On January 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) (Press release, Hookipa Pharma, JAN 18, 2022, View Source [SID1234605515]). 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.

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"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.

About HB-202/HB-201
HB-201 and HB-202/HB-201 are HOOKIPA’s lead oncology candidates engineered with the company’s proprietary replicating arenaviral vector platform. Each single-vector compound uses a different arenavirus backbone (Lymphocytic Choriomeningitis Virus for HB-201 and Pichinde Virus for HB-202), while expressing the same antigen, an E7E6 fusion protein derived from HPV16. In pre-clinical studies, alternating administration of HB-201 and HB-202 resulted in a ten-fold increase in immune response and better disease control than either compound alone. HOOKIPA’s HB200 program includes HB-201, which is being tested clinically as a single vector therapy and HB-201 used as an alternating vector combination with HB-202.

About the HB-200 trial (NCT04180215)
This Phase 1/2 clinical trial is an open-label trial exploring different dose levels and dosing schedules in individuals with treatment-refractory HPV16+ head and neck cancers who progressed on standard of care, including check point inhibitors. The trial is evaluating HB-201 as a monotherapy, as an alternating 2-vector therapy with HB-202, and in combination with a PD-1 inhibitor. The primary endpoint of Phase 1 is a recommended Phase 2 dose. Secondary endpoints include safety and tolerability, as well as preliminary efficacy defined by RECIST 1.1. The study also includes exploratory objectives on immunogenicity and pharmacodynamic biomarkers. The Phase 2 part of the trial, assessing HB-201 and HB-202/HB-201 in combination with pembrolizumab in 1st- and post-standard of care (2nd+) line settings, is ongoing.