Tegoprubart for the Prevention of Rejection in Kidney Transplant: Update of Emerging Data from an Ongoing Trial
- Transplantation: Clinical - I
November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
Abstract Time: 10:00 AM - 12:00 PM
- 2102 Transplantation: Clinical
- Gill, John S., St Paul's Hospital, Vancouver, British Columbia, Canada
- Bornstein, Jeffrey D., Eledon Pharmaceuticals, Irvine, California, United States
Tegoprubart is a monoclonal antibody directed against the CD40 ligand (CD40L), a key mediator of co-stimulation. Inhibition of CD40L should result in a decrease in both cell and antibody mediated immunity and create a more tolerogenic immune environment. Tegoprubart has been shown to be effective in animal models and is currently being studied in kidney transplant recipients. It is being assessed to determine whether it can provide similar prevention of rejection as tacrolimus with superior graft function.
12 adults receiving a kidney transplant from either a living or deceased donor will be enrolled. To be eligible, this must be their first transplant, they must be seropositive for EBV, free of donor specific antibodies, have low panel reactive antibodies, and the organ cannot be from an extended criteria donor or have a prolonged cold ischemia time. All participants will receive rATG and a regimen consisting of tegoprubart 20 mg/kg IV administered every 3 weeks after initial loading, mycophenolate and corticosteroids. The primary endpoint is safety at one year. Secondary endpoints include characterizing the pharmacokinetic profile of tegoprubart, the incidence of biopsy proven rejection (BPAR) and changes in estimated glomerular filtration rate (eGFR).
As of the abstract submission deadline, May 2023, 5 participants have been transplanted, and 3 are ongoing. No participant has experienced rejection. One discontinued due to an SAE of BK viremia and another for mild alopecia and fatigue. BK viremia was the only SAE reported to date, and the drug appears safe and well tolerated. Participant information is summarized in Table 1, and mean eGFR is summarized in Figure 1.
Improved graft function may improve long term outcomes in kidney transplantation. It is postulated that tegoprubart could be an alternative therapy for prevention of rejection in kidney transplant recipients. Data to date are encouraging, with no rejections, a good safety profile and excellent allograft function.
- Commercial Support – Eledon Pharmaceuticals Inc