Candel Initiates Phase 3 AURORA Trial, Advances Aglatimagene Toward BLA and Launch

Candel Therapeutics has initiated the global pivotal Phase 3 AURORA trial (NCT07660094) of aglatimagene besadenovec plus valacyclovir in combination with continued pembrolizumab in patients with metastatic non-squamous non-small cell lung cancer (NSCLC) whose disease progressed despite treatment with pembrolizumab and platinum-based chemotherapy. The company also announced plans to submit a Biologics License Application (BLA) for aglatimagene in intermediate- to high-risk localized prostate cancer in the fourth quarter of 2026, with a potential commercial launch in 2027, and appointed a new Chief Commercial Officer.

The global, randomized, open-label AURORA trial is expected to enroll patients with metastatic Stage IV non-squamous NSCLC across approximately 150 sites worldwide, randomized 1:1 to receive either aglatimagene plus valacyclovir for two injection courses with continued pembrolizumab, or standard-of-care docetaxel chemotherapy. The first trial site is activated and open to enrollment. The study's primary endpoint is overall survival, with secondary endpoints including safety and quality-of-life assessments. The U.S. Food and Drug Administration previously granted Fast Track Designation to aglatimagene for the treatment of NSCLC. Candel has engaged Parexel International to support execution of the trial.

The Phase 3 AURORA trial builds on results from the company's Phase 2 clinical trial (NCT04495153), which demonstrated extended long-term survival in patients with advanced NSCLC who had shown an inadequate response to immune checkpoint inhibitors. In that trial, 50% of 46 per-protocol patients survived beyond 24 months despite prior inadequate response to ICI and multiple adverse baseline prognostic factors. Among evaluable patients with non-squamous histology and progressive disease at baseline, median overall survival was 25.4 months.

Candel plans to submit a BLA for aglatimagene in localized prostate cancer in the fourth quarter of 2026, following positive Phase 3 clinical trial results and the FDA's Regenerative Medicine Advanced Therapy designation. Approximately 65,000 patients in the United States are diagnosed each year with intermediate- to high-risk localized prostate cancer and are candidates for radiotherapy-based treatment with curative intent. The company has adopted a partnership-driven commercial model, working with EVERSANA on commercialization and IDEA Pharma on strategic positioning. The new Chief Commercial Officer, who will join on July 6, 2026, will lead Candel's commercial strategy and launch readiness for aglatimagene in intermediate- to high-risk localized prostate cancer.

In connection with the appointment, on July 6, 2026, the Compensation Committee granted the incoming Chief Commercial Officer stock options to purchase an aggregate of 285,000 shares of common stock, with a per share exercise price of $10.03, under the company's 2025 Inducement Plan. The options will vest 25% on the first anniversary of the start date and 75% in 36 equal monthly installments. In a separate grant on June 30, 2026, the company granted one new employee stock options to purchase 25,000 shares at an exercise price of $10.30, under the same vesting schedule.

Candel is a clinical-stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies. Aglatimagene, the lead product candidate from its adenovirus platform, has also completed successful Phase 2a clinical trials in NSCLC and pancreatic ductal adenocarcinoma, and a pivotal, placebo-controlled Phase 3 clinical trial in localized prostate cancer, conducted under a Special Protocol Assessment agreed with the FDA and published in The Lancet Oncology. The FDA has granted Fast Track and Regenerative Medicine Advanced Therapy Designations for aglatimagene in newly diagnosed localized prostate cancer, Fast Track Designation in NSCLC, and both Fast Track and Orphan Drug Designations in PDAC. Linoserpaturev, the lead candidate from the HSV platform, is in an ongoing Phase 1b clinical trial in recurrent high-grade glioma, with initial results published in Nature and Science Translational Medicine and Fast Track and Orphan Drug Designations from the FDA.

Candel will present at Canaccord Genuity's 46th Annual Growth Conference on August 12, 2026 at 12 PM EDT in Boston.