Candel Therapeutics (CADL) Study Result summary

Phase III trial design and objectives

• Phase III trial enrolled 745 patients with intermediate- to high-risk localized prostate cancer, randomized 2:1 to CAN-2409 plus valacyclovir and radiation or standard of care, stratified by short-term androgen deprivation therapy use, under a Special Protocol Assessment with the FDA.

• Primary endpoint was disease-free survival (DFS), including post-treatment biopsies at two years, recurrence, and death from any cause.

Key efficacy results

• Study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in DFS for CAN-2409 (hazard ratio 0.7, p=0.0155), with a 14.5% relative improvement at 54 months and a 30% reduction in risk of recurrence or death; effect increased over time.

• Pathological complete response rate at two years was 80.4% for CAN-2409 vs. 63.6% for placebo (p=0.0015); negative biopsy rate was 84.4% vs. 63.6%.

• Significant increase in patients achieving PSA nadir <0.2 ng/mL: 67.1% in CAN-2409 vs. 58.6% in placebo (p=0.0164).

• Prostate cancer–free survival analysis showed a highly significant effect (p=0.0046; HR 0.6) for CAN-2409.

• All key subgroups (race, age, risk, ADT use) favored CAN-2409 for DFS.

Safety and tolerability

• CAN-2409 demonstrated a favorable safety profile, with lower rates of serious adverse events and treatment discontinuations compared to placebo; safety profile was consistent with previous studies and no new safety signals identified.

• Most common adverse events were mild to moderate flu-like symptoms, fever, and chills.

• Over 1,000 patients have been dosed with CAN-2409 to date, supporting its favorable tolerability profile.

• Lower incidence of urinary side effects in CAN-2409 arm compared to placebo.