HOOKIPA Pharma (HOOK) Earnings Call Presentation

HB-200 Program and Clinical Trials - Hookipa Pharma's HB-200 is a targeted immunotherapy for HPV16+ cancers, with a pivotal Phase 2/3 trial expected to start in Q4 2024[14, 16] - The FDA has aligned on the pivotal Phase 2/3 design and protocol for HB-200, and the EMA has granted PRIME designation[16] - A Phase 1/2 study of HB-200 in recurrent/metastatic HPV16+ HNSCC showed promising antitumor activity as a monotherapy[25, 26] - The combination of HB-200 and pembrolizumab demonstrated a manageable safety profile, in line with monotherapy profiles[28, 30] - The Phase 2/3 trial will be a seamless study with approximately 250 patients, with a Phase 2 primary analysis expected in 2026 and a Phase 3 primary analysis in 2028[47, 48] Clinical Data and Efficacy - In patients with PD-L1 CPS ≥1, HB-200 + pembrolizumab showed an objective response rate (ORR) of 371% and a disease control rate (DCR) of 686%[32] - In the PD-L1 CPS ≥20 sub-population, the confirmed ORR was 529%, with a complete response (CR) rate of 176% and a DCR of 824%[37] - Preliminary progression-free survival (PFS) in the PD-L1 CPS ≥20 population was 163 months, and median overall survival (OS) was unreached, with 158% of subjects experiencing death events[42, 43, 44] - Neoadjuvant HB-200 plus chemotherapy showed an early efficacy signal with a deep response rate of 81% (17 of 21 patients)[51] Oncology Strategy and Market - Hookipa Pharma is pursuing a patient-centric oncology strategy, starting with HB-200 in head and neck cancer, with potential applicability to additional antigens and HPV16+ targets[55, 56]