ProstAtak (aglatimagene besadenovec) / Candel Therap - LARVOL DELTA

Digital Pathology in Relation to Immune Activation Following Aglatimagene Besadenovec Immunotherapy in Localized Prostate Cancer (ASTRO 2026) - "These findings show that adding aglatimagene to standard-of-care EBRT increases intratumoral lymphocyte infiltration and remodels the TME beyond EBRT alone. This immune signature, detected even in tumor-positive biopsies, supports the hypothesis that aglatimagene contributes to local tumor control through sustained immune surveillance and continued lymphocyte engagement with tumor cells. 1) DeWeese et al."

Digital Pathology • Late-breaking abstract • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Overall survival after treatment with CAN-2409 plus valacyclovir in combination with continued ICI in patients with stage III/IV NSCLC with an inadequate response to ICI. (ASCO 2024) - P2 | "Baseline treated pt median age was 67 [43-88] yrs, 44% female, 68% on aPD(L)1 alone and 32% aPD(L)1 + pemetrexed regimen. Experimental treatment with CAN-2409+valacyclovir in NSCLC pts following an inadequate response to ICI is well tolerated and results in the induction of a cytotoxic and memory circulating T cell response associated with shrinkage of injected and uninjected lesions and a raised tail of the survival curve. mOS of the evaluable population was estimated as 22.0m, markedly longer than the expected mOS of 11.6-14.5m."

Clinical • Combination therapy • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD4 • CD8 • GZMB • IFNG

P2s: Practice-changing, Paradigm-shifting Clinical Trials in Urology: Extended follow-up shows accumulating benefit for patients treated with CAN-2409+prodrug in combination with standard of care external beam radiation (EBRT) in men with localized prosta (AUA 2026) - P3 | "Aglatimagene, a replication-defective adenovirus encoding HSV-tk, combined with valacyclovir (prodrug), induces immunogenic cell death. Aglatimagene significantly improved PCa-specific DFS when added to SoC EBRT±ADT. Further exploratory analyses after extended follow-up show accumulating benefit for PCa-specific clinical outcomes. If approved, aglatimagene could represent a new therapy for pts treated with EBRT with curative intent for localized PCa."

Clinical • Combination therapy • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urology

Neoadjuvant CAN-2409+Prodrug plus chemoradiation for borderline resectable or locally advanced non-metastatic pancreatic adenocarcinoma (PDAC) (SITC 2023) - "CAN-2409+prodrug reduced CA19–9 levels, suggesting an effect on tumor volume consistent with CAN-2409’s mechanism of action. Biomarker analysis demonstrated systemic activation of the immune response."

Clinical • Metastases • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • CA 19-9 • CD8 • IFNG • IL10

Aglatimagene besadenovec (CAN-2409) with radiotherapy for patients with localised prostate cancer: a phase 3, multicentre, randomised, double-blind, placebo-controlled trial. (PubMed, Lancet Oncol) - P3 | "Aglatimagene plus valacyclovir was associated with longer disease-free survival than placebo plus valacyclovir when added to standard of radiotherapy for the treatment of localised prostate cancer, offering a meaningful benefit without increasing clinically significant toxicity."

Journal • P3 data • Acute Kidney Injury • Dermatology • Genito-urinary Cancer • Infectious Disease • Influenza • Nephrology • Oncology • Prostate Cancer • Renal Disease • Respiratory Diseases • Solid Tumor

Phase 3, randomized, placebo-controlled clinical trial of CAN-2409+prodrug in combination with standard of care external beam radiation (EBRT) for newly diagnosed localized prostate cancer. (ASCO 2025) - P3 | "CAN-2409 is a replication-defective adenovirus encoding the HSV-tk gene that, when combined with valacyclovir (prodrug), results in immunogenic cell death. In this randomized, double-blind, Phase 3 trial, CAN-2409 significantly reduced the risk of PrCa recurrence or death when added to SoC EBRT+/- ADT. The addition of CAN-2409 was not associated with significant added toxicity. These data represent the first potentially new therapy for patients with intermediate and high risk PrCa in over 20 years."

Clinical • Combination therapy • P3 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Phase 3, Randomized, Placebo Controlled Clinical Trial of CAN-2409+Prodrug in Combination with Standard of Care External Beam Radiation (EBRT) for Newly Diagnosed Localized Prostate Cancer (ASTRO 2025) - P3 | "CAN-2409+prodrug significantly improved DFS by 30% compared to placebo when added to hypofractionated or conventional EBRT +/- ADT, with a good tolerability profile. We observed a significant decrease in tumor presence in post treatment biopsies. This therapeutic regimen may represent the first significant advance for localized PrCa in over 20 years."

Clinical • Combination therapy • P3 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

CAN-2409 With Continued Immune Checkpoint Inhibitor (ICI) in Patients With Stage III/IV NSCLC With Inadequate Response to ICI (IASLC-WCLC 2025) - "Introduction : We previously reported local and systemic immune activation associated with encouraging overall survival (OS) data after two intra-tumoral injections of CAN-2409 plus prodrug (valacyclovir) in patients with unresectable, stage III/IV non-small cell lung cancer (NSCLC), after inadequate response to immune checkpoint inhibitors (ICI). This data supports the rationale for a larger, randomized, controlled clinical trial of CAN-2409 in pts with non-squamous histology with advanced NSCLC, after progression on ICI. treatment."

Checkpoint inhibition • Clinical • IO biomarker • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

First report of safety/tolerability and preliminary antitumor activity of CAN-2409 in inadequate responders to immune checkpoint inhibitors for stage III/IV NSCLC. (ASCO 2022) - P2 | "Two doses of CAN-2409 (5x1011 vp) are given 5-7w apart via bronchoscopic or percutaneous injection into a lung tumor, disease-positive lymph node or peripheral metastasis, followed by valacyclovir...Median age was 70 years; 86% stage IV; 32% squamous; 11% PD-L1 >50%; 82% receiving pembrolizumab and 18% nivolumab... The addition of CAN-2409 for patients with advanced NSCLC and inadequate response to front-line ICI (± chemo) appears to be well tolerated. Preliminary clinical data suggest that CAN-2409 induced a clinical response in 4/14 evaluable patients and produced disease stabilization in most patients entering the trial with PD, with evidence of abscopal effect in a subset of patients."

Checkpoint inhibition • Clinical • IO biomarker • Fatigue • Immune Modulation • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8 • PD-L1

First efficacy and multi-omic analysis data from phase 1 clinical trial of oncolytic viral immunotherapy with CAN-2409 + valacyclovir in combination with nivolumab and standard of care in newly diagnosed high-grade glioma (SITC 2022) - "Additional biomarker analysis and canonical correlation analysis with clinical responses are ongoing. Download figure Open in new tab Download powerpoint Abstract 1477 Figure 1 Schema of treatment and biomarker timepoints Conclusions Combination treatment of CAN-2409/valacyclovir plus nivolumab and SoC induces profound immunological changes and appears to associate with encouraging survival data."

Clinical • Combination therapy • IO biomarker • Late-breaking abstract • Oncolytic virus • P1 data • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor • CCL11 • CCL19 • CD27 • CD40 • CD63 • CD69 • CD8 • CXCL1 • CXCL13 • CXCL9 • GZMA • ICOSLG • IFNG • IL10 • IL5 • IL7 • LAMP3 • TNFRSF9

A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec (clinicaltrials.gov) - P2 | N=45 | Recruiting | Sponsor: Candel Therapeutics, Inc. | Trial completion date: Aug 2026 ➔ Feb 2027 | Trial primary completion date: Aug 2026 ➔ Feb 2027

Biomarker • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Second Quarter 2026 & Recent Highlights (The Manila Times) - "The Company continues to advance its pre-BLA readiness initiative, including its Chemistry, Manufacturing, and Controls (CMC) activities, preparation of clinical study reports, and BLA modules: Process validation campaign for drug substance and drug product is being executed at our contract development and manufacturing organization. The campaign is progressing well and is a critical CMC activity to enable the anticipated BLA submission in Q4 2026; New clinical material has been produced and is intended to be used in the pivotal phase 3 clinical trial of aglatimagene in NSCLC."

FDA filing • Trial status • Lung Non-Squamous Non-Small Cell Cancer • Prostate Cancer

Candel Therapeutics to Present Extended Data from Phase 3 Results of Aglatimagene Besadenovec at ASTRO 2026 (GlobeNewswire)

P3 data • Prostate Cancer

Intraprostatic gene therapy with aglatimagene as an adjunct to radiotherapy (PubMed, Strahlenther Onkol) - No abstract available

Journal • Gene Therapies

Aglatimagene: Protection of patent related to method of use until 2034 (Candel Therap) - Corporate Presentation

Patent • Oncology

Candel Therapeutics Announces Initiation of Global Pivotal Phase 3 AURORA Trial Evaluating Aglatimagene Besadenovec (CAN-2409) in Advanced Non-Small Cell Lung Cancer Patients with Inadequate Response to Immune Checkpoint Inhibitors (The Manila Times) - "Candel has engaged Parexel International to support execution of this global pivotal trial...The global, randomized, open-label AURORA trial is expected to enroll patients with metastatic Stage IV non-squamous NSCLC across approximately 150 sites worldwide..."

Trial status • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer

LuTK03: Aglatimagene Besadenovec + Prodrug and Pembrolizumab vs Docetaxel for Stage IV Non-Squamous NSCLC Progressing on Pembrolizumab (AURORA) (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: Candel Therapeutics, Inc.

New P3 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Candel Therapeutics Announces Publication in The Lancet Oncology of Pivotal Phase 3 Data Demonstrating Significant Improvement in Disease-Free Survival with Aglatimagene Besadenovec (CAN-2409) in Localized Prostate Cancer (The Manila Times) - "30% improvement in DFS in the aglatimagene arm, compared to placebo (hazard ratio 0.70; 95% confidence interval (CI) 0.52-0.94; p=0.016); 38% improvement in prostate cancer-specific DFS (prostate cancer recurrence or prostate cancer related death) (hazard ratio 0.62; 95% confidence interval 0.44-0.87; p=0.0046); Aglatimagene improved pathological complete response rate in a post-hoc blinded review of biopsies collected two years after completion of radiotherapy, with 80% (167/209) of patients in the aglatimagene treatment arm observed with negative biopsies, versus 63% (62/98) observed in the placebo group (p=0.0018); A generally favorable safety profile, with the most common treatment-related adverse events (chills, flu-like symptoms, fatigue, pyrexia, pollakiuria, and nausea) observed to be grades 1-2 and self-limited."

P3 data • Prostate Cancer

ProstAtak: “Aglatimagene significantly improved prostate cancer-specific disease-free survival after extended follow-up“; Prostate cancer (Candel Therap) - AUA 2026

P3 data • Genito-urinary Cancer • Oncology • Prostate Cancer

Candel Therapeutics Reports Extended Clinical Benefit Over Multiple Clinical Endpoints in Patients from Phase 3 Trial of Aglatimagene Besadenovec (CAN-2409) in Localized Prostate Cancer Under Prolonged Follow-up at AUA 2026 Annual Meeting (GlobeNewswire) - "Extended follow-up data from the phase 3 study (20 months after reported topline data, median follow-up 58 months) confirmed a statistically significant and clinically meaningful improvement in prostate cancer–specific disease-free survival (DFS) of 39% after aglatimagene administration compared to placebo, reinforcing the potential of aglatimagene to reduce the risk of tumor recurrence in men receiving radiotherapy for localized disease. Clinical benefit demonstrated in the intention-to treat (ITT) population by secondary and clinically relevant exploratory endpoints with numerical improvements observed in time to biochemical failure (TTBF), lower incidence of and increased time to metastases, and increased time to salvage anti-cancer treatment (TTNT)."

P3 data • Prostate Cancer

Anticipated Milestones:…Aglatimagene besadenovec (CAN-2409) (GlobeNewswire) - "(i) Updated extended follow-up data from the positive phase 3 clinical trial of aglatimagene in patients with localized, intermediate- to high-risk localized prostate cancer, will be reported in an oral presentation at the AUA 2026 Annual Meeting...; (ii) The Company plans to initiate a pivotal phase 3 clinical trial of aglatimagene in patients with metastatic, non-squamous, NSCLC, and progressive disease despite ICI treatment in June 2026; (iii) Biomarker data related to the effects of aglatimagene in patients with localized prostate cancer is expected in Q3 2026; (iv) Submission of BLA for aglatimagene in prostate cancer is planned for Q4 2026."

Biomarker • Clinical data • FDA filing • New P3 trial • P3 data • Lung Non-Squamous Non-Small Cell Cancer • Prostate Cancer

Candel Therapeutics to Host Investor Conference Call Following Presentation of Extended Data from Phase 3 Trial of Aglatimagene Besadenovec in Localized Prostate Cancer at the American Urological Association 2026 Annual Meeting (GlobeNewswire) - "The discussion will follow the oral plenary presentation of these data by Mark G. Garzatto, M.D., Professor of Urology at Oregon Health & Science University and the Portland VA Medical Center, at the American Urological Association (AUA) 2026 Annual Meeting."

P3 data • Prostate Cancer

Candel Therapeutics…announced that it entered into a product commercialization agreement (the 'Agreement') with EVERSANA, a leading provider of global commercialization services to the life sciences industry, to support the potential U.S. commercial launch of aglatimagene besadenovec (aglatimagene or CAN-2409) for the treatment of intermediate- to high-risk, localized prostate cancer (GlobeNewswire) - "Under the terms of the agreement, EVERSANA will provide Candel with a broad suite of integrated commercialization services including data and analytics, medical affairs, market access and field operations. EVERSANA joins IDEA Pharma, a division of SAI MedPartners (IDEA), which has been providing path-to-market strategies and strategic positioning for aglatimagene."

Licensing / partnership • Prostate Cancer

HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM (clinicaltrials.gov) - P1/2 | N=62 | Recruiting | Sponsor: The Methodist Hospital Research Institute | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • Gene Therapies • Glioblastoma • Oncology • Solid Tumor

HSV-tk + Valacyclovir + SBRT + Chemotherapy for Recurrent GBM (clinicaltrials.gov) - P1/2 | N=62 | Recruiting | Sponsor: David Baskin MD | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • Gene Therapies • Glioblastoma • Oncology • Solid Tumor