On October 1, 2019 Immunomic Therapeutics, Inc. reported that it has assumed sponsorship of the Investigational New Drug (IND) application for ITI-1000 from the University of Florida (UF) (Press release, Immunomic Therapeutics, OCT 1, 2019, View Source [SID1234539969]). ITI-1000 is currently being investigated in a Phase 2 ATTAC-II trial at UF and Duke. The Phase 2 protocol will remain active, the existing Principal Investigators (PIs) from UF and Duke will remain in place, and the existing relationships with the pioneers of this cancer immunotherapy, Drs. Duane Mitchell, M.D., and John Sampson, M.D., Ph.D., will stay intact.
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ITI-1000 is an investigational dendritic cell vaccine therapy currently in a Phase 2 clinical trial (ATTAC-II) for the treatment of the aggressive brain tumor, Glioblastoma Multiforme (GBM). ITI-1000 is designed to target the pp65 viral antigen of Cytomegalovirus (CMV) that is expressed in GBM, but not in normal brain cells. In the ongoing ATTAC-II study (NCT02465268), some of the GBM patients’ white blood cells are removed, matured into dendritic cells and vaccinated against the pp65 viral protein, then returned to the patient. The company believes this approach may harness the body’s immune system to recognize, attack and destroy tumor cells that express CMV, which is over-expressed in GBM.
"We are very excited to lead the clinical development of ITI-1000 and assume responsibilities of the ATTAC-II study in GBM," said Dr. William Hearl, CEO of Immunomic Therapeutics. "We look forward to building upon the research momentum and exciting data generated with this program from our academic partners at Duke and the University of Florida. Our development plans will involve continuing to support the progress of the current study and potentially opening other clinical studies employing ITI-1000 in GBM. Importantly, this will add more data to our programs for GBM and supports our ongoing efforts to apply our novel UNITE platform in oncology."
About ITI-1000 and the Phase 2 (ATTAC-II) Study
ITI-1000 is an investigational dendritic cell vaccine therapy currently in a Phase 2 clinical trial (ATTAC-II) for the treatment of GBM. ITI-1000 was discovered using Immunomic’s proprietary investigational lysosomal targeting technology, UNITE, in the context of cell therapy. In May 2017, Immunomic exclusively licensed a patent portfolio from Annias Immunotherapeutics for use in combination with UNITE and ITI-1000, allowing Immunomic to combine UNITE with a patented and proprietary CMV immunotherapy platform. The ATTAC-II study (NCT02465268) is a Phase II randomized clinical trial enrolling patients with newly diagnosed GBM that will explore whether dendritic cell (DC) vaccines, including ITI-1000, targeting the CMV antigen pp65 expressed as fusion protein with UNITE improves survival. This study will enroll up to 120 subjects at 3 clinical sites in the United States. Immunomic expects to report interim data from this study. For more information on the ATTAC-II study, please visit www.clinicaltrials.gov.
About UNITE
ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein, an endogenous protein in humans, for immune processing and MHC-II presentation to helper T-cells. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.