secwatch.observer — SEC 8-K summary
======================================

Issuer:     HOOKIPA Pharma Inc. (HOOK)
CIK:        0001760542
Form:       8-K
Filed at:   2024-06-04T23:59:59+00:00
Accession:  0001104659-24-068248
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

HOOKIPA reports 53% ORR in CPS≥20 subgroup from Phase2 HB-200 + pembro trial at ASCO
--------------------------------------------------------------------------------

- Among 35 evaluable first-line HPV16+ HNSCC patients, ORR 37%, CR 11%, DCR 69% per RECIST 1.1.
- In CPS≥20 subgroup (N=17, registrational target): ORR 53%, CR 18%, DCR 82%; PFS 16.3 mo, OS rate 88% at 9 mo.
- HB-200 + pembrolizumab well-tolerated; Grade≥3 TRAEs in 15%, no treatment-related deaths.
- Company plans to begin pivotal Phase 2/3 trial in Q4 2024 with FDA alignment on path to accelerated approval.
- Data presented as oral abstract at ASCO 2024; median follow-up for CPS≥20 subgroup was 8.4 months.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1760542/000110465924068248/0001104659-24-068248-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1760542/000110465924068248/tm2416401d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-24-068248

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer