Candel Therapeutics Extends Aglatimagene Study Follow-Up to 12 Months

Candel Therapeutics announced an additional 12 months of extended follow-up from its study of aglatimagene plus valacyclovir in combination with continued ICI therapy in patients with advanced NSCLC who had an inadequate response to prior ICI treatment. Among the 46 patients who received two administrations of aglatimagene, 23 patients - 50% - remained alive at 24 months. Additionally, 16 patients - 35% - survived beyond 30 months, 12 patients - 26% - survived beyond 36 months, 11 patients - 24% - survived beyond 40 months, and 6 patients - 13% - exceeded 50 months of survival. These outcomes represent an improvement from the prior data cut, in which 39% of the patients in the per-protocol population were alive at 24 months. Among evaluable patients surviving beyond 24 months and with PD-L1 status available, 85% had baseline PD-L1 TPS below 50%, a population typically less responsive to ICI. These findings highlight the ability of aglatimagene to convert immunologically "cold," ICI-resistant tumors into immune-active microenvironments. Long-term survivors exhibited robust upregulation of genes associated with sustained immune activation and antigen presentation. These findings reflect increased local inflammation and recruitment of immune effector populations within the tumor microenvironment following aglatimagene treatment and may have contributed to the durable anti-tumor immune responses observed in long-term survivors. The company plans to advance this program into a pivotal phase 3 clinical trial in patients with NSCLC with non-squamous histology, with trial initiation expected in Q2. The FDA has previously granted Fast Track designation for aglatimagene plus valacyclovir in combination with ICI therapy for the treatment of patients with stage III/IV NSCLC who are resistant to first-line PD-(L)1 inhibitor therapy and who do not harbor activating molecular driver mutations, or who have progressed on directed molecular therapy.