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HB-200

Phase 1

HPV16+ Squamous Cell Carcinoma | Small molecule | Oncology |HOOKIPA Pharma Inc.|Last Updated: Jan 20, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment7
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06373380A Study of HB-202/HB-201 in People With Human Papilloma Virus 16-Positive Head and Neck Squamous Cell Cancer (HPV 16+ HNSCC)EARLY_PHASE1 ACTIVE NOT_RECRUITING 7Apr 15, 2024Apr 1, 2027Jan 20, 20267 United States
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Study Endpoints
Primary Endpoints
Evaluable for overall survival
up to 3 years

Patients who have received at least one dose of treatment will be considered evaluable. Origin time point will be from start of treatment.

Secondary Endpoints
Number of participants with adverse events (type, frequency, severity).
1 year
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
HB-200 armEXPERIMENTALHB-202 and HB-201 will be given in an alternating fashion for 4 total treatments.
Interventions
NameTypeDescription
HB-200DRUGHB-200 arm will receive HB-202 and HB-201 (HB-202: 1 x 10 \^7 RCV FFU and HB201: 5 x 106 RCV FFU) in an alternating fashion every (21 days) intravenously for 4 doses (2 doses each of HB-202 and HB-201 alternating).
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Pathologically (histologically or cytologically) proven diagnosis of HPV16+ squamous cell carcinoma of the head and neck post standard of care definitive therapy. * History of histologically confirmed HPV16+ squamous cell cancer (from in-house or local evaluation by HPV16 R...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06373380studyFirstPostDate: changed