CD40-CD40L interaction is an attractive target for blocking T-cell–mediated B-cell–driven autoimmunity and prevention of solid organ transplant rejection. External proof-of-concept for inhibition of this pathway has been previously established in patients with a broad range of autoimmune diseases, including systemic lupus erythematosus, rheumatoid arthritis, Sjögren syndrome, liver transplant, and Graves disease.
We are enrolling healthy subjects in a single-ascending-dose Phase 1 clinical trial. The first-in-human trial will measure safety and pharmacokinetics as well as receptor occupancy and T-cell–dependent antibody responses. Top-line data are expected in the second half of 2020.