HOOKIPA Pharma Announces FDA Clearance of its Investigational New Drug Application for HB-700 for the Treatment of KRAS-Mutated Cancers

NEW YORK and VIENNA, Austria, April 24, 2024 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today 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. 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.

“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.”

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 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 may benefit more patients than single mutation inhibitors.