ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., a privately held, clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, today announced 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. 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 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 having unmethylated MGMT promoter mutations.
For more information on the Phase 1 trial of ITI-1001 in GBM, please visit www.clinicaltrials.gov, NCT05698199
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.
ITI’s UNITE platform leverages the ability to engineer chimeric proteins, directing antigen presenting cells to present antigens to the immune system through a targeted pathway and driving a robust immune response. UNITE vaccines are distinct in that they combine two components: nucleic acid constructs that encode a specific antigen and an endogenous Lysosomal Associated Membrane Protein (LAMP-1) sequence. The UNITE platform harnesses LAMP-1 as a means of presenting the vaccine target to the immune system, resulting in antibody production, inflammatory cytokine release, and establishing critical immunological memory, something that other vaccine approaches commonly lack. This approach could put UNITE technology at the crossroads of immunotherapies in multiple indications, including cancer, human allergy, animal health, and infectious disease. Preclinical data is currently being developed to explore whether LAMP-1 nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses in tumor types that otherwise do not provoke an immune response.
About Immunomic Therapeutics, Inc.
Immunomic Therapeutics, Inc. (ITI) is a privately-held, clinical-stage biotechnology company pioneering the development of vaccines through its proprietary technology platform UNITE®, which is designed to utilize the body’s natural biochemistry to develop vaccines that generate broad immune responses. ITI is primarily focused on applying the UNITE platform to oncology indications, where it could potentially have broad applications, including development of antigen-derived antibodies as biologics in a number of cancers. The company has built a pipeline leveraging UNITE with programs in oncology, animal health, infectious disease, and allergy. ITI maintains its headquarters in Rockville, Maryland. For more information, please visit www.immunomix.com.
This press release includes statements relating to the current progress of the ITI-1001 program for Glioblastoma Multiforme (GBM) and ITI’s technology platform and development efforts. These statements and other statements regarding our future plans and goals constitute “forward-looking statements” and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations, including, without limitation, whether we are able to capitalize on the ITI-1001 program, achieve positive results in our clinical trials to develop an immunotherapy that is successful in treating GBM, and be able to advance the utilization of our UNITE® platform. You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.