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Candel Therapeutics Receives Orphan Drug Designation from the European Medicines Agency for CAN-2409 in Glioma
NEEDHAM, Mass., Sept. 15, 2022 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Nasdaq: CADL) (Candel or the Company), a late clinical stage biopharmaceutical
About this update from Candel Therapeutics, Inc.
[{"type":"text","content":"NEEDHAM, Mass., Sept. 15, 2022 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Nasdaq: CADL) (Candel or the Company), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, today announced that the European Medicines Agency (EMA) Committee for Orphan Medical Products (COMP) has issued a positive opinion on the Company’s application for orphan drug designation for CAN-2409 for the treatment of glioma. CAN-2409, a genetically modified adenovirus and the Company’s most advanced investigational therapy, is currently being evaluated in multiple phase 2 and phase 3 clinical trials for lung, brain, pancreatic and prostate cancers. The orphan drug designation follows the U.S. Food and Drug Administration (FDA) fast track designation, which was granted in June 2021, for CAN-2409 in combination with valacyclovir following standard of care treatment in newly diagnosed high-grade glioma. 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.\" 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 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. In addition, there must be sufficient clinical or non-clinical data to suggest the product candidate may produce clinically relevant outcomes, and grounds to indicate it can provide a significant benefit over any currently authorized products. The designation can provide financial and regulatory incentives, including a 10-year period of marketing exclusivity in the EU after product approval, protocol assistance from the EMA at reduced fees during the product development phase and access to centralized marketing authorization. About CAN-2409 CAN-2409, Candel’s most advanced oncolytic vira...