Immunicum announced that the Company has submitted an Investigational New Drug (IND) application to the Food and Drug Administration (FDA) in the U.S. The application is requesting approval to treat kidney cancer patients in the U.S. with Immunicum’s lead cancer immune primer, INTUVAX®, in its ongoing MERECA (MEtastatic REnal cell CArcinoma) phase II-trial.
Immunicum’s INTUVAX® is a unique cancer immune primer currently being tested in clinical trials for the treatment of kidney cancer and liver cancer as well as GIST (gastrointestinal stromal tumor). As previously reported, results from Immunicum’s completed phase I/II-trial for treatment of kidney cancer have been promising.
Today’s announcement of the submission of the IND application to the FDA is one more step forward in the Company’s clinical plans to expand it’s testing of INTUVAX® into the U.S. Approval from the FDA is expected within 30 days.
