Drug combination composition for treating tumor diseases, and application thereof

A combined drug and composition technology, applied in the field of biomedicine, can solve the problem that there is no combination of anti-PD-1 monoclonal antibody and anti-VEGFR-2 antibody approved for marketing, so as to prolong the progression-free survival and overall survival , Improve the duration of therapeutic response, and the effect of high drug safety

Pending Publication Date: 2022-02-25
BEIJING DONGFANG BIOTECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, there are many monoclonal anti-PD-1 monoclonal antibody drugs and anti-VEGFR-2 monoclonal antibody drugs that have been approved for clinical use or marketed, but there is still no combination of anti-PD-1 monoclonal antibody and anti-VEGFR-2 antibody. The drug has been approved for marketing. In order to meet the treatment needs of tumor patients and improve the research and development progress of antibody drugs as soon as possible, it is urgent to develop a combination drug of monoclonal antibody with clinical value. Is the combined drug effect of two monoclonal antibody drugs better than that of a single drug? It can further improve the efficacy of the drug under the premise of reducing the dosage, which is worthy of exploration and research

Method used

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  • Drug combination composition for treating tumor diseases, and application thereof
  • Drug combination composition for treating tumor diseases, and application thereof
  • Drug combination composition for treating tumor diseases, and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Example 1 of the present invention provides a combined drug composition for the treatment of tumor diseases, including an anti-PD-1 monoclonal antibody targeting PD-1 and an anti-VEGFR-2 monoclonal antibody targeting VEGFR-2 .

[0031] Further, anti-PD-1 monoclonal antibodies include DFPD1-9, DFPD1-10, DFPD1-11, DFPD1-12, DFPD1-13, Nivolumab, Pembrolizumab, toripalimab, sintilimab, tiram Rizumab, camrelizumab, pembrolizumab, or cepalimumab.

[0032] Among them, Nivolumab, Pembrolizumab, Toripalimab, Sintilimab, Tislelizumab, Camrelizumab, Pembrolizumab or Sepalimumab are all listed products .

[0033] Among them, DFPD1-9, DFPD1-10, DFPD1-11, DFPD1-12, and DFPD1-13 are the anti-PD-1 monoclonal antibodies provided by the application number CN201510312910.8, and DFPD1-9 includes as shown in SEQ ID No: 2 The light chain variable region shown and the heavy chain variable region shown in SEQ ID No: 1; DFPD1-10 includes the light chain variable region shown in SEQ ID No: 3 ...

Embodiment 2

[0061] On the basis of Example 1, Example 2 of the present invention further provides a combination drug composition for treating tumor diseases, including an anti-PD-1 monoclonal antibody targeting PD-1 and an anti-PD-1 monoclonal antibody targeting VEGFR-2 anti-VEGFR-2 monoclonal antibody.

[0062] Preferably, the anti-PD-1 monoclonal antibody is toripalimab.

[0063] Preferably, the anti-VEGFR-2 monoclonal antibody is antibody N-3, and antibody N-3 includes a light chain variable region as shown in SEQ ID No:8 and a heavy chain variable region as shown in SEQ ID No:9 .

[0064] Preferably, the administration of toripalimab and antibody N-3 is sequential.

[0065] The dosage of toripalimab is 100-400 mg, given once every 3 weeks.

[0066] The dosage of antibody N-3 was 4-20 mg / kg, given once every 3 weeks.

[0067] Both toripalimab and antibody N-3 were administered intravenously.

Embodiment 3

[0069] Example 3 of the present invention further provides a combination drug composition for treating tumor diseases on the basis of Example 2. The difference from Example 2 is that the dosage of toripalimab is 240 mg, given once every 3 weeks ; The dosage of antibody N-3 was 8 mg / kg, and other schemes were the same as in Example 2.

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Abstract

The invention relates to the field of biological medicines, and particularly provides a drug combination composition for treating tumor diseases. The composition comprises an anti-PD-1 monoclonal antibody taking PD-1 as a target spot and an anti-VEGFR-2 monoclonal antibody taking VEGFR-2 as a target spot. Through combined application of the anti-PD-1 monoclonal antibody and the anti-VEGFR-2 monoclonal antibody, not only is the medication safety higher, but also the treatment response duration is effectively prolonged, the progression-free lifetime and the total lifetime of cancer patients are prolonged, and the health condition and the life quality of the patients are improved. The drug combination composition can be used for treating non-small cell lung cancer, glioma, colorectal cancer, liver cancer, HER2 negative metastatic breast cancer, metastatic gastric adenocarcinoma, metastatic melanoma and metastatic renal cell carcinoma, and especially can be used for effectively treating non-small cell lung cancer and liver cancer.

Description

technical field [0001] The invention relates to the technical field of biomedicine, in particular to a combined drug composition and application for treating tumor diseases. Background technique [0002] Immunotherapy is a hot field of tumor treatment, and the PD-1 target is an important target of immunotherapy. The anti-PD-1 monoclonal antibody drugs on the market today have remarkable clinical efficacy, which greatly fills the clinical needs of tumor treatment. PD-1 is a key immune checkpoint receptor expressed on the surface of activated T cells. After encountering PD-L1 and PD-L2 ligand molecules on the surface of tumor cells, it inhibits the activation of T cells and invading tumor cells It will escape the surveillance of the immune system, while the use of anti-PD-1 monoclonal antibody inhibitors will relieve the inhibition of tumor cells on T cell activation, and the patient's autoimmune T cells will be activated in large numbers, thereby killing tumor cells. At pre...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395A61P35/00A61P35/04
CPCC07K16/2818C07K16/2863A61P35/00A61P35/04A61K2039/507
Inventor 白义
Owner BEIJING DONGFANG BIOTECH
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