HOOKIPA Pharma Inc. announced positive updated results from its Phase 2 clinical trial of HB-200 in combination with pembrolizumab in patients with recurrent/metastatic human papillomavirus 16 positive (HPV16+) head and neck cancer. The updated data presented at the ASCO 2024 Annual Meeting is as of March 29, 2024 (cutoff date) and includes 46 patients treated with HB-200 plus p Embrolizumab in the first line setting. The company also have alignment on a clinical development strategy with the U.S. Food and Drug Administration with a path to potential accelerated approval.

Importantly, its pivotal seamless Phase 2/3 trial is just the beginning--our platform continues to demonstrate the potential power of arenaviral-based immunotherapies to help provide targeted treatments for patients across disease areas and indications. Results: HB-200 in combination with Pembrolizumab: Data were presented as of March 29, 2024, and included 46 first line patients with HPV16+, PD-L1 positive, recurrent or metastatic head and neck squamous cell carcinoma. HB-200 in combination withpembrolizumab received Fast Track Designation from the U.S. food and Drug Administration and PRIME designation from the European Medicines Agency for the treatment of first-line HPV16+ recurrent/metastatic oropharyngeal squamous cell carcinoma.

These designations are supported by preliminary clinical evidence from the Phase 1/2, open-label, clinical trial (NCT04180215) evaluating safety, T cell response, and efficacy based on objective response rate (ORR) and disease control rate (DCR) as defined by RECIST 1.1.