HOOKIPA Pharma Inc. announced that its Investigational New Drug (IND) Application for a Phase 1/2 clinical trial of HB-201, a TheraT®*-based immunotherapy, for the treatment of Human Papilloma Virus (HPV)-positive cancers is now effective following the clearance by the U.S. Food and Drug Administration (FDA).
HB-201 (LCMV) is a TheraT®-based product candidate expressing a non-oncogenic but highly antigenic E6/E7 fusion protein derived from HPV16. In animal models, HB-201 was observed to induce strong immunogenicity, resulting in a robust E6 and E7 antigen specific CD8+ T cell response. HOOKIPA will now start a clinical trial with the goal to provide therapeutic benefit to patients with HPV16+ cancers. Based on the magnitude of response shown in pre-clinical models, HOOKIPA believes that HB-201 has the potential to induce levels of CD8+ T cells that were previously only attainable with adoptive cell therapies. However, HOOKIPA’s approach is designed to directly reprogram the patient’s immune system with an off the shelf systemic administration. This approach eliminates the need for any ex vivo logistics that burden adoptive cell therapy and any related ex vivo cellular approaches.
HOOKIPA intends to start the Phase 1/2 clinical trial in the second half of 2019 with preliminary safety and efficacy data expected in late 2020 or early 2021. It will be HOOKIPA’s first clinical trial in immuno-oncology. In addition to obtaining both safety and efficacy of the targeted patient population, this program will also have a built-in translational component which will allow HOOKIPA to validate its mechanism of action within patients and further drive clinical development via a rigorous scientific method.