The Fully Human Therapeutic Monoclonal Antibody Platform (HuMAb)

1. Antibodies = immune defense and therapeutic breakthrough!
2. The Structure of Antibodies
3. Generating Therapeutic Antibodies for Clinical Application
4. Key Strategic Choices
5. Competitive Advantage
6. Biological Validation as a Critical Step for Product Selection
7. Business Model
8. NovImmune’s pipeline for Therapeutic Monoclonal Antibodies

SCIENTIFIC PLATFORMS: HuMAb
8. NovImmune’s pipeline for Therapeutic Monoclonal Antibodies

Pipeline Development Strategy

  • NovImmune’s current pipeline consists of several different monoclonal programmes at various stages of discovery and development, all focused in the field of immune-related disorders and inflammation
  • To continue to acquire proprietary targets from biotechnology companies and academic laboratories
  • First two products are in GMP manufacturing and clinical development.

    The first two therapeutic monoclonal antibodies, NI-0401 and NI-0501, selected by NovImmune as its first two drugs have already been fully validated in terms of medical relevance in the very large medical field of autoimmune diseases and inflammation.

    The unique feature of the first two NovImmune drugs is that they are the fully human versions of humanised therapeutic monoclonal antibodies that have already been fully validated, not only in animal models of human diseases, but also in Phase I and Phase II clinical trials in Psoriasis and Type I Diabetes. In addition, they are currently being evaluated in Inflammatory Bowel Disease.

NI-0401 and NI-0501:
  • NI-0401 targets the CD3 antigen, a key regulator in the activation of T-cells. The proliferation of activated T-cells is a hallmark of many autoimmune diseases, including insulin-dependent diabetes, Crohn’s disease, multiple sclerosis and rheumatoid arthritis, and of organ transplant rejection.
  • NI-0501 targets interferon-gamma, a key cytokine involved in the regulation of immune and inflammatory responses. Interferon-gamma is overexpressed in autoimmune diseases such as systemic lupus erythematosus, Crohn’s disease and several forms of vasculitis.

NI-0401 has received regulatory approval to enter clinical trials and NI-0501 is currently in preclinical development and GMP manufacturing.

© Novimmune 2008