HOOKIPA Pharma Inc. announced that the Company has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for HB-700, a novel arenaviral therapeutic vaccine for the treatment of KRAS-mutated cancers. HOOKIPA's HB-700 program is designed to treat KRAS-mutated lung, colorectal, pancreatic and other cancers by targeting the five most prevalent KRAS mutations in these disease indications: G12D, G12V, G12R, G12C and G13D. This program has the potential to benefit more patients than single mutation inhibitors.

The IND submission achieves a final $10 million milestone payment from Roche. 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. 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, G12 C and G13D) and may benefit more patients than single mutation inhibitor. The IND submission achieves a final $10 million milestone payment from Roche. Effective April 25, 2024, the Company will regain full control of the associated intellectual property portfolio and have full collaboration and licensing rights for the HB-700 program.

The Company will publish preclinical data in an abstract at the American Society for Clinical Oncology (ASCO) 2024 Annual Meeting.