• Initial data suggests 12-month survival is consistent with an increased tail on the maturing survival curve
• Negative or low PD-L1 status appears to be associated with long survival in CAN-2409 treated patients
• Biomarker data suggests association between immune cell activation and survival
• Topline overall survival data expected in Q2 2024

NEEDHAM, Mass., Sept. 26, 2023 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc.(Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing viral immunotherapies to help patients fight cancer, today announced updated activity data from its ongoing, open-label, phase 2 clinical trial of CAN-2409 plus valacyclovir in combination with continued immune checkpoint inhibitor (ICI) treatment in patients with non-resectable, stage III/IV non-small cell lung cancer (NSCLC), who have an inadequate response to front line anti-PD(L)1 therapy. These patients historically have had an expected median overall survival of 10-13 months (Reckamp K et al. J Clin Onc 2022;40:2295-2306). The aim of the CAN-2409 immunotherapy antitumor strategy is to raise the tail on the survival curve by increasing the number of long survivors beyond 10-13 months.

In 2022, the Company presented data from this phase 2 clinical trial where patients who received two administrations of CAN-2409 plus prodrug demonstrated: 1) increased infiltration of CD8+ cytotoxic T cells in the tumor microenvironment, systemic expansion of effector T cells and increased soluble granzyme B levels in peripheral blood, 2) favorable changes in the trajectory of tumor progression, 3) decreased tumor size of target lesions in most patients, and 4) reduced size of uninjected tumor lesions (Aggarwal C et al. Abstract #9037 ASCO June 2022 and Aggarwal C et al. Candel Virtual R&D Day, December 2022). These data were further confirmed in the current update.

Highlights as of August 1, 2023 data cutoff, include:

• As of data cutoff (August 1, 2023), 40 patients across Cohort 1 (stable disease at enrollment; n=5) and Cohort 2 (progressive disease at enrollment; n=35) were evaluable, as they received two courses of CAN-2409 + valacyclovir and completed the 12-week treatment window.
• While overall survival is not yet mature, Candel has observed an encouraging number of long survivors, which the Company believes that CAN-2409 may induce a new state of functional immunosurveillance and durable disease control in a subset of the patients.
  • Of the 40 evaluable patients, 15 patients have lived ≥ 12 months; of these, 10 patients have lived > 18 months, of whom 70% (7/10) were alive as of last follow up. All 4 patients (100%) with OS > 24 months were alive at last follow up, with the longest reaching 31.7 months (data cutoff August 1, 2023).
  • An additional 18 out of the 40 evaluable patients are also alive but have not yet reached 12 months of follow up.
• Notably, many patients treated with CAN-2409 have had long survival (≥ 12 months) despite having disease features generally associated with advanced disease and reduced likelihood to benefit from ICI therapy, such as low or negative PD-L1 expression, including:
  • Amongst patients alive ≥ 12 months with known PD-L1 status (14/15), 93% had negative or low PD-L1 score (