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agenT-797

Phase 2

Pneumonia | Small molecule | Infectious Disease |Agenus Inc.|Last Updated: May 29, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment90
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07615010A Clinical Trial to Evaluate agenT-797 Plus Standard of Care in Participants With Severe Pneumonia With Moderate to Severe Acute Hypoxemic Respiratory FailurePHASE2 RECRUITING 90May 22, 2026Aug 1, 2027May 29, 20264 United States, Ukraine
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Study Endpoints
Primary Endpoints
Number of Deaths (All-cause Mortality)
Day 1 through Day 28
Secondary Endpoints
Number of Oxygenation Support-free Days
Day 1 through Day 28
Time to Resolution of Hypoxemia
Day 1 through Day 28
Number of Ventilator-free Days
Day 1 through Day 28
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
agenT-797 plus SOCEXPERIMENTALParticipants will receive agenT-797 and SOC.
Placebo plus SOCPLACEBO_COMPARATORParticipants will receive placebo and SOC.
Interventions
NameTypeDescription
agenT-797DRUGIntravenous infusion
PlaceboDRUGIntravenous infusion
Standard of Care (SOC)DRUGAntimicrobial therapy and corticosteroids per applicable guidelines.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Key Inclusion Criteria: * Admission to an intensive care unit (ICU) with severe pneumonia of any etiology (viral, bacterial, fungal, or mixed), with and without trauma based on clinical suspicion * Acute hypoxemic respiratory failure (AHRF) * Evidence of moderate to severe acute respiratory distres...

Countries:United StatesUkraine
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Recent Changes (Last 90 Days)
LOWMay 29, 2026NCT07615010NEW_TRIAL: changed
LOWMay 29, 2026NCT07615010NEW_TRIAL: changed
LOWMay 29, 2026NCT07615010NEW_TRIAL: changed