HOOKIPA Pharma Inc. announced its final pivotal Phase 2/3 trial design for HB-200 in combination with pembrolizumab. The Phase 2/3 trial design and protocol are based on alignment with the U.S. Food and Drug Administration (FDA) following the Company?s Type C meeting with the FDA. The seamless Phase 2/3 trial is for the investigational product HB-200 in combination with pembrolizumab for the treatment of patients with Human Papillomavirus 16-positive (HPV16+) recurrent/metastatic PD-L1 CPS = 20 oropharyngeal squamous cell carcinoma (OPSCC) in the first line setting.

The Company anticipates the first patient will be enrolled in the fourth quarter of 2024. The Company also announced acceptance of its HB-200 study abstract as an oral presentation at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting in the head and neck cancer session to be held on June 4, 2024. The presentation will include data for approximately 40 head and neck cancer patients treated with HB-200 in combination with pembrolizumab.

HB-200 in combination with pembrolizumab pivotal Phase 2/3 trial design summary: The trial will treat patients with HPV16+ recurrent/metastatic PD-L1 CPS = 20 oropharyngeal squamous cell carcinoma in the first line setting. The trial is expected to enroll approximately 250 patients across the seamless Phase 2/3 design. Patients will be randomized one-to-one for HB-200 plus pembrolizumab or placebo plus pembrolizumab.

The primary endpoints are objective response rate for the Phase 2 portion and overall survival for the Phase 3 portion. The Company may seek accelerated approval based on data from the Phase 2 portion of the trial, from approximately half of the Phase 2/3 study patients, if favorable. Phase 2 primary analysis expected in 2026 with potential subsequent filing for accelerated approval.