HOOKIPA has received a US$10m milestone under its 2022 agreement with Roche to develop an arenaviral immunotherapy for KRAS-mutated cancers.
The Vienna-based arenavirus specialist got the non-dilutive milestone payment for advancing its drug programme HB-700, a novel arenaviral immunotherapy for KRAS-mutated cancers, for the start of the manufacturing process to support a Phase I clinical trial. HOOKIPA plans to submit an Investigational New Drug Application (IND) to the US Food and Drug Administration in the first half of 2024.
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 Ib 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 commercialisation milestone-based payments up to approximately $930m for both programs, plus royalties.
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 are assumed causative for cancer. While KRAS-mutated, tumour-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.
HOOKIPA’s replicating arenaviral technology has been demonstrated to induce potent antigen-specific T cell responses and promising anti-tumour activity in a Phase I clinical trial in which patients with advanced Human Papillomavirus 16-positive head and neck cancers were treated. Preclinical studies suggest that arenaviral immunotherapies might 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.
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 common KRAS mutations such as G12D, G12V, G12R, G12C and G13D and thereby may benefit more patients than single mutation inhibitors.