US 11066656

US patent 11066656, titled "PH20 polypeptide variants, formulations and uses thereof," was issued to Halozyme, Inc. on July 20, 2021, from an application filed on June 25, 2020. The inventors are Ge Wei, H. Michael Shepard, Qiping Zhao, and Robert James Connor.

Abstract:
The patent describes modified PH20 hyaluronidase polypeptides, specifically those exhibiting increased stability and/or increased activity. It also covers compositions, formulations, and various uses of these modified polypeptides.

Independent Claims Overview:

• Independent Claim 1: This claim covers a modified PH20 polypeptide that shows increased stability compared to its unmodified counterpart. The increased stability is demonstrated by greater resistance to denaturation under conditions such as elevated temperature (above 30° C.), agitation, low salt concentrations (less than 100 mM), or the presence of denaturing excipients like preservatives. The unmodified PH20 polypeptide can be a specific sequence (SEQ ID NO: 7) or a C-terminal truncated, soluble fragment with at least 85% sequence identity to SEQ ID NO: 7.
• Independent Claim 25: This claim is directed to a pharmaceutical composition comprising the modified PH20 polypeptide of Claim 1 and a pharmaceutically acceptable excipient.
• Independent Claim 30: This claim covers a method for identifying or selecting a modified hyaluronan-degrading enzyme (like PH20) that exhibits stability under denaturing conditions. The method involves comparing the enzyme's activity in the presence of a denaturing agent/condition to its activity in the absence of that agent/condition. A modified enzyme is selected if its activity in the denaturing condition is at least 5% of its activity in the non-denaturing condition.
• Independent Claim 31: This claim provides another method for identifying or selecting a modified hyaluronan-degrading enzyme with increased stability under denaturation. This method involves comparing the activity of a modified enzyme in a denaturing condition to the activity of the unmodified enzyme in the same denaturing condition. An enzyme is selected if the modified version shows greater activity.

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