Ilixadencel

Unassigned

New Medicines

Metastatic renal cell carcinoma - before nephrectomy followed by sunitinib post-nephrectomy

Information

Advanced therapy medicinal product (ATMP)
Immunicum
Immunicum

Development and Regulatory status

Phase II Clinical Trials
Phase II Clinical Trials
Phase II Clinical Trials
Feb 20 · In its latest corporate presentation, Immunicum reports that clinical GMP manufacturing is in place and commercial scale activities initiated. Preparations are taking place for FDA & EMA regulatory authority meetings, with feedback anticipated mid 2020. Next survival update also planned for mid 2020 [4].
Mar 18 · EMA grants Advanced Therapy Medicinal Product (ATMP) certificate for ilixadencel. The certificate was granted after a review of manufacturing quality and non-clinical data [3].

Category

An off-the-shelf pro-inflammatory allogeneic dendritic cell vaccine. The aim of the vaccine is to load a patient's autologous dendritic cells with their own tumour antigens, in vivo, to stimulate an immune response against tumour cells.
Renal cancers account for approximately 2-3% of all malignancies, with the highest incidence in Western countries. Males are more likely to be affected than females, with a ratio of 1.5:1. The incidence of kidney cancer begins to rise after the age of 40 and is highest in people aged between 60 and 70 years [1].
Metastatic renal cell carcinoma - before nephrectomy followed by sunitinib post-nephrectomy
Intratumoural

Trial or other data

Sep 20 · Immunicum releases the results from the complete analysis of topline data from the exploratory PII MERECA trial. The trial achieved the complete and durable response in patients with metastatic RCC 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 [3].
Apr 15 · PII MERECA (MEtasatic REnal Cell CArcinoma) that assessed the safety and efficacy of intratumourally administered ilixadencel before nephrectomy followed by sunitinib post-nephrectomy compared with sunitinib alone in patients with metastatic renal cell cancer starts (MERECA; IM201; NCT02432846). It will enrol 88 patients in the US, Czech Republic, France, Hungary, Latvia, Poland, Spain, Sweden and UK (Churchill Hospital in Oxford and Royal Preston Hospital). Primary outcomes are overall survival and 18 months survival rate from randomisation overall in mRCC patients and by each subgroup i.e. in high risk and intermediate risk mRCC patients; collection of these data is due to complete Aug 19 [2].