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Candel Therapeutics Announces It Expects to Report Topline Data from its Phase 2 Clinical Trial of CAN-2409 in Non-Small Cell Lung Cancer in the Second Quarter of 2024
Based on forthcoming completion of patient enrollment and duration of follow-up in Cohort 2 from the phase 2 trial in late-stage NSCLC NEEDHAM, Mass., June
About this update from Candel Therapeutics, Inc.
[{"type":"text","content":"Based on forthcoming completion of patient enrollment and duration of follow-up in Cohort 2 from the phase 2 trial in late-stage NSCLC NEEDHAM, Mass., June 13, 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 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 inhibitor therapy (Cohort 2). “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 ...