HOOKIPA Pharma (HOOK) Status Update summary

Pipeline and Strategic Focus

• The arenavirus platform supports therapies for oncology and infectious diseases, including programs in HPV16+ head and neck cancer, KRAS-mutated tumors, hepatitis B, and HIV, with partnerships such as Gilead for infectious disease indications.

• HB-700 targets KRAS-mutated cancers and recently cleared IND with the FDA.

HB-200 Clinical Data and Efficacy

• HB-200 plus pembrolizumab in first-line HPV16+ head and neck cancer showed a 37%–53% objective response rate, 11%–18% complete response rate, and 69%–82% disease control rate, with the highest rates in the PD-L1 CPS ≥20 subgroup.

• Median progression-free survival reached up to 16.3 months, with a 9-month overall survival rate near 90% and median OS not reached in the CPS ≥20 group.

• 62%–67% of responders remained on treatment at data cutoff, indicating durable responses.

• Combination therapy induced robust and sustained HPV16-specific CD8+ T cell responses.

Safety and Tolerability

• HB-200 plus pembrolizumab was generally well tolerated, with most adverse events being mild to moderate; grade ≥3 treatment-related adverse events occurred in 15% of patients, with no treatment-related deaths.

• Serious treatment-related adverse events occurred in 4% of patients, and 4% discontinued HB-200 due to adverse events.