ROCKVILLE, Md.--(BUSINESS WIRE)--Immunomic Therapeutics, Inc. (ITI), a privately held, Maryland-based biotechnology company is proud to announce a travel fund for patients enrolled in a Phase II clinical study that employs their investigational LAMP-Vax™ technology to treat glioblastoma multiforme (GBM).
Although the study, “Vaccine Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme (ATTAC-II),” is not formally sponsored by Immunomic, the Company is funding a program to bring brain tumor patients who may be eligible to enroll in the study to and from the trial sites, including at the University of Florida (UF) and Duke University (Duke) for the duration of their treatment. Enrollment for the study began in August 2016.
The ATTAC II Study is a National Cancer Institute funded, Investigator Initiated clinical trial that will explore whether dendritic cell (DC) vaccines targeting the human CMV antigen pp65 expressed as fusion protein with LAMP-Vax technology improves survival of newly-diagnosed GBM patients. The technology utilized in the trial is part of a recently announced licensing agreement. The agreement combines Immunomic’s investigational LAMP-Vax, with a patented and proprietary CMV immunotherapy platform, developed at Duke University by Drs. Duane A. Mitchell and John H. Sampson and licensed to Annias Immunotherapeutics and now Immunomic Therapeutics, Inc. This approach could harness the body’s immune system to recognize, attack and destroy tumor cells that express CMV antigens, which are thought by some to be over-expressed in a variety of human cancers, including GBM.
Duane A. Mitchell, M.D., Ph.D., director of the UF Brain Tumor Immunotherapy Program and co-director of the Preston A. Wells, Jr. Center for Brain Tumor Therapy, is the study’s Principal Investigator. Sites for the study include University of Florida in Gainesville, with a referring site in Orlando, and a second site at Duke University, slated to open later this year.
“The travel fund will enable more GBM patients to receive this investigational treatment,” said Teri Heiland, Ph.D., Immunomic’s Senior Vice President of Research and Development. “We are proud to support such a cause and help patients and their families who are going through this process to have access to potential new therapeutic approaches.”
Travel agent Lisa McKay, Lisa@lisamckay.com, is partnering with Immunomic on this initiative and will coordinate the travel for patients. For more information about the patient travel fund or the clinical trial, visit http://www.immunomix.com/gbm-travel-fund/.
Immunomic Therapeutics, Inc. (ITI) is a privately-held clinical stage biotechnology company pioneering the study of the LAMP-based nucleic acid immunotherapy platforms. These investigational technologies have the potential to alter how we use immunotherapy for cancer, allergies and animal health. On the heels of two landmark deals in 2015, including an exclusive worldwide license with Astellas Pharma Inc. to explore the use of LAMP-Vax for use in the prevention and treatment of allergic diseases which resulted in over $350M in licensing revenue that year, the company has now focused on the application of LAMP technology in oncology. For information about ITI and LAMP Technology, visit www.immunomix.com.
ITI’s investigational LAMP-Vax platform is thought to work by encoding the Lysosomal Associated Membrane Protein, an endogenous protein in humans. 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 LAMP-Vax technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. LAMP 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 LAMP 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 LAMP-Vax 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.
About the ATTAC-II Trial
The ATTAC-II trial will examine whether the addition of pp65-LAMP mRNA vaccine plus granulocyte-macrophage colony-stimulating factor (GM-CSF), to dose-intensified temozolomide improves overall survival in patients with newly diagnosed GBM. One hundred and twenty patients will be randomized to receive autologous dendritic cells primed with different versions of LAMP + pp65 mRNA constructs plus GM-CSF, or other blood cells with GM-CSF (control) after standard external beam radiation with concurrent temozolomide. Cycles of temozolomide and booster vaccines will follow the initial vaccination. The primary endpoint of the trial is overall survival and secondary endpoints include progression-free survival and determining the immunologic effects of vaccination with full versus short-LAMP pp65 RNA fusions. Funding for this trial comes from the National Cancer Institute. Immunomic Therapeutics holds the rights to the LAMP sequence for its application in cancer immunotherapy, among other applications.