ProstAtak (aglatimagene besadenovec) / Candel Therap - LARVOL DELTA

Anticipated Milestones (GlobeNewswire) - "Updated mOS data and 'long tail' of survival analysis from the phase 2a open-label clinical trial of CAN-2409 in patients with stage III/IV NSCLC who had progressed, despite ICI treatment (NCT04495153) is expected in Q1 2026; Updated data on prostate cancer-specific DFS, time to salvage anti-cancer therapy, and time to metastasis from the positive phase 3 clinical trial of CAN-2409 in patients with intermediate-to-high-risk localized prostate cancer after extended follow-up is expected in Q2 2026; The Company plans to initiate a pivotal phase 3 clinical trial of CAN-2409 in NSCLC in Q2 2026; Data on local and systemic biomarkers of immune activation from a mechanistic, supportive clinical trial of CAN-2409 in patients with localized prostate cancer, is expected in Q3 2026; The Company expects to present mature mOS data and an update on long-term survivors from arm C of its phase 1b clinical trial of CAN-3110 in patients with recurrent glioblastoma in Q4 2026."

Clinical data • New P3 trial • Glioblastoma • Non Small Cell Lung Cancer • Prostate Cancer

CAN-2409 in NSCLC Clinical Data (GlobeNewswire) - "Patients with non-squamous (NSQ) histology exhibited greater expansion of effector and memory T cell populations following CAN-2409 treatment compared to patients with squamous (SQ) histology; latent immune signatures were associated with lack of response and poor outcome in patients with SQ histology; Robust systemic immune activation in NSQ patients was observed after the second CAN-2409 course, with increased CD8+ central memory T cells and elevated soluble granzymes associated with long-term survival."

P2a data • Non Small Cell Lung Cancer

Candel Therapeutics Showcases Immunotherapy Leadership at SITC 2025... (GlobeNewswire) - "Paul Peter Tak, M.D., Ph.D., FMedSci, will present Candel’s positive phase 3 clinical trial data of CAN-2409 in patients with newly diagnosed, localized prostate cancer and discuss the next wave of innovation in immunotherapy during an invited faculty presentation and subsequent panel discussion. The Company plans to submit a Biologics License Application (BLA) for CAN-2409 in prostate cancer in the fourth quarter of 2026."

FDA filing • P3 data • Prostate Cancer

Advanced analytics identify a differential immune response to CAN-2409+valacyclovir in non-squamous vs squamous NSCLC, linked to improved survival in patients with progressive ICI-refractory NSCLC (SITC 2025) - P2 | "Background We previously reported that administration of two intratumoral injections of CAN-2409 combined with prodrug (valacyclovir) prolonged median overall survival (mOS) in patients with unresectable stage III/IV non-small cell lung cancer (NSCLC), who had progressed on immune checkpoint inhibitor (ICI) treatment, doubling mOS compared to historical controls treated with docetaxel. (FNIH) by: AbbVie Inc., Amgen Inc., Boehringer-Ingelheim Pharma GmbH & Co. KG., Bristol-Myers Squibb, Celgene Corporation, Genentech Inc, Gilead, GlaxoSmithKline plc, Janssen Pharmaceutical Companies of Johnson & Johnson, Novartis Institutes for Biomedical Research, Pfizer Inc., and Sanofi.Trial Registration NCT04495153 ClinicalTrials.govEthics Approval Patients participating in the study provided an IRB-approved informed consent at their participating institutions."

Clinical • IO biomarker • Metastases • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD4 • CD8 • HAVCR2 • ITGAX

Phase 3, Randomized, Placebo-Controlled Clinical Trial of CAN-2409 + Prodrug in Combination with Standard of Care Radiation Therapy for Newly Diagnosed, Localized Prostate Cancer with Curative Intent (SITC 2025) - No abstract available

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

CAN-2409 with Radiotherapy for Localized Prostate Cancer: A Phase 3, Randomized, Placebo-Controlled Clinical Trial (PCF 2025) - No abstract available

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

The effect of oncolytic virotherapy on pediatric brain tumor- a systematic review. (PubMed, Childs Nerv Syst) - "OVT appears safe and feasible in pediatric brain tumors, with signals of clinical benefit in selected patients. Larger, controlled trials are needed to clarify its survival impact and define optimal therapeutic strategies."

Journal • Review • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • Diffuse Intrinsic Pontine Glioma • Ependymoma • Glioblastoma • Glioma • High Grade Glioma • Oncology • Pain • Pediatrics • Solid Tumor

Trinity Capital Inc. Provides $130 Million in Growth Capital to Candel Therapeutics, Supporting Development of Viral Immunotherapies to Fight Cancer - "Trinity's investment will be used to support Candel's clinical development of CAN-2409, as well as pre-commercial and launch readiness activities for CAN-2409 in prostate cancer, pending regulatory approval."

Financing • Prostate Cancer

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) - No abstract available

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

Candel Therapeutics to Present at the SITC 2025 Annual Meeting (GlobeNewswire) - "...the Company will present insights from its enLIGHTEN Discovery Platform, and additional data from the CAN-2409 (aglatimagene besadenovec) program in non-small cell lung cancer (NSCLC)....Dr. Paul Peter Tak, M.D., Ph.D., FMedSci, will also present Candel’s positive phase 3 clinical trial data of CAN-2409 in patients with intermediate-to-high-risk localized prostate cancer as part of an invited faculty presentation and panel discussion on the state of the cancer 'and beyond' immunotherapy field, including both opportunities and obstacles for developing the next wave of breakthrough therapeutics."

Clinical data • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Prostate Cancer

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

Candel Therapeutics Presents Phase 3 Clinical Trial of CAN-2409 in Localized Prostate Cancer at ASTRO 2025 (GlobeNewswire) - "CAN-2409 significantly improved prostate cancer-specific outcomes (HR 0.62; p=0.0046). Effects observed in both moderate hypofractionated EBRT (HR 0.52, CI 0.30 – 0.93, p=0.0236) and conventional EBRT (HR 0.76, CI 0.53 – 1.07, p=0.1131). Demonstrated safety and compatibility across radiation therapy modalities, with both conventional radiation therapy (~78 Gy in 2 Gy fractions, ~72% of patients) and moderate hypofractionated radiation therapy (60 Gy in 3 Gy fractions, ~25% of patients) showing similar tolerability profiles."

P3 data • Prostate Cancer

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

Candel Therapeutics to Present Phase 3 Results of CAN-2409 in Localized Prostate Cancer at ASTRO 2025 (GlobeNewswire)

P3 data • Prostate Cancer

Novel immunotherapy strategy shows promising long-term survival in certain advanced NSCLC patients (Medical Xpress) - "At a median follow-up of 32.4 months, median overall survival (OS) for the eligible population was 24.5 months, with 37% of patients still alive more than two years post-treatment. In patients with progressive disease at baseline, median OS was 21.5 months."

P2a data • Non Small Cell Lung Cancer

Anticipated Milestones (GlobeNewswire) - "Additional clinical and biomarker activity data from an ongoing phase 1b clinical trial evaluating repeat doses of CAN-3110 in patients with recurrent high-grade glioma (rHGG), is expected in Q4 2025; Candel plans to host a virtual Research and Development event in Q4 2025; Submission of BLA for CAN-2409 in prostate cancer expected in Q4 2026."

FDA filing • P1 data • Glioma • Prostate Cancer

Candel Therapeutics Receives EMA Orphan Designation for CAN-2409 for the Treatment of Pancreatic Cancer (GlobeNewswire) - "Candel Therapeutics...announced that the European Medicines Agency (EMA) has granted Orphan Designation for CAN-2409 (aglatimagene besadenovec) for the treatment of pancreatic cancer. This designation complements CAN-2409’s existing U.S. Food and Drug Administration (FDA) Orphan Drug Designation and FDA Fast Track Designation for the treatment of pancreatic ductal adenocarcinoma (PDAC) awarded to CAN-2409 in April 2024 and December 2023, respectively, and underscores the significant unmet medical need in this disease beyond the U.S....The Company previously reported positive overall survival (OS) data from its randomized controlled phase 2a clinical trial of CAN-2409 plus valacyclovir in borderline resectable PDAC, demonstrating remarkable survival benefits with estimated median OS of 31.4 months in the CAN-2409 plus standard of care arm versus 12.5 months in the standard of care control arm, supported by immunological biomarker data."

Orphan drug • Pancreatic Adenocarcinoma

PrTK03: Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer (clinicaltrials.gov) - P3 | N=711 | Active, not recruiting | Sponsor: Candel Therapeutics, Inc. | Trial completion date: Dec 2024 ➔ Dec 2030 | Trial primary completion date: Dec 2024 ➔ Aug 2024

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

Intratumoral Gene Mediated Cytotoxic Immunotherapy in Patients With Resectable Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Candel Therapeutics, Inc. | Active, not recruiting ➔ Completed

Trial completion • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES) (clinicaltrials.gov) - P2 | N=187 | Active, not recruiting | Sponsor: Candel Therapeutics, Inc.

Trial completion date • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • 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. (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

Candel Therapeutics Receives FDA Regenerative Medicine Advanced Therapy Designation for CAN-2409 for the Treatment of Prostate Cancer (GlobeNewswire) - "Candel Therapeutics, Inc...announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to CAN-2409 (aglatimagene besadenovec), the Company’s biological immunotherapy lead candidate, for the treatment of newly diagnosed localized prostate cancer in patients with intermediate-to-high-risk disease. CAN-2409 was also previously granted FDA Fast Track designation for the same indication....The RMAT designation was granted on the basis of the positive data from Candel’s phase 3 randomized, placebo-controlled clinical trial evaluating the efficacy and safety of CAN-2409 plus valacyclovir (prodrug), together with standard of care (SoC) external beam radiation therapy, in newly diagnosed, localized, intermediate-to-high-risk prostate cancer."

FDA event • Prostate Cancer

Candel Therapeutics to Host Investor Conference Call Featuring Expert Clinical Perspectives on CAN-2409 Phase 3 Prostate Cancer Data Following 2025 ASCO Presentation (GlobeNewswire) - "Candel Therapeutics, Inc...today announced that Candel management will host a webcast and conference call on Tuesday, June 3, 2025, at 1:00PM ET. The call will discuss the Company’s positive phase 3 clinical results for CAN-2409 in localized, intermediate-to-high risk prostate cancer, which demonstrated a statistically significant 30% reduction in disease recurrence compared with placebo when combined with standard-of-care radiation therapy. The discussion will follow Dr. Theodore DeWeese’s* oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting."

P3 data • Prostate Cancer

Candel Therapeutics Presents Positive Phase 3 CAN-2409 Results in Localized Prostate Cancer at ASCO 2025 (GlobeNewswire) - P3 | N=711 | NCT01436968 | Sponsor: Candel Therapeutics, Inc. | "Key Findings to be Presented at ASCO 2025 Include: (i) Primary Endpoint: Statistically significant improvement in DFS for CAN-2409 plus radiation therapy (n=496) vs. radiation therapy alone (n=249) (p=0.0155; HR 0.7) in the intent to treat population; (ii) Secondary & Exploratory Endpoints:...In an analysis that focused on prostate-specific outcomes (e.g., censored mortality due to other causes), CAN-2409 showed a highly significant effect (p=0.0046; HR 0.62) on prostate cancer-free survival. Significant increase in the proportion of patients achieving a prostate-specific antigen (PSA) nadir (<0.2 ng/ml) was observed in the treatment arm compared to the placebo control arm (67.1% vs. 58.6%, respectively; p=0.0164). CAN-2409 induced 80.4% pathological complete responses in the two-year post-treatment biopsies compared to 63.6% observed in the control arm (p=0.0015)."

P3 data • Prostate Cancer

Candel Therapeutics Reports First Quarter 2025 Financial Results and Recent Corporate Highlights (GlobeNewswire) - "Anticipated Milestones: Clinical and biomarker activity data from an ongoing phase 1b clinical trial evaluating repeat doses of CAN-3110 in patients with rHGG expected in Q4 2025; Submission of BLA for CAN-2409 in prostate cancer expected in Q4 2026."

FDA filing • P1 data • Glioma • Prostate Cancer