Data Readout

Candel to unveil biomarker data from Phase 3 prostate gene therapy in Q3

The readout follows extended survival follow-up already promised for aglatimagene besadenovec, with a BLA submission planned before any of that data is public.

By AppliedXLJuly 13, 2026Trial NCT01436968

Executive Summary

Candel Therapeutics plans to disclose biomarker data from its Phase 3 prostate cancer trial in the third quarter, a secondary dataset arriving ahead of the primary survival result and the regulatory filing that depends on it.
The company has told investors it intends to submit a Biologics License Application in the fourth quarter, making this quarter's disclosures a preview of the evidence base regulators will eventually see.
The trial's primary completion date has moved repeatedly over its history, a pattern that raises the bar for how convincing the maturing dataset needs to be before a filing lands on schedule.
No other program has reached this phase testing the same viral gene-therapy mechanism in this prostate cancer population, so the result will be read without a same-class benchmark.

The disclosure

Candel Therapeutics said it expects to share additional biomarker data from its Phase 3 prostate cancer program in the third quarter of 2026, with the guided window running from July 1 through September 30. The data come from NCT01436968, a Phase 3 trial testing aglatimagene besadenovec, an adenoviral gene therapy, combined with standard radiation therapy against radiation plus placebo in men with localized, intermediate-to high-risk prostate cancer. Chief Executive Paul Peter Tak told investors in March that the company would present follow-up clinical data from the trial in the second quarter of 2026 and biomarker data in the third quarter, ahead of a planned Biologics License Application submission in the fourth quarter. Candel+1

What the trial tests

The trial's registered primary endpoint is disease-free survival, measured as time from randomization to the first failure event in the intent-to-treat population, comparing the aglatimagene arm against a placebo control arm. The biomarker data due in the third quarter is not that primary endpoint; it is supplementary evidence that will sit alongside the survival result as the company builds its BLA package. The trial targets enrollment of 711 patients and has run since September 2011, with a Fast Track designation granted by the FDA for CAN-2409 in localized primary prostate cancer and a Regenerative Medicine Advanced Therapy designation granted in May 2025 for the newly diagnosed intermediate-to-high-risk population. NCT01436968+1

A history of delay

The trial's primary completion date has moved three times since 2020: from December 2022 to June 2023, then to December 2024, then to August 2024, a net cumulative delay of 731 days. The trial's status changed from Recruiting to Active, not recruiting in September 2021, meaning enrollment closed years before the current disclosure cycle. Registry activity of this kind, three completion-date amendments layered onto a trial that started in 2011, sets the frame for judging whether the extended follow-up and biomarker data due this year read as mature evidence or as an evolving picture. NCT01436968

No same-class comparator

No other industry trial has reached Phase 3 testing the HSV-TK target in this prostate cancer population, and Candel's own competitive search returned no other program on this target-indication pairing. The nearest related trial is Candel's own Phase 3 program testing the same HSV-TK-directed adenoviral mechanism in non-small cell lung cancer, a different indication. Beyond that, the prostate cancer field is populated by mechanistically distinct approaches, including PSMA-targeted radiopharmaceuticals, androgen-receptor inhibitors, and PARP inhibitors in Phase 3 testing, none of which share aglatimagene's viral immunotherapy mechanism. With no validated same-mechanism precedent in this indication, the disease-free survival result that eventually follows this biomarker disclosure would need to hold up on its own terms rather than against a comparable class benchmark. NCT01436968

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.