Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TNX-832 · 1 trial · 3 indications
To evaluate the safety of escalating dose levels of TNX-832 in subjects with suspected or proven bacteria-induced ALI/ARDS. Safety was assessed by number of treatment emergent adverse events, and changes in vital signs, ECGs, laboratory, coagulation and pulmonary function parameters from baseline. Immunogenicity (serum anti-TNX-832 antibody response) was evalutated.
maximum observed concentration (Cmax)
Area under the plasma concentration curve from time 0 extrapolated to infinite time (AUC0-inf). AUClast (area under the serum concentration-time curve from the time of dosing to the time of the last observed concentration).
t1/2 (terminal elimination phase half life). Tmax (time to maximum serum concentration).
Volume of distribution (Vd) based on the terminal elimination phase, also referred to as VZ; in mL/kg. Volume of distribution at steady state (Vss), calculated as the Mean residence Time times Clearance; in mL/kg.
Total body clearance, CL=Dose/AUC; in mL/hr/kg
| Arm | Type | Description |
|---|---|---|
| TNX-832 | EXPERIMENTAL | Anti-tissue factor antibody |
| Drug Placebo | PLACEBO_COMPARATOR | Placebo control |
| Name | Type | Description |
|---|---|---|
| TNX-832 | BIOLOGICAL | Single intravenous dose of TNX-832 at 0.06, 0.08 or 0.10 mg/kg |
| Placebo | DRUG | Single intravenous dose of saline control |
Inclusion Criteria: 1. ≥ 18 years 2. Suspected or proven bacterial infection 3. Receiving positive pressure ventilation through an endotracheal tube 4. Have ALI/ARDS, defined as having all of the following: * bilateral infiltrates consistent with pulmonary edema * Hypoxemia * no clinical ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| ImmunityBio Inc | IBRX | 1 | PHASE2 | Nogapendekin alfa inbakicept |
| Bluejay Diagnostics, Inc. | BJDX | 2 | - | Undisclosed |
| CytoSorbents Corporation | CTSO | 1 | - | Undisclosed |
| Danaher Corporation | DHR | 3 | - | Undisclosed |
| Spectral AI, Inc. Class A | MDAI | 1 | N/A | Undisclosed |
TNX-832 is a monoclonal antibody being developed for sepsis, a life-threatening condition caused by the body's response to an infection. It is also being studied in patients with acute lung injury and acute respiratory distress syndrome, which are common complications of sepsis. The drug is currently in Phase 1 clinical development.
TNX-832 is a monoclonal antibody, but its specific molecular target has not been disclosed in the available information. The drug is being studied for its potential effects in sepsis and related conditions such as acute lung injury and acute respiratory distress syndrome.
TNX-832 is being developed by ImmunityBio, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IBRX. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for the treatment of sepsis.
TNX-832 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial has been completed, and the drug is not currently in active clinical trials.
TNX-832 has been studied in one clinical trial, identified as NCT01438853. This Phase 1 trial, titled 'Effects of TNX-832 (Sunol cH36) in Subjects With Acute Lung Injury/Acute Respiratory Distress Syndrome,' was completed and enrolled 18 participants. The study was conducted in the United States and Canada.
Yes, TNX-832 is also known as Sunol cH36. The clinical trial NCT01438853 refers to the drug as TNX-832 (Sunol cH36), indicating that these names are used interchangeably for the same investigational monoclonal antibody.