Candel Therapeutics Receives FDA Regenerative Medicine Advanced Therapy Designation for CAN-2409 for the Treatment of Prostate Cancer

Core Viewpoint - Candel Therapeutics has received FDA's Regenerative Medicine Advanced Therapy (RMAT) designation for its lead candidate CAN-2409, aimed at treating newly diagnosed localized prostate cancer in patients with intermediate-to-high-risk disease, highlighting the potential of this therapy to address significant unmet medical needs [1][5][9] Group 1: FDA Designation and Implications - The RMAT designation is designed to expedite the development and review of regenerative medicine therapies for serious or life-threatening diseases, providing opportunities for intensive FDA guidance and support [2] - This designation allows for mechanisms that can speed up the Biologics License Application (BLA) review and approval process, including rolling review and priority review [2] Group 2: Clinical Trial Results - Positive data from a phase 3 randomized, placebo-controlled trial showed that CAN-2409 plus valacyclovir, combined with standard of care external beam radiation therapy, met its primary endpoint, demonstrating a statistically significant improvement in disease-free survival (DFS) [3][4] - The trial indicated a 30% reduction in the risk of prostate cancer recurrence or death (HR 0.70; p=0.0155) for patients receiving CAN-2409 compared to placebo, with a 38% risk reduction in prostate-specific DFS (HR 0.62; p=0.0046) [4] - The treatment also resulted in a significant increase in patients achieving a prostate-specific antigen (PSA) nadir of <0.2 ng/ml (67.1% vs. 58.6%; p=0.0164) and an 80.4% pathological complete response in post-treatment biopsies [4] Group 3: Future Plans and Expectations - The company anticipates submitting the BLA for CAN-2409 by the end of 2026, aiming to introduce a new treatment option for early-stage prostate cancer, a field that has seen minimal innovation in the past two decades [6] - The RMAT designation is expected to facilitate the BLA filing process, bringing the company closer to achieving its objective of providing a new treatment option [6] Group 4: About CAN-2409 - CAN-2409 is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to tumors, inducing a CD8+ T cell-mediated immune response against cancer cells [7][8] - The therapy has shown encouraging activity in combination with standard treatments and has been dosed in over 1,000 patients with a favorable tolerability profile [8][9]