Saposin C pharmaceutical compositions and methods of treating cancer
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Publication Number
US-11590227-B2
Publication Date
2023-02-28
Expiration Date
Abstract
Disclosed are pharmaceutical compositions containing saposin C and phosphatidylserine that are useful for treating various cancers. Also disclosed are methods for assaying potency of a test composition comprising saposin C and an anionic phospholipid.
Core Innovation
The invention relates to assaying potency of a test composition comprising saposin C and an anionic phospholipid. The potency is assayed in vitro by contacting the test composition with glucocerebrosidase and 4-methylumbelliferyl-β-D-glucopyranoside (4-MUG), and by determining the level of 4-methylumbellierone (4-MU) formed as a result of cleavage of 4-MUG. A control assay is performed by contacting a control composition with glucocerebrosidase and 4-MUG, and determining the level of 4-MU formed in the control assay.
Relative potency is determined by comparing the level of 4-MU formed in the first assay to the level of 4-MU formed in the control assay, thereby determining the relative potency of the test composition compared to the control composition. The disclosed testing framework is used to support evaluation of SapC formulated with an anionic phospholipid, including phosphatidylserine lipid and dioleoyl phosphatidylserine (DOPS), in pharmaceutical compositions intended for cancer treatment.
The disclosed invention further includes an in vitro method for comparing potency of a test composition comprising saposin C and an anionic phospholipid to the potency of a reference standard comprising saposin C and the anionic phospholipid. This comparison is performed by carrying out a series of glucocerebrosidase/4-MUG assays with different amounts of the test composition, determining the level of 4-MU formed in each assay, and comparing the 4-MU-level data from the series to the 4-MU-level data generated on the reference standard.
Claims Coverage
The partial content includes two independent claims. Both independent claims center on in vitro glucocerebrosidase/4-MUG assays that quantify 4-MU formation, and compare a test composition comprising saposin C and an anionic phospholipid to a control composition or to a reference standard.
Relative potency by 4-MU formation in test and control assays
Carrying out a first glucocerebrosidase/4-MUG assay that contacts a test composition comprising saposin C and an anionic phospholipid with glucocerebrosidase and 4-MUG, determining the level of 4-MU formed, carrying out a control assay that contacts a control composition with glucocerebrosidase and 4-MUG, determining the level of 4-MU formed in the control assay, and comparing the level of 4-MU formed in the first assay to the level of 4-MU formed in the control assay to determine relative potency.
Potency comparison across test amounts versus a reference standard
Carrying out a series of glucocerebrosidase/4-MUG assays contacting glucocerebrosidase and 4-MUG with different amounts of a test composition comprising saposin C and an anionic phospholipid, determining the level of 4-MU formed in each assay, and comparing 4-MU-level data from the series of assays to 4-MU-level data generated in glucocerebrosidase/4-MUG assays on a reference standard comprising saposin C and the anionic phospholipid, thereby comparing potency.
Overall coverage focuses on quantifying 4-MU formed from cleavage of 4-MUG by glucocerebrosidase in vitro and using those 4-MU levels to determine relative potency compared to a control composition or a reference standard for compositions comprising saposin C and an anionic phospholipid.
Stated Advantages
Enables determination of relative potency of a test composition compared to a control composition.
Enables comparison of potency of a test composition to the potency of a reference standard.
Documented Applications
Potency assay and evaluation for SapC formulated with phosphatidylserine lipid, including DOPS, in aqueous and lyophilized pharmaceutical compositions intended for cancer treatment, including solid tumors and HGG.
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