Wednesday, HOOKIPA Pharma Inc ( HOOK ) received clearance from the FDA for its Investigational New Drug (IND) application for HB-700, a novel arenaviral therapeutic vaccine for the treatment of KRAS-mutated cancers.

In January, Roche terminated the collaboration and licensing agreement for HOOKIPA’s HB-700 program in 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 company says the program can benefit more patients than single mutation inhibitors.

The IND submission achieves a final $10 million milestone payment from Roche Holdings AG (OTC:RHHBY).

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. 

Earlier this year, HOOKIPA Pharma ( HOOK ) announced to focus its resources on prioritizing the clinical development of a randomized trial for its HB-200 program in human papillomavirus 16 positive (HPV16+) head and neck squamous cell carcinoma (HNSCC) and its two Gilead Science Inc -partnered infectious disease cure programs for hepatitis B and human immunodeficiency virus.

Price Action: HOOK shares are up 1.29% at $0.75 at the last check Wednesday.

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