Candel Therapeutics announced promising Phase 1b clinical trial results for CAN-2409 combined with nivolumab and standard care in newly diagnosed high-grade glioma patients. The study, published in •Neuro-Oncology•, showed a tolerable safety profile and potential survival benefits, particularly in a subset of patients. The trial investigated the combination therapy’s efficacy and explored biomarkers associated with immune response and survival.

This research is important because high-grade glioma, particularly glioblastoma, carries a poor prognosis despite existing treatments. Current immunotherapies have shown limited success in this aggressive cancer type. The positive findings from this study offer a potential new avenue for improving outcomes in a patient population with significant unmet medical needs. The identified biomarkers could help personalize treatment strategies and identify patients most likely to benefit from this combination therapy.

The Phase 1b trial enrolled 41 patients, 35 of whom completed the treatment regimen. Median overall survival was 15.1 months, but a subset of patients with methylated MGMT promoter and gross total tumor resection demonstrated a median overall survival of 30.6 months. Biomarker analysis revealed correlations between baseline tumor immune cell composition and survival, as well as systemic immune activation at specific time points post-treatment. Increases in T cell receptor density and richness were observed after CAN-2409 treatment but before nivolumab initiation, suggesting the potential of CAN-2409 to enhance immune response.

While Candel is currently prioritizing CAN-3110 for recurrent high-grade glioma, the positive results from this CAN-2409 study suggest its potential as a broader anti-cancer therapy across multiple tumor types. The data reinforce the possibility of developing personalized treatment approaches based on individual immune profiles, and further investigation in larger trials may validate these findings and pave the way for improved treatment options for high-grade glioma patients.

Source link: https://www.globenewswire.com/news-release/2025/04/01/3053320/0/en/Candel-Therapeutics-Announces-Publication-of-Phase-1b-Clinical-Trial-Data-on-the-Combination-of-CAN-2409-and-Nivolumab-plus-Standard-of-Care-in-Newly-Diagnosed-High-Grade-Glioma-Pa.html

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Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.