OPKO Health has been granted a patent for a polypeptide combining chorionic gonadotropin and coagulation factor, along with related polynucleotides. The patent also covers pharmaceutical compositions and methods of use. The claim specifies a highly modified form of Factor VIIa with specific characteristics. GlobalData’s report on OPKO Health gives a 360-degree view of the company including its patenting strategy. Buy the report here.

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According to GlobalData’s company profile on OPKO Health, Peptide pharmacophores was a key innovation area identified from patents. OPKO Health's grant share as of May 2024 was 47%. Grant share is based on the ratio of number of grants to total number of patents.

Human chorionic gonadotropin-modified factor viia polypeptide

Source: United States Patent and Trademark Office (USPTO). Credit: OPKO Health Inc

A recently granted patent (Publication Number: US11976106B2) discloses a novel human chorionic gonadotropin carboxy terminal peptide (CTP)-modified human active Factor VII (FVIIa) polypeptide. This modified polypeptide consists of three CTP molecules attached in tandem to the C-terminal end of FVIIa, ensuring a substantially pure and active form. The CTP-modified FVIIa exhibits specific characteristics, including a high sialic acid content, high glycosylation form, low oxidized form, high percentage of carboxylated glutamic acid residues, charged N-glycans, and a potency of at least 10,500 U/mg. The amino acid sequence of this modified polypeptide is specified in SEQ ID NO: 7, with a purity level of at least 90%.

Furthermore, the patent claims detail the manufacturing process of the CTP-modified FVIIa, involving steps such as stably transfecting cells with an expression vector, obtaining overexpressing cell clones, expanding and harvesting these clones, filtering the solution, and purifying the CTP-modified FVIIa to achieve a desired concentration. The method ensures a high level of expression and secretion of the modified polypeptide, with a potency ranging from 15,563 U/mg to 23,608 U/mg. Notably, the manufacturing process is animal-free and results in a highly glycosylated, sialylated, and O-glycan content CTP-modified FVIIa, with specific glycosylation patterns and charged N-glycan percentages. The purification steps involve various chromatography columns and virus inactivation methods, ultimately yielding a purified CTP-modified FVIIa with a viral log reduction factor (LRF) of about 22. The patent also includes a composition comprising the CTP-modified FVIIa and a pharmaceutically acceptable carrier, highlighting the potential therapeutic applications of this novel polypeptide.

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GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies across the world’s largest industries.