Hookipa Pharma announces FDA clearance of IND application for HB-700

HOOKIPA Pharma 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. 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. “We are proud to have another IND cleared for a potentially powerful oncology program. Our HB-700 program targets five KRAS-mutations found in multiple cancer indications with a single product candidate,” said Joern Aldag, Chief Executive Officer at HOOKIPA. “Importantly, the submission of the IND results in us receiving a final $10 million milestone payment. We continue to define our clinical development strategy which includes the possibility of collaboration or partnership for this program.”