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FDA clears ImmunoCellular IND application of Phase I ICT-121 trial

ImmunoCellular Therapeutics has received FDA clearance for physician sponsored investigative new drug (IND) application to begin Phase I trial of ICT-121.

The trial will initially test the vaccine in up to 20 patients with recurrent glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer.

ICT-121 is IMUC’s novel dendritic-cell-based vaccine targeting CD-133, an antigen that is highly expressed by multiple solid tumors.

IMUC president and CEO Manish Singh said, "Preclinical studies conducted by IMUC indicate that ICT-121 effectively targets CD-133, a protein that is over-expressed by a very wide range of solid tumors, including glioblastoma, pancreatic, breast, non-small-cell lung cancer, and several other malignancies associated with poor survival and limited treatment options."

The ICT-121 is the company’s second dendritic-cell-based vaccine to enter the clinic. Like ICT-107, ICT-121 targets the cancer stem cells (CSCs) that are believed to be the root cause of many cancers, according to IMUC.