Swedish biopharmaceutical firm Immunicum has started patient enrolment in the US for the ongoing Phase II MERECA clinical trial of its drug candidate ilixadencel to treat renal cell carcinoma.
Ilixadencel is a cell therapy product and a cancer immune primer designed for specific reactivation of the immune system to detect and destroy tumour cells.
The drug candidate’s active ingredient includes activated allogeneic dendritic cells that are sourced from healthy blood donors and intended to trigger an inflammatory response upon intratumoural injection.
The Phase II trial is currently being conducted in eight European countries, as well as the US to evaluate the safety and clinical efficacy potential of ilixadencel.
Immunicum chief medical officer Dr Peter Suenaert said: "With the first metastatic kidney cancer patient enrolled in the United States, we have achieved another important milestone for Immunicum.
“The continued expansion of our clinical programme underscores the dedication of our team to realise ilixadencel's potential and to execute a global clinical trial, including meeting all regulatory and manufacturing requirements in the US which are significant for a cell-based therapy.”
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The MERECA trial will monitor the tumour-specific immune activation of two intratumoural ilixadencel doses before surgical removal of the tumour-affected kidney followed by systemic treatment with sunitinib.
Additionally, the trial will investigate the activating effects of ilixadencel on the immune system and clinical benefit data through survival rate at 18 months, and will also measure median overall survival for all subjects.