On November 30, 2021 Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical-stage biotechnology company pioneering the study of LAMP-mediated nucleic acid-based immunotherapy, reported the opening of a new clinical study in collaboration with Dr. Duane Mitchell at the University of Florida (Press release, Immunomic Therapeutics, NOV 30, 2021, View Source [SID1234596263]). RENEW (NCT04963413) is designed to evaluate the ability to generate pp65 Lysosomal Associated Mediated Protein (LAMP) RNA-pulsed dendritic cells in patients who have completed standard external beam radiation and concomitant temozolomide and who are receiving adjuvant temozolomide chemotherapy at the time of enrollment.
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This is an extension of the Phase 2 ATTAC-II study (NCT02465268) where eligibility is limited to those patients who have had surgery but have not yet received chemoradiation. The RENEW pilot study will enroll adult patients with newly diagnosed WHO Grade IV glioma (GBM) who have completed standard of care surgery and chemoradiation and who are currently receiving adjuvant temozolomide chemotherapy.
"The RENEW pilot study’s expansion of the eligibility criteria allow a number of untreated patients with GBM to participate in a clinical study that includes our novel dendritic cell vaccine," said Dr. Bill Hearl, Chief Executive Officer at Immunomic Therapeutics, Inc. "We look forward to continued evaluation of ITI’s platform in both the ongoing ATTAC-II and the RENEW studies in an effort to address this clear and pressing unmet medical need."
ITI is developing several dendritic cell vaccines for the treatment of cancer, including ITI-1000 for glioblastoma multiforme (GBM), with key opinion leaders in cancer immunotherapy for brain tumors, John Sampson, M.D., Ph.D. from Duke University and Duane Mitchell, M.D., Ph.D. from the University of Florida. ITI’s dendritic cell vaccine is designed to target the pp65 viral antigen of Cytomegalovirus (CMV) that is expressed in GBM, but not in normal brain cells. In the ATTAC studies, the GBM patients’ white blood cells are removed, matured into dendritic cells (DCs), and modified to generate a vaccine to the pp65 viral protein when fused to the Lysosomal Associated Membrane Protein 1 (LAMP1) protein for antigen presentation. This dendritic cell vaccine is then returned to the patient. As observed in the ATTAC studies (ATTAC-GM: NCT00693639), ITI believes this approach may harness the body’s immune system to recognize, attack and destroy tumor cells that express CMV in GBM and potentially other cancers.
About Glioblastoma (GBM)
According to the American Association of Neurological Surgeons, GBM is an aggressive brain cancer that often results in death within 15 months of diagnosis. GBM develops from glial cells (astrocytes and oligodendrocytes), grows rapidly, and commonly spreads into nearby brain tissue. GBM is classified as Grade IV, the highest grade, in the World Health Organization (WHO) brain tumor grading system. The American Brain Tumor Association reports that GBM represents about 15% of all primary brain tumors and approximately 10,000 cases of GBM are diagnosed each year in the U.S.
About ITI-1000 and the Phase 2 (ATTAC-II) Study
ITI-1000 is an investigational dendritic cell vaccine therapy currently in a Phase II clinical trial (ATTAC-II) for the treatment of GBM. ITI-1000 was developed 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, placebo-controlled clinical trial enrolling patients with newly diagnosed GBM that will explore whether dendritic cell (DC) vaccines, including ITI-1000, targeting the CMV antigen pp65 improves survival. This study is enrolling up to 120 subjects at three clinical sites in the United States. For more information on the ATTAC-II study, please visit (NCT02465268).
About UNITE
ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein 1 (LAMP1), 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 puts UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in a Phase II clinical trial 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 LAMP1 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.