ROCKVILLE, Md.--(BUSINESS WIRE)--Immunomic Therapeutics, Inc. (‘ITI’), a privately-held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, today announced that Kristen Batich, MD, Ph.D. and a team from Duke University School of Medicine will present clinical data at the 2021 Society for Neurology (SNO) Annual Meeting being held in Boston, MA, November 18-21st, 2021.
The data to be presented at the SNO meeting are from three sequential clinical trials utilizing Cytomegalovirus (CMV)–specific dendritic cell vaccines that encode the chimeric CMV protein LAMP-pp65 in patients with primary Glioblastoma. The patients were given serial vaccination through adjuvant temozolomide cycles. The Phase II ATTAC study (NCT00639639) led to an expanded cohort trial (ATTAC-GM: NCT00693639) resulting in positive immunologic and clinical response. The larger confirmatory trial, ELEVATE (NCT02366728), revealed significantly longer overall survival (OS) in patients randomized to LAMP pp65 RNA loaded DC vaccines combined with tetanus-diphtheria booster. The results demonstrate that a CMV pp65-LAMP RNA-pulsed dendritic cell vaccination was associated with positive immunologic and clinical response in patients with glioblastoma (GBM).
“The clinical data to be presented demonstrates the potential impact of our UNITE technology platform, powered by LAMP, and will help validate our therapeutic approach utilizing vaccines to treat difficult cancers like glioblastoma,” said Dr. Teri Heiland, Chief Scientific Officer of Immunomic Therapeutics, Inc. “We are encouraged by the immunological response shown with this patient group and we look forward to Dr. Batich’s presentation of these positive findings at the SNO meeting.”
Abstract Session: Clinical Trials I
Title: Reproducibility of clinical trials using CMV-targeted dendritic cell vaccines in patients with glioblastoma
Date and Time: Friday, November 19, 2021 4:45 PM – 4:50 PM EST
Location: Ballroom C, Hynes Convention Center, Boston, MA
Kristen A. Batich, MD, PhD
Duke University Medical Center
Durham, United States
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 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 improve survival. This study is enrolling up to 120 subjects at 3 clinical sites in the United States. For more information on the ATTAC-II study, please visit www.clinicaltrials.gov.
ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein 1 (LAMP-1), 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 LAMP-1 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.
About Immunomic Therapeutics, Inc.
Immunomic Therapeutics, Inc. (ITI) is a privately held, clinical stage biotechnology company pioneering the development of vaccines through its investigational proprietary technology platform, UNiversal Intracellular Targeted Expression (UNITE), which is designed to utilize the body’s natural biochemistry to develop vaccines that have the potential to generate broad immune responses. The UNITE platform has a robust history of applications in various therapeutic areas, including infectious diseases, oncology, allergy and autoimmune diseases. ITI is primarily focused on applying the UNITE platform to oncology, where it could potentially have broad applications, including targeting viral antigens, cancer antigens, and producing antigen-derived antibodies as biologics. In 2020, an investment of over $77M by HLB Co., LTD, a global pharmaceutical company, enabled ITI to accelerate application of its immuno-oncology platform, in particular to glioblastoma multiforme, and rapidly advance other key candidates in the pipeline. The Company has built a pipeline from UNITE with four wholly owned oncology programs, the lead of which is in a Phase 2 clinical study for Glioblastoma Multiforme (GBM). ITI has formed several academic collaborations with leading Immuno-oncology researchers at Duke University and the University of Florida. ITI maintains its headquarters in Rockville, Maryland. For more information, please visit www.immunomix.com.