公开(公告)号：US10227403B2

公开(公告)日：2019-03-12

申请号：US15144733

申请日：2016-05-02

Applicant: INCUBE LABS, LLC

Inventor： Mir Imran ,  Mercedes Morales ,  Radhika Korupolu ,  Elaine To ,  Joel Harris ,  Mir Hashim

IPC: A61K38/28 ,  A61K9/00 ,  A61K9/14 ,  A61K9/16 ,  A61K9/20 ,  C07K16/00 ,  C07K16/24

Abstract: Embodiments of the invention provide shaped masses (SM) comprising one or more drugs such as proteins or polypeptides and methods for forming and delivering such SM's. One embodiment provides a SM comprising a drug e.g., a protein or polypeptide having a biological activity in the body of a mammal. The SM is formed by compression of a precursor material (PM) comprising the drug wherein an amount of biologically active drug in the SM is a minimum level to that in the PM. Drugs which may be incorporated into the SM include insulin, incretins and immunoglobulins e.g., interleukin neutralizing antibodies or TNF-α-inhibiting antibodies. Embodiments of the invention are particularly useful for the oral delivery of drugs which would be degraded within the GI tract, wherein the SM containing the drug is formed as or incorporated into a tissue penetrating member which is inserted into the intestinal wall after oral ingestion.

公开(公告)号：US20180208651A9

公开(公告)日：2018-07-26

申请号：US15144733

申请日：2016-05-02

Applicant: INCUBE LABS, LLC

Inventor： Mir Imran ,  Mercedes Morales ,  Radhika Korupolu ,  Elaine To ,  Joel Harris ,  Mir Hashim

IPC: C07K16/24 ,  A61K38/28

CPC classification number: C07K16/241 ,  A61K9/0065 ,  A61K9/145 ,  A61K9/146 ,  A61K9/1623 ,  A61K9/1635 ,  A61K9/1641 ,  A61K9/2018 ,  A61K9/2027 ,  A61K9/2031 ,  A61K38/28 ,  C07K16/00 ,  C07K16/244 ,  C07K2317/21 ,  C07K2317/24 ,  C07K2317/40 ,  C07K2317/76

Abstract: Embodiments of the invention provide shaped masses (SM) comprising one or more drugs such as proteins or polypeptides and methods for forming and delivering such SM's. One embodiment provides a SM comprising a drug e.g., a protein or polypeptide having a biological activity in the body of a mammal. The SM is formed by compression of a precursor material (PM) comprising the drug wherein an amount of biologically active drug in the SM is a minimum level to that in the PM. Drugs which may be incorporated into the SM include insulin, incretins and immunoglobulins e.g., interleukin neutralizing antibodies or TNF-α-inhibiting antibodies. Embodiments of the invention are particularly useful for the oral delivery of drugs which would be degraded within the GI tract, wherein the SM containing the drug is formed as or incorporated into a tissue penetrating member which is inserted into the intestinal wall after oral ingestion.

公开(公告)号：US20200247906A1

公开(公告)日：2020-08-06

申请号：US16857929

申请日：2020-04-24

Applicant: InCube Labs, LLC

Inventor： Mir Imran ,  Radhika Korupolu ,  Elaine To ,  Joel Harris ,  Mir Hashim

IPC: C07K16/40

Abstract: Embodiments provide swallowable devices, preparations and methods for delivering therapeutic agents (TAs) within the GI tract such as antibodies (AP-antibodies) or other proteins which neutralize PCSK9 molecules. Many embodiments provide a swallowable device e.g., a capsule for delivering TAs into the intestinal wall (IW). Embodiments also provide TA preparations that are configured to be contained within the capsule, advanced from the capsule into the IW and/or peritoneum and degrade to release the TA into the bloodstream to produce a therapeutic effect. The preparation can be operably coupled to delivery means having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the IW. Embodiments are particularly useful for delivery of AP-antibodies and related TA's for the treatment of cholesterol, lipid and related conditions where such TAs are poorly absorbed and/or degraded within the GI tract.

公开(公告)号：US10689460B2

公开(公告)日：2020-06-23

申请号：US15260260

申请日：2016-09-08

Applicant: Incube Labs, LLC

Inventor： Mir Imran ,  Radhika Korupolu ,  Elaine To ,  Joel Harris ,  Mir Hashim

IPC: C07K16/40 ,  A61K39/00

Abstract: Embodiments provide swallowable devices, preparations and methods for delivering therapeutic agents (TAs) within the GI tract such as antibodies (AP-antibodies) or other proteins which neutralize PCSK9 molecules. Many embodiments provide a swallowable device e.g., a capsule for delivering TAs into the intestinal wall (IW). Embodiments also provide TA preparations that are configured to be contained within the capsule, advanced from the capsule into the IW and/or peritoneum and degrade to release the TA into the bloodstream to produce a therapeutic effect. The preparation can be operably coupled to delivery means having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the IW. Embodiments are particularly useful for delivery of AP-antibodies and related TA's for the treatment of cholesterol, lipid and related conditions where such TAs are poorly absorbed and/or degraded within the GI tract.

公开(公告)号：US20190062451A9

公开(公告)日：2019-02-28

申请号：US15260260

申请日：2016-09-08

Applicant: Incube Labs, LLC

Inventor： Mir Imran ,  Radhika Korupolu ,  Elaine To ,  Joel Harris ,  Mir Hashim

IPC: C07K16/40

CPC classification number: C07K16/40 ,  A61K2039/505 ,  A61K2039/54 ,  A61K2039/542 ,  A61K2039/545 ,  C07K2317/21 ,  C07K2317/76

Abstract: Embodiments provide swallowable devices, preparations and methods for delivering therapeutic agents (TAs) within the GI tract such as antibodies (AP-antibodies) or other proteins which neutralize PCSK9 molecules. Many embodiments provide a swallowable device e.g., a capsule for delivering TAs into the intestinal wall (IW). Embodiments also provide TA preparations that are configured to be contained within the capsule, advanced from the capsule into the IW and/or peritoneum and degrade to release the TA into the bloodstream to produce a therapeutic effect. The preparation can be operably coupled to delivery means having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the IW. Embodiments are particularly useful for delivery of AP-antibodies and related TA's for the treatment of cholesterol, lipid and related conditions where such TAs are poorly absorbed and/or degraded within the GI tract.