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Publication Number
US-10898542-B2
Publication Date
2021-01-26
Expiration Date
Abstract
The invention relates to a topical composition containing a variant of an OB-fold protein, and also to the process for preparing the same.
Core Innovation
The patent describes topical ophthalmological compositions comprising a variant of a wild-type OB-fold protein (nanofitin) applied to a patient’s eye so that the variant passes through the cornea. The variant has between 5 and 20 mutated residues in the interface of binding of the wild-type OB-fold protein to its natural ligand. The wild-type OB-fold protein is selected from OB-fold proteins derived from Sulfolobus species, including Sac7d or Sac7e derived from Sulfolobus acidocaldarius, Sso7d derived from Sulfolobus solfataricus, DBP7 derived from Sulfolobus tokodaii, Ssh7b derived from Sulfolobus shibatae, Ssh7a derived from Sulfolobus shibatae, and p7ss derived from Sulfolobus solfataricus.
The document further specifies that the mutated residues are selected from the Sac7d residue set consisting of V2, K3, K5, K7, Y8, K9, G10, E14, T17, K21, K22, W24, V26, G27, K28, M29, S31, T33, D36, N37, G38, K39, T40, R42, A44, S46, E47, K48, D49, A50 and P51. In the described ophthalmological use, topical ophthalmic administration is intended to have a protein penetrate through the eye, while the variant passes through the cornea.
Beyond the ophthalmic context, the patent content also describes topical cosmetic or therapeutic compositions containing OB-fold protein variants (nanofitins) that bind selected targets. The stated goal in the described background and supporting content is to avoid systemic delivery by using topical delivery that permits passage through relevant ocular or skin tissues.
Claims Coverage
The provided independent claims are clm-00001 and clm-00009. Each independent claim centers on topically applying an ophthalmological composition comprising an OB-fold protein variant so that it passes through the cornea, with the variant defined by 5 to 20 mutated residues in the binding interface to the natural ligand; clm-00001 frames this as a method of administering to the eye of a patient, while clm-00009 frames it as a method of having protein penetrate through the eye.
Topical ophthalmological administration for corneal passage
A method for administering a variant of a wild-type OB-fold protein by topically applying an ophthalmological composition comprising the variant to the eye of a patient, wherein the variant passes through the cornea of the patient.
Mutation-defined binding interface variants (5 to 20 mutated residues)
The variant has between 5 and 20 mutated residues in the interface of binding of the wild-type OB-fold protein to its natural ligand.
Selected Sulfolobus-derived wild-type OB-fold proteins
The wild-type OB-fold protein is selected from the group consisting of Sac7d or Sac7e derived from Sulfolobus acidocaldarius, Sso7d derived from Sulfolobus solfataricus, DBP7 derived from Sulfolobus tokodaii, Ssh7b derived from Sulfolobus shibatae, Ssh7a derived from Sulfolobus shibatae, and p7ss derived from Sulfolobus solfataricus.
Specified mutated residue set from Sac7d
The mutated residues are selected from the group consisting of V2, K3, K5, K7, Y8, K9, G10, E14, T17, K21, K22, W24, V26, G27, K28, M29, S31, T33, D36, N37, G38, K39, T40, R42, A44, S46, E47, K48, D49, A50 and P51 of Sac7d.
Topical ophthalmological application to enable protein penetration through the eye
A method for having a protein penetrate through the eye of a patient by topically applying an ophthalmological composition comprising the variant to the eye of the patient, wherein the variant passes through the cornea of the patient.
Across clm-00001 and clm-00009, the claimed coverage is directed to topical ophthalmological delivery of a cornea-penetrating OB-fold protein variant. The core requirement is that the variant is defined by a specified number of mutated residues located in the binding interface to the wild-type natural ligand, with the wild-type OB-fold protein restricted to enumerated Sulfolobus-derived family members and the mutated residues drawn from a defined Sac7d residue set.
Stated Advantages
Corneal penetration is achieved upon topical ophthalmological administration (variant passes through the cornea).
Documented Applications
Topical ophthalmic administration using an ophthalmological composition to have a protein penetrate through the eye of a patient, including penetration through the cornea.
Topical skin/scalp application in a topical anti-inflammatory psoriasis-like inflammation model with significant PASI reduction.
Human skin penetration.
Rabbit cornea penetration.
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