DNAtrix announced the treatment of the first patient with DNX-2440, an oncolytic virus expressing OX40 ligand (OX40L). The first-in-human Phase 1 study is evaluating the safety and efficacy of DNX-2440, administered by Alcyone's Microtip Cannula at the time of biopsy, to patients with recurrent glioblastoma for whom surgery is not possible or planned. DNX-2440 is the second DNAtrix oncolytic adenovirus to advance into the clinic.
DNX-2440 is engineered from DNAtrix's highly potent oncolytic adenovirus, DNX-2401 (tasadenoturev), which has already demonstrated the ability to selectively kill tumor cells and trigger a powerful immune response directed against the tumor in several clinical studies. In addition to these mechanisms, DNX-2440 expresses OX40L, a critical costimulatory molecule known to enhance antitumor immune responses.
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Extensive preclinical data have shown that DNX-2440 elicits tumor-specific immune memory and an abscopal effect (shrinking of an untreated tumor distant from the treated tumor), leading to prolonged survival in difficult-to-treat animal models of cancer, including gliomas, melanomas, and breast and lung cancers.
"Based on our observations from past studies with DNX-2401, we expect DNX-2440 to be safely administered and well tolerated, and to enhance clinical responses and prolong survival in patients with this devastating disease," said Ricardo Diez Valle, MD, Principal Investigator of the study at Clínica Universidad de Navarra, in Spain.
"DNX-2440 should trigger an immune response directed to tumors that are otherwise refractory to single agent immunotherapies," said Frank Tufaro, PhD, CEO of DNAtrix. "We now have two unique products in development and are planning to evaluate DNX-2440 for other malignancies, reinforcing our commitment to developing oncolytic immunotherapies for difficult to treat tumors."