Genenta Science’s Temferon Gets Orphan Drug Nod for Glioblastoma Multiforme

The FDA has granted Orphan Drug status to Genenta Science’s Temferon, an investigational cell therapy for treatment of glioblastoma multiforme, the most common primary brain tumor.

Temferon is designed to reprogram the tumors through the direct delivery of immunomodulatory molecules.

The candidate therapy is being evaluated in a phase 1/2a clinical trial in newly diagnosed patients with glioblastoma multiforme who are considered less likely to respond well to chemotherapy.

The FDA grants the Orphan Drug designation for investigational treatments for diseases affecting fewer than 200,000 people in the U.S., including incentives such as user fee exemptions and a seven-year marketing exclusivity period upon FDA approval.