HOOKIPA to Present Complete HB-200 Phase 1 Results and Recommended Phase 2 Dose for HB-202/HB-201 for the Treatment of Advanced HPV16+ Cancers at ASCO

• Phase 1 data show single-vector HB-201 and 2-vector HB-202/HB-201 were generally well tolerated, rapidly induced tumor-specific T cells and showed anti-tumor activity in heavily pre-treated head and neck cancer patients
• Poster presentation to include data supporting recommended Phase 2 dose for alternating 2-vector HB-202/HB-201 and Phase 2 development plans in head and neck cancers

HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced that complete HB-200 Phase 1 results (NCT04180215) for single-vector HB-201 and alternating 2-vector HB-202/HB-201 in patients with advanced Human Papillomavirus 16-positive (HPV16+) cancers, including the recommended Phase 2 dose for HB-202/HB-201, will be shared in a poster presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 3-7, 2022. Data as of March 31, 2022 will be presented on 68 patients, 54 of whom had head and neck squamous cell carcinoma (HNSCC).

“We look forward to sharing the full Phase 1 data results on our HB-200 program at ASCO. The final analysis shows that HB-201 and 2-vector HB-202/HB-201 were generally well tolerated and showed anti-tumor activity in these difficult-to-treat patients. We also will share additional translational data that continue to show robust tumor-specific T cell responses from use of our HB-200 therapies,” said Joern Aldag, Chief Executive Officer at HOOKIPA. “We are continuing to advance this truly novel science through the clinic, and the learnings from this phase help deepen our understanding of the potential of our technology. These insights inform our path as we advance the 2-vector HB-202/HB-201 immunotherapy into the ongoing Phase 2 HNSCC portion of the study, as well as our approach to our HB-300 program in prostate cancer.”

The abstract is available on the ASCO website with key details noted below:

• Recommended Phase 2 dose (RP2D) of HB-200 arenavirus-based cancer immunotherapies in patients with HPV16+ cancers
  
  
  • Abstract # 2517, Developmental Therapeutics – Immunotherapy
    
    
    • Poster session: Sunday, June 5, 8:00 a.m. – 11:00 a.m. CDT
    • Poster discussion session: Sunday, June 5, 11:30 a.m. – 1:00 p.m. CDT in Hall D2

• Presenter: Siqing Fu, M.D., Ph.D., Professor of Investigational Cancer Therapeutics and principal investigator at The University of Texas MD Anderson Cancer Center

• Key findings:
  
  
  • Single-vector HB-201 and 2-vector HB-202/HB-201 immunotherapies were generally well tolerated and showed anti-tumor activity in heavily pre-treated patients with HPV16+ head and neck cancer
  • HB-201 was evaluated at three dose levels, with two dosing schedules and two administration routes for safety, efficacy and immunogenicity
  • HB-202/HB-201 was evaluated at four dose levels and two administration routes for safety, efficacy, and the recommended Phase 2 dose
  • Anti-tumor activity in this heavily pre-treated patient population was observed with HB-201 and HB-202/HB-201 treatments alone, including sustained tumor control and partial responses.