The invention concerns immunotoxins and methods of using the immunotoxins for the treatment of autoimmune diseases and T cell malignancies. The immunotoxins are targeted via an antibody that is specific to T cells. This allows the specific ablation of malignant T cells and resting T cells. The transient ablation of resting T cells can "reset" the immune system by accentuating tolerizing responses. The toxin portion of the immunotoxin is genetically engineered to maintain bioactivity when recombinantly produced in Pichia pastoris. Data are available in transgenic animals expressing human CD3epsilon which supports the effects of the immunotoxin against T cells.
- Treatment of autoimmune diseases such as multiple sclerosis, lupus, type I diabetes, aplastic anemia
- Treatment of T cell leukemias and lymphomas such as cutaneous T cell leukemia/lymphoma (CTCL)
- Specificity of the immunotoxin avoids the killing of non-T cells, reducing side-effects associated with other mechanisms of treatment (e.g., radiation and cyclophosphamide) such as infection and induced malignancy.
- A GMP production process has already been successfully implemented, and patient doses are available.
- All testing required for an FDA issued IND has been completed, allowing faster evaluation of the efficacy of the invention.