Molecular Target: CD3-epsilon
CD3-epsilon (or CD3ε) is a molecule that sits on the surface of a white blood cell called a T-cell, or T-lymphocyte. In humans, CD3-epsilon is encoded by the CD3E gene on Chromosome 11.
The CD3ε molecule, along with four other membrane-bound polypeptides (CD3-gamma, -delta, -zeta, and -eta) form the CD3 complex. The CD3 complex, in turn, is associated with the T-cell receptor (TCR), which consists of additional molecules also on the surface of the T-cell, whose job is to recognize and combine with antigens.
When an antigen binds to the T-cell receptor, the CD3 complex sends signals through the cell membrane to the cytoplasm inside the T-cell. This causes activation of the T-cell that rapidly divide to produce new T-cells sensitized to fight the particular antigen to which the TCR were exposed.
While T-cell activation is critical for the human immune system to properly fight bacterial, viral or parasitic infections, abnormal T-cell induction can cause and worsen numerous human diseases, including T-cell lymphoma and leukemia, human malignancies, autoimmune disorders, cardiovascular disease, and transplant rejection.
Novimmune's NI-0401 monoclonal antibody (mAb) is intended to alter auto-aggressive T-cell responses by targeting the T-cell receptor complex.
A Phase I and Phase IIa clinical trial in Crohn's disease, and a Phase I / II open-label study in renal allograft transplantation have been completed.
- Modulate T-cell activity with a best in class mAb.
- Phase I / IIa completed two trials in Crohn's disease
(no human anti-human antibodies [HAHA])
- Phase I / Proof-of-Concept completed in renal allograft transplantation
- Subcutaneous formulation and drug supply available
- Excellent shelf life, e.g. stable at @5°C, 36 months