Candel Therapeutics Reports Extended Survival Tail Observed in Trial of Aglatimagene Besadenovec (CAN-2409) in Advanced Non-Small Cell Lung Cancer Patients with Inadequate Response to Immune Checkpoint Inhibitors

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• The biomarker data presented here reinforces the multimodal anti-tumor activity of aglatimagene. Consistent with its proposed prime-boost mechanism, we observed expansion of T-cell receptor diversity in both tumor tissue and peripheral blood following treatment, reflecting a broadening of the adaptive immune response

  60% confidence

• These outcomes compare favorably with historical reference median overall survival of 9.8–11.8 months reported for patients with progressive disease following ICI treatment receiving standard-of-care docetaxel, representing approximately a two-fold improvement in median overall survival

  60% confidence

• With its differentiated mechanism of action and favorable safety profile observed to date, aglatimagene represents a novel therapeutic approach for solid tumors, with the potential to improve outcomes beyond current standards of care

  60% confidence

• Median overall survival was 25.4 months among 46 evaluable patients in per-protocol population, 21.5 months in cohort 2 with progressive disease at baseline, and 25.4 months in cohort 2 patients with non-squamous histology

  60% confidence

• Similar TCR repertoire expansion was previously reported in patients with glioblastoma treated with aglatimagene, supporting a consistent immunologic signature across tumor types

  60% confidence

• More than 1,000 patients have been dosed with aglatimagene in clinical trials with a favorable tolerability profile to date

  60% confidence

• These updated survival data further strengthen our previously reported findings, demonstrating the potential of aglatimagene to meaningfully extend survival for patients with advanced NSCLC who have limited treatment options after failing to respond to, or progressing despite, ICI therapy

  60% confidence

• Among evaluable patients surviving beyond 24 months and with PD-L1 status available, 85% (17/20) had baseline PD-L1 TPS below 50%, a population typically less responsive to ICI

  60% confidence

• Long-term survivors exhibited enhanced interferon signaling and activation of myeloid and antigen-presenting cell programs, with significant increases in expression of IFNγ, CSF1, CX3CL1, and IL1β

  60% confidence

• 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

  60% confidence