FDA Grants Orphan Drug Designation to DNX-2401 for Malignant Glioma

The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to DNAtrix’s DNX-2401, a conditionally-replicative oncolytic adenovirus for malignant glioma. Glioma is the most common form of primary brain cancer, the treatment of which remains a significant unmet medical need. The DNX-2401 program was previously granted fast track status by the FDA. 

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 antiglioma immune effect that can lead to durable tumor destruction and long-term survival in some patients. DNX-2401, which has been engineered to be highly potent and selective for killing tumors, is currently being evaluated in clinical studies in the United States and Europe.

The FDA's orphan drug program designates a special status to drugs and biologics intended to treat, diagnose, or prevent diseases and disorders that affect fewer than 200,000 people in the United States. Under the designation, companies are provided with development and commercial incentives for designated compounds.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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