Candel Therapeutics Announces Initiation of Global Pivotal Phase 3 AURORA Trial Evaluating Aglatimagene Besadenovec (CAN-2409) in Advanced Non-Small Cell Lung Cancer Patients with Inadequate Response to Immune Checkpoint Inhibitors

About this update from Candel Therapeutics, Inc.

Phase 3 clinical trial will evaluate aglatimagene besadenovec plus valacyclovir in combination with continued pembrolizumab versus standard-of-care docetaxel chemotherapy in patients with metastatic, non-squamous, non-small cell lung cancer (NSCLC) with progressive disease despite prior pembrolizumab and platinum chemotherapyGlobal pivotal phase 3 trial expected to enroll patients in 1:1 randomization across more than 150 sites; first site now open for enrollmentPrimary endpoint is overall survivalCandel has engaged Parexel International to support execution of this global pivotal trial NEEDHAM, Mass., June 30, 2026 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve disease outcomes for patients with cancer, today announced the initiation of the global pivotal phase 3 AURORA trial (NCT07660094), evaluating aglatimagene besadenovec (aglatimagene or CAN-2409) plus valacyclovir in combination with continued pembrolizumab in patients with metastatic non-squamous NSCLC whose disease has progressed despite treatment with pembrolizumab and platinum-based chemotherapy. 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 (NSCLC-SAQ and EORTC QLQ-30). The U.S. Food and Drug Administration (FDA) previously granted Fast Track Designation to aglatimagene for the treatment of NSCLC. To support the efficient global execution of this pivotal trial, Candel has engaged Parexel International, a leading global clinical research organization with extensive experience in oncology and a global network of nearly 2,500 sites. Parexel will provide clinical operations support across the trial's global sites. “Patients whose lung cancer progresses despite immune checkpoint inhibitor therapy have limited treatment options, and outcomes with standard chemotherapy remain poor,” said Roy Herbst, M.D.,...

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