DNAtrix announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to DNX-2401, a conditionally-replicative oncolytic adenovirus for malignant glioma. DNX-2401, which has been engineered to be highly potent and selective for killing tumors, is currently being evaluated in clinical studies.
Oncolytic virus therapy is based on the concept of using live viruses to selectively infect and replicate in cancer cells, with minimal destruction of normal tissue. Virus replication amplifies the input dose of the oncolytic virus and helps spread the agent to adjacent tumor cells. Moreover, there is evidence for a long-lasting anti-glioma immune effect that can lead to durable tumor destruction and long-term survival in some patients.
Previously the FDA had granted Fast Track status to the DNX-2401 clinical program.
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