Hookipa hopes for a head and neck fast track

24 July 2024

Within days, troubled Hookipa has ousted its leaders and begun a phase 2/3 study of its lead project, HB-200, as it aims for accelerated approval in HPV16-positive head and neck cancer. HB-200, a modified arenavirus said to activate an HPV16+ specific T-cell response, is being tested alongside Keytruda, versus Keytruda alone, in first-line patients with PD-L1 expression of 20% or more. This population fared best in a phase 1/2 Keytruda combo, ASCO recently heard, although the project will now need to replicate this in a controlled study. The group’s stock has been in the doldrums since early data from the same trial, and things got worse earlier this year when Hookipa lost Roche as a KRAS partner. The focus is now squarely on HB-200 – which combines HB-201 and HB-202 – and Hookipa hopes to file for accelerated approval based on the phase 2 portion of the newly listed trial, which has a primary endpoint of overall response rate; data are due in 2026. The phase 3 part, meanwhile, will report overall survival data in 2028, to support full approval. Completing the study might be a problem, though: in March Hookipa had $93m in cash, and it has limited means of raising more given its depressed share price.

Phase 2 data with HB-200 + Keytruda