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

Portions of this data were previously communicated on August 29, 2019. Ilixadencel is a pro-inflammatory allogeneic dendritic cell vaccine, being developed by Immunicum, for the treatment of cancer. The vaccine, called INTUVAX®, för njurcancer (RCC) och Fast Track Designation (FTD) för ilixadencel för behandling av den sällsynta sjukdomen gastrointestinal stromalcellstumör (GIST). Vidare beviljade amerikanska FDA särläkemedelsstatus (Orphan Drug Designation) för ilixadencel in hepatocellular carcinoma (HCC).

Ilixadencel rcc

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.

It insists that the response rate data warrants the continued clinical development of ilixadencel in RCC – the most common form of kidney cancer – as well as “other solid tumour indications.”

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. A combination of ilixadencel plus sunitinib has shown a complete tumour response in patients with metastatic renal cell carcinoma (RCC) in a recent phase 2 clinical trial.. Ilixadencel is an off-the-shelf immune primer for the treatment of solid tumours.

Immunicum has announced an update on its corporate and clinical development strategy. “With the information presented today at the corporate update event, we aim to provide an overview of our position as a cell therapy company, discuss strategic opportunities we intend to leverage and confirm our long-term mission for Immunicum,” commented Sven Rohmann, CEO of Immunicum.

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. The Phase 1 portion of the trial (NCT01525017) covered patients with newly diagnosed metastatic renal cell carcinoma, or mRCC.

Ilixadencel-Sunitinib Combo Improves Response In Certain Patients With Metastatic RCC In Phase II Trial wb.md/38xBsq0 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 … 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 Under 2020 beviljade den amerikanska läkemedelsmyndigheten FDA Immunicum Regenerative Medicine Advanced Therapy (RMAT) designation för njurcancer (RCC) och Fast Track Designation (FTD) för ilixadencel för behandling av den sällsynta sjukdomen gastrointestinal stromalcellstumör (GIST). Renal Cell Carcinoma (RCC) showed that five patients had complete response and data on survival benefit in all patients showed that a higher percentage of ilixadencel patients were alive as per data cut-off in July 2019. Follow-up on survival data in December 2019 demonstrated a separation in survival curves in favor of the ilixadencel group. 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 … 2020-12-10 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.
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Ilixadencel appears to be a typical neoadjuvant opportunity that could be applied to many solid tumours as it can be injected into any primary or secondary solid tumour above 2cm in diameter prior to surgical excision.

Ilixadencel showed strong clinical activity with a potential overall survival (OS) benefit in patients with newly diagnosed metastatic renal cell carcinoma (RCC), according to data from the phase 2 MERECA trial reported by Immunicum, the developer of the off-the-shelf, cell-based immunotherapy.1 ORLANDO, Florida — Combining intratumoral injections of ilixadencel, an off-the-shelf dendritic cell–based primer, with sunitinib improved responses in patients with newly diagnosed synchronous May 20 · FDA grants Regenerative Medicine Advanced Therapy (RMAT) designation to ilixadencel for the treatment of mRCC.
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Ilixadencel is being tested in Phase I and II clinical trials, in several solid tumour indications and combinations (see Exhibit 1). The most advanced programme is in RCC, where ilixadencel is being tested in Phase II (MERECA study) in combination with Pfizer’s approved TKI sunitinib. Recruitment in this trial was completed in early January 2018.

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. 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.