HOOKIPA Pharma to Host Investor Call on HB-200 and Planned Path to Registration

• HOOKIPA announces alignment with FDA on pivotal trial design and protocol for HB-200 in combination with pembrolizumab
• HB-200 program receives Priority Medicines (PRIME) designation from EMA
  

NEW YORK and VIENNA, Austria, April 10, 2024 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ: HOOK, HOOKIPA or the Company), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today 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 (FDA) and the European Medicines Agency (EMA). 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. Complete details and registration information are included below.

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 (HPV16+) recurrent/metastatic PD-L1 CPS ≥ 20 oropharyngeal squamous cell carcinoma (OPSCC) 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.

“There is a significant unmet need for patients with OPSCC, and we are excited to share our pivotal Phase 2/3 trial design and demonstrate how we hope to provide better treatment options for these patients,” said Joern Aldag, Chief Executive Officer of HOOKIPA. “We have had positive conversations with our regulators as we have outlined our clinical trial plans for HB-200. The FDA is aligned on our clinical trial design and protocol, while EMA’s PRIME designation is additional validation for the potential of our HB-200 program. We look forward to sharing more details on our upcoming call.”