Candel's CAN-2409 meets phase 3 prostate cancer endpoint; BLA submission targeted for Q4 2026

Candel Therapeutics, Inc.

Phase 3 trial met primary endpoint: DFS improvement with HR 0.7 (p=0.0155) vs placebo in intermediate-to-high risk localized prostate cancer.
14.5% relative improvement in DFS at 54 months; 80.4% pathological complete responses at 2-year biopsy vs 63.6% in control (p=0.0015).
Phase 2b trial in low-to-intermediate risk active surveillance patients showed numerical improvement but did not reach statistical significance.
Company intends to initiate FDA discussions and submit Biologics License Application for CAN-2409 in Q4 2026; trial conducted under SPA.
Safety profile consistent with prior studies; most common adverse events were mild-to-moderate flu-like symptoms, fever, and chills.

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