On September 15, 2022 Candel Therapeutics, Inc. (Nasdaq: CADL) (Candel or the Company), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, reported 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 (Press release, Candel Therapeutics, SEP 15, 2022, View Source [SID1234619592]). 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.
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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 viral immunotherapy product candidate, is a genetically modified adenovirus that is designed to encode the herpes simplex virus thymidine kinase (HSV-tk) gene. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills infected and nearby cancer cells. Intratumoral administration of CAN-2409 results in immunogenic cell death, followed by the release of tumor-specific neoantigens in the tumor microenvironment. At the same time, the adenoviral vector elicits a strong pro-inflammatory effect in the tumor microenvironment, creating the optimal conditions to induce a specific CD8+ cytotoxic T cell-mediated immune response against the injected tumor and the uninjected distant metastases. This dual mechanism of antigen unmasking and immune activation may enable CAN-2409 to generate a powerful and lasting immune response against a variety of the patient’s tumor-associated neoantigens, minimizing the possibility for immune escape and development of tolerance.
Because of its versatility, CAN-2409 may have the potential to treat a broad range of solid tumors. Encouraging activity has been shown in several preclinical and clinical settings as monotherapy as well as in combination with standard of care radiation therapy, surgery, chemotherapy, and immune checkpoint inhibitor treatment. Furthermore, more than 700 patients have been dosed to date with a favorable safety profile, supporting the potential for combination with other therapeutic strategies without inordinate concern of overlapping adverse events. Currently, Candel 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 clinical trials.