Candel Therapeutics Receives EMA Orphan Drug Designation for CAN-2409 in Glioma

The European Medicines Agency (EMA) Committee for Orphan Medical Products issued a positive opinion on Candel Therapeutics’ CAN-2409 for the treatment of patients with glioma, a tumor that forms when glial cells grow out of control usually in the brain but sometimes in the spinal cord.

CAN-2409 is a genetically modified adenovirus that is designed to encode the herpes simplex virus thymidine kinase (HSV-tk) gene, the company said, adding that HSV-tk is an enzyme that locally converts the orally administered antiviral drug valacyclovir into a toxic metabolite that kills infected and nearby cancer cells.

The FDA granted Fast Track designation to the investigational treatment in June 2021 in combination with valacyclovir following standard of care treatment in newly diagnosed high-grade glioma.

The company said it plans to work with the EMA and the FDA to bring the treatment to patients. Candel said it will begin a phase 3 clinical trial later this year.