Candel Therapeutics (CADL) Jefferies London Healthcare Conference 2024 summary

Key program updates and clinical progress

• Approaching a major inflection point with upcoming data readouts in about 900 patients next month, including two randomized clinical trials in December.

• Focused on viral immunotherapies for difficult-to-treat solid tumors, with intra-tumoral delivery to induce systemic anti-tumor immunity.

• CAN-3110, a next-generation oncolytic HSV, shows doubling of median overall survival in recurrent high-grade glioma and is being tested for multiple injections.

• CAN-2409, an engineered adenovirus, is in late-stage trials for pancreatic, non-small cell lung, and early localized prostate cancers, with Fast Track and orphan drug designations.

• enLIGHTEN Discovery Platform enables rapid development of new viral immunotherapies and partnerships, such as with UPenn for CAR T cell delivery.

Clinical trial results and patient outcomes

• CAN-3110 demonstrated dramatic tumor reduction and long-term survival in glioblastoma patients, with some alive over 18 months and one considered cured after two years.

• CAN-2409 in pancreatic cancer showed median overall survival of 28.8 months vs. 12.5 months for control, with similar promising results in metastatic cases.

• In non-small cell lung cancer, CAN-2409 doubled expected median overall survival in patients with progressive metastatic disease.

• Early localized prostate cancer trials indicate improved progression-free survival and disease-free survival compared to standard of care, with extensive follow-up over five years.

• Mouse models and biomarker data support systemic anti-tumor immunity and significant changes in tumor microenvironment.

Regulatory and commercial outlook

• Phase 3 prostate cancer trial enrolled 711 patients, with primary endpoint of disease-free survival; active surveillance trial targets progression-free survival.

• BLA filing for the prostate product in the U.S. expected about two years after positive readout, with manufacturing based on established adenovirus technology.

• Fast Track and orphan drug designations received for key indications, and Special Protocol Assessment agreed with FDA for prostate cancer trial.

• Significant commercial opportunity identified in early prostate cancer, with unmet need for well-tolerated interventions.

• Ongoing and future data readouts in Q1 include mature survival and biomarker data for multiple indications.