HOOKIPA announces pivotal Phase 2/3 trial design for HB-200 in combo with pembrolizumab; FDA alignment

HOOKIPA Pharma Inc.

Pivotal Phase 2/3 trial for HB-200 + pembrolizumab in first-line HPV16+ recurrent/metastatic OPSCC; FDA alignment achieved.
Trial expected to enroll ~250 patients; Phase 2 primary analysis in 2026 with potential accelerated approval filing.
First patient enrollment anticipated in Q4 2024.
HB-200 abstract accepted as oral presentation at ASCO 2024 with data from ~40 patients in head and neck cancer.
Company also received PRIME designation from EMA for HB-200 in combination with pembrolizumab.

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