Core Insights - Candel Therapeutics, Inc. will host a virtual Research and Development (R&D) Event on December 5, 2025, focusing on its viral immunotherapy approach and oncology pipeline [1][2] Company Overview - Candel Therapeutics is a clinical-stage biopharmaceutical company developing multimodal biological immunotherapies aimed at eliciting systemic anti-tumor immune responses [11][12] - The company has two clinical-stage platforms based on genetically modified adenovirus and HSV gene constructs, with CAN-2409 as the lead candidate from the adenovirus platform [12][13] R&D Event Details - The R&D Day will feature presentations from executive leadership, clinical investigators, and scientific advisors, providing an overview of the company's pipeline [2] - Key presentations will include an introduction by Paul Peter Tak, CEO, and discussions on immuno-oncology innovations [2][3] Product Candidates - CAN-2409 is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the HSV-tk gene to tumors, showing potential for treating a broad range of solid tumors [9] - More than 1,000 patients have been dosed with CAN-2409 in clinical trials, demonstrating a favorable tolerability profile [9][12] - CAN-3110 is a first-in-class, replication-competent HSV-1 oncolytic viral immunotherapy candidate, currently in a phase 1b clinical trial for recurrent high-grade glioma [10][13] Clinical Trials and Regulatory Designations - Candel has completed successful phase 2a trials for CAN-2409 in non-small cell lung cancer and pancreatic ductal adenocarcinoma, and a pivotal phase 3 trial in localized prostate cancer [12] - The FDA has granted Fast Track and Regenerative Medicine Advanced Therapy Designations to CAN-2409 for various cancer treatments [12]

Core Insights - Candel Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies for cancer treatment [3][4] - The company will present at the Jefferies Global Healthcare Conference on November 18, 2025 [1][2] Company Overview - Candel specializes in off-the-shelf, multimodal viral immunotherapies that aim to elicit individualized, systemic anti-tumor immune responses [3] - The company has two clinical-stage platforms based on genetically modified adenovirus and herpes simplex virus (HSV) [3] Clinical Trials and Designations - Candel has completed successful phase 2a clinical trials for its lead product candidate CAN-2409 in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC) [4] - CAN-2409 has received Fast Track Designation from the FDA for treating PDAC and stage III/IV NSCLC in specific patient populations [4] - The FDA has also granted Regenerative Medicine Advanced Therapy (RMAT) Designation and Orphan Drug Designation to CAN-2409 for localized prostate cancer and PDAC, respectively [4] Additional Product Candidates - CAN-3110, the lead candidate from the HSV platform, is currently in a phase 1b clinical trial for recurrent high-grade glioma and has received Fast Track and Orphan Drug Designations from the FDA [5] - Candel's enLIGHTEN™ Discovery Platform is designed to create new viral immunotherapies for solid tumors using advanced analytics [5]

Core Insights - Candel Therapeutics has appointed Dr. Bali Pulendran to its Research Advisory Board, enhancing its expertise in systems immunology and vaccinology as it advances its viral immunotherapy candidates [1][2][3] Company Overview - Candel Therapeutics is a clinical-stage biopharmaceutical company focused on developing multimodal viral immunotherapies to elicit systemic anti-tumor immune responses [4] - The company has established two clinical-stage platforms based on genetically modified adenovirus and herpes simplex virus (HSV) gene constructs [4] Product Development - Candel's lead product candidate, CAN-2409, has completed successful phase 2a clinical trials in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC) [5] - A pivotal phase 3 clinical trial of CAN-2409 in localized prostate cancer is underway, conducted under a Special Protocol Assessment (SPA) with the FDA [5] - CAN-2409 has received Fast Track Designation from the FDA for multiple indications, including PDAC and stage III/IV NSCLC [5] - CAN-3110, the lead candidate from the HSV platform, is currently in a phase 1b clinical trial for recurrent high-grade glioma and has also received Fast Track and Orphan Drug Designations from the FDA [6] Research and Development - Dr. Pulendran's expertise is expected to provide valuable insights into the immune system's response to therapies, aiding in the advancement of CAN-2409 and CAN-3110 [2][3] - Candel's enLIGHTEN™ Discovery Platform leverages human biology and advanced analytics to create new viral immunotherapies for solid tumors [6]

Core Insights - Candel Therapeutics announced promising interim data from its phase 1b clinical trial of CAN-3110 in recurrent glioblastoma, along with a publication in a high-impact journal [1][2] Clinical Trial Findings - The publication details findings from 97 tumor biopsies from two patients, revealing a discordance between immune biomarkers and imaging results, indicating that conventional imaging may misinterpret immune infiltration as disease progression [3][5] - CAN-3110 induced significant changes in the tumor microenvironment, with one patient achieving a complete pathological response [3][4] - The study identified T cell clonotypes targeting CAN-3110 epitopes, supporting the dual mechanism of action of the therapy [4][5] Survival Data - Updated median overall survival (mOS) was reported as 11.8 months for arm A and 12.0 months for arm B, with some patients surviving significantly longer [5][6] - In arm C, 9 patients received multiple administrations of CAN-3110, with a median follow-up of 8.9 months; 4 out of 9 patients were alive at the time of data cutoff [6] Future Directions - The company plans to design a small phase 2 clinical trial for CAN-3110 in recurrent glioblastoma, collaborating with the glioblastoma community and regulators [8] - CAN-3110 has received FDA Fast Track and Orphan Drug Designations, indicating its potential as a treatment for recurrent high-grade glioma [8][11] Company Overview - Candel Therapeutics focuses on developing multimodal biological immunotherapies, with CAN-3110 being a first-in-class oncolytic viral immunotherapy candidate [9][10] - The company has established platforms based on genetically modified adenovirus and herpes simplex virus, with ongoing clinical trials for other product candidates [10][11]