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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE3 | Tozorakimab |
| GSK plc Sponsored ADR | GSK | 3 | PHASE1 | Pn-MAPS30plus, PCV20 |
| Pfizer Inc. | PFE | 4 | - | Undisclosed |
| Sanofi SA Sponsored ADR | SNY | 1 | - | Undisclosed |
| Gilead Sciences, Inc. | GILD | 1 | - | Undisclosed |
| Grace Therapeutics, Inc. | GRCE | 1 | N/A | Undisclosed |
agenT-797 is an investigational therapy being studied for use in pneumonia, relapsed/refractory solid tumors, relapsed/refractory multiple myeloma, and adult respiratory distress syndrome. It is being developed by Agenus Inc. and is currently in Phase 2 clinical trials for severe pneumonia with acute hypoxemic respiratory failure.
agenT-797 is being developed by Agenus Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AGEN. The company is conducting clinical trials to evaluate the safety and efficacy of agenT-797 across multiple indications.
agenT-797 is currently in Phase 2 clinical development. A Phase 2 trial is recruiting participants with severe pneumonia and moderate to severe acute hypoxemic respiratory failure. Earlier Phase 1 trials for other indications have been completed.
agenT-797 is being studied in a Phase 2 trial with NCT number NCT07615010, which is recruiting participants with severe pneumonia. Completed Phase 1 trials include NCT04582201 for adult respiratory distress syndrome, NCT04754100 for relapsed/refractory multiple myeloma, and NCT05108623 for relapsed/refractory solid tumors.
agenT-797 is not FDA approved. It is an investigational drug currently in clinical development. A Phase 2 trial is ongoing, and earlier Phase 1 trials have been completed, but the drug has not yet received regulatory approval for any indication.