Candel Therapeutics Announces Positive Phase 3 Trial Results for CAN-2409 in Prostate Cancer

Candel Therapeutics, Inc. recently reported positive topline data from its phase 3 randomized clinical trial evaluating CAN-2409 viral immunotherapy in localized prostate cancer patients at intermediate-to-high risk for disease progression. This trial, conducted in the United States under a Special Protocol Assessment with the FDA, enrolled 745 patients to assess the efficacy and safety of CAN-2409 plus prodrug viral immunotherapy in combination with standard external beam radiation therapy. The results demonstrated a statistically significant improvement in disease-free survival (DFS) compared to the control arm, meeting its primary endpoint.

Key findings from the trial included a significant improvement in DFS for the CAN-2409 treatment arm, a 14.5% relative improvement at 54 months, a higher proportion of patients achieving a prostate-specific antigen nadir (<0.2 ng/ml), and a significant increase in the pathological complete response rate in post-treatment biopsies. Importantly, the safety profile of CAN-2409 was consistent with previous studies, with flu-like symptoms being the most common adverse events observed.

Following these promising results, Candel intends to engage in discussions with the FDA regarding the regulatory pathway for CAN-2409 in intermediate-to-high-risk localized prostate cancer, with plans to submit a biologics license application in the fourth quarter of 2026.

Additionally, the company disclosed that its phase 2b randomized clinical trial evaluating CAN-2409 in patients with low-to-intermediate risk localized prostate cancer undergoing active surveillance did not meet statistical significance despite showing numerical improvements in certain endpoints. The safety profile of CAN-2409 in this trial was also consistent with previous findings.

The company plans to present more details from these trials at a scheduled meeting and provided presentations of the trial results on its investor relations section of the website. These positive results mark significant progress in the development of CAN-2409 for the treatment of prostate cancer.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Candel Therapeutics’s 8K filing here.

Candel Therapeutics Company Profile

Candel Therapeutics, Inc, a clinical stage biopharmaceutical company, engages in the development immunotherapies for the cancer patients. It develops CAN-2409, which is in Phase II clinical trials for the treatment of pancreatic cancer; Phase III clinical trials for the treatment of prostate cancer; and Phase II clinical trials for the treatment of lung cancer, as well as has completed Phase Ib/II clinical trials for the treatment of high-grade glioma.