Evaluating Safety and Efficacy of TOL101 Induction Versus Anti-Thymocyte Globulin to Prevent Kidney Transplant Rejection

Induction therapy with antibodies is administered during transplant surgery and for a short
period of time following transplant surgery in an effort to render the immune system less
able to mount an initial rejection response. In general, induction therapy is associated
with better outcomes compared to the absence of induction therapy. However, currently used
induction agents, some of which are not labeled or indicated for induction therapy in
transplantation, have drawbacks related to long-term immune system suppression increasing
susceptibility to opportunistic infections or malignancies, and other immune-mediated side
effects.

An unmet medical need exists for a more specific approach to prevent acute organ rejection,
without unnecessarily exposing the patient to non-specific or open-ended immune suppression,
which may exacerbate the risks of infections and malignancies. TOL101 is a novel antibody
that targets a very specific immune cell type that is critical in the acute organ rejection
response. In this two-part study, TOL101 will be evaluated for the prophylaxis of acute
organ rejection when used as part of an immunosuppressive regimen that includes steroids,
MMF, and tacrolimus in first time kidney transplant recipients.

This study will test the hypothesis that a more specific approach (with TOL101) to
prevention of acute organ rejection may provide similar or better efficacy than the
currently used induction antibodies (such as Anti-Thymocyte Globulin or Thymoglobulin) while
carrying fewer risks in terms of opportunistic infections, malignancies and adverse effects.