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US 2025/0367284 A1Published application
Anti-transferrin receptor fusion proteins and methods of use thereof
AssigneeDenali Therapeutics Inc.
InventorsAnnie ARGUELLO, Tina GIESE, Gunasekaran KANNAN, Mihalis S. KARIOLIS, Cathal S. MAHON, Junhua WANG
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Abstract
Certain embodiments provide a fusion protein comprising an iduronate 2-sulfatase (IDS) amino acid sequence, an IDS variant amino acid sequence, or a catalytically active fragment thereof; and an anti-transferrin receptor (TfR) antibody as described herein, as well as methods of use thereof.
Claims17
1-101. (canceled)
A method for making a fusion protein, wherein the fusion protein comprises:
- (a) two light chain amino acid sequences, each consisting of SEQ ID NO:
- 5;
- (b) a first heavy chain amino acid sequence, a linker, and an IDS amino acid sequence, which together consist of SEQ ID NO:
- 17 or SEQ ID NO:18;
- and
- (c) a second heavy chain amino acid sequence, a linker, and an IDS amino acid sequence, which together consist of SEQ ID NO:17 or SEQ ID NO:18;
- and
- wherein the method comprises
- (i) expressing the fusion protein in Chinese Hamster Ovary (CHO) cells;
- and
- (ii) purifying the fusion protein using a series of chromatography steps comprising Protein A affinity chromatography;
- and wherein the fusion protein comprises at least about 6 mol/mol sialic acid:fusion protein.
9 more elements
A method for making a fusion protein pharmaceutical composition comprising a fusion protein, wherein the fusion protein comprises:
- (a) two light chain amino acid sequences, each consisting of SEQ ID NO:
- 5, and
- (b) a first heavy chain amino acid sequence, a linker, and an IDS amino acid sequence, which together consist of SEQ ID NO:17 or SEQ ID NO:
- 18;
- and
- (c) a second heavy chain amino acid sequence, a linker, and an IDS amino acid sequence, which together consist of SEQ ID NO:17 or SEQ ID NO:
- 18;
- wherein the method comprises
- (i) expressing the fusion protein in Chinese Hamster Ovary (CHO) cells;
- and
- (ii) purifying the fusion protein using a series of chromatography steps comprising Protein A affinity chromatography;
- wherein the fusion protein pharmaceutical composition comprises a pharmaceutically acceptable excipient selected from the group consisting of trehalose, sucrose, mannitol, polyethylene glycol, polypropylene glycol, polyethylene-polypropylene glycol, and glycine;
- and wherein the fusion protein comprises at least about 6 mol/mol sialic acid:fusion protein.
10 more elements
Dependencies are inferred from the claim text.