CAN-2409 (aglatimagene besadenovec) plus valacyclovir (prodrug)

June 2, 2026: Candel Therapeutics, Inc. (NASDAQ: CADL) announced publication in The Lancet Oncology of results from its randomized, double-blind, placebo-controlled, multicenter pivotal Phase 3 trial (NCT01436968) of aglatimagene besadenovec (CAN-2409) plus valacyclovir added to standard-of-care curative-intent radiotherapy in intermediate- to high-risk localized prostate cancer (n=745). The trial met its primary endpoint, showing a 30% improvement in disease-free survival (DFS) vs placebo plus valacyclovir (HR 0.70; 95% CI 0.52–0.94; p=0.016), and a 38% improvement in prostate cancer-specific DFS (HR 0.62; 95% CI 0.44–0.87; p=0.0046). In a post-hoc blinded review of biopsies ~2 years after radiotherapy, negative biopsies were 80% (167/209) with aglatimagene vs 63% (62/98) with placebo (p=0.0018). Safety was generally favorable, with common treatment-related AEs primarily grade 1–2 and self-limited.

The company cited extended follow-up presented at the AUA 2026 Annual Meeting: 39% improvement in prostate cancer-specific DFS after ~20 additional months (median follow-up 58 months as of March 15, 2026), with favorable trends in secondary/exploratory endpoints.

Candel said these data will support a planned BLA submission for aglatimagene in Q4 2026.