Hookipa Pharma receives PRIME designation for HB-200 program

HOOKIPA Pharma announced that members of HOOKIPA’s Executive Team will host an investor call summarizing the Company’s constructive regulatory interactions with the U.S. Food & Drug Administration and the European Medicines Agency. HOOKIPA and the FDA have aligned on the design and protocol of the Company’s upcoming pivotal Phase 2/3 clinical trial of HB-200 in combination with pembrolizumab. The investor call will be held on April 25, 2024, at 8:00 a.m. ET. The Company also announced that EMA has granted PRIME designation for the investigational product HB-200 in combination with pembrolizumab for the treatment of patients with Human Papillomavirus 16-positive recurrent/metastatic PD-L1 CPS greater than or equal to 20 oropharyngeal squamous cell carcinoma in the first line setting. PRIME designation is intended to expedite development and review of drug candidates, alone or in combination with other drugs. Eligibility and approval are based on preliminary clinical evidence and indicate that the drug candidate may offer substantial improvement over existing therapies.