Immunomic Therapeutics begins ITI-1001 Phase 1 trial in glioblastoma

Immunomic Therapeutics, Inc., a clinical-stage biotech company specializing in nucleic acid immunotherapy platforms, has dosed the first patient in a Phase 1 clinical trial of its groundbreaking ITI-1001 plasmid DNA (pDNA) vaccine. Aimed at treating Glioblastoma Multiforme (GBM), a particularly aggressive form of brain cancer, the trial is a landmark development in the field. Conducted at the Dana-Farber Cancer Institute in Boston, Massachusetts, the study is led by Dr. David Reardon, Clinical Director, Center for Neuro-Oncology.

ITI-1001 is an investigational pDNA vaccine developed using Immunomic’s proprietary UNITE platform. Designed to target specific viral antigens expressed in GBM but not in normal brain cells, ITI-1001 could represent a transformative approach to treating newly diagnosed GBM patients. The UNITE platform itself is engineered to direct antigen-presenting cells to stimulate a robust immune response, leveraging chimeric proteins for targeted action.

“Dosing the first patient with ITI-1001 in this Phase 1 trial is a significant milestone for Immunomic Therapeutics. This is the first time this pDNA vaccine is administered in humans,” said Dr. Teri Heiland, Chief Scientific Officer of Immunomic Therapeutics. The company aims to evaluate both the safety and preliminary efficacy of the ITI-1001 vaccine in patients who have limited treatment options for this devastating form of cancer. Top-line data for the study is expected to be released in the second quarter of 2025.

The first-of-its-kind, single-center, open-label Phase 1 clinical trial is structured to assess the safety, tolerability, immunogenicity, and preliminary efficacy of an 8 mg dose of ITI-1001 in patients newly diagnosed with GBM. Given the urgency to find effective treatments for GBM, the advancement of ITI-1001 into clinical trials marks a critical juncture not only for Immunomic Therapeutics but also for the broader medical community focused on battling brain cancer.