Candel Therapeutics Inc., a clinical-stage biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its lead candidate, CAN-2409 (aglatimagene besadenovec), for the treatment of newly diagnosed localized prostate cancer in patients with intermediate-to-high-risk disease. This designation is intended to expedite the development and review process for regenerative medicine therapies addressing serious or life-threatening conditions. The RMAT designation was granted based on positive data from Candel's phase 3 clinical trial of CAN-2409 in combination with valacyclovir and standard of care radiation therapy. Candel aims to submit a Biologics License Application by the end of 2026, with the designation helping to facilitate the application process.
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