Candel Therapeutics receives FDA RMAT designation to CAN-2409

Candel Therapeutics (CADL) announced that the U.S. Food and Drug Administration, FDA, has granted Regenerative Medicine Advanced Therapy, RMAT, designation to CAN-2409, the Company’s biological immunotherapy lead candidate, for the treatment of newly diagnosed localized prostate cancer in patients with intermediate-to-high-risk disease. CAN-2409 was also previously granted FDA Fast Track designation for the same indication. The FDA’s RMAT designation is intended to expedite the development and review of regenerative medicine therapies intended to treat, modify, reverse, or cure serious or life-threatening diseases where preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition.