Candel Therapeutics (CADL) presented detailed updates on its lead candidate, aglatimogen besadenovec, at the 12th Annual Cantor Fitzgerald Global Healthcare Conference on September 10, 2026. The company emphasized its ongoing efforts to advance the drug’s development for localized prostate cancer, targeting a Biologics License Application (BLA) submission by the end of 2025. A Special Protocol Assessment (SPA), first granted in 2010 and reaffirmed after a 2019 protocol amendment, underpins the trial’s design, ensuring regulatory alignment from the outset. Biomarker data is expected by Q3 or Q4 2025, with a critical deadline of before October for Q3 reporting to meet internal timelines.
The Phase III trial enrolled 745 patients with intermediate- or high-risk localized prostate cancer receiving external beam radiotherapy (EBRT). Key results included a 30% improvement in disease-free survival (DFS), with a hazard ratio of 0.7, and a 80% pathological complete response rate at two-year follow-ups—compared to 63% in the control group. Only two prostate cancer-related deaths were reported across the trial, one in the active treatment arm and one in the placebo group within the high-risk cohort, alongside 50 unrelated deaths. The secondary endpoint, a PSA nadir below 0.2 nanograms per milliliter, was also met. The trial’s median follow-up period reached 50.3 months, or approximately six years.
Aglatimogen is administered in three courses over a patient’s lifetime, with each session lasting 15 to 20 minutes in an outpatient clinic. The treatment involves a 0.5 mL injection into each of the prostate’s four quadrants, followed by a two-week course of valacyclovir to mitigate potential side effects. The company’s CEO, Paul Peter Tak, described the manufacturing timeline as “extremely tight,” noting a Type B FDA meeting on manufacturing lasted just six minutes—a sign of alignment with regulatory expectations. The company also highlighted a Phase I-B/II-A trial for recurrent glioblastoma, with 62 patients dosed.
Candel’s stock (CADL) closed at $11.33 on the day of the presentation, down 6.9% from the previous close of $12.17, though it saw a 2.9% uptick in after-hours trading at $11.34. The stock’s 52-week range spans $4.35 to $14.00, reflecting volatility in its development-stage valuation.
