Inozyme Pharma. has filed a patent for novel soluble ENPP1 or ENPP3 polypeptides, along with compositions and methods for treating diseases associated with an ENPP1 or ENPP3 deficiency, such as pathological calcification or pathological ossification. The patent claims have been canceled. GlobalData’s report on Inozyme Pharma 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 Inozyme Pharma, Adeno-associated virus vectors was a key innovation area identified from patents. Inozyme Pharma's grant share as of September 2023 was 7%. Grant share is based on the ratio of number of grants to total number of patents.

Treatment of diseases associated with enpp1 or enpp3 deficiency

Source: United States Patent and Trademark Office (USPTO). Credit: Inozyme Pharma Inc

A recently filed patent (Publication Number: US20230313158A1) describes a soluble ENPP1 polypeptide that lacks both Somatomedin B (SMB) domain 1 and SMB domain 2 of ENPP1. The polypeptide also lacks a negatively charged bone-targeting domain. It has a reduced ability to homodimerize and reduced affinity for the human insulin receptor compared to the wild-type soluble ENPP1 polypeptide. The polypeptide may have one or more amino acid modifications that reduce homodimerization by a certain percentage. It may also have an amino acid sequence that is at least a certain percentage identical to amino acids 190 to 925 of SEQ ID NO: 1, with an amino acid substitution at position 816, 817, or 818 relative to SEQ ID NO: 1. The ENPP1 polypeptide demonstrates greater proteolytic resistance to a protease, resulting in increased protein purity and decreased protein cleavage compared to the wild-type soluble ENPP1 polypeptide. The protease may be trypsin or trypsin-like proteases. The polypeptide may also be a fusion protein with an Fc domain.

The patent also describes a method of reducing, reversing, and/or preventing pathological calcification in a subject by administering the soluble ENPP1 polypeptide. The calcification may be soft tissue calcification, arterial calcification, or vascular calcification. The subject may be ENPP1 deficient and/or have a pathogenic mutation in the ABCC6 gene. The soft tissue affected by calcification may include atherosclerotic plaques, muscular arteries, joints, spine, articular cartilage, vertebral disk cartilage, vessels, and connective tissue. The patent further includes an isolated polynucleotide comprising a coding sequence for the soluble ENPP1 polypeptide, a method of making the soluble ENPP1 polypeptide using recombinant polynucleotides, and a method of formulating the soluble ENPP1 polypeptide into a pharmaceutical composition.

Additionally, the patent describes a soluble ENPP3 polypeptide that lacks both Somatomedin B (SMB) domain 1 and SMB domain 2 of ENPP3. Similar to the ENPP1 polypeptide, the ENPP3 polypeptide has a reduced ability to homodimerize and reduced affinity for the human insulin receptor compared to the wild-type soluble ENPP3 polypeptide. It may have one or more amino acid modifications that reduce homodimerization by a certain percentage. The polypeptide may also be a fusion protein with an Fc domain and may include a heterologous moiety such as a glycosylated amino acid, PEGylated amino acid, farnesylated amino acid, acetylated amino acid, biotinylated amino acid, or lipid moiety. The method of reducing pathological calcification in a subject by administering the soluble ENPP3 polypeptide is similar to the method described for the ENPP1 polypeptide. The subject may have various diseases associated with calcification, including chronic kidney disease, end stage renal disease, calcific uremic arteriolopathy, calciphylaxis, ossification of the posterior longitudinal ligament, hypophosphatemic rickets, autosomal recessive hypophosphatemic rickets type 2, osteoarthritis, aging-related hardening of arteries, idiopathic infantile arterial calcification, Generalized Arterial Calcification of Infancy, and calcification of atherosclerotic plaques.

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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