Aglatimagene besadenovec (CAN-2409) - (ULYSSES)

Aug. 13, 2026: Candel Therapeutics (NASDAQ: CADL) said it plans a BLA submission in Q4 2026 for aglatimagene besadenovec in localized intermediate- to high-risk prostate cancer. In the pivotal randomized phase 3 trial, published in The Lancet Oncology, aglatimagene plus standard-of-care radiotherapy showed a statistically significant benefit versus radiotherapy alone; extended follow-up presented at AUA 2026 reported a 39% improvement in prostate cancer-specific disease-free survival after a median 58 months among 745 patients, with favorable trends across secondary/exploratory endpoints and no new safety signals. An extended biomarker analysis from this trial is scheduled for presentation at ASTRO in Q3 2026.

For NSCLC, the company activated the first site in June 2026 for the global pivotal phase 3 AURORA trial (NCT07660094) in metastatic stage IV non-squamous NSCLC progressing despite pembrolizumab and platinum chemotherapy. The study will randomize patients 1:1 to aglatimagene plus valacyclovir with continued pembrolizumab versus docetaxel; the primary endpoint is overall survival.

For linoserpaturev in recurrent glioblastoma, after IND clearance in Q1 2026, Candel is preparing a potential randomized phase 2 dose-regimen-finding trial and expects long-term survival data from arm C of its phase 1b trial in recurrent high-grade glioma in Q4 2026. Cash was $201.6 million as of June 30, 2026, with runway expected into Q1 2028.