DNAtrix is developing potent oncolytic immunotherapies for the treatment of cancer using genetically modified viruses.
DNAtrix’s first product, DNX-2401 (tasadenoturev), has demonstrated robust efficacy and safety in more than a decade of scientific and clinical research.
DNX-2401 is an oncolytic immunotherapy designed to fulfill the dual requirements of high potency and safety. To accomplish this, two stable genetic changes in the adenovirus genome were engineered so it replicates selectively in retinoblastoma (Rb) pathway deficient cells and infects tumor cells efficiently. Results from both pre-clinical and clinical studies indicate that DNX-2401 (1) replicates in human tumors for weeks, (2) elicits tumor necrosis, (3) triggers intratumoral immune cell infiltration, and (4) can lead to long term patient benefit.
Recurrent Glioblastoma (rGBM)
DNX-2401 has completed early-stage clinical studies establishing its activity and safety profile as a monotherapy treatment for recurrent glioblastoma (GBM). In the multicenter Phase 2 CAPTIVE study in combination with the checkpoint inhibitor, pembrolizumab (Keytruda), recurrent GBM patients had a median overall survival of 12.5 months, which compares favorably by months to what would be expected for the patient population when receiving standard of care therapies. Based on these results, a Phase 3 study called IGNITE is planned.
DNX-2401 has been granted Fast Track and Orphan designation by the FDA, Orphan and PRIME designation by the EMA, and PIM designation by MHRA for rGBM.
Diffuse Intrinsic Pontine Glioma (DIPG)
A Phase 1 study evaluating DNX-2401 as a potential treatment for patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) has completed enrollment and data is expected in 2021.
DNX-2401 has been granted Fast Track & Rare Pediatric Disease designations by the FDA for DIPG.