On June 13, 2023 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing viral immunotherapies to help patients fight cancer, reported that, in the second quarter of 2024, it expects to report topline overall survival data from its ongoing, open-label, phase 2 clinical trial of CAN-2409 plus valacyclovir in combination with continued immune checkpoint inhibitor treatment (ICI) in patients with non-resectable, stage III/IV non-small cell lung cancer (NSCLC) who progressed while on treatment with PD-(L)1 ienhibitor therapy (Cohort 2) (Press release, Candel Therapeutics, JUN 13, 2023, View Source [SID1234632650]).

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"As we approach full enrollment of a cohort of approximately 40 patients with documented radiographic progression on PD-(L)1 inhibitor treatment, we expect that we will be able to report topline overall survival data for this cohort in the second quarter of 2024," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. "In conjunction with this topline data, we will assess whether the effect on tumor biology previously reported could translate into improved survival, which we believe is what matters to patients and regulators. We remain optimistic that this expected dataset could help initiate discussions with regulators about a future potentially registrational clinical trial in this indication of serious unmet disease."

Dr. Tak continued, "In the near-term, we continue to expect to present additional clinical and immunological biomarker activity data from this clinical trial in the third quarter of this year. To date, we have reported mechanistic evidence that CAN-2409 plus valacyclovir can induce a systemic anti-tumor response in ICI inadequate responders, which had shown improvement of injected and uninjected tumor size and an overall beneficial effect on tumor growth over time."

In 2022, the Company presented preliminary evidence that CAN-2409 plus valacyclovir, when added to first line PD-(L)1 inhibitor therapy, in late-stage NSCLC patients showing

radiographic progression despite at least 18 weeks of ICI treatment, is able to 1) induce local and systemic reduction in the size of tumor lesions, with an abscopal effect in uninjected lesions (Aggarwal C et al. J Clin Oncol 2022;40(16) Suppl:9037 [ASCO abstract]), and 2) change the tumor growth trajectory after follow up, and significantly decrease the monthly rate of tumor growth (Aggarwal C et al. Virtual R&D Day, December 2022). These data supported the application for Fast Track designation, granted by the U.S. Food and Drug Administration for this program in April 2023. The Company remains on target to present additional clinical and immunological biomarker activity data in the third quarter of 2023. Based on enrollment rates and duration of follow-up in Cohort 2, the Company expects to present top line data for overall survival in this Cohort, a key clinical endpoint of interest to regulatory bodies in this patient population, in the second quarter of 2024.

CAN-2409 is an investigational off-the-shelf viral immunotherapy designed to induce an individualized, systemic immune response against the patient’s specific tumor. CAN-2409 plus valacyclovir in combination with continued PD-(L)1 inhibitors is being evaluated in an ongoing, open-label phase 2 clinical trial (NCT04495153) in patients with non-resectable, stage III/IV NSCLC and an inadequate response to ICI treatment.