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.
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
2.
Hyaluronidase Enzyme Formulations for High Volume Administration
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.
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.
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
In one aspect, the present disclosure provides a prefilled autoinfusion device for delivery of a medicament comprising hyaluronidase. 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 via a profiled autoinfusion device.
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.
A method for producing a hyaluronidase polypeptide may include: a) introducing a nucleic acid molecule operably linked to a promotor into a eukaryotic cell, the nucleic acid molecule encoding a hyaluronidase polypeptide and including a stop codon; (b) culturing the cells in a growth medium having copper sulfate, L-glutamine, and L-cysteine sulfate under conditions whereby an encoded hyaluronidase polypeptide is produced by expression of the introduced nucleic acid molecule and secreted by the cell, the growth medium being devoid of sodium butyrate and insulin; and (c) recovering the expressed polypeptide.
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Excipients for use in the manufacture of pharmaceutical preparations Drug delivery agents in the form of polymers that facilitate the delivery of pharmaceutical preparations; Drug delivery agents in the form of high glass-transition surfactant polymers that facilitate the delivery of pharmaceutical preparations
05 - Pharmaceutical, veterinary and sanitary products
35 - Advertising and business services
36 - Financial, insurance and real estate services
42 - Scientific, technological and industrial services, research and design
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
Drug delivery agents in the form of liquid for subcutaneous delivery that facilitate the delivery of pharmaceutical preparations; enzymes for medical purposes, namely, for facilitating delivery of fluids or pharmaceuticals; drug delivery agents consisting of pharmaceuticals containing enzymes that facilitate delivery of fluids and a wide range of pharmaceuticals; Pharmaceutical preparations for use in the treatment and prevention of metabolic conditions and disorders, endocrine conditions and disorders, diabetes, diabetic complications, hormonal diseases and disorders, dermatological conditions and disorders, and for the treatment of cancer and in hydration; Pharmaceutical preparations for use in dermatology; Pharmaceutical preparations for use in aesthetic skin treatments; Hyaluronic acid for pharmaceutical purposes, namely, recombinant human hyaluronidase formulation for use in in-vitro fertilization procedures; enzymes for medical purposes, namely, recombinant human hyaluronidase formulation for use in in-vitro fertilization procedures Administration of a discount program enabling patients to obtain discounts on prescription drugs through use of a discount card provided by a copay discount program; business administration of a program enabling patients to obtain discounts on prescription drugs through a cash-pay program for uninsured and underinsured patients Insurance benefits verification and prior authorization assistance in the health industry; copay assistance programs, namely, providing financial assistance to uninsured and underinsured patients for prescription medications Scientific research and development services for the integration of technologies, therapies, and other systems for pharmaceuticals and drug delivery systems Providing medical information in the field of subcutaneous fluid administration; providing medical information in the field of subcutaneous delivery of a wide range of pharmaceuticals
9.
Hyaluronidase Enzyme Formulations for High Volume Administration
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.
A61M 5/20 - Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
A61M 5/315 - PistonsPiston-rodsGuiding, blocking or restricting the movement of the rodAppliances on the rod for facilitating dosing
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
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.
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 38/47 - Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
A61K 39/00 - Medicinal preparations containing antigens or antibodies
A61K 47/18 - AminesAmidesUreasQuaternary ammonium compoundsAmino acidsOligopeptides having up to five amino acids
A61K 47/20 - Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
A61K 47/22 - Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
A61K 47/26 - Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharidesDerivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
12.
NUCLEIC ACID AND HYALURONIDASE COMBINATIONS AND DOSING REGIMENS
Provided are combination dosing regimens comprising administering hyaluronidase and a lipid nanoparticle composition. Combinations and compositions containing the hyaluronidase and a lipid nanoparticle composition are provided.
A61K 31/7105 - Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
A61K 9/1271 - Non-conventional liposomes, e.g. PEGylated liposomes or liposomes coated or grafted with polymers
C12N 9/26 - Hydrolases (3.) acting on glycosyl compounds (3.2) acting on alpha-1, 4-glucosidic bonds, e.g. hyaluronidase, invertase, amylase
An autoinjector includes a housing extending along a longitudinal axis having a proximal end and a distal end. A needle extends at least partially from the distal end of the housing. A needle guard assembly is coupled to the housing. The needle guard has a needle guard extension that is moveable relative to the housing distally along the longitudinal axis from a retracted position where the needle extends distally past the needle guard extension and an extended position where the needle guard extension extends distally past the needle. A retainer is coupled between the needle guard extension and the housing to retain the needle guard extension relative to the housing in a blocking position and is moveable relative to the housing to an unblocked position to allow the needle guard extension to move relative to the housing to the extended position.
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
A61M 5/20 - Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
A61M 5/50 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
An injector includes a housing having a proximal end and a distal end extending along a longitudinal axis, a medicament container disposed at least partially within the housing, a plunger disposed within the medicament container, a ram configured to move the plunger relative to the medicament container, the ram disposed within the housing and moveable relative to the housing between a pre-firing position and a fired position, an energy source configured to move the ram from the pre-firing position to the fired position, and a dampener disposed within the housing and configured to engage the ram to reduce an initial force exerted by the ram on the plunger when the ram is moved from the pre-firing position to the fired position.
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.
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
A61K 38/47 - Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
C07K 16/30 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
C07K 16/32 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products from oncogenes
18.
Combination therapy with antibody-drug conjugates and hyaluronidases
Provided are combination dosing regimens comprising administering an antibody-drug conjugate and hyaluronidase. Combinations and compositions containing the antibody-drug conjugate and hyaluronidase are provided. The dosing regimens and combinations are for treating or preventing cancer.
A61K 38/40 - Transferrins, e.g. lactoferrins, ovotransferrins
A61K 38/47 - Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
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-LI antibody.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Drug delivery agents in the form of polymers that facilitate the delivery of pharmaceutical preparations; Drug delivery agents in the form of high glass-transition surfactant polymers that facilitate the delivery of pharmaceutical preparations
40 - Treatment of materials; recycling, air and water treatment,
42 - Scientific, technological and industrial services, research and design
Goods & Services
Custom manufacture of reformulated pharmaceuticals for
easier patient delivery; custom manufacturing, processing,
and treating the therapeutic molecules of others;
biomanufacturing for others, namely, manufacturing
therapeutic molecules of others using biological organisms
in the manufacturing process; custom manufacture of
reformulated pharmaceuticals and therapeutics. Research and development in the field of pharmaceuticals and
drug delivery; scientific and medical research, namely,
conducting clinical trials for others; scientific research
and design and development, namely, product design and
development in the field of excipients and formulations for
use with therapeutic biologics; scientific research and
design, namely product design and development in the field
of therapeutic formulation development; consulting in the
fields of product design and development in the field of
therapeutic formulation and excipient development; chemical
engineering in the nature of formulation and reformulation
of therapeutic compositions; development of new technology
for others in the field of biomaterials, biotechnology and
nanotechnology.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Drug delivery agents in the form of liquid for subcutaneous
delivery that facilitate the delivery of pharmaceutical
preparations; enzymes for medical purposes, namely, for
facilitating delivery of fluids or pharmaceuticals; drug
delivery agents consisting of pharmaceuticals containing
enzymes that facilitate delivery of fluids and a wide range
of pharmaceuticals; pharmaceutical preparations for use in
the treatment and prevention of metabolic conditions and
disorders, endocrine conditions and disorders, diabetes,
diabetic complications, hormonal diseases and disorders,
dermatological conditions and disorders, and for the
treatment of cancer and in hydration; pharmaceutical
preparations for use in dermatology; pharmaceutical
preparations for use in aesthetic skin treatments;
hyaluronic acid for pharmaceutical purposes, namely,
recombinant human hyaluronidase formulation for use in
in-vitro fertilization procedures; enzymes for medical
purposes, namely, recombinant human hyaluronidase
formulation for use in in-vitro fertilization procedures.
An injector includes a housing having a longitudinal axis extending between a proximal end and a distal end, a latch assembly disposed within the housing, the latch assembly including a latch body extending along the longitudinal axis, a rod disposed within the latch body and moveable between an initial position where a proximal end of the rod contacts the proximal end of the housing and a retracted position where the proximal end of the rod is spaced apart from the proximal end of the housing; and a latch spring configured to urge the rod toward the initial position. A ram disposed within the housing and moveable relative to the latch body between a pre-firing position and a fired position. An energy source configured to move the ram from the pre-firing position to the fired position.
05 - Pharmaceutical, veterinary and sanitary products
35 - Advertising and business services
36 - Financial, insurance and real estate services
42 - Scientific, technological and industrial services, research and design
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
Drug delivery agents in the form of liquid for subcutaneous
delivery that facilitate the delivery of pharmaceutical
preparations; enzymes for medical purposes, namely, for
facilitating delivery of fluids or pharmaceuticals; drug
delivery agents consisting of pharmaceuticals containing
enzymes that facilitate delivery of fluids and a wide range
of pharmaceuticals; pharmaceutical preparations for use in
the treatment and prevention of metabolic conditions and
disorders, endocrine conditions and disorders, diabetes,
diabetic complications, hormonal diseases and disorders,
dermatological conditions and disorders, and for the
treatment of cancer and in hydration; pharmaceutical
preparations for use in dermatology; pharmaceutical
preparations for use in aesthetic skin treatments;
hyaluronic acid for pharmaceutical purposes, namely,
recombinant human hyaluronidase formulation for use in
in-vitro fertilization procedures; enzymes for medical
purposes, namely, recombinant human hyaluronidase
formulation for use in in-vitro fertilization procedures. Administration of a discount program enabling patients to
obtain discounts on prescription drugs through use of a
discount card provided by a copay discount program; business
administration of a program enabling patients to obtain
discounts on prescription drugs through a cash-pay program
for uninsured and underinsured patients. Insurance benefits verification and prior authorization
assistance in the health industry; copay assistance
programs, namely, providing financial assistance to
uninsured and underinsured patients for prescription
medications. Scientific research and development services for the
integration of technologies, therapies, and other systems
for pharmaceuticals and drug delivery systems. Providing medical information in the field of subcutaneous
fluid administration; providing medical information in the
field of subcutaneous delivery of a wide range of
pharmaceuticals.
Provided are combination dosing regimens comprising administering a monoclonal antibody, such as dupilumab, and hyaluronidase. Combinations and compositions containing the monoclonal antibody and hyaluronidase are provided. The dosing regimens and combinations with dupilumab are for treating or preventing allergic diseases such as atopic dermatitis (eczema), asthma and nasal polyps which result in chronic sinusitis, eosinophilic esophagitis, and prurigo nodularis.
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 39/00 - Medicinal preparations containing antigens or antibodies
A61K 38/17 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans
A61K 38/47 - Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
An injector includes a housing, a needle, and a needle shield removably coupled to the needle. A guard assembly is coupled to the housing and includes a guard holder coupled to the needle shield and having at least one engagement feature extending radially inward and a needle guard extension removably coupled to the guard holder. The needle guard extension is coupled to the guard holder and separated from the housing in an initial position, coupled to the guard holder and coupled to the housing in an engaged position, and separated from the guard holder and coupled to the housing in an active position. The guard holder couples to the needle shield to remove the needle shield from the needle when the needle shield extension is moved from the engaged position to the active position.
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
A61M 5/46 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests having means for controlling depth of insertion
40 - Treatment of materials; recycling, air and water treatment,
42 - Scientific, technological and industrial services, research and design
Goods & Services
Custom manufacture of reformulated pharmaceuticals for easier patient delivery; Custom manufacturing, processing, and treating the therapeutic molecules of others; Biomanufacturing for others, namely, manufacturing therapeutic molecules of others using biological organisms in the manufacturing process; Custom manufacture of reformulated pharmaceuticals and therapeutics Research and development in the field of pharmaceuticals and drug delivery; scientific and medical research, namely, conducting clinical trials for others; Scientific research and design and development, namely, product design and development in the field of excipients and formulations for use with therapeutic biologics; Scientific research and design, namely product design and development in the field of therapeutic formulation development; Consulting in the fields of product design and development in the field of therapeutic formulation and excipient development; Chemical engineering in the nature of formulation and reformulation of therapeutic compositions; Development of new technology for others in the field of biomaterials, biotechnology and nanotechnology
30.
Hyaluronidase enzyme formulations for high volume administration
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.
The present disclosure provides a method of determining one or more parameters of an injection of a formulation in a human subject, the method comprising: administering to an animal subject via subcutaneous injection from a high volume autoinjector about 3 mL to about 50 mL of a formulation comprising a therapeutically effective amount of a hyaluronidase enzyme; measuring one or more parameters of the subcutaneous injection in the animal subject; and determining the same one or more parameters of the subcutaneous injection in the human subject from the one or more measured parameters from the animal subject; wherein the one or more parameters are selected from injection time, injection force, and injection site reaction data.
An injector includes a housing, a medicament container disposed within the housing, a needle, a needle guard moveable relative to the housing from an extended position to a retracted position to a lockout position. A trigger is disposed within the housing and is coupled to the needle guard. A latch is disposed within the housing and engageable with the trigger. A ram movable relative to the latch, and an energy source is configured to urge the ram distally relative to the latch along the longitudinal axis. The trigger is engageable with the ram such that movement of the needle guard from the retracted position to the lockout position is dependent upon the position of the ram relative to the latch.
A61M 5/315 - PistonsPiston-rodsGuiding, blocking or restricting the movement of the rodAppliances on the rod for facilitating dosing
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
33.
COMBINATION THERAPY WITH ANTIBODY-DRUG CONJUGATES AND HYALURONIDASES
Provided are combination dosing regimens comprising administering an antibody-drug conjugate and hyaluronidase. Combinations and compositions containing the antibody-drug conjugate and hyaluronidase are provided. The dosing regimens and combinations are for treating or preventing cancer.
A61K 38/47 - Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 31/4985 - Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
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.
An injector includes a housing extending along a longitudinal axis, the housing having a distal end and a protrusion extending from the distal end. A cap rotatably and releasably coupled to the distal end of the housing, the cap has a proximal end. An aperture extends through the cap proximate the proximal end. The proximal end includes an indent defined thereon distal to the aperture, the indent being asymmetrical about a vertical plane that extends through the longitudinal axis. The protrusion extends into the indent in an initial position. The cap is rotatable relative to the housing about the longitudinal axis between the initial position and a released position wherein the protrusion is spaced circumferential from the indent.
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
An injector includes a housing extending along a longitudinal axis, the housing having a distal end and a protrusion extending from the distal end. A cap rotatably and releasably coupled to the distal end of the housing, the cap has a proximal end. An aperture extends through the cap proximate the proximal end. The proximal end includes an indent defined thereon distal to the aperture, the indent being asymmetrical about a vertical plane that extends through the longitudinal axis. The protrusion extends into the indent in an initial position. The cap is rotatable relative to the housing about the longitudinal axis between the initial position and a released position wherein the protrusion is spaced circumferential from the indent.
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
An injector includes a housing extending along a longitudinal axis, the housing has a proximal end and a distal end. A medicament container defines a volume therein. A needle is coupled to and extending from a distal end of the medicament container. An energy system has a first energy source and a second energy source. The first energy source is configured to be activated before the second energy source.
A61M 5/20 - Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
39.
MODIFIED HYALURONIDASES AND USES IN TREATING HYALURONAN-ASSOCIATED DISEASES AND CONDITIONS
Provided are combinations, compositions and kits containing a hyaluronan degrading enzyme, such as a soluble hyaluronidase, for treatment of hyaluronan-associated conditions, diseases and disorders. In one example, the products include an additional agent or treatment. Such products can be used in methods for administering the products to treat the hyaluronan-associated diseases and conditions, for example, hyaluronan-associated cancers, for example, hyaluronan-rich tumors. The methods include administration of the hyaluronan degrading enzyme composition alone or in combination with other treatments. Also provided are methods and compositions for providing sustained treatment effects in hyaluronan-associated diseases and conditions.
A61K 38/47 - Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
A61K 31/337 - Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
C12N 9/26 - Hydrolases (3.) acting on glycosyl compounds (3.2) acting on alpha-1, 4-glucosidic bonds, e.g. hyaluronidase, invertase, amylase
C12N 11/089 - Enzymes or microbial cells immobilised on or in an organic carrier the carrier being a synthetic polymer obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
In one aspect, the present disclosure provides a platform attachment for angled subcutaneous injection and for delivery of a medicament comprising hyaluronidase. 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 via a platform attachment for angled subcutaneous injection.
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
In one aspect, the present disclosure provides a platform attachment for angled subcutaneous injection and for delivery of a medicament comprising hyaluronidase. 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 via a platform attachment for angled subcutaneous injection.
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
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.
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.
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 38/47 - Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
A61K 39/00 - Medicinal preparations containing antigens or antibodies
A61K 47/18 - AminesAmidesUreasQuaternary ammonium compoundsAmino acidsOligopeptides having up to five amino acids
A61K 47/20 - Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
A61K 47/22 - Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
A61K 47/26 - Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharidesDerivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
44.
PH20 POLYPEPTIDE VARIANTS, FORMULATIONS AND USES THEREOF
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.
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
45.
PH20 POLYPEPTIDE VARIANTS, FORMULATIONS AND USES THEREOF
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.
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
46.
PH20 polypeptide variants, formulations and uses thereof
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.
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
An injector includes a housing having a proximal end and a distal end opposite the proximal end. The housing extends along a longitudinal axis. A medicament container is disposed within the housing, the medicament container contains a medicament. A needle is coupled to a proximal end of the medicament container and in fluid communication with the medicament container. A trigger mechanism includes a needle guard retractably coupled to the proximal end of the housing and is movable along the longitudinal axis between an extended position, an intermediate position, and a retracted position. A cap is removably coupled to the proximal end of the housing and the needle guard is in the intermediate position when the cap is coupled to the proximal end of the housing.
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
A61M 5/20 - Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
A61M 5/50 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
An injector includes a housing having a proximal end and a distal end opposite the proximal end. The housing extends along a longitudinal axis. A medicament container is disposed within the housing, the medicament container contains a medicament. A needle is coupled to a proximal end of the medicament container and in fluid communication with the medicament container. A trigger mechanism includes a needle guard retractably coupled to the proximal end of the housing and is movable along the longitudinal axis between an extended position, an intermediate position, and a retracted position. A cap is removably coupled to the proximal end of the housing and the needle guard is in the intermediate position when the cap is coupled to the proximal end of the housing.
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
A61M 5/50 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
49.
PH20 POLYPEPTIDE VARIANTS, FORMULATIONS AND USES THEREOF
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.
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
50.
PH20 POLYPEPTIDE VARIANTS, FORMULATIONS AND USES THEREOF
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.
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
51.
PH20 POLYPEPTIDE VARIANTS, FORMULATIONS AND USES THEREOF
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.
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
52.
Hyaluronidase enzyme formulations for high volume administration
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.
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.
In one aspect, the present disclosure provides a prefilled autoinfusion device for delivery of a medicament comprising hyaluronidase. 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 via a prefilled autoinfusion device.
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.
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
05 - Pharmaceutical, veterinary and sanitary products
35 - Advertising and business services
36 - Financial, insurance and real estate services
42 - Scientific, technological and industrial services, research and design
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
Drug delivery agents in the form of liquid for subcutaneous delivery that facilitate the delivery of pharmaceutical preparations; enzymes for medical purposes, namely, for facilitating delivery of fluids or pharmaceuticals; drug delivery agents consisting of pharmaceuticals containing enzymes that facilitate delivery of fluids and a wide range of pharmaceuticals; pharmaceutical preparations for use in the treatment and prevention of metabolic conditions and disorders, endocrine conditions and disorders, diabetes, diabetic complications, hormonal diseases and disorders, dermatological conditions and disorders, and for the treatment of cancer and in hydration; pharmaceutical preparations for use in dermatology; pharmaceutical preparations for use in aesthetic skin treatments; Hyaluronic acid for pharmaceutical purposes, namely, recombinant human hyaluronidase formulation for use in in-vitro fertilization procedures; enzymes for medical purposes, namely, recombinant human hyaluronidase formulation for use in in-vitro fertilization procedures Administration of a discount program enabling patients to obtain discounts on prescription drugs through use of a discount card provided by a copay discount program; business administration of a program enabling patients to obtain discounts on prescription drugs through a cash-pay program for uninsured and underinsured patients Insurance benefits verification and prior authorization assistance in the health industry; copay assistance programs, namely, providing financial assistance to uninsured and underinsured patients for prescription medications Scientific research and development services for the integration of technologies, therapies, and other systems for pharmaceuticals and drug delivery systems Providing medical information in the field of subcutaneous fluid administration; providing medical information in the field of subcutaneous delivery of a wide range of pharmaceuticals
05 - Pharmaceutical, veterinary and sanitary products
35 - Advertising and business services
36 - Financial, insurance and real estate services
42 - Scientific, technological and industrial services, research and design
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
Drug delivery agents in the form of liquid for subcutaneous delivery that facilitate the delivery of pharmaceutical preparations; enzymes for medical purposes, namely, for facilitating delivery of fluids or pharmaceuticals; drug delivery agents consisting of pharmaceuticals containing enzymes that facilitate delivery of fluids and a wide range of pharmaceuticals; pharmaceutical preparations for use in the treatment and prevention of metabolic conditions and disorders, endocrine conditions and disorders, diabetes, diabetic complications, hormonal diseases and disorders, dermatological conditions and disorders, and for the treatment of cancer and in hydration; pharmaceutical preparations for use in dermatology; pharmaceutical preparations for use in aesthetic skin treatments; Hyaluronic acid for pharmaceutical purposes, namely, recombinant human hyaluronidase formulation for use in in-vitro fertilization procedures; enzymes for medical purposes, namely, recombinant human hyaluronidase formulation for use in in-vitro fertilization procedures Administration of a discount program enabling patients to obtain discounts on prescription drugs through use of a discount card provided by a copay discount program; business administration of a program enabling patients to obtain discounts on prescription drugs through a cash-pay program for uninsured and underinsured patients Insurance benefits verification and prior authorization assistance in the health industry; copay assistance programs, namely, providing financial assistance to uninsured and underinsured patients for prescription medications Scientific research and development services for the integration of technologies, therapies, and other systems for pharmaceuticals and drug delivery systems Providing medical information in the field of subcutaneous fluid administration; providing medical information in the field of subcutaneous delivery of a wide range of pharmaceuticals
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.
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.
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
A jet injector that includes a prefilled syringe. The syringe includes a fluid chamber that contains a medicament. The syringe also has an injection-assisting needle, and a plunger is movable within the fluid chamber. A housing is configured for allowing insertion of the needle to a penetration depth. An energy source is configured for biasing the plunger to produce an injecting pressure in the medicament in the fluid chamber of between about 80 and 1000 p.s.i. to jet inject the medicament from the fluid chamber through the needle to an injection site.
A61M 5/28 - Syringe ampoules or cartridges, i.e. ampoules or cartridges provided with a needle
A61M 5/30 - Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or cartridges
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
A61M 5/46 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests having means for controlling depth of insertion
A61M 5/48 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests having means for varying, regulating, indicating or limiting injection pressure
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.
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
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.
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.
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.
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
administration of a discount program enabling patients to obtain discounts on prescription drugs through use of a discount card provided by a copay discount program; business administration of a program enabling patients to obtain discounts on prescription drugs through a cash-pay program for uninsured and underinsured patients
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.
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C12N 9/26 - Hydrolases (3.) acting on glycosyl compounds (3.2) acting on alpha-1, 4-glucosidic bonds, e.g. hyaluronidase, invertase, amylase
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
78.
PH20 polypeptide variants, formulations and uses thereof
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.
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
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.
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61K 38/47 - Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
A61K 47/22 - Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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.
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
81.
PH20 polypeptide variants, formulations and uses thereof
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.
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
82.
PH20 polypeptide variants with a modification at position 324 of the PH20 polypeptide and a method of making thereof
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.
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
A61K 9/00 - Medicinal preparations characterised by special physical form
C07K 14/00 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof
C12N 9/26 - Hydrolases (3.) acting on glycosyl compounds (3.2) acting on alpha-1, 4-glucosidic bonds, e.g. hyaluronidase, invertase, amylase
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
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.
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 38/47 - Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
A61K 47/18 - AminesAmidesUreasQuaternary ammonium compoundsAmino acidsOligopeptides having up to five amino acids
A61K 47/20 - Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
A61K 47/22 - Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
A61K 47/26 - Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharidesDerivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
VIIV HEALTHCARE UK (NO. 7) LIMITED (United Kingdom)
Halozyme, Inc. (USA)
Inventor
Han, Kelong
Weber, Andrew
Labarre, Michael James
Brehm, Jessica
Akhavein, Nima
Velthuisen, Emile
Abstract
Provided are combination dosing regimens comprising administering cabotegravir and hyaluronidase. Combinations and compositions containing the cabotegravir and hyaluronidase are provided. The dosing regimens and combinations are for treating or preventing Human Immunodeficiency Virus (HIV) infection.
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.
A61P 43/00 - Drugs for specific purposes, not provided for in groups
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
86.
SOLUBLE HYALURONIDASE GLYCOPROTEIN (sHASEGP), PROCESS FOR PREPARING THE SAME, USES AND PHARMACEUTICAL COMPOSITIONS COMPRISING THEREOF
Provided are soluble neutral active Hyaluronidase Glycoproteins (sHASEGP's), methods of manufacture, and their use to facilitate administration for in vitro fertilization, as well as administration of molecules, or to alleviate glycosaminoglycan associated pathologies. Minimally active polypeptide domains of the soluble, neutral active sHASEGP domains are described that include asparagine-linked sugar moieties required for a functional neutral active hyaluronidase domain. Included are modified amino-terminal leader peptides that enhance secretion of sHASEGP. Sialated and pegylated forms of the sHASEGPs also are provided. Methods of treatment by administering sHASEGPs and modified forms thereof also are provided.
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.
A61P 43/00 - Drugs for specific purposes, not provided for in groups
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
88.
PH20 polypeptide variants, formulations and uses thereof
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.
A61P 43/00 - Drugs for specific purposes, not provided for in groups
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
89.
PH20 POLYPEPTIDE VARIANTS, FORMULATIONS AND USES THEREOF
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.
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
90.
PH20 polypeptide variants, formulations and uses thereof
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.
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
91.
PH20 polypeptide variants, formulations and uses thereof
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.
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
92.
PH20 polypeptide variants, formulations and uses thereof
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.
A61P 43/00 - Drugs for specific purposes, not provided for in groups
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
93.
COMBINATION THERAPY WITH A HYALURONAN-DEGRADING ENZYME AND AN IMMUNE CHECKPOINT INHIBITOR
Provided are methods of treatment of cancers with combinations of and compositions containing a soluble hyaluronidase, such as a polymer-modified soluble hyaluronidase, and an immune checkpoint inhibitor for treating cancers, including solid and non-solid tumors. The combinations and compositions also are provided.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61K 38/47 - Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
A61K 31/573 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
C12N 9/26 - Hydrolases (3.) acting on glycosyl compounds (3.2) acting on alpha-1, 4-glucosidic bonds, e.g. hyaluronidase, invertase, amylase
C12N 15/00 - Mutation or genetic engineeringDNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purificationUse of hosts therefor
A61K 47/60 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
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.
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61K 47/20 - Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
A61K 47/18 - AminesAmidesUreasQuaternary ammonium compoundsAmino acidsOligopeptides having up to five amino acids
A61K 38/47 - Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
A61K 47/26 - Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharidesDerivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
A61K 47/22 - Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
A61K 9/00 - Medicinal preparations characterised by special physical form
The disclosure provides pharmaceutical compositions comprising an anti-PD-1 antibody or an anti-PD-LI antibody formulated for subcutaneous delivery, wherein the pharmaceutical compositions further comprise an endoglycosidase hydrolase enzyme such as a hyaluronidase.
A61K 38/47 - Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
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.
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 38/47 - Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
A61K 47/18 - AminesAmidesUreasQuaternary ammonium compoundsAmino acidsOligopeptides having up to five amino acids
A61K 47/20 - Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
A61K 47/26 - Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharidesDerivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
A61P 31/00 - Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
Aspects of the disclosure include telomerase inhibitor compositions formulated for subcutaneous administration. Compositions according to certain embodiments include a hyaluronidase enzyme and a telomerase inhibitor having an oligonucleotide and a lipid moiety linked to the 5′ and/or 3′ end of the oligonucleotide. Methods for subcutaneously administering the telomerase inhibitor compositions, such as in the treatment of a neoplasm are also described. Kits having or not having a subcutaneous injector are also provided.
Aspects of the disclosure include telomerase inhibitor compositions formulated for subcutaneous administration. Compositions according to certain embodiments include a hyaluronidase enzyme and a telomerase inhibitor having an oligonucleotide and a lipid moiety linked to the 5' and/or 3' end of the oligonucleotide. Methods for subcutaneously administering the telomerase inhibitor compositions, such as in the treatment of a neoplasm are also described. Kits having or not having a subcutaneous injector are also provided.
A61K 31/7088 - Compounds having three or more nucleosides or nucleotides
A61K 31/7125 - Nucleic acids or oligonucleotides having modified internucleoside linkage, i.e. other than 3'-5' phosphodiesters
A61K 38/27 - Growth hormone [GH], i.e. somatotropin
A61K 38/47 - Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
A61K 47/54 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
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.
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C12N 9/26 - Hydrolases (3.) acting on glycosyl compounds (3.2) acting on alpha-1, 4-glucosidic bonds, e.g. hyaluronidase, invertase, amylase
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
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.
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
