Halozyme, Inc.

The disclosure provides pharmaceutical compositions comprising an anti-PD-1 antibody or an anti-PD-L1 antibody. In some aspects, the pharmaceutical compositions are formulated for subcutaneous delivery. In some aspects, the pharmaceutical compositions further comprise an endoglycosidase hydrolase enzyme. Other aspects of the present disclosure are directed to methods of subcutaneously delivering a pharmaceutical composition comprising an anti-PD-1 antibody or an anti-PD-L1 antibody.

In one aspect, the present disclosure provides a formulation comprising a hyaluronidase enzyme and a therapeutically effective amount of an active ingredient. In another aspect, the present disclosure provides a method of administering a high volume of the formulation in a single administration to treat a disease or disorder in a subject.

An injector includes a housing that has a proximal end and a distal end that extends along a longitudinal axis. A medicament container contains a volume of a medicament. A button coupled to the housing is rotatable about the longitudinal axis between a locked position and an unlocked position and movable along the longitudinal axis between a pre-firing position and a firing position. A latch is at least partially disposed within the button, a ram is movable relative to the latch, and an energy source urges the ram distally along the longitudinal axis. The ram is prevented from moving relative to the latch by the button in the pre-firing position. Rotation of the button to the unlocked position and movement of the button distally along the longitudinal axis relative to the housing into the firing position allows the ram to move relative to the latch.

In one aspect, the present disclosure provides a formulation comprising a hyaluronidase enzyme and a therapeutically effective amount of an active ingredient. In another aspect, the present disclosure provides a method of administering a high volume of the formulation in a single administration to treat a disease or disorder in a subject.

Modified PH20 hyaluronidase polypeptides, including modified polypeptides that exhibit increased stability and/or increased activity, are provided. Also provided are compositions and formulations and uses thereof.

The disclosure provides pharmaceutical compositions comprising an antibody and at least two antioxidants. In some aspects, pharmaceutical composition is formulated for subcutaneous delivery. In some aspects, the pharmaceutical composition further comprises an endoglycosidase hydrolase enzyme. Other aspects of the present disclosure are directed to methods of subcutaneously delivering the pharmaceutical composition.

The disclosure provides pharmaceutical compositions comprising an anti-PD-1 antibody or an anti-PD-L1 antibody. In some aspects, the pharmaceutical compositions are formulated for subcutaneous delivery. In some aspects, the pharmaceutical compositions further comprise an endoglycosidase hydrolase enzyme. Other aspects of the present disclosure are directed to methods of subcutaneously delivering a pharmaceutical composition comprising an anti-PD-1 antibody or an anti-PD-L1 antibody.

Provided herein are combination dosing regimens comprising administering an antibody-drug conjugate (ADC) and a hyaluronidase. In embodiments, the hyaluronidase is a soluble hyaluronidase. In embodiments, the ADC and hyaluronidase are administered subcutaneously. Pharmaceutical compositions comprising an ADC and a hyaluronidase are also provided. In embodiments, the dosing regimens and the pharmaceutical compositions are used in a method of treating or preventing cancer, a cardiometabolic disease/disorder, an inflammatory disease/disorder, or an autoimmune disease/disorder in a patient in need thereof.