Core Insights - CAN-2409 demonstrated improved disease-free survival in patients with intermediate-to-high-risk localized prostate cancer compared to placebo, regardless of the radiation therapy modality used [1][2][5] - The study represents the first significant advancement in localized, non-metastatic prostate cancer treatment in over 20 years [2][5] Clinical Trial Details - The phase 3 clinical trial (NCT01436968) enrolled 745 patients, randomized 2:1 to receive either CAN-2409 plus valacyclovir with standard care or standard care alone [2] - The trial achieved a 30% improvement in disease-free survival (HR 0.7, p=0.0155) and a 38% improvement in prostate cancer-specific disease-free survival (HR 0.62, p=0.0046) [2] - At two years, the pathological complete response rates were 80.4% in the treatment group compared to 63.6% in the control group (p=0.0015) [2] Efficacy and Safety - CAN-2409's efficacy was maintained across different radiation modalities, including moderate hypofractionated radiation, which is more convenient for patients [4][5] - Safety profiles were similar between treatment and control groups, with grade ≥ 3 treatment-related adverse events being comparable [6] Regulatory and Development Plans - The company plans to submit a Biologics License Application for CAN-2409 in Q4 2026 [5] - CAN-2409 has received various designations from the FDA, including Regenerative Medicine Advanced Therapy Designation and Fast Track Designation for multiple cancer types [8]

Core Viewpoint - Candel Therapeutics has received Orphan Designation from the European Medicines Agency (EMA) for its investigational drug CAN-2409 for the treatment of pancreatic cancer, complementing its existing FDA designations, highlighting the significant unmet medical need in this area [1][5]. Group 1: Regulatory Designations - CAN-2409 has received Orphan Drug Designation and Fast Track Designation from the FDA for pancreatic ductal adenocarcinoma (PDAC) [1][5]. - The EMA's Orphan Designation provides benefits such as reduced regulatory fees, clinical protocol assistance, and up to 10 years of market exclusivity in the EU if approved [4]. Group 2: Clinical Trial Results - In a phase 2a clinical trial, CAN-2409 plus valacyclovir showed a median overall survival (OS) of 31.4 months compared to 12.5 months in the control arm, indicating significant survival benefits [3]. - Three out of seven patients treated with CAN-2409 were alive at the data cut-off, with survival times of 66.0, 63.6, and 35.8 months, suggesting a long tail of survival [3]. Group 3: Mechanism of Action - CAN-2409 is a replication-defective adenovirus designed to deliver the HSV-tk gene to tumor cells, leading to immunogenic cell death and the release of tumor antigens [2][6]. - The treatment aims to induce a systemic immune response against multiple therapy-resistant solid tumors, including prostate cancer and non-small cell lung cancer (NSCLC) [2][7]. Group 4: Company Overview - Candel Therapeutics focuses on developing off-the-shelf multimodal biological immunotherapies to elicit individualized anti-tumor immune responses [8]. - The company has established two clinical-stage platforms based on genetically modified adenovirus and HSV gene constructs, with CAN-2409 being the lead candidate from the adenovirus platform [8].