Candel Drug Cuts Prostate Cancer Recurrence Risk by 39% in Phase 3 Data

Candel Therapeutics Inc.’s experimental drug aglatimagene besadenovec cut the risk of prostate cancer recurrence by 39% in a phase 3 trial, boosting prospects for a new treatment option for the first time in two decades.

"What is particularly compelling is the clear translation of biologic activity into meaningful clinical benefit," said Mark G. Garzotto, a professor at Oregon Health & Science University who presented the data Friday at the American Urological Association annual meeting. "These results move us closer to what matters most to patients—living free from cancer."

The study, with a median follow-up of 58 months, showed a statistically significant improvement in prostate cancer-specific disease-free survival (p=0.0031) compared to placebo. In a large subgroup of intermediate-risk patients, who made up 85% of the 745-patient trial, the therapy led to a 90% reduction in time to metastasis.

The positive data strengthens Candel's plan to submit a Biologics License Application to the U.S. Food and Drug Administration in the fourth quarter of 2026. If approved, aglatimagene besadenovec, also known as CAN-2409, could become the first new therapy for men with localized prostate cancer in over 20 years, addressing a significant unmet need where about 30% of patients see their disease return within 10 years.

The treatment involves injecting a modified adenovirus (CAN-2409) into the tumor, designed to deliver a gene that helps trigger cell death. This process is intended to provoke a patient-specific immune response against the cancer, attacking both the treated tumor and distant cancer cells.

"We are seeing consistent, favorable trends across multiple clinically relevant secondary and exploratory endpoints," Paul Peter Tak, President and Chief Executive Officer of Candel, said in a statement. He noted the results reinforce confidence that the drug could provide durable control of both local and systemic disease.

In the intermediate-risk subgroup, the rate of metastatic disease was 0.24% for patients receiving the drug, compared with 2.35% in the placebo arm. The company had previously reported that the treatment led to a higher rate of cancer being eradicated at a microscopic level in biopsies taken two years after treatment.

The extended follow-up data provides strong evidence for the drug's long-term efficacy, a key factor for regulatory review. Investors will now watch for the planned BLA submission in Q4 2026, which will be the next major catalyst for the company.

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