How Modified IL2 Proteins Can Treat Human Diseases

This patent describes new versions of the human immune protein Interleukin-2 (IL2), called muteins, designed to specifically target certain immune responses for treating various human diseases.

What it covers

This patent generally covers engineered versions of human Interleukin-2 (hIL2), known as muteins, which are proteins modified to have specific, or 'biased,' effects on the immune system. It also includes the pharmaceutical mixtures containing these muteins, the methods for creating these modified proteins, and the genetic tools (recombinant vectors and cells) that carry the instructions for making them. The ultimate goal is to use these biased IL2 muteins as a treatment for human diseases. For example, a specific IL2 mutein might be designed to boost only the anti-tumor immune cells, avoiding side effects on other immune cells.

What it doesn't cover

• —Does not cover the use of unmodified, natural human Interleukin-2 (hIL2) for therapeutic purposes.
• —Does not cover other types of immune-modulating proteins or small molecule drugs that are not IL2 muteins.
• —Does not cover IL2 muteins that are not 'biased' to specifically activate or suppress certain immune cell populations.
• —Does not cover methods of treatment that do not involve administering these specific IL2 muteins or their formulations.
• —Does not cover methods for preparing IL2 muteins that do not involve recombinant vectors or cells.

The clever bit

The novelty lies in creating 'biased' IL2 muteins. This means engineering the protein to specifically activate only certain parts of the immune system, rather than broadly stimulating all IL2-responsive cells, which can lead to severe side effects with unmodified IL2.

Why it matters

Interleukin-2 (IL2) is a powerful protein that helps the immune system fight cancer and infections, but its natural form can cause severe side effects by activating too many different types of immune cells. This patent focuses on 'biased' IL2 muteins, which are designed to be more precise, potentially offering safer and more effective treatments for conditions like cancer and autoimmune diseases. This precision could unlock the full therapeutic potential of IL2 by minimizing unwanted immune activation.

Real-world examples

• 1.Bempegaldesleukin (NKTR-214)
• 2.Roche's RG7461 (fused IL2)
• 3.Sanofi's SAR444245 (IL2 mutein)
• 4.Alkermes' nemvaleukin alfa (IL2 fusion protein)
• 5.Companies developing next-generation cytokine therapies for oncology