Candel Therapeutics Reports Both Prolonged Median Overall Survival and Long Tail of Survival in Phase 2a Clinical Trial of CAN-2409 in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Non-Responsive to Immune Checkpoint Inhibitor (ICI) Treatment

• Experimental treatment with CAN-2409 was associated with a median overall survival (mOS) of 24.5 months in patients with advanced NSCLC who had an inadequate response to ICI treatment, failed several chemotherapy regimens, and presented with multiple negative prognostic factors at enrollment (90% of the patients had stage IV disease, most patients had low or undetectable PDL-1 expression, > 90% were current or former smokers, and most patients had failed multiple lines of chemotherapy)
• mOS of 21.5 months was observed in patients with progressive disease at baseline despite ICI therapy (cohort 2), markedly exceeding mOS which has been reported in published literature for this population with standard of care of docetaxel chemotherapy (mOS of 9.8-11.8 months)
• Long tail of survival observed in 37% (15/41) of patients with progressive disease despite ICI treatment at enrollment, who were still alive more than 2 years after CAN-2409 administration at the time of data cutoff (March 3, 2025)
• Evidence of a systemic immune response with regression of both injected and uninjected lesions observed in approximately two-thirds of patients with metastatic disease and at least one uninjected tumor (abscopal effect)

• Statistically significant improved overall survival in non-squamous NSCLC compared to squamous NSCLC after experimental treatment with CAN-2409, supported by immunological biomarker data; mOS of 25.4 months in per protocol population of patients with non-squamous NSCLC with progressive disease at baseline despite ICI
• CAN-2409 continued to exhibit a generally favorable safety and tolerability profile throughout the extended follow-up period, with no new safety signals identified

Excerpt from the Press Release:

NEEDHAM, Mass., March 26, 2025 (GLOBE NEWSWIRE) — Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced final survival data from a phase 2a clinical trial of CAN-2409 in patients with stage III/IV NSCLC, inadequately responding to ICI treatment. mOS was 24.5 months in 46 evaluable patients receiving 2 courses of CAN-2409 (per protocol population; cohort 1 and 2) and 21.5 months in evaluable patients from cohort 2 (n=41) that presented with progressive disease at baseline, despite ICI treatment. mOS in patients with progressive disease despite ICI treatment, was 9.8-11.8 months in other studies, including those with standard of care of docetaxel chemotherapy, which has a very poor prognosis, did not exceed 12 months in other published studies.^{(1, 2)} This final analysis included extended follow-up data (1 year after the previous data cut) with a median follow up time for the per protocol population of 32.4 months. Data showed a sizable percentage of patients with survival exceeding 24 months, evidence of a long tail of survival, with 37% of patients with progressive disease despite treatment with ICI alive 2 years after CAN-2409 administration.

Biomarker research showed an enhanced immunological and clinical response after CAN-2409 administration in patients with non-squamous histology compared to squamous histology, and improved mOS was observed in this population (25.4 months in patients with progressive disease despite ICI treatment and non-squamous NSCLC, n=33).

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