On March 3, 2020 Immunomic Therapeutics, Inc., a privately held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, reported that it successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding its First-In-Human (FIH) Phase I trial and development plans for ITI-1001 (Press release, Immunomic Therapeutics, MAR 3, 2020, View Source [SID1234555119]). The FDA addressed the Company’s questions and provided feedback on key components of the planned IND application for the candidate, ITI-1001, for the treatment of newly diagnosed Glioblastoma Multiforme (GBM).
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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), expressed in GBM, but not in normal brain cells.
"We are pleased to have completed our pre-IND meeting with the FDA, which marks an important development milestone for Immunomic and the ITI-1001 program," said Dr. William Hearl, CEO of Immunomic Therapeutics. "We appreciate the guidance from the FDA as we move forward with our plans to initiate a Phase 1 trial for GBM in the US, which we hope will bring us closer to providing a therapeutic option to patients with this devastating disease."
In the planned First-In-Human (FIH) Phase I trial, Immunomic will evaluate the safety, tolerability, immunogenicity and preliminary efficacy of ITI-1001 in patients with Newly-Diagnosed Glioblastoma (GBM) Having Unmethylated MGMT Promoter Mutations. The Phase 1 trial is anticipated to start in 2021.
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. 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.