Phase 2/3 pivotal trial design and protocol for HB-200 in combination with pembrolizumab for the first-line treatment of patients with HPV16+ recurrent or metastatic OPSCC aligns with U.S. Food and Drug Administration (FDA) feedback HB-200 program received Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) Received FDA clearance for Investigational New Drug (IND) application for HB-700 for the treatment of KRAS mutated cancers   NEW YORK and VIENNA, May 09, 2024 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ:HOOK, ‘HOOKIPA')), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today reported financial results and recent business highlights for the first quarter of 2024. "The first quarter was about focus at HOOKIPA. We are embarking on a pivotal trial for HB-200 in combination with pembrolizumab and made important decisions to align our organization for late-stage clinical trial execution. We also added to the depth of our executive team with a new Chief Development Officer, Mark Winderlich, who brings crucial experience to help us execute on our clinical development strategy," said Joern Aldag, Chief Executive Officer of HOOKIPA. "We have made great progress and have an FDA-aligned pivotal Phase 2/3 trial design that is patient-centric and we believe has a high probability of success. Our path forward is clear, and the team is excited to take a major step on our path to deliver better outcomes for patients." Business Highlights and Recent Developments Oncology HOOKIPA is preparing to start a seamless pivotal Phase 2/3 trial of HB-200 in combination with pembrolizumab for the treatment of patients with Human Papillomavirus 16-positive (HPV16+) recurrent/metastatic PD-L1 CPS ≥ 20 oropharyngeal squamous cell carcinoma (OPSCC) in the first line setting. The Phase 2/3 trial design and protocol are based on alignment with the FDA following the Company's Type C meeting. EMA granted PRIME designation to the investigational product HB-200 in combination with pembrolizumab. PRIME designation is intended to expedite development and review of drug candidates, alone or in combination with other drugs. Eligibility and approval are based on preliminary clinical evidence and indicate that the drug candidate may offer substantial improvement over existing therapies. The Company anticipates the first patient will be enrolled in the fourth quarter of 2024. HB-200 was accepted for an oral abstract presentation at the ASCO 2024 Annual Meeting with data from approximately 40 patients treated with HB-200 in combination with pembrolizumab. The HB-700 program is a novel arenaviral immunotherapy for KRAS-mutated cancers, including the five mutations that are the primary causes of lung, pancreatic and colon cancers. The Company received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for HB-700 for the treatment of KRAS-mutated cancers. Effective April 25, 2024, HOOKIPA regained full control of the associated intellectual property portfolio and has full collaboration and licensing rights for this program. Infectious Disease HB-400 is currently being evaluated in a Phase 1 trial and is one of two independent development programs in HOOKIPA's collaboration and license agreement with Gilead Sciences, Inc. (Gilead). Gilead is solely responsible for further development and commercialization of the HBV product candidate. HB-500 is an investigational therapeutic vaccine for the treatment of human immunodeficiency virus (HIV), also partnered with Gilead. HOOKIPA received FDA clearance of its IND application in the fourth quarter of 2023 and expects to initiate a Phase 1 clinical trial of HB-500 in people with HIV in the second quarter of 2024. Under the collaboration agreement with Gilead, HOOKIPA is eligible for a milestone payment upon dosing the first patient in this trial. Corporate and Financial Updates Corporate Highlights On January 29, 2024, HOOKIPA provided an update on its business priorities and oncology partnership programs. The Company announced that it will focus its resources in two strategic areas: (1) the clinical development of a randomized trial for its HB-200 program and (2) its two Gilead-partnered infectious disease cure programs for hepatitis B and HIV. Mark Winderlich, Ph.D., joined the Company on April 1, 2024, as Chief Development Officer to lead HOOKIPA's clinical research and development organization. Financial Highlights HOOKIPA received a final $10.0 million milestone payment under its now-terminated HB-700 collaboration agreement with Roche. The success-based milestone payment was achieved in connection with HOOKIPA's submission of an IND application for HB-700 for the treatment of KRAS mutated tumors. Total revenues of $36.6 million, mainly driven by the recognition of previously received upfront and milestone payments under the now-terminated Roche collaboration, as well as the recent HB-700 milestone achievement, led to a profitable first quarter of 2024. Anticipated Catalysts & Milestones Program Indication Upcoming Anticipated Catalysts Oncology Programs HB-200 HPV16+ HNSCC Additional Phase 2 first-line data for HB-200 in combination with pembrolizumab (ASCO 2024) Pivotal study start (4Q 2024) HB-700 KRAS Publication of preclinical data (ASCO 2024) Infectious Disease Programs: Gilead-Partnered HB-400 HBV Gilead-led: Phase 1b actively enrolling Next milestone: Initiation of Phase 2 (timing determined by Gilead)