Candel Therapeutics announced that its lead immunotherapy candidate, CAN-2409, received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for treating newly diagnosed, localized prostate cancer in intermediate-to-high-risk patients. This builds upon the previously granted Fast Track designation for the same indication. The RMAT designation was based on positive Phase 3 trial data showing CAN-2409 significantly improved disease-free survival and reduced the risk of prostate cancer recurrence or death.
This RMAT designation is particularly important because it highlights the potential of CAN-2409 to address a significant unmet need in prostate cancer treatment. The positive Phase 3 trial results, demonstrating a substantial improvement in disease-free survival, underscore the potential clinical impact of this therapy. This is particularly relevant given the limited innovation in early-stage prostate cancer treatment in recent decades. The expedited development and review process afforded by the RMAT designation could lead to faster patient access to a potentially life-changing therapy.
CAN-2409, in combination with standard radiotherapy, demonstrated a 30% risk reduction in prostate cancer recurrence or death compared to the placebo group in the Phase 3 trial. Additionally, there was a significant increase in patients achieving a very low prostate-specific antigen (PSA) level, suggesting improved tumor control. The therapy also showed a high pathological complete response rate in post-treatment biopsies. Importantly, the safety profile remained consistent with previous studies. The trial design, including the primary endpoint, was pre-agreed upon with the FDA. A Biologics License Application (BLA) submission is anticipated by the end of 2026.
The RMAT designation for CAN-2409 significantly strengthens its development trajectory. The FDA’s commitment through intensive guidance and expedited review processes could accelerate the path toward potential approval. This could position CAN-2409 as a promising new treatment option for intermediate-to-high-risk localized prostate cancer, offering patients a much-needed therapeutic advance. This also sets the stage for Candel Therapeutics to establish itself as a key player in the field of cancer immunotherapy.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
