Genenta's brain cancer cell therapy gets FDA orphan drug status
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- The U.S. Food and Drug Administration (FDA) granted orphan drug designation (ODD) to Genenta Science's (NASDAQ:GNTA) to Temferon to treat glioblastoma multiforme (GBM), a type of brain cancer.
- Temferon is a cell therapy aimed at reprograming the tumor microenvironment by delivering immunomodulatory molecules directly to tumors, according to the company.
- The drug is being evaluated in a phase 1/2a trial in newly diagnosed patients with GBM who have an unmethylated MGMT gene promoter (uMGMT-GBM).
- The FDA grants orphan drug status to therapies which treat or prevent rare diseases that affect fewer than 200K people in the U.S. The designation provides certain incentives, including seven years of market exclusivity, if approved.
- Glioblastoma is a type of cancer which begins as a growth of cells in the brain or spinal cord.