NEEDHAM, Mass., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced the appointment of Carl H. June, M.D., to Candel’s Research Advisory Board (RAB). Dr. June, an internationally recognized expert in cancer immunotherapy, and a pioneer in developing the first U.S. Food and Drug Administration (FDA)-approved CAR- ...

Core Viewpoint - Candel Therapeutics, Inc. is actively engaging with investors through participation in multiple upcoming conferences, highlighting its focus on developing innovative immunotherapies for cancer treatment [1][2]. Group 1: Company Overview - Candel Therapeutics is a clinical-stage biopharmaceutical company dedicated to creating off-the-shelf multimodal biological immunotherapies aimed at eliciting systemic anti-tumor immune responses [3]. - The company has developed two clinical-stage platforms based on genetically modified adenovirus and herpes simplex virus (HSV) gene constructs [3]. Group 2: Product Development - Candel's lead product candidate, CAN-2409, has successfully completed phase 2a clinical trials for non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), and is undergoing a pivotal phase 3 trial for localized prostate cancer [4]. - CAN-2409 has received several designations from the FDA, including Regenerative Medicine Advanced Therapy Designation for localized prostate cancer, and Fast Track Designation for both NSCLC and prostate cancer [4]. - The second lead product candidate, CAN-3110, is currently in a phase 1b clinical trial for recurrent high-grade glioma (rHGG) and has also received Fast Track and Orphan Drug Designations from the FDA [5]. Group 3: Upcoming Events - Candel Therapeutics will participate in the following investor conferences: - Citi's 2025 Biopharma Back to School Conference on September 3, 2025, at 9:00 AM ET [2]. - Cantor Global Healthcare Conference on September 4, 2025, at 8:00 AM ET [2]. - H.C. Wainwright 27th Annual Global Investment Conference on September 5, 2025, at 7:00 AM ET [2]. - Live webcasts of these presentations will be available and archived for up to 90 days [2].

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 Canaccord Genuity 45th Annual Growth Conference from August 12-14, 2025 [1][2] Company Overview - Candel Therapeutics specializes in off-the-shelf multimodal biological 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] Product Development - CAN-2409 is the lead product candidate from the adenovirus platform, which has completed successful phase 2a trials in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC) [4] - A pivotal phase 3 trial of CAN-2409 in localized prostate cancer has been conducted under a Special Protocol Assessment (SPA) with the FDA, and it received Regenerative Medicine Advanced Therapy (RMAT) Designation in May 2025 [4] - CAN-3110 is the lead candidate from the HSV platform, currently in a phase 1b trial for recurrent high-grade glioma (rHGG), and has received Fast Track and Orphan Drug Designations from the FDA [5] Discovery Platform - Candel's enLIGHTEN™ Discovery Platform utilizes human biology and advanced analytics to develop new viral immunotherapies for solid tumors [5]

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].

Core Insights - Candel Therapeutics, Inc. has been added to multiple Russell indexes as part of the 2025 Russell US Indexes annual reconstitution, effective June 30, 2025, which reflects the company's progress in clinical programs and discovery efforts in cancer immunotherapy [1][2][3] Company Overview - Candel is a clinical-stage biopharmaceutical company focused on developing multimodal biological 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] Clinical 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 ongoing under a Special Protocol Assessment (SPA) with the FDA [5] - CAN-2409 has received Fast Track Designation from the FDA for multiple indications, including treatment-resistant PDAC and localized prostate cancer [5] Strategic Importance of Index Inclusion - Inclusion in the Russell Value indexes is expected to enhance Candel's engagement with the investment community and support its pre-commercialization efforts for CAN-2409 [3] - Russell indexes are widely utilized by investment managers and institutional investors, with approximately $10.6 trillion in assets benchmarked against them [3] Future Prospects - The company is preparing for a potential submission of a Biologics License Application for CAN-2409 and continues to advance its innovative immunotherapy platform across various solid tumors [3] - Candel's enLIGHTEN™ Discovery Platform aims to leverage human biology and advanced analytics to create new viral immunotherapies for solid tumors [6]

Core Viewpoint - Candel Therapeutics has appointed Charles Schoch as the permanent Chief Financial Officer after his successful tenure as interim CFO, demonstrating strong financial leadership and guiding the company through significant operational and financial milestones [1][2]. Company Leadership - Charles Schoch has been with Candel since November 2021, serving in various financial roles, including VP of Finance and Corporate Controller, before becoming interim CFO in January 2024 [2][3]. - Under Schoch's leadership, the company raised approximately $86 million following positive phase 3 clinical trial results for CAN-2409 in localized prostate cancer [2]. Financial Management - Schoch has established strong investment banking relationships and has effectively managed capital during a complex market environment, supporting Candel's strategic priorities [2][4]. - The finance function under Schoch oversees financial close processes, internal controls, SEC reporting, financial planning, procurement, payroll, and treasury operations [2]. Clinical Development - Candel is focused on developing multimodal biological immunotherapies, with CAN-2409 as the lead product candidate from its adenovirus platform [5]. - The company has completed successful phase 2a clinical trials for CAN-2409 in non-small cell lung cancer and pancreatic ductal adenocarcinoma, and a pivotal phase 3 trial in localized prostate cancer [6][7]. Regulatory Designations - CAN-2409 has received Fast Track Designation from the FDA for multiple cancer treatments and has also been granted Regenerative Medicine Advanced Therapy Designation for localized prostate cancer [6][7]. - The company is preparing for a Biologics License Application submission for CAN-2409 in localized prostate cancer [2]. Future Outlook - Schoch expressed optimism about Candel's financial foundation and disciplined capital allocation, focusing on sustainable growth and advancing the clinical pipeline [4].

Core Insights - Candel Therapeutics has appointed Dr. Maha Radhakrishnan to its Board of Directors, effective June 4, 2025, to enhance its strategic capabilities as it moves towards Biologics License Application (BLA) submission and commercial development [1][2][4] Company Overview - Candel Therapeutics is a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies aimed at treating cancer [5] - The company has two clinical-stage platforms based on genetically modified adenovirus and herpes simplex virus (HSV) gene constructs [5] Product Development - Candel's lead product candidate, CAN-2409, is being developed for intermediate-to-high-risk prostate cancer, with BLA submission anticipated in Q4 2026 [2][4] - Recent successful phase 2a clinical trials of CAN-2409 were completed in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC) [6] - CAN-2409 has received Fast Track Designation from the FDA for treating PDAC and stage III/IV NSCLC in specific patient populations [6] Leadership Experience - Dr. Radhakrishnan brings over 20 years of experience in product development and commercialization from major biotechnology and pharmaceutical companies [3] - Her previous roles include Senior Vice President and Chief Medical Officer at Biogen and Global Head of Medical at Sanofi [3] Future Outlook - The company aims to leverage Dr. Radhakrishnan's expertise as it prepares for the BLA submission and advances its innovative immunotherapy candidates [2][4]

Core Insights - Candel Therapeutics announced positive phase 3 clinical results for CAN-2409 in localized, intermediate-to-high risk prostate cancer, showing a statistically significant 30% reduction in disease recurrence compared to placebo when combined with standard-of-care radiation therapy [1][10] Company Overview - Candel Therapeutics is a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to combat cancer [11] - 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 [11] Clinical Development - CAN-2409 (aglatimagene besadenovec) is designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to tumors, inducing a systemic immune response against cancer [8] - The investigational therapy has shown encouraging results in monotherapy and combination settings with standard treatments, with over 1,000 patients dosed and a favorable tolerability profile [9][10] - Candel is also evaluating CAN-2409 in non-small cell lung cancer (NSCLC) and borderline resectable pancreatic adenocarcinoma (PDAC) [10] Regulatory Status - CAN-2409 has received Fast Track Designation from the FDA for multiple indications, including PDAC and stage III/IV NSCLC, and has been granted Orphan Drug Designation for PDAC [10] Upcoming Events - Candel will host a webcast and conference call on June 3, 2025, to discuss the phase 3 clinical results and insights from leading prostate cancer specialists [1][5]

Core Viewpoint - Candel Therapeutics, Inc. announced that an abstract for an oral presentation regarding its phase 3 clinical trial of CAN-2409 in localized prostate cancer has been accepted for the 2025 ASCO Annual Meeting, highlighting the company's focus on developing immunotherapies for cancer treatment [1]. Group 1: Clinical Trial and Presentation Details - The oral presentation will feature data from the phase 3 clinical trial of CAN-2409, targeting patients with intermediate-to-high risk localized prostate cancer [1]. - The session is scheduled for June 3, 2025, at the ASCO Annual Meeting in Chicago, IL, with Dr. Theodore DeWeese as the presenter [8]. Group 2: Product Information - CAN-2409 is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the HSV-tk gene to tumors, inducing a systemic immune response against cancer cells [5]. - The therapy has shown promising results in previous trials, including a significant improvement in disease-free survival when combined with standard radiation therapy in localized prostate cancer [6]. Group 3: Clinical Development and Regulatory Designations - Candel's clinical development program for CAN-2409 includes positive phase 2a trials in non-small cell lung cancer and pancreatic ductal adenocarcinoma, as well as a successful phase 3 trial in localized prostate cancer [6][9]. - The FDA has granted Fast Track Designation for CAN-2409 for multiple cancer types, including localized prostate cancer and PDAC, indicating its potential therapeutic significance [9].

Core Insights - Candel Therapeutics announced final survival data from a phase 2a clinical trial of CAN-2409 in patients with stage III/IV non-small cell lung cancer (NSCLC) who inadequately responded to immune checkpoint inhibitor (ICI) treatment, showing a median overall survival (mOS) of 24.5 months in evaluable patients [1][5] - The study demonstrated a significant survival benefit compared to standard treatments, with 37% of patients with progressive disease alive two years after CAN-2409 administration [1][5] - The treatment showed improved mOS in non-squamous NSCLC patients, with a mOS of 25.4 months observed in this subgroup [2][5] Clinical Trial Results - The final analysis included 46 evaluable patients, with a median follow-up time of 32.4 months, revealing a long tail of survival [1][4] - Patients with progressive disease at baseline had a mOS of 21.5 months, significantly exceeding the 9.8-11.8 months reported for standard docetaxel chemotherapy [5][8] - A systemic immune response was observed in approximately two-thirds of patients, indicating an abscopal effect [5][8] Safety and Tolerability - CAN-2409 maintained a favorable safety and tolerability profile throughout the extended follow-up period, with no new safety signals identified [5][8] - Dropout rates during the trial were comparable to other clinical trials in similar populations, indicating the treatment's feasibility [4][6] Future Development - Based on positive findings, Candel plans to advance the development program for CAN-2409, including preparations for a potentially registrational clinical trial in NSCLC patients with non-squamous histology [7][10] - The FDA has granted Fast Track Designation for CAN-2409 in combination with ICI treatment for stage III/IV NSCLC patients resistant to first-line therapy [7][10] About CAN-2409 - CAN-2409 is an investigational, off-the-shelf, replication-defective adenovirus designed to induce a systemic immune response against tumors [8][9] - The treatment has shown encouraging activity in various solid tumors and has been well tolerated in over 1,000 patients [9][11]