Plasmid DNA vaccine for brain cancer enters Phase I trial

MRI of the brain showing glioblastoma

Immunomic Therapeutics has commenced its Phase I clinical trial evaluating ITI-1001, a plasmid DNA (pDNA) vaccine, for the treatment of Glioblastoma Multiforme (GBM), a rare but aggressive form of brain cancer.

ITI-1001 is an investigational plasmid DNA vaccine therapy designed to target the pp65, IE-1 and gB viral antigens of Cytomegalovirus (CMV) which are expressed in GBM, but not in normal brain cells.

The study is being conducted at the Dana-Farber Cancer Institute in Boston, Massachusetts and is being led by Dr David Reardon, Clinical Director, Center for Neuro-Oncology.

“Dosing of the first patient in the Phase I clinical trial of ITI-1001 in patients with GBM is a significant clinical development milestone for Immunomic, representing the first time this pDNA vaccine is being administered in humans,” said Dr Teri Heiland, Chief Scientific Officer of Immunomic Therapeutics. “We are eager to evaluate the safety and preliminary efficacy in this patient population, who have only limited treatment options for this devastating disease and expect to read out top-line data in the second quarter of 2025.”

The single-centre, open label, Phase I clinical trial is designed to evaluate the safety, tolerability, immunogenicity and preliminary efficacy of 8mg of ITI-1001 in newly diagnosed GBM patients.

Edited by Diana Spencer, Senior Digital Content Editor, Drug Discovery World

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