# How a Special Enzyme Helps Deliver Immune Drugs Under the Skin

> This patent describes a specific, modified human hyaluronidase enzyme that helps the body absorb immune globulin drugs when injected just under the skin, making treatments easier for patients.

- **Patent:** US 10588983
- **Original title:** Soluble glycosaminoglycanases and methods of preparing and using soluble glycosaminoglycanases
- **Owner:** Halozyme
- **Granted:** 2020
- **Status:** Active
- **Times cited:** 7
- **Field:** biotech, pharmaceutical, telecommunications

## What it does

The patent claims a method for boosting a subject's immune system by injecting immune globulin (IG) and a special soluble hyaluronidase enzyme under the skin. This specific hyaluronidase is a "soluble neutral active human hyaluronidase glycoprotein" (sHASEGP) that works well at the body's neutral pH. It has at least one sugar molecule attached to an asparagine amino acid and is a shortened version of a larger natural enzyme, specifically containing amino acids 36-464 of SEQ ID NO: 1, but truncated at its C-terminus at specific points like amino acid 477 or 483. This enzyme helps the IG spread and absorb better. For example, a patient needing a large dose of immune globulin can receive it as a less painful subcutaneous injection instead of an intravenous infusion, thanks to this enzyme.

## What it does NOT cover

- Does not cover administering hyaluronidase and immune globulin through methods other than subcutaneous injection (e.g., intravenous infusion).
- Does not cover using this specific hyaluronidase to deliver therapeutic molecules other than immune globulin for immune system modulation.
- Does not cover hyaluronidase enzymes that contain the complete, full-length amino acid sequence of SEQ ID NO: 1.
- Does not cover hyaluronidase enzymes that lack the specific asparagine-linked sugar moiety required by the claims.
- Does not cover hyaluronidase polypeptides with C-terminal truncations outside the specified amino acid residues (e.g., 477-494 of SEQ ID NO: 1) or with less than 95% sequence identity to the claimed truncated forms.

## The clever bit

The novelty lies in identifying and engineering a specific, truncated, and glycosylated human hyaluronidase that remains soluble and active at neutral pH, making it ideal for co-administration with other drugs to enhance their subcutaneous absorption.

## Real-world examples

1. Halozyme's ENHANZE drug delivery technology platform
2. Herceptin Hylecta (trastuzumab and hyaluronidase-zzxf)
3. Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf)
4. Darzalex Faspro (daratumumab and hyaluronidase-fihj)
5. Hyqvia (immune globulin infusion 10% with recombinant human hyaluronidase)

## Why it matters

This technology is important because it makes it possible to deliver large volumes of drugs, like immune globulin, through a simple injection under the skin rather than a lengthy intravenous infusion. This significantly improves convenience and quality of life for patients who require regular treatments. Halozyme, the assignee, has built a platform around this type of enzyme to enable subcutaneous delivery for many different therapeutic areas.

## Frequently asked questions

### What does How a Special Enzyme Helps Deliver Immune Drugs Under the Skin cover?

This patent describes a specific, modified human hyaluronidase enzyme that helps the body absorb immune globulin drugs when injected just under the skin, making treatments easier for patients.

### Who owns patent US 10588983?

Halozyme owns this patent, granted in 2020.

### When does this patent expire?

This patent is expected to expire on February 23, 2038, when the invention enters the public domain.

### What is patent US 10588983 cited by?

This patent has been cited by 7 later patents that build on its ideas.

### What problem does this patent solve?

This technology is important because it makes it possible to deliver large volumes of drugs, like immune globulin, through a simple injection under the skin rather than a lengthy intravenous infusion. This significantly improves convenience and quality of life for patients who require regular treatments. Halozyme, the assignee, has built a platform around this type of enzyme to enable subcutaneous delivery for many different therapeutic areas.

### What does this patent NOT cover?

Does not cover administering hyaluronidase and immune globulin through methods other than subcutaneous injection (e.g., intravenous infusion).

**Full plain-English explainer:** https://patentbrief.org/patent/us/10588983/soluble-glycosaminoglycanases-and-methods-of-preparing-and-using-soluble-glycosa

**Original patent:** https://patents.google.com/patent/US10588983

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_Source: PatentBrief — https://patentbrief.org. Patent facts are from public records; the plain-English explanation is PatentBrief's._


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