DNX-2401 (Tasadenoturev)

DNAtrix is developing potent oncolytic immunotherapies for the treatment of cancer using genetically modified viruses. 

DNX-2401 is developed to have attractive characteristics needed for safety and efficacy.

  • Novel Mechanism: oncolytic immunotherapies that kill tumor cells and trigger an antitumor immune response
  • Versatility: Individual therapies can be engineered for a wide variety of cancers
  • Excellent Safety: Demonstrated across multiple clinical studies
  • Combinability: Excellent safety and ease of administration make them suitable for combination therapy with many classes of drugs
Designation Granting Organization Date Additional Information
PRIority MEdicines (PRIME) European Medicines Agency (EMA) July 27, 2016 Learn more >
Orphan Medicinal Product European Commission February 9, 2016 Learn more >
Orphan Drug FDA October 7, 2014 Learn more >
Fast Track Status U.S. Food and Drug Administration (FDA) June 17, 2014 Learn more >

DNX-2401 is based on engineering stable genetic changes to adenovirus genomes to ensure safety and to enhance anti-tumor efficacy. Two stable genetic changes cause DNX-2401 to (1) replicate selectively in retinoblastoma (Rb) pathway deficient cells and (2) infect cells that express certain RGD-binding integrins more efficiently. Because virtually all tumor cells are defective in Rb function and already in the cell cycle, DNX-2401 replicates in and kills these tumor cells selectively and efficiently.

DNAtrix’s lead product, DNX-2401, has demonstrated a potent anti-tumor mechanism of action by (1) replicating in human tumors (2) eliciting tumor necrosis and (3) triggering an immune response.