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Plant lignan or enterolactone and PD-1/PD-L1 inhibitor combined pharmaceutical composition and application thereof

A PD-L1 and PD-1 technology, applied in the field of biomedicine, can solve the problem of insensitivity to immunotherapy in patients with malignant tumors, and achieve the effect of accelerating the transformation of clinical application and inhibiting immune escape.

Pending Publication Date: 2022-06-24
HARBIN MEDICAL UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In order to solve the problem that patients with malignant tumors are not sensitive to immunotherapy, the present invention provides a pharmaceutical composition for combining phytolignans or enterolactones with PD-1 / PD-L1 inhibitors and its application

Method used

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  • Plant lignan or enterolactone and PD-1/PD-L1 inhibitor combined pharmaceutical composition and application thereof
  • Plant lignan or enterolactone and PD-1/PD-L1 inhibitor combined pharmaceutical composition and application thereof
  • Plant lignan or enterolactone and PD-1/PD-L1 inhibitor combined pharmaceutical composition and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] In this example, the anti-tumor effect of the combination of enterolide (ENL) preparation and PD-1 / PD-L1 inhibitor was investigated through mouse experiments.

[0051] experimental method:

[0052]Twenty-four BALB / c female mice were selected, and 4T1 cells were subcutaneously inoculated into the mice. Mice were randomly divided into four groups: control group (Control), PD-L1 / PD-1 inhibitor group (PD-L1 / PD-1 inhibitor), ENL group and ENL combined with PD-L1 / PD-1 inhibitor group (ENL). +PD-L1 / PD-1 inhibitor). All groups were administered by intraperitoneal injection. ENL was administered daily at a dose of 1 mg / kg / mouse / day; PD-L1 / PD-1 inhibitors were administered once every three days at a dose of 1 mg / kg / mouse / day. 50ug / mouse / 3 days. The control group was given the same amount of prepared solvent for intraperitoneal injection.

[0053] Monitoring the weight change of mice, we get figure 1 The comparison chart of the body weight changes of the mice in each group is...

Embodiment 2

[0059] In this example, the anti-tumor effect of the combination of flax lignan preparations and PD-1 / PD-L1 inhibitors was investigated through mouse experiments.

[0060] experimental method:

[0061] Twenty-four BALB / c female mice were selected, and the 4T1 cell line was subcutaneously inoculated into the mice. Mice were randomly divided into four groups: control group (Control), PD-L1 / PD-1 inhibitor group (PD-L1 / PD-1 inhibitor), flax lignan group (Flaxseedlignan) group and flax lignan combined with PD -L1 / PD-1 inhibitor group (Flaxseed lignan+PD-L1 / PD-1 inhibitor).

[0062] The preparation method of the flax lignan preparation used in this example is as follows: 10 g of defatted flax seeds are placed in 100 mL of pure water, and the liquid is collected after boiling for 5 minutes to obtain the flax lignan preparation. The volume is 500uL / mouse / day; the PD-L1 / PD-1 inhibitor is administered every three days at a dose of 50ug / mouse / 3 days. The control group was given the sa...

Embodiment 3

[0070] In this example, 16S rDNA sequencing analysis was further performed on the feces of each group of mice collected before the mice were sacrificed in Example 2.

[0071] First, compare the relative abundance bar chart at the bacterial phylum level, and the results are as follows Figure 23 As shown, the results show an increase in Verrucomicrobia (Verrucomicrobia) abundance following flax lignan treatment.

[0072] Next, a bar chart comparison of bacterial genus-level relative abundance was performed. The result is as Figure 24 shown, relative to the control group, Blautia (Bacteroides), Bacteroides (Bacteroides) and Akkermansia (Akermansia) in the flax lignan group and PD-L1 / PD-1 inhibitor group The abundance was elevated in the flax lignans combined with PD-L1 / PD-1 inhibitor group. The abundance of Clostridium (Clostridium) was significantly increased in the flax lignans combined with PD-L1 / PD-1 inhibitor group. Relative to the control group, Lactobacillus (Lactoba...

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Abstract

The invention relates to a plant lignan or enterolactone and PD-1 / PD-L1 inhibitor combined pharmaceutical composition and application thereof, and belongs to the technical field of biological medicine. In order to solve the problem that malignant tumor patients are insensitive to immunotherapy, the invention provides a plant lignan or enterolactone and PD-1 / PD-L1 inhibitor combined pharmaceutical composition which comprises an effective dose of a plant lignan preparation or an enterolactone preparation and an effective dose of a PD-1 / PD-L1 inhibitor. The combined pharmaceutical composition disclosed by the invention can increase the proportion of immune cells with an anti-cancer function and inhibit immune escape of cancer cells. The proportion of CD4 and CD8 positive cells can be up-regulated through combined medication, and the effect of inhibiting growth of mouse breast cancer is superior to that of independent medication of plant lignans, enterolactone or PD-L1 / PD-1 inhibitors. The invention provides an unprecedented effective auxiliary or synergistic treatment strategy for immunotherapy of malignant tumors.

Description

technical field [0001] The invention belongs to the technical field of biomedicine, and in particular relates to a combination pharmaceutical composition of plant lignans or enterolactones and PD-1 / PD-L1 inhibitors and applications thereof. Background technique [0002] Malignant tumors have a high incidence, high heterogeneity and aggressiveness, insidious initial onset, easy metastasis, and easy recurrence after treatment. Its prevention and treatment has become a major public health problem plaguing the world. The treatment effect of malignant tumor patients under the traditional mode of surgery, radiotherapy and chemotherapy or targeted therapy is poor, and most patients develop drug resistance, recurrence and metastasis during the treatment process, which increases the social and economic burden. Immunotherapy is an emerging means of fighting malignant tumors, and is known as the "most breakthrough" research progress. [0003] Immune checkpoints PD-1 (Programmed death...

Claims

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Application Information

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IPC IPC(8): A61K45/06A61K31/7032A61K31/365A61P35/00
CPCA61K45/06A61K31/7032A61K31/365A61P35/00A61K2300/00
Inventor 吴昊刘树林
Owner HARBIN MEDICAL UNIVERSITY
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