Updated survival data from the randomized phase 2 MERECA trial (NCT02432846) evaluating the off-the-shelf immunotherapy ilixadencel in combination with sunitinib (Sutent) versus sunitinib alone for the first-line treatment of newly diagnosed patients with metastatic renal cell carcinoma (mRCC) demonstrated a separation in Kaplan-Meier survival curves in favor of the combination, according to

BioStock: Immunicums ilixadencel erhåller Renegerative Medicine Advanced Therapy från FDA. tor, maj 07, 2020 14:45 CET. Utvecklingen av Immunicums

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.

Ilixadencel

Pressmeddelande 7 december 2020 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 Ilixadencel has consistently maintained a positive safety and tolerability profile and demonstrated initial signs of efficacy as seen in the randomized Phase II MERECA trial. Ilixadencel is currently moving towards late-stage clinical development. For more information, please contact: Alex Karlsson-Parra, CSO, Immunicum Telephone: +46 8 732 8400 26 Feb 2021 the positive impact on overall survival that ilixadencel may achieve for [patients with kidney cancer],” said Sven Rohmann, MD, PhD. 26 Aug 2020 The active ingredient in ilixadencel is activated allogeneic dendritic cells, which are derived from healthy blood donors. The intratumoral injection 26 Jan 2021 FDA Grants Orphan Drug Designation to Ilixadencel for Soft Tissue Sarcoma January 26, 2021 - The FDA has granted the cell-based, off-the- 7 Feb 2020 The MERECA study evaluated intratumoral ilixadencel administration prior to kidney removal of the primary tumor-affected kidney followed by 569P Intratumoral injection of allogeneic pro-inflammatory dendritic cells ( ilixadencel) in combination with anti-CTLA-4 treatment induce complete tumour 11 Feb 2020 Combining intratumoral injections of ilixadencel with sunitinib improved responses in patients with newly diagnosed synchronous metastatic We have shown that intratumoral injections of the immune primer ilixadencel (pro -inflammatory allogeneic dendritic cells) are safe in renal-cell carcinoma. Here FDA has now granted ilixadencel Orphan Drug Designation for its potential use in sarcoma and liver cancer, and Fast Track Designation for GIST. The Phase Ib 18 Feb 2021 “The Orphan Drug Designations awarded by both the EMA and the FDA for ilixadencel in the GIST indication represent an important step Immunicum's clinical program ilixadencel uses dendritic cells sourced from healthy human donors that are specifically activated to produce significant amounts 9 Sep 2019 A combination therapy of ilixadencel plus sunitinib (Sutent) achieved complete tumor responses in patients with metastatic renal cell carcinoma 27 Jan 2021 The FDA has granted the cell-based, off-the-shelf immune primer ilixadencel an orphan drug designation for use as a treatment option in Immunicums fas II-studie MERECA, som testar ilixadencel i patienter med njurcancer, befinner sig nu i slutfasen. Igårkom bolaget med en uppdatering från Patients in the Phase 1b part of the study will be treated with ilixadencel at an increasing dose and frequency, in combination with standard doses and schedules 29 Aug 2019 Immunicum's allogeneic dendritic cell vaccine ilixadencel has failed to better the survival rate Pfizer's Sutent achieved in a phase 2 metastatic 26 Mar 2021 relating to the designation of "Ilixadencel" as an orphan medicinal product under.

2021-03-03 · Ilixadencel is an investigational anti-cancer vaccine that uses dendritic cells, a type of immune cell, to instruct T-cells to attack and destroy cancer cells. After being isolated from healthy donors, dendritic cells undergo a procedure to become activated and produce certain substances that trigger strong immune responses.

Genom att kombinera ilixadencel med moderna immunterapier och standardbehandling Ilixadencel fungerar så att den efter att ha injicerats i tumören aktiverar patientens eget immunförsvar. Effekten sprids genom hela kroppen.

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.

“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 2017-06-23 2021-03-03 Adding the off-the-shelf, cell-based immunotherapy ilixadencel to frontline sunitinib was associated with an overall survival benefit in patients with metastatic renal cell carcinoma. Ilixadencel showed strong clinical activity with a potential overall survival (OS) benefit in patients with newly diagnosed metastatic renal cell carcinoma (RCC), January 26, 2021 - 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. FDA. Ilixadencel Gets Orphan Drug Designation for Soft Tissue Sarcoma. 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 announcement from Immunicum AB. The FDA has granted the cell-based, off-the-shelf immune Therefore, we will continue to test ilixadencel in preclinical studies that will enable us to define and design the most beneficial treatment regimens that then could be tested in clinical trials,” commented Associate Professor Alex Karlsson-Parra, Chief Scientific Officer of Immunicum. A CT26 tumor model The FDA awarded ilixadencel RMAT based on the results of the previously announced Phase II MERECA clinical trial. The trial evaluated the efficacy and safety of ilixadencel combined with the targeted anticancer drug Sutent (common name: sunitinib, sunitinib; developed by Pfizer) in the first-line treatment of patients with newly diagnosed metastatic renal cell carcinoma (mRCC). 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).

The vaccine, called INTUVAX®, Ilixadencel is an off-the-shelf cell-based immunotherapy indicated for solid tumors like hepatocellular carcinoma, gastrointestinal stromal tumors, and mRCC.
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Oncol. 2019, 9. 18 Aug 2020 Immunicum AB (publ) Announces Update on Survival Data from Phase II MERECA Trial of Ilixadencel in Kidney Cancer. — Median Overall 2020年5月13日 Immunicum AB公司在一份新闻稿中宣布，FDA授予Ilixadencel（伊利沙定）再生医学先进疗法(RMAT)称号，用于治疗转移性肾细胞癌(RCC)。 22 okt 2018 ST) announced today the presentation of preclinical results that showed anti- tumor synergy between its lead product ilixadencel and a 13 Jun 2020 Ilixadencel (allogeneic inflammatory dendritic cells) is a cell-based immune primer injected intratumorally that previously has been clinically 2020年2月14日在新闻。试验结果显示，Ilixadencel可以改善新诊断的转移性肾癌的反应.

Ilixadencel is a cell-based, off-the-shelf immune primer, for the treatment of Soft Tissue Sarcoma (STS).
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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 announcement from Immunicum AB.

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 .

Pressmeddelande 7 december 2020 Immunicum AB (publ) erhåller Fast Track Designation från FDA för ilixadencel för behandling av GIST

2021-03-03 · Ilixadencel is an investigational anti-cancer vaccine that uses dendritic cells, a type of immune cell, to instruct T-cells to attack and destroy cancer cells. After being isolated from healthy donors, dendritic cells undergo a procedure to become activated and produce certain substances that trigger strong immune responses. In the ilixadencel combination arm, ilixadencel was administered prior to surgery, and sunitinib was administered after surgery. In the monotherapy, treatment also occurred after surgery. 2 The co-primary end points of the MERECA study were OS and the overall 18-month survival rate from randomization in different subgroups of patients with metastatic RCC. 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.

After being isolated from healthy donors, dendritic cells undergo a procedure to become activated and produce certain substances that trigger strong immune responses. In the ilixadencel combination arm, ilixadencel was administered prior to surgery, and sunitinib was administered after surgery. In the monotherapy, treatment also occurred after surgery. 2 The co-primary end points of the MERECA study were OS and the overall 18-month survival rate from randomization in different subgroups of patients with metastatic RCC. 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. BioStock: Stadiga framsteg för Immunicums ilixadencel under det gångna året mån, dec 23, 2019 08:42 CET Medan två av dessa befinner sig i preklinisk utvärdering är bolagets huvudkandidat, ilixadencel, på god väg genom kliniska studier där den testas som en del i kombinationsbehandling inom ett flertal cancertyper.