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Topical treatment of immune checkpoint inhibitor induced diarrhoea, colitis or enterocolitis using antibodies and fragments thereof

An enterocolitis, inhibitor technology, applied in the field of topical treatment of diarrhea, colitis or enterocolitis induced by immune checkpoint inhibitors using antibodies and fragments thereof, which can solve harmful cancer therapy efficacy side effects, disease recurrence And other issues

Pending Publication Date: 2021-07-23
蒂洛特斯制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This is detrimental to the effectiveness of cancer therapy and systemically produces unwanted side effects and, in the case of melanoma, recurrence of the underlying disease

Method used

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  • Topical treatment of immune checkpoint inhibitor induced diarrhoea, colitis or enterocolitis using antibodies and fragments thereof
  • Topical treatment of immune checkpoint inhibitor induced diarrhoea, colitis or enterocolitis using antibodies and fragments thereof
  • Topical treatment of immune checkpoint inhibitor induced diarrhoea, colitis or enterocolitis using antibodies and fragments thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment approach

[0220]According to one embodiment of the present invention, the one or more ICP inhibitors are a combination of antibodies specific for PD-1 and / or PD-L1 and antibodies specific for CTLA-4, preferably specific for Antibodies against PD-1 or PD-L1 in combination with antibodies specific for CTLA-4. According to another embodiment of the present invention, the antibody specific for PD-1 is selected from the following: pembrolizumab and nivolumab, and the antibody specific for PD-L1 is selected from the following: atezolizumab, avelumab The mAb and durvalumab, and the antibody specific for CTLA-4 are selected from the group consisting of ipilimumab and tremelimumab. According to another embodiment of the invention, the patient to be treated with the composition of the invention suffers from ICP inhibitor-induced diarrhea, colitis or enterocolitis using any one or more of the ICPs listed above caused by inhibitor therapy.

[0221] For administration of antibodies specific for CT...

Embodiment 1 and Embodiment 2

[0258] Materials and methods in the examples

[0259] Preparation of citrate-TRIS buffer pH 7: Prepare 100 mM sodium citrate solution (2.942 g and make up to 100.0 mL with purified water). A 100 mM citric acid solution was prepared (3.842 g was dissolved and diluted to 200.0 ml with purified water). The pH of the citric acid solution was adjusted to 3.5 using sodium citrate solution. A 1M TRIS solution was prepared (12.114 g and made up to 100.0 ml with purified water). Adjust the pH of the citrate buffer to pH 7.0 using TRIS solution.

[0260] Preparation of pellets

[0261] Formulation components (pellet core)

[0262]

[0263] *relative to the dry mix before addition of adalimumab

[0264] Preparation steps:

[0265] Dry Blending: The excipients required for each batch (batch size: 10 g) were mixed at 50 rpm for a predetermined period of about 5 minutes using the mixer attachment (dual paddle mixer) from the Caleva Multilab equipment.

[0266] Wet blending: After th...

Embodiment 1

[0278] The uncoated pellets of Example 1 disintegrated rapidly in Citrin-TRIS pH 7.0 buffer, resulting in rapid and almost complete release of adalimumab within 1 hour. On the other hand, the release of adalimumab from the uncoated pellets of Example 2 was sustained for the duration of the experiment.

[0279]

[0280] Release from adalimumab delayed (enteric-coated) release pellet core

[0281] Two batches of adalimumab pellets were coated with Eudragit L30D-55 dispersion. After 2 hours in 0.1N HCl, the coated pellets were completely acid resistant (no adalimumab release). After exchange to citrate-TRIS pH 7.0 buffer (to mimic the pH of the lumen of the small intestine), adalimumab release started (≥5% release).

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Abstract

The present invention relates to the therapeutic topical use of compositions containing antibody molecules or functional fragments or derivatives specific to tumour necrosis factor alpha (TNF[alpha]), for treating or preventing immune checkpoint (ICP) inhibitor-induced adverse events.

Description

[0001] field of invention [0002] The present invention relates to the therapeutic properties of compositions comprising antibody molecules and functional fragments and derivatives specific for tumor necrosis factor alpha (TNFα) in the local treatment of at least one gastrointestinal adverse event induced by cancer therapy in a patient Use, preferably, is induced by one or more immune checkpoint (ICP) inhibitors. In particular, the present invention relates to the therapeutic use of such compositions for the topical treatment of diarrhea, colitis and / or enterocolitis induced by immune checkpoint (ICP) inhibitors, especially when ICP inhibitors have not been discontinued as in patients treated for cancer; and use of such compositions as at least partly preventing or treating ICP inhibitor-induced diarrhea, colitis and / or enterocolitis in patients receiving ICP inhibitor therapy. Background technique [0003] In recent years, the use of inhibitors that target so-called immune ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K16/24A61K39/00A61K9/00A61K9/14
CPCC07K16/241A61K9/0053A61K9/145A61K2039/505A61K9/1623A61K9/5026A61P1/14
Inventor E.M.富勒F.瓦鲁姆R.布拉沃J.斯普莱斯M.内德尔科维奇普罗蒂克O.格斯特纳C.布鲁诺
Owner 蒂洛特斯制药股份有限公司
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