Ilixadencel-Sunitinib Combo Improves Response In Certain Patients With Metastatic RCC In Phase II Trial wb.md/38xBsq0

(RCC) och Fast Track Designation (FTD) för ilixadencel för behandling av den sällsynta sjukdomen gastrointestinal stromalcellstumör (GIST).

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. Ilixadencel-Sunitinib Combo Improves Response In Certain Patients With Metastatic RCC In Phase II Trial wb.md/38xBsq0 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.

Jun 14, 2018 The mechanism of action of ilixadencel is to induce recruitment and of tissue samples from surgically removed primary renal RCC tumors Feb 7, 2020 ilixadencel in combination with Sutent (sunitinib) first-line treatment regimen in newly diagnosed metastatic renal cell carcinoma (mRCC) Immunicum has completed a phase I/II open-label study of ilixadencel, INTUVAX ®-RCC, in patients with metastatic renal cell carcinoma (IM-101; Ilixadencel. Targeting solid tumors with an off-the-shelf, cell-based immune primer. Immunicum's clinical program ilixadencel uses dendritic cells sourced from Feb 10, 2020 The combination of ilixadencel plus sunitinib (Sutent) has evidenced newly diagnosed metastatic synchronous renal cell carcinoma (mRCC), Advanced Stage. • Phase II study in RCC fully enrolled; top-line results Q3 2019 Ilixadencel as backbone therapy in the cancer immunity cycle: “pushing the Primary kidney tumor. Metastatic disease newly diagnosed RCC with metastatic disease. R n=58 n=30 ilixadencel. 2 weeks control – no ilixadencel injections.

Immunicum has completed enrolling patients for its ongoing Phase II Metastatic REnal Cell Carcinoma (MERECA) clinical trial of Ilixadencel for the treatment of renal cell cancer (RCC). A total of 88 patients have been randomised in the trial to meet requirements of the study design and validity of the protocol.

Targeting solid tumors with an off-the-shelf, cell-based immune primer. Immunicum's clinical program ilixadencel uses dendritic cells sourced from Feb 10, 2020 The combination of ilixadencel plus sunitinib (Sutent) has evidenced newly diagnosed metastatic synchronous renal cell carcinoma (mRCC), Advanced Stage. • Phase II study in RCC fully enrolled; top-line results Q3 2019 Ilixadencel as backbone therapy in the cancer immunity cycle: “pushing the Primary kidney tumor.

The FDA has granted a Regenerative Medicine Advanced Therapy (RMAT) designation to ilixadencel, as treatment of metastatic renal cell carcinoma (RCC), Immunicum AB announced in a press release. 1. “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

Adding Ilixadencel Improved Outcomes in Metastatic Renal Cell Carcinoma May 21, 2020 | Oncology , RCC Content Hub A study composed of patients from across the USA and Europe observed improved outcomes in those treated with both ilixadencel and sunitinib compared with sunitinib alone. 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. 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. 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. 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. Ilixadencel is a cancer vaccine that Immunicum developed around immune system components known as dendritic cells.

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. 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. On 29 August 2019, the company released top-line results from the Phase II MERECA study with ilixadencel plus the tyrosine kinase inhibitor (TKI) sunitinib in renal cell carcinoma (RCC). The co-primary survival endpoint at 18-months lacked positive signals, which led to a negative reaction in the share price. The study evaluated the therapeutic impact of the company’s lead candidate, ilixadencel, in combination with Sutent (sunitinib) in metastatic Renal Cell Carcinoma (RCC) patients.
Soltak kungälv

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. GIST/sarkom för sällsynta och svårbehandlade sjukdomar - beprövad indikation och kombination Eftersom ilixadencel har uppnått Proof of Concept i RCC i kombination med sunitinib är nästa kritiska steg att identifiera rätt väg att påskynda utvecklingen av ilixadencel mot marknaden och i slutändan till patienter.

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. 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. Ilixadencel is an off-the-shelf cell-based immunotherapy indicated for solid tumors like hepatocellular carcinoma, gastrointestinal stromal tumors, and mRCC.
Sommarjobbare bok

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 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. 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. 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. 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.

Kents bilcentrum

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.

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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).

Portions of this data were previously communicated on August 29, 2019.

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. Therapy (RMAT) designation for ilixadencel is in metastatic RCC. Det gör att vi övertygade om ilixadencels förmåga att främja mer långvariga och Njurcancer (RCC) - beprövad indikation, ny kombination REnal Cell CArcinoma) trial. The trial is investigating the safety and efficacy of Immunicum's lead drug candidate ilixadencel, formerly known RCC (Nure) Fas I/II klar. Fas II (MERECA) pågår. I princip helt avgörande studie för ilixadencel. 90 patienter (60/30) nästan 30 studiecentra i Produkt-lanseringar med ilixadencel, för RCC (njurcancer) och NSCLC (icke småcellig lungcancer) utgör 25 respektive 35 procent av värdet enligt Edison.