On June 30, 2026 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, reported 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.
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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., Deputy Director and Chief of Medical Oncology and Hematology at Yale Cancer Center and co-Principal Investigator of AURORA. "The survival results observed with aglatimagene in the phase 2 trial are particularly encouraging and support advancing the program into the pivotal phase 3 AURORA trial."
"The initiation of this first global phase 3 trial of a viral immunotherapy at NYU Langone Health marks an important milestone in advancing aglatimagene as a potentially first-in-class immunotherapy for patients with NSCLC," said Daniel Sterman, M.D., Thomas and Suzanne Murphy Professor of Medicine and Cardiothoracic Surgery at NYU Langone Health and co-Principal Investigator. Charu Aggarwal, M.D., M.P.H., Leslye M. Heisler Professor of Medicine at the University of Pennsylvania’s Perelman School of Medicine; Section Chief, Thoracic and Head & Neck Cancer; and Director of the Penn Center for Cancer Care Innovation at the University of Pennsylvania is also a co-Principal Investigator on AURORA.
The phase 3 AURORA trial builds on encouraging 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 (ICI). 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 despite prior ICI (intended patient population of the phase 3 trial), median overall survival was 25.4 months.
"This is a pivotal moment for Candel and, most importantly, for the patients we aim to serve," said Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel. "Disease progression following ICI therapy remains associated with poor survival outcomes and a substantial unmet medical need. Building on our completed phase 2 clinical trial, we have refined the target patient population by integrating clinical and biomarker insights to maximize the likelihood of success of the phase 3 trial. Our data suggest that aglatimagene may offer a novel approach by inducing an individualized, systemic anti-tumor immune response in patients who have very limited therapeutic options."
Lung cancer is the leading cause of cancer death in the United States, and NSCLC represents approximately 77% of all lung cancer cases.1 Despite widespread use of ICI as first-line treatment for patients without actionable mutations, approximately 60% of patients experience disease progression within one year.2 These patients face limited therapeutic options, with docetaxel remaining the current standard of care and delivering a median overall survival of just 9.8 to 11.8 months.3,4
About aglatimagene besadenovec (CAN-2409)
Aglatimagene besadenovec, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid proteins promote inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. Aglatimagene has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with aglatimagene in clinical trials with a favorable tolerability profile to date, supporting the potential for use with standard of care, when indicated. Aglatimagene is currently not approved by the FDA or any other regulatory authority for any use.
(Press release, Candel Therapeutics, JUN 30, 2026, View Source [SID1234669016])