On June 16, 2020 Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms and Ichor Medical Systems ("Ichor"), a privately held biotech company based in San Diego, CA, reported that the companies have entered into a license agreement to support the development of ITI’s investigational plasmid DNA vaccine therapy, ITI-1001 (Press release, Immunomic Therapeutics, JUN 16, 2020, View Source [SID1234561129]).
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ITI will leverage Ichor’s TriGrid Electroporation technology to increase cellular uptake of ITI-1001 when administered to patients with newly diagnosed Glioblastoma, or GBM. DNA vaccines delivered by conventional injection have experienced challenges to delivery efficiency, resulting in suboptimal immune responses in clinical trials. Ichor’s TriGrid technology utilizes the application of electrical fields in a target tissue to increase intracellular nucleic acid uptake in the local area, resulting in enhanced gene expression.
"We are excited to partner with Ichor on our ITI-1001 program. Their TriGrid technology is a great match for our nucleic acid approach. By combining our technologies, we aim to enhance immune responses to the viral antigens of Cytomegalovirus (CMV) expressed in GBM patients, and potentially achieve immune responses that target CMV-expressing GBM tumor tissue in the brain in our upcoming Phase I study with ITI-1001," said Dr. William Hearl, CEO of Immunomic Therapeutics. "We are pleased to collaborate with a recognized leader in the delivery of nucleic acid-based medicines and we look forward to initiating patient dosing in 2021."
ITI-1001, which leverages ITI’s proprietary and investigational UNITE platform to treat patients with newly diagnosed GBM, is designed to target the pp65, IE-1, and gB viral antigens of CMV, expressed in GBM, but not in normal brain cells. In March 2020, ITI announced that it had 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. 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).
In the planned First-In-Human Phase I trial, ITI will evaluate the safety, tolerability, immunogenicity and preliminary efficacy of ITI-1001 in patients with newly-diagnosed GBM having unmethylated MGMT promoter mutations. The Phase I trial is anticipated to start in 2021.
"DNA vaccines are a promising platform for both therapeutic and prophylactic applications. Randomized, placebo-controlled trials have demonstrated that the TriGrid improves the potency of DNA vaccines compared to conventional injection," said Ichor CEO Bob Bernard. "We are eager to deploy our TriGrid technology with ITI’s UNITE-based GBM DNA vaccine to target an aggressive cancer for which novel therapies are desperately needed."
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.