On February 13, 2023 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapies based on its proprietary arenavirus platform, reported that it has achieved a $10 million non-dilutive milestone payment under its collaboration agreement with Roche to develop HB-700, a novel arenaviral immunotherapy for KRAS-mutated cancers (Press release, Hookipa Pharma, FEB 13, 2023, View Source [SID1234627103]). The success-based milestone payment reflects the start of the HB-700 manufacturing process to support a Phase 1 clinical trial. HOOKIPA plans to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration in the first half of 2024.
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"We’re really pleased to start the year strongly by achieving this milestone in our collaboration with Roche to develop HB-700 for KRAS-mutated cancers," said Joern Aldag, Chief Executive Officer at HOOKIPA. "We’re excited to advance the HB-700 program, our third in oncology, and we’re eager to explore the potential of our technology in addressing another unmet need in cancer."
In October 2022, HOOKIPA and Roche announced a strategic collaboration agreement to license and develop HB-700 for KRAS-mutated cancers and an option for a second, undisclosed arenaviral immunotherapy. Through the collaboration, HOOKIPA is conducting research and early clinical development through Phase 1b for HB-700. Upon the completion of the Phase 1b trial, Roche has the right to assume development responsibility and to commercialize licensed products across multiple indications upon approval. Under the collaboration, HOOKIPA is eligible for research, development and commercialization milestone-based payments up to approximately $930 million for both programs, plus royalties.
About KRAS-mutated cancers
KRAS is a gene that acts as an on/off switch for cell growth. When there is a mutation, or error, in the gene, cells can grow out of control. KRAS mutations are among the most common mutations that cause cancer. While KRAS-mutated, tumor-specific treatments exist, there remains an opportunity to target a broader range of KRAS-mutations simultaneously and thereby potentially help more people impacted by these cancers.
About HOOKIPA’s arenaviral technology
HOOKIPA’s novel, replicating arenaviral technology has demonstrated the ability to induce potent antigen-specific T cell responses and promising anti-tumor activity in a Phase 1 clinical trial which treated patients with advanced Human Papillomavirus 16-positive head and neck cancers. Preclinical studies have also demonstrated the ability of arenaviral immunotherapies to break self-tolerance and induce potent T cell responses to tumor self-antigens and mutated epitopes, or target parts of a mutated, cancer-causing gene. These findings provide scientific rationale for the HB-700 program.
About HB-700
HB-700 is an investigational arenaviral immunotherapy designed to treat KRAS-mutated lung, colorectal, pancreatic and other cancers. HB-700 is a replicating 2-vector therapy that targets the most common KRAS mutations (G12D, G12V, G12R, G12C and G13D) and thereby may benefit more patients than single mutation inhibitors.