Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
agenT-797 · 4 trials · 4 indications
This will be determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0).
This will be determined according to the NCI CTCAE v5.0.
This will be determined according to the NCI CTCAE v5.0.
This will be determined according to the NCI CTCAE v5.0.
This will be determined by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0.
| Arm | Type | Description |
|---|---|---|
| agenT-797 plus SOC | EXPERIMENTAL | Participants will receive agenT-797 and SOC. |
| Placebo plus SOC | PLACEBO_COMPARATOR | Participants will receive placebo and SOC. |
| Part 1: Monotherapy with agenT-797 | EXPERIMENTAL | 3+3 Dose escalation of agenT-797 will be administered as a single intravenous (IV) infusion. |
| Part 2: agenT-797 in Combination with approved ICIs | EXPERIMENTAL | Single prespecified dose of agenT-797 administered by IV infusion in combination with approved ICIs administered in accordance with manufacturer instructions and institutional guidelines as per standard of care |
| Allogeneic iNKT Cells | EXPERIMENTAL | 3+3 Dose escalation of agenT-797 will be administered by intravenous infusion every 2 weeks (each cycle is 14 days \[2 weeks\]). |
| Dosage and Cohorts | EXPERIMENTAL | Cohort 1: 100 × 10\^6 iNKT cells; Cohort 2: 300 × 10\^6 iNKT cells; Cohort 3: 1000 × 10\^6 iNKT cells Dosage Frequency and Mode of Administration: agenT-797 will be administered to hospitalized participants as a single intravenous infusion. |
| Name | Type | Description |
|---|---|---|
| agenT-797 | DRUG | Intravenous infusion |
| Placebo | DRUG | Intravenous infusion |
| Standard of Care (SOC) | DRUG | Antimicrobial therapy and corticosteroids per applicable guidelines. |
| Approved ICIs | DRUG | Nivolumab and pembrolizumab |
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...
Top 4 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE3 | Tozorakimab |
| GSK plc Sponsored ADR | GSK | 3 | PHASE1 | Pn-MAPS30plus |
| Agenus Inc. | AGEN | 1 | PHASE2 | agenT-797 |
| Merck & Co., Inc. | MRK | 1 | PHASE1 | V175, V175A |
agenT-797 is an investigational small molecule being studied for pneumonia, relapsed/refractory multiple myeloma, adult respiratory distress syndrome, and solid tumors. It is currently in Phase 2 clinical development for severe pneumonia with moderate to severe acute hypoxemic respiratory failure.
agenT-797 targets CD1d, a protein involved in antigen presentation. By engaging CD1d, the drug is designed to modulate immune responses in the conditions being studied, including pneumonia and multiple myeloma.
agenT-797 is being developed by Agenus Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol AGEN. The company is conducting clinical trials of agenT-797 across multiple indications.
agenT-797 is in Phase 2 clinical development for severe pneumonia. It has completed Phase 1 trials in solid tumors, relapsed/refractory multiple myeloma, and adult respiratory distress syndrome. The drug is investigational and not yet approved.
agenT-797 is being evaluated in NCT07615010, a Phase 2 trial for severe pneumonia with acute hypoxemic respiratory failure, currently recruiting 90 participants in the United States and Ukraine. Completed Phase 1 trials include NCT05108623 for solid tumors, NCT04754100 for multiple myeloma, and NCT04582201 for ARDS.
agenT-797 is a distinct investigational agent developed by Agenus Inc. No alternative names for this drug have been reported in clinical trial registrations. It is being studied as a monotherapy and in combination with standard of care in various indications.