CD3 ribbon model
CD3-epsilon
Ribbon model of the CD3ε protein molecule.
Product Pipeline

NI-0401

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.

Product Snapshot

NI-0401 anti-CD3-epsilon

Goal

  • Modulate T-cell activity with a best in class mAb.

Status

  • 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
    (no HAHA)
  • Subcutaneous formulation and drug supply available
  • Excellent shelf life, e.g. stable at @5°C, 36 months