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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 developed by Tonix Pharmaceuticals Holding Corp. (ticker TNXP) for use in kidney transplantation. It is designed as an immunosuppressive therapy to help prevent rejection of transplanted kidneys. TNX-1500 is currently in Phase 1 clinical development and has not been approved by the FDA.
TNX-1500 targets CD40L, a protein involved in immune system signaling. By binding to CD40L, the drug is intended to modulate the immune response that contributes to transplant rejection. This CD40L-targeting approach is being studied in the context of kidney transplant immunosuppression.
TNX-1500 is being developed by Tonix Pharmaceuticals Holding Corp., which trades under the ticker symbol TNXP. Tonix is the sponsor of the clinical development program for TNX-1500 in kidney transplantation.
TNX-1500 is in Phase 1 clinical development. A Phase 1 first-in-human study in healthy subjects has been completed, and a Phase 2 study in kidney transplant recipients is listed as not yet recruiting. TNX-1500 is investigational and has not been approved by the FDA.
TNX-1500 has been studied in two registered clinical trials. NCT07473752 was a completed Phase 1 randomized, double-blind, placebo-controlled single ascending dose study in 26 healthy subjects in the United States. NCT07204080 is a Phase 2 trial in kidney transplant recipients with an enrollment of 5, listed as not yet recruiting.
TNX-1500 is being developed for use in kidney transplant recipients as an immunosuppressive therapy. The goal is to help prevent kidney transplant failure and rejection by suppressing the immune response. It is investigational and is being evaluated in clinical trials, including a Phase 2 study in kidney transplant recipients.