Candel targets Q4 2026 BLA for prostate cancer therapy, opens NSCLC phase 3 trial
Candel reported second-quarter 2026 results with $201.6 million in cash, said to fund operations into the first quarter of 2028, alongside progress on its lead program.
Candel Therapeutics said it is planning to submit a Biologics License Application for aglatimagene besadenovec in localized, intermediate- to high-risk prostate cancer in the fourth quarter of 2026.1 The company said its process validation campaign for drug substance and drug product is being executed at its contract development and manufacturing organization, and is progressing well as a critical CMC activity to enable the anticipated BLA submission in Q4 2026.1
On the prostate cancer data, Candel reported that among 745 patients enrolled in the randomized, double-blind, placebo-controlled trial, the aglatimagene arm exhibited a 39% improvement in prostate cancer-specific disease-free survival compared to placebo after a median follow-up of 58 months, with data as of March 15, 2026.1 The company added that there were no new safety signals or additional toxicities observed.1
In lung cancer, Candel said that in June 2026, it activated the first clinical trial site of the global pivotal phase 3 AURORA trial (NCT07660094), which will evaluate aglatimagene plus valacyclovir in combination with continued pembrolizumab in patients with metastatic non-squamous NSCLC whose disease has progressed despite pembrolizumab and platinum-based chemotherapy.1 The trial design calls for enrollment of patients with metastatic stage IV non-squamous NSCLC across approximately 150 sites worldwide, randomized 1:1 to receive either two courses of aglatimagene plus valacyclovir with continued pembrolizumab or standard-of-care docetaxel chemotherapy, with overall survival as the primary endpoint.1
For its glioblastoma program, the company said it is advancing next-stage development planning for recurrent glioblastoma following FDA clearance of its Investigational New Drug application for linoserpaturev in Q1 2026, with enabling work underway to support a potential randomized phase 2 dose-regimen-finding study.1
On finances, Candel reported cash and cash equivalents of $201.6 million as of June 30, 2026, compared with $119.7 million as of December 31, 2025, which it said is expected to be sufficient to fund operations into the first quarter of 2028.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.