DNAtrix’s DNX-2401 is an oncolytic virus designed specifically for treating Glioblastoma (the most aggressive brain tumor), for which there is no cure. DNX-2401 has been evaluated in a Phase I dose-escalation study at the MD Anderson Cancer Center and easily met its key safety endpoint with no product-related toxicities. Remarkably, direct injection of DNX-2401 into human brain tumors also led to extensive tumor killing with no harm to normal brain cells. Patient survival was prolonged potentially with several complete responders, and one patient in remission 25 months post-treatment. Once approved by regulatory authorities, DNX-2401 could be used to treat virtually all cases of high-grade glioma.
While results from many anti-cancer drug trials have been disappointing so far, molecularly targeted agents are likely to have synergistic antitumor effects in combination. The further classification of GB may lead to personalized therapies for groups of patients. Research has shown that DNX-2401 should be compatible and effective in combination with some of the small-molecule and biologic therapies currently approved or in development. The excellent safety profile already observed for DNX-2401 is not expected to add to the toxicity (sometimes significant) associated with systemic agents, and it has a unique mechanism mode of action.
Compelling results from a Phase 1 clinical study conducted at MDACC indicate that DNX-2401 can (1) replicate in human tumors for a period of weeks to months, (2) trigger immune cell infiltration into the tumor not observed with other therapies (3) cause ongoing tumor destruction detectable by MRI and (4) achieve a complete response (CR) to therapy. Equally important is DNX-2401’s superior clinical safety profile of no significant or associated side effects observed at any dose. DNX-2401 therapy does not preclude the use of other anti-cancer agents.