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Immunopotentiator, immunotherapy pharmaceutical composition and its preparation and application

The technology of an immunotherapy drug and an immunopotentiator is applied in the field of immunotherapy pharmaceutical composition and its preparation, and immunopotentiator, which can solve the problems such as the toxic and side effects of adjuvants, and achieve the effects of less side effects, improved presentation efficiency, and convenient use.

Active Publication Date: 2022-04-12
FUDAN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are still many difficulties in the research and development of adjuvants, one of which is the toxic and side effects of adjuvants, the second is the effectiveness of adjuvants, and the third is the relationship between the adjuvant’s ability to effectively improve the immune response of the antigen and its dose-effect

Method used

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  • Immunopotentiator, immunotherapy pharmaceutical composition and its preparation and application
  • Immunopotentiator, immunotherapy pharmaceutical composition and its preparation and application
  • Immunopotentiator, immunotherapy pharmaceutical composition and its preparation and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0199] Example 1, IFN-α / GM-CSF / VACCINE triggers humoral immunity and cellular immunity in wild-type mice

[0200] 1.1 Optimal dosage ratio of GM-CSF, IFN-α and VACCINE

[0201] In order to verify that the mixture of GM-CSF, IFN-α and VACCINE achieves the same effect as the injection of GM-CSF (3×GM-CSF+VACCINE) 3 days before injection of hepatitis B vaccine, the effects of GM-CSF, IFN-α and VACCINE The optimal dosage ratio of the mixture was tested. We found that when 10μg GM-CSF and 10000IUIFN-α were mixed with 1μg VACCINE, the DTH response induced in normal mice was not different from that of 3×GM-CSF+VACCINE, but was significantly higher than other dose combinations. At the same time, we also saw that after 10μg GM-CSF, 10000IU IFN-α and 1μg VACCINE mixed immunization and 3×GM-CSF+VACCINE immunization, the anti-HBsAg produced by ordinary mice was the highest, and there was no significant statistical difference between the two difference, the anti-HBsAg produced by other d...

Embodiment 2

[0232] Example 2, IFN-α / GM-CSF / VACCINE breaks the immune tolerance of rAAV-1.3HBV mice

[0233] In Example 1, we found that IFN-α / GM-CSF / VACCINE combined immunization and 3×GM-CSF+VACCINE can stimulate humoral immunity and cellular immunity in wild-type mice, especially can significantly improve HBV-specific CTL killing ability of CD8+ effector T cells. The key problem that chronic hepatitis B is difficult to treat is the immune tolerance caused by HBV, and the body cannot complete the clearance of HBV by itself. In previous experiments, we found that 3×GM-CSF+VACCINE successfully broke the immune tolerance of HBV-sAg transgenic mice, promoted the clearance of HBsAg and the production of anti-HBsAg. In this experiment, we established a hepatitis B model in mice infected with adenovirus and recombinant hepatitis B virus (rAAV8-1.3HBV), and used this model to evaluate the effectiveness of the optimized IFN-α / GM-CSF / VACCINE combined immunization regimen. immune effect.

[0234...

Embodiment 3

[0262] In order to verify that GM-CSF, IFNα-2b and tumor antigen polypeptide or protein vaccine are mixed to achieve an immune activation response, first we use prostate cancer antigen epitope peptide (PAP, its sequence is: CMSAMTNLAALFPPEG, as shown in SEQID NO.1 ), using the polypeptide and carrier protein (KLH) coupling method for coupling. After purification, mix 50 μg of the conjugated vaccine with 10 μg GM-CSF and 10,000 IU IFNα-2b and supplemented with aluminum adjuvant, and subcutaneously immunize common BALB / C mice, with an interval of 2 weeks between each time, a total of 2 times , while the coupled antigen peptide 50 μg mixed aluminum adjuvant group was used as the control, and the immunization procedures were consistent. Two weeks after immunization, the serum of the mice was collected for ELISA to detect the level of humoral immunity. Afterwards, the paws were stimulated with 10 μg of polypeptide-conjugated BSA, and the swelling size of the paws was measured for ...

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Abstract

The invention discloses an immune enhancer, which at least includes interferon and granulocyte-macrophage colony-stimulating factor, and an immunotherapy pharmaceutical composition, which at least includes an antigen and the above-mentioned immune enhancer. The invention also discloses the preparation method of the immunotherapy pharmaceutical composition, the application of the above immune enhancer and immunotherapy pharmaceutical composition. The immunopotentiator provided by the invention can significantly improve the immune ability of the body, improve the antigen presentation efficiency of the body, and enable the body to establish effective immune activation and response; produce stronger antibodies and cellular immune protection responses and the ability to remove pathogens, can It is used in the treatment of diseases and tumors caused by microorganisms such as viruses and bacteria.

Description

[0001] This application claims the priority of the Chinese patent application submitted to the China Patent Office on March 13, 2017, with the application number 201710021679.6 and the title of the invention "An Immunotherapy Pharmaceutical Composition and Its Use", the entire contents of which are incorporated herein by reference In this application. technical field [0002] The invention relates to the field of biomedicine, in particular to an immune enhancer, an immunotherapeutic pharmaceutical composition and its preparation and application. Background technique [0003] As people's nutritional status, sanitation conditions, and medical care levels have greatly improved, the average life expectancy has risen steadily. In addition to infectious diseases such as major infectious diseases such as hepatitis B, AIDS, tuberculosis and HPV, persistent infectious diseases and tumors caused by other pathogenic microorganisms have become major problems that endanger people's healt...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/39A61K39/29A61P1/16A61P31/20A61P31/00A61P35/00
CPCA61K39/12A61K39/39A61K2039/55505A61K2039/55522A61K2039/55516C12N2730/10134A61K39/001186A61K39/0011A61K39/001157A61K39/001193A61K39/001182A61K39/001153A61K39/001156A61K2300/00A61K39/092A61K2039/545A61K2039/804A61K2039/812A61K2039/82A61K2039/836A61K2039/844A61K2039/868A61K2039/884A61K2039/892A61P1/16A61P31/00A61P31/18A61P31/20A61P35/00C12N2740/16034C12N2750/14143A61K2039/5256A61K2039/6081C12N2710/20034C07K14/005C12N15/86A61K39/292A61K39/21A61K2039/541A61K2039/80A61K39/29C12N7/00C07K14/52C07K14/535C07K14/565C12N2730/10011C12N2730/10034
Inventor 王宾赵卫东赵干钟一维
Owner FUDAN UNIV
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