dm+d

Unassigned

New Medicines

Intuvax RCCMetastatic renal cell carcinoma - before nephrectomy followed by sunitinib post-nephrectomy

Information

Intuvax RCC
New molecular entity
Immunicum
Immunicum

Development and Regulatory status

Phase II Clinical Trials
Phase II Clinical Trials
Phase II Clinical Trials
Dec 20In its latest annual report, Immunicum says it is exploring collaboration opportunities for its products and interactions with potential partners as it moves forward towards the market [7].
Nov 20Immunicum announces that it is advancing to late-stage development for ilixadencel, and is preparing a clinical trial [5].
May 20FDA grants Regenerative Medicine Advanced Therapy (RMAT) designation to ilixadencel for the treatment of mRCC. The decision was made based on the results from the MERECA trial [6].
Feb 20In 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 18EMA 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 20Immunicum 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].
Aug 20The PII MERECA trial demonstrated a confirmed objective response rate (ORR) of 42.2% (19/45) patients for the ilixadencel treatment group versus 24.0% (6/25) for the sunitinib control group. The median OS value could not be calculated yet in either group as the data was not matured. Median Overall Survival (OS) was reached at 25 months in the control group treated with sunitinib, while the final median OS value in the ilixadencel treatment group was not reached, indicating a survival benefit in the trial’s co-primary endpoint. The proportion of patients alive was 43% (24 out of 56) of patients in the ilixadencel treatment group compared with 33% (10 out of 30) of patients in the control group [5].
Apr 15PII 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].