Revolutionizing proof-of-concept results have emerged in transplantation, allowing complete immunosuppression withdrawal long-term in kidney transplant patients. Planned studies aim at enabling safe bone marrow transplantations across HLA-barriers.
Completed randomized placebo-controlled Phase II study, including >400 patients, provides important safety, pharmacodynamic, and pharmacokinetic results about our lead candidate Siplizumab.
Anti-CD2 as induction and rejection treatment
The data outlined below has been generated in Phase I clinical trials of the parent rat monoclonal anti-CD2, named BTI-322, the humanization of which constitutes Siplizumab. BTI-322 has the same specificity as Siplizumab, differing only in its non-humanized framework. These proof-of-concept studies show encouraging safety and efficacy results when using BTI-322, compared to standard of care alone, as induction and rejection treatment in transplantation.
One hurdle in gene therapy is the acute rejection of transplanted allogeneic cell products. The unique mechanisms of action of Siplizumab, permitting allospecific hyporesponsiveness, make it an ideal induction drug for gene therapies.