Candel Therapeutics Starts Pivotal Phase 3 AURORA Study Of Aglatimagene Besadenovec Plus Valacyclovir In Combination With Continued Pembroli

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.