

(GIST). Immunicum erhöll Fast Track Designation från FDA för ilixadencel för för njurcancer (RCC) och Fast Track Designation (FTD) för ilixadencel  A randomized phase II study with ilixadencel, a cell-based immune primer, plus sunitinib versus sunitinib alone in synchronous metastatic renal cell carcinoma. #wewontrest #cancer #CAR-T @BCF_1982 #RCC #Nätverket mot cancer Se och läs Immunicums Ilixadencel blir skräddarsytt i patientens  Immunicums ledande produkt ilixadencel utnyttjar den unika och kritiska mation om de pågående studierna inom RCC och GIST, se avsnittet  De prekliniska resultaten visar hur ilixadencel genererar komplementära immunologiska Njurcancer (RCC) Rekryteringen har slutförts till den pågående  Ilixadencel är en off-the shelf - produkt framtagen från friska allogena Fas II Fas III Ilixadencel IM-201 Njure (RCC) Ilixadencel IM-102 Lever (HCC) Ilixadencel  Cancercentrum (RCC). Du kan också I studierna hittills har ilixadencels säkerhetsprofil olika cancerformer där ilixadencel skulle kunna  Bernie Maddog har fått RCC, Immunicum AB, 20-02-06 12:32 Detta pga alla nya potentiella behandlingar så det är orimligt att Ilixadencel når  Fas II delen av ILIAD, där man utvärderar effekt av ilixadencel i med BMS nivolumab + ipilimumab i RCC innan man tar ställning till fas III. Bolaget har även en pågående fas II-studie inom njurcancer (RCC) kallad Det intressantaste med verkningsmekanismen av ilixadencel är att  att cancerimmunaktiveraren ilixadencel kombinerats med standardläkemedel Regionala cancercentrums (RCC) samverkansgrupp beslöt vid sitt möte 18  The addition of the off-the-shelf cancer immune primer ilixadencel to sunitinib (Sutent) trended toward a benefit in overall survival (OS) compared with sunitinib alone as a first-line treatment FDA Grants RMAT Designation to Ilixadencel in Metastatic RCC "We are very excited to have received the RMAT designation for ilixadencel in kidney cancer as it recognizes both the potential of our novel therapeutic approach as well as the clear need for viable therapies to address this difficult-to-treat disease." The active ingredient in ilixadencel is activated allogeneic dendritic cells, which are derived from healthy blood donors.
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ORLANDO – Combining intratumoral injections of ilixadencel, an off-the-shelf dendritic cell–based primer, with sunitinib improved responses in patients with newly diagnosed synchronous metastatic renal cell carcinoma in the phase 2 MERECA trial.

Ilixadencel has been tested in these cancers in combination with several standard-of-care cancer therapies like chemotherapy. 2018-06-07 The first half of the year for one of Sweden’s top immuno-oncology (IO) companies, Immunicum, has been one of continued progress for the company’s main project, MERECA, which is exploring the effects of their off-the-shelf IO candidate ilixadencel in combination with the tyrosine kinase inhibitor (TKI) sunitinib in metastatic Renal Cell Carcinoma (RCC) patients. According to the latest (July) follow-up update from the MERECA trial (ilixadencel in renal cell carcinoma; RCC), the mOS was reached at 25.3 months in the sunitinib (control) group, while in the ilixadencel plus sunitinib group the mOS has not been reached yet. In the ilixadencel group, 43% of patients were still alive, vs 33% in the control group. Ilixadencel is an off-the-shelf cancer immune primer developed for the treatment of solid tumors. The MERECA clinical trial evaluated the therapeutic impact of combining ilixadencel with sunitinib in advanced kidney cancer. For the study, 88 newly-diagnosed, intermediate- and poor-prognosis patients with metastatic RCC were enrolled.

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. Feb 20 · In its latest corporate presentation, Immunicum reports that clinical GMP manufacturing is in place and commercial scale activities initiated.

Ilixadencel: unique off-the-shelf cell therapy that kick-starts immune response. Phase 2 Phase 1/2 RCC: intratumoral injection in kidney of metastatic patients  These data support the continued clinical development of ilixadencel as an immune primer in RCC and other solid tumors, to provide cancer  Phase II controlled study in RCC completed, latest survival update August Ilixadencel: a unique off-the-shelf intratumoral immune primer. Beskrivning: Two Intuvax (ilixadencel) vaccinations (10 milj cells/vaccination) 14 days apart before nephrectomy, followed by Sunitinib treatment post-nephrectomy  RMAT designation from the FDA for their top drug candidate ilixadencel.

Feb 20 · In its latest corporate presentation, Immunicum reports that clinical GMP manufacturing is in place and commercial scale activities initiated. By: Gina Columbus From: onclive.com The addition of the off-the-shelf cancer immune primer ilixadencel to sunitinib (Sutent) trended toward a benefit in overall survival (OS) compared with sunitinib alone as a first-line treatment for patients with newly diagnosed metastatic renal cell carcinoma (RC… 2017-06-23 · Ilixadencel is a cancer vaccine that Immunicum developed around immune system components known as dendritic cells. The Phase 1 portion of the trial ( NCT01525017) covered patients with newly diagnosed metastatic renal cell carcinoma, or mRCC. That is a cancer that has spread from the kidneys to other parts of the body. 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. Intratumoral administration of an immune primer is a therapeutic vaccine strategy aimed to trigger dendritic cell 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.