COMPLEX OF BOTULINUM NEUROTOXIN E AND ITS BINDING PROTEIN AS A FORMULATION WITH ENHANCED POTENCY

    公开(公告)号:US20220288173A1

    公开(公告)日:2022-09-15

    申请号:US17200822

    申请日:2021-03-13

    申请人: Prime Bio, Inc.

    IPC分类号: A61K38/48 C07K1/18 C07K1/14

    摘要: Compositions comprising the L complex or the M complex of the botulinum neurotoxin E with its associated neurotoxin binding protein(s) (NBP), methods of making, and methods of use to treat pain and wrinkles by injecting locally. Methods of making and isolating the L and M complex comprise a multi-step process of: providing a bacterial cultured media comprising the complex of botulinum neurotoxin E and neurotoxin binding proteins; centrifuging and pelletizing the cultured media; stirring the pelletized culture at 0 to 10° C. over a period of 4 to 24 hours; centrifuging the stirred solution to obtain a supernatant; precipitating the supernatant and filtering to obtain the precipitate; and dissolving the precipitate, centrifuging and filtering to obtain a solution comprising M complex and/or L complex of botulinum neurotoxin E and its NBP; and passing the solution through a functionalized sephadex ion exchange column to isolate the complex.

    METHOD FOR THE DETECTION OF CLOSTRIDIUM NEUROTOXINS USING A NOVEL SUBSTRATE

    公开(公告)号:US20220390461A1

    公开(公告)日:2022-12-08

    申请号:US17339263

    申请日:2021-06-04

    申请人: Prime Bio, Inc.

    摘要: The present invention provides a method for detecting and assaying Clostridium neurotoxins and identification of serotypes of botulinum neurotoxins in various food matrices and clinical samples. This method is also used for detection of BoNT inside the neuronal and epithelial cells. The method comprises detecting and assaying the presence of a Clostridium neurotoxin in a sample by: exposing the sample containing a Clostridium neurotoxin to a sample comprising a novel SNAMPXIN/SNAMP universal recombinant substrate fusion protein capable of producing a detectable FRET, following cleavage; detecting and assaying the presence of the Clostridium neurotoxin by measuring a change in the energy transfer or the luminescence signal; and detecting and assaying an electrophoretic mobility pattern of one or more cleaved protein bands or a degraded protein, using a high throughput automated system to identify the different serotypes of the Clostridium neurotoxin. SNAMPXIN/SNAMP is formed from parts of BoNT substrates SNAP-25 and VAMP.

    Pharmaceutical Composition Comprising P80 Protein

    公开(公告)号:US20220081473A1

    公开(公告)日:2022-03-17

    申请号:US17024302

    申请日:2020-09-17

    申请人: Prime Bio, Inc.

    IPC分类号: C07K14/33 C07K1/18 A61K45/06

    摘要: Present invention relates to a pharmaceutical composition comprising P80 with drugs, dyes, small molecules, biomolecules, proteins or combination thereof. P80 enhances the transportation of molecules associated with it. The P80 is a tight junction modulators to enhance the permeability of the intestinal epithelium so as to facilitate drug delivery. The invention further provides a process for the preparation, isolation and purification of p80 protein.

    Complex of botulinum neurotoxin E and its binding protein as a formulation with enhanced potency

    公开(公告)号:US11957740B2

    公开(公告)日:2024-04-16

    申请号:US17200822

    申请日:2021-03-13

    申请人: Prime Bio, Inc.

    IPC分类号: A61K38/48 C07K1/14 C07K1/18

    摘要: Compositions comprising the L complex or the M complex of the botulinum neurotoxin E with its associated neurotoxin binding protein(s) (NBP), methods of making, and methods of use to treat pain and wrinkles by injecting locally. Methods of making and isolating the L and M complex comprise a multi-step process of: providing a bacterial cultured media comprising the complex of botulinum neurotoxin E and neurotoxin binding proteins; centrifuging and pelletizing the cultured media; stirring the pelletized culture at 0 to 10° C. over a period of 4 to 24 hours; centrifuging the stirred solution to obtain a supernatant; precipitating the supernatant and filtering to obtain the precipitate; and dissolving the precipitate, centrifuging and filtering to obtain a solution comprising M complex and/or L complex of botulinum neurotoxin E and its NBP; and passing the solution through a functionalized sephadex ion exchange column to isolate the complex.