CellDex Therapeutics signed an agreement with MDxHealth under which the latter’s epigenetic MGMT test will be used to aid patient stratification into a Phase III clinical study evaluating Celldex’s immunotherapeutic vaccine rindopepimut, in patients with newly diagnosed, surgically resected glioblastoma multiforme (GBM). The international ACT IV trial, which CellDex confirmed the start of just a couple of days ago, is expected to recruit 374 patients with EGFRvIII-expressing GBM. The study will compare therapy using rindopepimut plus GM-CSF added to standard-of-care treatment using temozolomide.
Methylation of the DNA repair gene MGMT has been shown to be both prognostic and predictive in glioblastoma patients undergoing alkylating agent-based therapy, MDx notes. The MGMT prognostic assay will be used to determine the methylation status of the MGMT promotor gene in patients enrolled in the rindopepimut study, to ensure the two arms of the clinical trial are balanced.
CellDex is an antibody-based combination immunotherapy company, which is leveraging its Precision Targeted Immunotherapy Platform to develop a pipeline of candidates for treating cancer and other disorders. The PTI Platform comprises a complementary portfolio of monoclonal antibodies, antibody-targeted vaccines and immunomodulators used in optimal combinations to create novel disease-specific drug candidates. Rindopepimut is designed to target the tumor-specific EGFRvIII variant of the epidermal growth factor receptor, which CellDex says is linked to poor long-term survival, independently of other factors such as extent of resection and age.