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HOOKIPA Announces First Patient Enrolled in Phase 2 Trial Evaluating HB-200 and Pembrolizumab for Treatment of Head and Neck Cancer and Reports FDA’s Fast Track Designation

HOOKIPA Announces First Patient Enrolled in Phase 2 Trial Evaluating HB-200 and Pembrolizumab for Treatment of Head and Neck Cancer and Reports FDA’s Fast Track Designation

  • First patient dosed with HB-200 and pembrolizumab combination for treatment of 1st-line advanced/metastatic head and neck cancer in Phase 2 arm of ongoing Phase 1/2 trial
  • Fast Track Designation granted for HB-200 in combination with pembrolizumab for treatment of 1st-line head and neck cancer

NEW YORK and VIENNA, Austria, Jan. 18, 2022 - HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, announced that the first patient has been dosed with HB-200 in combination with pembrolizumab for the treatment of 1st-line advanced/metastatic Human Papillomavirus 16 Positive (HPV16+) squamous cell head and neck cancers (HNSCC) in a Phase 2 arm of the ongoing Phase 1/2 trial (NCT04180215). In addition, the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the Company’s novel immunotherapy candidates, single-vector HB-201 and alternating 2-vector HB-202/HB-201, both in combination with pembrolizumab, for the treatment of 1st-line advanced/metastatic HPV16+ HNSCC.

“Given our HB-200 clinical data to date, we believe that combining HB200 with pembrolizumab in earlier line settings has the potential--by inducing unprecedented levels of tumor antigen-specific CD8+ T cells--to overcome the limitations of checkpoint inhibitor monotherapy,” said Joern Aldag, Chief Executive Officer at HOOKIPA.We’re eager to work closely with the FDA through the development process as we hope to bring new options to patients with HNSCC. Fast Track Designation for our lead oncology candidates is a great recognition of the promise of our versatile arenaviral platform to deliver novel immunotherapies which can address unmet needs in cancer.”

The Company reiterates its HB-200 program guidance as follows:

  • Additional Phase 1 monotherapy data in mid-2022;
  • Initial 1st-line data and post-standard of care (2nd+ line) data, both in combination with pembrolizumab, in 2H 2022;
  • Initiation of the randomized 1st-line Phase 2 study (pembrolizumab vs. pembrolizumab + HB-200) in 1H 2023.

Fast Track Designation is granted by the FDA for products that demonstrate the potential to address unmet medical needs in serious or life-threatening conditions. The designation, which is based on a review of pre-clinical and clinical data, enables early and frequent communication with the FDA through the drug development process, a rolling submission of a New Drug Application, as well as eligibility for Accelerated Approval and Priority Review if relevant criteria are met. Fast Track Designation was granted to the planned Phase 2 randomized trial of HB-201 and HB-202/HB-201 in combination with pembrolizumab for the treatment of 1st-line advanced/metastatic HPV16+ HNSCC.

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