Candel’s CAN-2409 hits goal in Phase III prostate cancer trial

Shares of US clinical stage biopharma Candel Therapeutics (Nasdaq: CADL) leapt 166% to $12.25 in pre-market activity today, after it announced results from a multicenter Phase III clinical trial evaluating its CAN-2409 viral immunotherapy in localized prostate cancer patients.

The study CAN-2409 in intermediate-to-high-risk, localized prostate cancer met its primary endpoint, by demonstrating statistically significant improvement in disease-free survival in patients who received CAN-2409 plus prodrug (valacyclovir) combined with standard of care compared to standard of care alone.

The 2:1 randomized, double-blind, placebo-controlled, multicenter clinical trial enrolled 745 patients (intent to treat population, ITT) to evaluate the effectiveness and safety of CAN-2409 plus prodrug (valacyclovir) viral immunotherapy in combination with standard of care external beam radiation therapy to improve disease-free survival (DFS) in patients with intermediate-to-high risk, localized prostate cancer. Patients were randomized and stratified for the use of short-term (< 6 months) androgen deprivation therapy (ADT).