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CADL-News
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Candel Therapeutics Publishes Phase 2a NSCLC Trial Results
Candel Therapeutics announced the publication of final phase 2a clinical trial results of aglatimagene besadenovec plus valacyclovir in patients with stage III/IV NSCLC who had shown inadequate response to ICI. The trial demonstrated a median overall survival, mOS, of 24.5 months in the evaluable population, substantially exceeding historical benchmarks for standard-of-care docetaxel chemotherapy in this patient population. Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel commented, "Aglatimagene's ability to reinvigorate anti-tumor immunity in checkpoint-refractory patients through a systemic immune response, combined with its favorable safety profile, positions this approach as a potentially transformative option for patients with limited therapeutic alternatives. These results support the advancement of our pivotal phase 3 AURORA trial, which is enrolling patients globally."
Candel Therapeutics Announces Novel Immunological Biomarker Data for Prostate Cancer
Candel Therapeutics announced novel immunological biomarker data from the ongoing phase 2 PrTK05 trial in patients with intermediate-risk localized prostate cancer. These data, together with histologic and clinical data from the intermediate-risk prostate cancer subgroup of the PrTK03 phase 3 trial, are expected to be presented at a future scientific meeting. Key highlights: Novel systemic immune data demonstrated T-cell activation following local administration of aglatimagene. Together with recently disclosed evidence of persistent local immune remodeling, these findings provide mechanistic support for the long-term clinical outcomes, including disease-free survival and prolonged time to biochemical failure, time to metastasis, and time to salvage anti-cancer therapy, observed in this patient population; Biodistribution and shedding data from the PrTK05 phase 2 trial remain on track for inclusion in the planned Q4 2026 Biologics License Application submission to the U.S. Food and Drug Administration, FDA, for localized prostate cancer
Candel Therapeutics Presents New Biomarker Data at ASTRO 2026 for Prostate Cancer
Candel Therapeutics announced the presentation of new biomarker data from its completed phase 3 clinical trial of aglatimagene besadenovec in patients with localized intermediate- to high-risk prostate cancer at the American Society for Radiation Oncology, ASTRO, Annual Meeting 2026. Key Highlights from ASTRO 2026 Presentation: The Company previously reported that two years after treatment, 80% of evaluable aglatimagene patients had negative prostate biopsies versus 63% of control patients; Aglatimagene significantly increased overall lymphocytic fraction compared to control, with both arms showing immune activation from radiation therapy; In paired biopsies from patients with residual tumor, aglatimagene significantly increased intratumoral lymphocyte fraction, lymphocyte-tumor enrichment, and lymphocyte-tumor mixing
Candel Therapeutics Publishes Phase 3 Trial Results for Aglatimagene
Candel Therapeutics announced the publication of results from its pivotal Phase 3 trial of Aglatimagene in The Lancet Oncology. The trial, which enrolled 745 patients with intermediate- to high-risk localized prostate cancer, demonstrated a 30% improvement in disease-free survival compared to radiotherapy alone. Candel noted the findings support a planned Biologics License Application submission in Q4 2026. "The publication of this pivotal phase 3 trial in The Lancet Oncology provides important peer-reviewed validation of the significance of these findings for patients with localized prostate cancer," said Paul Peter Tak, president and CEO of Candel.
Candel Therapeutics Extends Aglatimagene Study Follow-Up to 12 Months
Candel Therapeutics announced an additional 12 months of extended follow-up from its study of aglatimagene plus valacyclovir in combination with continued ICI therapy in patients with advanced NSCLC who had an inadequate response to prior ICI treatment. 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. These outcomes represent an improvement from the prior data cut, in which 39% of the patients in the per-protocol population were alive at 24 months. Among evaluable patients surviving beyond 24 months and with PD-L1 status available, 85% had baseline PD-L1 TPS below 50%, a population typically less responsive to ICI. These findings highlight the ability of aglatimagene to convert immunologically "cold," ICI-resistant tumors into immune-active microenvironments. Long-term survivors exhibited robust upregulation of genes associated with sustained immune activation and antigen presentation. These findings reflect increased local inflammation and recruitment of immune effector populations within the tumor microenvironment following aglatimagene treatment and may have contributed to the durable anti-tumor immune responses observed in long-term survivors. The company plans to advance this program into a pivotal phase 3 clinical trial in patients with NSCLC with non-squamous histology, with trial initiation expected in Q2. The FDA has previously granted Fast Track designation for aglatimagene plus valacyclovir in combination with ICI therapy for the treatment of patients with stage III/IV NSCLC who are resistant to first-line PD-(L)1 inhibitor therapy and who do not harbor activating molecular driver mutations, or who have progressed on directed molecular therapy.
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