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TNX-1500 · 2 trials · 5 indications
The primary endpoint is the cumulative incidence of all AEs and SAEs in subjects treated with TNX-1500 at 12-months (Day 364, Week 52).
The primary endpoint is the cumulative incidence of all AEs and SAEs in subjects treated with TNX-1500 at 12-months (Day 364, Week 52).
| Arm | Type | Description |
|---|---|---|
| Kidney Transplant Recipient | EXPERIMENTAL | - |
| Arm 1: TNX-1500 3 mg/kg | EXPERIMENTAL | - |
| Arm 2: TNX-1500 10 mg/kg | EXPERIMENTAL | - |
| Arm 3: TNX-1500 30 mg/kg | EXPERIMENTAL | - |
| Arm 4: Placebo | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| TNX-1500 | DRUG | This is an open-label, single-center, single-arm study to assess the safety and efficacy of TNX-1500, an Fc-modified anti-DF154 mAb in five adult kidney transplant recipients. |
| Kidney Transplant | PROCEDURE | Kidney Transplant |
| Placebo: USP 0.9% sterile saline for injection | DRUG | The placebo comparator arm (Arm 4) |
| Keyhole Limpet Hemocyanin (KLH) | BIOLOGICAL | KLH is not the primary therapeutic drug being tested. Instead, it is an "immunogenic T-cell dependent antigen" used as a challenge tool to assess the pharmacological and immunosuppressant effects of TNX-1500 |
Inclusion Criteria: 1. Male or female subjects ≥18 to 75 years of age. 2. Kidney transplant candidates with chronic kidney disease (stage IV or V) or end-stage kidney disease evaluated and listed for transplantation at Massachusetts General Hospital. 3. Recipient of an ABO-compatible, non-human leu...
TNX-1500 is an investigational small molecule being developed for use in kidney transplant recipients to address kidney transplant failure and rejection, and for immunosuppression after kidney transplantation. It is also being studied in a Phase 1 first-in-human trial involving healthy subjects to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics.
TNX-1500 targets CD40L, a protein involved in immune system signaling. By targeting CD40L, TNX-1500 is being studied for its potential role in immunosuppression in the setting of kidney transplantation.
TNX-1500 is being developed by Tonix Pharmaceuticals Holding Corp., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TNXP.
TNX-1500 is in Phase 2 clinical development for kidney transplant recipients. A Phase 1 first-in-human study in healthy subjects has been completed. TNX-1500 is investigational and has not been approved by the FDA.
TNX-1500 is involved in two clinical trials. NCT07204080 is a Phase 2 trial in kidney transplant recipients, not yet recruiting, with an enrollment of 5. NCT07473752 is a completed Phase 1 randomized, double-blind, placebo-controlled single ascending dose study in healthy subjects with an enrollment of 26.
No alternative names for TNX-1500 have been disclosed. It is identified solely by the code name TNX-1500 in clinical trial registrations.