Summary of Candel Therapeutics Conference Call Company Overview - Candel Therapeutics (CADL) is a clinical-stage biotech company focused on developing viral immunotherapy for difficult-to-treat cancers, utilizing two main platforms: HSV and adenoviral [1] Key Assets and Development Pipeline - The most advanced asset is CAN2409, an adenoviral platform targeting prostate cancer, with positive Phase 3 data recently unveiled and a BLA submission expected by the end of 2026 [2] - CAN2409 is also in development for non-small cell lung cancer (NSCLC) and pancreatic cancer, with fast track designation for all indications [3] - Another asset, CAN310, is a classical oncolytic virus in development for recurrent high-grade glioma [3] Clinical Data and Efficacy - CAN2409 has been administered to over 1,000 patients and shows synergy with radiation therapy, particularly in prostate cancer [4][5] - In NSCLC, a significant reduction of nearly 50% in tumor volume was observed in treated patients [6] - In recurrent high-grade glioma, median overall survival of at least 12 months was achieved with a single injection, compared to a median survival of 6-9 months in untreated patients [7] Discovery Platform - The Enlighten platform utilizes AI for data mining to design viral immunotherapies, aiming to combine with checkpoint inhibitors or cellular therapies for challenging cancers [7] Prostate Cancer Opportunity - Prostate cancer represents a multi-billion dollar opportunity due to the high prevalence and unmet medical need, especially in localized cases [11] - The trial included 745 patients, showing a 30% reduction in disease recurrence or death compared to placebo [14] - Significant effects on PSA levels, a key biomarker for recurrence, were noted, with a higher percentage of patients achieving pathological complete response [15] Safety and Tolerability - CAN2409 demonstrated a favorable safety profile, comparable to a prostate biopsy, with good tolerability among patients [15] Future Plans and Financials - Candel is ramping up CMC activities in preparation for commercial launch and is engaging with KOLs and medical affairs [16] - The company reported cash and cash equivalents of $92 million as of December, sufficient to support BLA submission in 2026 [22] Additional Insights - The pancreatic cancer trial indicated a significant improvement in median overall survival, with ongoing plans for a larger Phase 2 trial [17] - In lung cancer, adding CAN2409 to treatment for patients not responding to checkpoint inhibitors resulted in a median overall survival of 21 months, doubling expectations [20] Leadership and Achievements - The leadership team has extensive experience in drug development, and the company has exceeded its previous clinical milestones [21] Regulatory Engagement - Continuous discussions with the FDA regarding the BLA submission process are ongoing, focusing on CMC manufacturing and clinical package preparation [23][24]
Candel Therapeutics (CADL) 2025 Conference Transcript