Candel Therapeutics (CADL) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Program and pipeline overview

• Developing viral immunotherapies for hard-to-treat solid tumors, with two main assets in clinical development.

• Aglatimagen besadenovec is advancing toward BLA submission after meeting the primary endpoint in a pivotal phase III trial for localized prostate cancer.

• Positive data for aglatimagen in non-small cell lung cancer and paused but promising results in pancreatic cancer, with regulatory designations supporting its potential.

• Linoserpaturev is in phase I-B/II-A for recurrent glioblastoma, showing encouraging results and potential for expansion based on biomarker Nestin.

• Both assets are positioned as off-the-shelf therapies aiming to induce individualized anti-tumor immune responses.

Clinical trial results and endpoints

• Phase III trial in 745 intermediate/high-risk prostate cancer patients showed a 30% improvement in disease-free survival (DFS) with aglatimagen.

• Statistically significant improvement in pathological complete response at two years (80% vs. 63% for control).

• DFS included all-cause mortality and cancer-specific events, with rigorous, objective assessment methods.

• Secondary endpoints, including prostate cancer-specific DFS and exploratory endpoints, further supported efficacy.

• Long-term follow-up (median ~6 years) demonstrated meaningful improvements in patient outcomes and quality of life.

Administration, patient experience, and clinical relevance

• Aglatimagen is administered via three simple prostate injections, each paired with valacyclovir, over the course of radiotherapy.

• Procedure is outpatient, well-tolerated, and often less painful than standard biopsies, with minimal need for anesthesia.

• Treatment aims to reduce or delay the need for long-term androgen deprivation therapy (ADT), addressing a major unmet need.

• High support and intended use among key opinion leaders, with strong advocacy from both clinicians and patients.

• Education efforts have focused on the novelty of DFS as an endpoint and the significance of two-year biopsy results.