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iti-1001

Development stage
Phase 1
Lead developer
Immunomic Therapeutics
Modality
DNA Vaccines → Plasmid DNA → DNA Therapeutics → Nucleic Acid Therapeutics, Prophylactic Vaccines → Vaccines & Immunotherapeutics
Administration
Intramuscular
01

Overview

ITI-1001 is an investigational plasmid DNA vaccine developed for the treatment of glioblastoma multiforme (GBM), a rare and aggressive form of brain cancer. The vaccine leverages Immunomic Therapeutics' proprietary UNITE platform and is designed to target three human cytomegalovirus (CMV) antigens—pp65, IE-1, and gB—which are expressed in GBM tumors but not in normal brain cells. ITI-1001 consists of two DNA plasmids encoding these antigens as fusion proteins with LAMP1 to enhance immune presentation. Administered via intramuscular injection with electroporation, the vaccine aims to stimulate both cellular and humoral immune responses against tumor cells expressing CMV antigens. Preclinical studies have shown strong T-cell activation (CD4+ and CD8+) and significant anti-tumor activity in mouse models, while a Phase 1 clinical trial is ongoing to evaluate safety, tolerability, immunogenicity, and preliminary efficacy in newly diagnosed GBM patients[2][4][5][6].

Other names
ITI 1001ITI1001ITI-1001
02

Targets

IE1 (HCMV immediate-early protein 1)

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