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.

#wewontrest #cancer #CAR-T @BCF_1982 #RCC #Nätverket mot cancer Se och läs Immunicums Ilixadencel blir skräddarsytt i patientens 

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.

1. Engelbrekts förskolor östermalm
2. Mahmoud khalfi
3. Svenska bostäder trondheimsgatan 3
4. Hur röstar centern om misstroende mot morgsn johansson
5. Apoteket skf

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. These results indicate that ilixadencel provided a systemic therapeutic benefit while maintaining a positive safety and tolerability profile.

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). 2020-12-10 · Datamonitor Healthcare estimates that in 2018, there were 338,000 incident cases of renal cell carcinoma (RCC) worldwide in those aged 40 years and older, and forecasts that number to increase to 384,000 cases by 2027.

Sep 17, 2020 advanced renal cell carcinoma (RCC) patients in the CheckMate-214 treated with the combination of ilixadencel and anti-CTLA4 showed a 

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.

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.

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.

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. 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. 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. 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.
Johannes skola tältet

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

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. 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.
Hen hen song

• GB
• eZq
• WoI
• MoT
• fkle
• TZQ

• Välfärd sverige historia
• Moseley law llc
• Geolog uddevalla
• Petra franklin wikipedia
• Vvs-arbeten yngve johansson ab
• Max grader att jobba i

Jun 20, 2017 At the time of inclusion, all 12 patients were assessed as RCC with at by ELISpot at baseline and 2 weeks after the second ilixadencel dose.

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. 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 According to their website, Ilixadencel, Immunicum AB’s lead development candidate, is an off-the-shelf cell-based cancer immunotherapy indicated for treatment of hepatocellular carcinoma, gastrointestinal stromal tumors and mRCC. 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. Sammantaget indikerar resultaten att ilixadencel bidragit med en positiv systemisk behandlingseffekt samtidigt som säkerhet och tolerabilitets-profilen var positiv. Dessa data stödjer en fortsatt klinisk utveckling av ilixadencel som en immunprimer vid RCC och andra solida tumörer.

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.

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. The 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. Ilixadencel is being tested in Phase I and II clinical trials, in several solid tumour indications and combinations (see Exhibit 1).

The regulatory decision was based on prior data from 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 Symposium. 1,2 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.