On November 4, 2025 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company developing multimodal biological immunotherapies to help patients fight cancer, reported it will deliver three presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Anniversary Annual Meeting, taking place November 5–9, 2025, in National Harbor, Maryland.
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Together, these presentations underscore Candel’s leadership in the development of novel therapeutics, harnessing multi-omics insights and artificial intelligence (AI) to define therapeutic strategies based on a deeper understanding of the tumor microenvironment and biomarkers of response in multiple solid tumors.
"Candel’s presentations at SITC (Free SITC Whitepaper) 2025 exemplify our innovative approach to the discovery and development of novel immunotherapies," said Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel Therapeutics. "By leveraging next-generation research tools we are working to generate deep biological insights that inform every stage of drug development, from bench to bedside and back. This iterative process allows us to refine how we develop a novel class of immunotherapies that have the potential to improve clinical outcome in patients with difficult-to-treat solid tumors."
Invited Faculty Presentation and Panel Discussion:
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.
Title: 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
Presenter: Paul Peter Tak, M.D., Ph.D., FMedSci, President and CEO of Candel Therapeutics
Session: The Next Wave: Viruses, Cells and Next-gen PD-1 Bispecifics
Date/Time: Friday, Nov. 7, 2025, 3:55 – 5:35 p.m.
Location: Potomac Ballroom – Gaylord National Resort and Convention
CAN-2409 in NSCLC Clinical Data:
Daniel Sterman M.D., Thomas and Suzanne Murphy Professor of Medicine and Cardiothoracic Surgery, NYU Langone Health and Principal Investigator, will present a poster based on integration of clinical and biomarker data from the phase 2a open-label clinical trial of CAN-2409 in patients with stage III/IV NSCLC who had progressed, despite immune checkpoint inhibitor (ICI) treatment (NCT04495153). Patients received two courses of intratumoral CAN-2409 combined with valacyclovir prodrug along with continued ICI treatment. Leveraging previously reported clinical data,1,2,3 Multi-Omics Factor Analysis (MOFA) was applied to integrate over 3,000 data points from flow cytometry and proteomics analysis of serial samples to provide a deeper understanding of the relationship between clinical and biological responses to CAN-2409.
Key findings include:
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
Improved immune activation after CAN-2409 administration was observed in patients with NSQ histology compared to those with SQ histology, and this was associated with prolonged overall survival
"The enhanced immune activation and improved survival observed after CAN-2409 administration in patients with non-squamous disease, support the rationale for a phase 3 clinical of CAN-2409 in this subgroup of patients," said Dr. Sterman.
enLIGHTEN Discovery Platform Preclinical Data:
Anne Diers, Ph.D., Vice President of Research at Candel Therapeutics, will present a poster on the third preclinical candidate based on the enLIGHTEN Discovery Platform. An AI approach was used to interrogate The Cancer Genome Atlas (TCGA) RNA sequencing data and identify potential therapeutic payloads to be deployed in the tumor microenvironment to treat specific indications. The resulting therapeutic candidate consists of the Alpha-201 vector expressing IL-12 and IL-15 and has been designed for the treatment of breast cancer.
Key findings include:
Evidence of infection and payload-dependent PBMC-mediated tumor cell killing in vitro, showing that the engineered virus can trigger immune cells to attack cancer cells
Significant tumor growth suppression (60.0% ± 12.6 vs. vehicle) in the EMT6 mouse model of breast cancer
Evidence of a synergistic interaction between IL-12 and IL-15 payloads, with the combination producing nominally greater effects than either cytokine alone
Increased frequency of circulating Ki67+ CD8+ T cells, natural killer cells, and conventional dendritic cells type 2, as well as upregulation of inflammatory response pathways, including IFN-gamma/alpha responses, upon treatment with Alpha-201 IL-12-15
"The enLIGHTEN platform provides a new, systematic approach to cancer immunotherapy development," said Francesca Barone, M.D., Ph.D., Chief Scientific Officer at Candel. "By rationally identifying optimal combinations of immune targets for specific tumor types and validating them using our viral vector engineering capabilities, we can design multimodal therapies with the potential to overcome the immunosuppressive tumor microenvironment."
About CAN-2409
CAN-2409 (aglatimagene besadenovec), Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid proteins promote inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. CAN-2409 has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with CAN-2409 in clinical trials with a favorable tolerability profile to date, supporting the potential for combination with standard of care, when indicated.
(Press release, Candel Therapeutics, NOV 4, 2025, View Source [SID1234659387])