ITI Doses First Patient in its Phase 1 Clinical Trial of ITI-1001

On August 24, 2023 Immunomic Therapeutics, Inc., a privately held, clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, reported dosing of the first patient in its Phase 1 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 (Press release, Immunomic Therapeutics, AUG 24, 2023, View Source [SID1234634681]). 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.

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"Dosing of the first patient in the Phase 1 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," stated 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-center, open label, First-In-Human Phase 1 clinical trial is designed to evaluate the safety, tolerability, immunogenicity and preliminary efficacy of 8 mg of ITI-1001 in newly diagnosed GBM patients.

For more information on the Phase 1 trial of ITI-1001 in GBM, please visit www.clinicaltrials.gov, NCT05698199

About ITI-1001

ITI-1001 is an investigational plasmid DNA vaccine therapy that leverages Immunomic’s proprietary UNITE platform to treat patients with newly diagnosed GBM. ITI-1001 is 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.