---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-051581"
form_type: "8-K"
ticker: "HOOK"
cik: "0001760542"
company_name: "HOOKIPA Pharma Inc."
filed_at: "2024-04-25T23:59:59+00:00"
generated_at: "2026-06-03T08:09:20.634880+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# HOOKIPA announces pivotal Phase 2/3 trial design for HB-200 in combo with pembrolizumab; FDA alignment

## Summary
- Pivotal Phase 2/3 trial for HB-200 + pembrolizumab in first-line HPV16+ recurrent/metastatic OPSCC; FDA alignment achieved.
- Trial expected to enroll ~250 patients; Phase 2 primary analysis in 2026 with potential accelerated approval filing.
- First patient enrollment anticipated in Q4 2024.
- HB-200 abstract accepted as oral presentation at ASCO 2024 with data from ~40 patients in head and neck cancer.
- Company also received PRIME designation from EMA for HB-200 in combination with pembrolizumab.

## SEC filing metadata
- accession: 0001104659-24-051581
- form_type: 8-K
- ticker: HOOK
- cik: 0001760542
- company_name: HOOKIPA Pharma Inc.
- filed_at: 2024-04-25T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1760542/000110465924051581/0001104659-24-051581-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1760542/000110465924051581/tm2412672d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-051581
- JSON: https://secwatch.observer/filing/0001104659-24-051581.json
- Plain text: https://secwatch.observer/filing/0001104659-24-051581.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.