Candel Secures European Medicines Agency Orphan Drug Status For Brain Tumour Candidate

The European Medicines Agency (EMA) Committee for Orphan Medical Products (COMP) has issued a positive opinion on Candel Therapeutics’ CADL application for orphan drug designation for CAN-2409 for the treatment of glioma.

The EMA orphan drug designation for CAN-2409 follows the U.S. Food and Drug Administration (FDA) fast track designation for lead candidate in combination with valacyclovir ensuring standard of care treatment in newly diagnosed high-grade glioma.

Orphan drug designation in the European Union (EU) is granted by the European Commission based on a positive opinion issued by the EMA COMP.

The company is evaluating the effects of treatment with CAN-2409 in high-grade glioma, non-small cell lung cancer, pancreatic cancer, and prostate cancer in ongoing multiple phase 2 and phase 3 clinical trials.

Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel, said, "Glioma, while mercifully rare, is a devastating disease with significant morbidity and mortality. The EMA's orphan drug designation recognizes the high unmet need and the potential of CAN-2409 in this patient population. We look forward to working with the EMA and FDA in an effort to bring our investigational medicine to patients as we initiate our phase 3 clinical trial of CAN-2409 in high-grade glioma this year."

The EMA's orphan drug designation is potentially available to companies developing treatments for life-threatening or chronically debilitating conditions that affect no more than five in 10,000 persons in the EU region.

Price Action : Candel shares are trading around 4 percent higher at $3.64 on Thursday at the time of publication.