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Use of anti-PD-1 antibodies in treatment of malignancies

A technology of PD-1 and malignant tumors, which is applied in the field of treatment of malignant tumors and can solve the problems of inability to kill tumor cells

Inactive Publication Date: 2021-08-13
SHANGHAI JUNSHI BIOSCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the activated T cells infiltrating in the tumor microenvironment highly express PD-1 molecules, and the inflammatory factors secreted by activated leukocytes can induce tumor cells to highly express the ligands PD-L1 and PD-L2 of PD-1, resulting in the tumor microenvironment. Activated T cell PD-1 pathway is continuously activated, T cell function is inhibited, unable to kill tumor cells

Method used

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  • Use of anti-PD-1 antibodies in treatment of malignancies
  • Use of anti-PD-1 antibodies in treatment of malignancies
  • Use of anti-PD-1 antibodies in treatment of malignancies

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0137] Example 1: Clinical research on anti-PD-1 antibody monotherapy in the treatment of malignant tumors

[0138] Main inclusion criteria: Eligible subjects must be (1) aged 18 to 65 years old, (2) suffering from advanced or recurrent malignant tumors, (3) refractory to standard systemic therapy, (4) ECOG score 0 or 1, (5) no history of cancerous meningitis, active tuberculosis, autoimmune disease, or persistent infection, (6) no history of any systemic therapy within 4 weeks, (7) no history of any systemic therapy within 2 weeks Systemic steroids, minor surgery, or targeted therapy with tyrosine kinase inhibitors.

[0139] Subjects must have evaluable lesions according to the RECIST v 1.1 standard, and are not allowed to use anti-tumor drugs at the same time, or have been treated with anti-CTLA4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies.

[0140] Test drug: anti-PD-1 antibody toripalimab (WO2014206107).

[0141] The doses of anti-PD-1 antibody used in this test ar...

Embodiment 2

[0187] Example 2: Clinical Trial of Anti-PD-1 Antibody Treatment for Patients with Advanced or Recurrent Lymphoma

[0188] Main inclusion criteria: Eligible subjects must be (1) aged 18 to 70 years old, (2) patients with classical Hodgkin's lymphoma or B-cell non-Hodgkin's lymphoma confirmed by histology or cytopathology , (3) recurrent, refractory or progressive, currently no standard treatment, (4) ECOG score is 0 or 1, (5) must be more than 4 weeks from the last systemic chemotherapy, and must be more than 4 weeks from the last radiotherapy, according to the immune system The systemic drug used in the inhibitory dose must have been discontinued for at least 4 weeks, and the previous anti-tumor biological therapy has been completed for at least 4 weeks. 6) The subject must have at least one measurable lesion according to the RECIST v 1.1 standard.

[0189] Exclusion criteria: (1) Subjects with other malignant tumors in the past (except cured carcinoma in situ of the cervix a...

Embodiment 3

[0231] Example 3: Clinical research on the treatment of sarcoma with anti-PD-1 antibody

[0232] Main inclusion criteria:

[0233] Eligible subjects must (1) be 18 years of age or older, (2) have advanced malignancy, and (3) be evaluable by RECIST v1.1 and irRECIST criteria, but have difficulty or no criteria for standard therapy Treatment method, ECOG score 0 or 1, (4) normal organ or bone marrow function, (5) subjects with certain serious diseases will be excluded from the trial, agree to take effective contraceptive measures, (6) No previous immunotherapy, such as but not limited to other anti-CTLA-4, anti-PD-1 or anti-L1 antibodies, vaccines, etc.

[0234] Test drug: anti-PD-1 antibody toripalimab (WO2014206107).

[0235] Clinical design:

[0236] This trial is a US Phase I, multicenter, open-label study (NCT03474640). This study was used to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and antitumor activity of toripalimab in patients with advanc...

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Abstract

The present invention relates to the use of anti-PD-1 antibodies and / or antigen-binding fragments thereof in the treatment of malignancies. The present invention relates to the use of anti-PD-1 antibodies and / or antigen-binding fragments thereof in the treatment of sarcoma, preferably in the treatment of vacuolar soft tissue sarcoma, angiosarcoma and undifferentiated polymorphic sarcoma, and the use of anti-PD-1 antibodies and / or antigen-binding fragments thereof in the treatment of lymphoma.

Description

technical field [0001] The present invention relates to the use of anti-PD-1 antibody or its antigen-binding fragment in treating malignant tumors. Specifically, the present invention relates to the use of anti-PD-1 antibodies or antigen-binding fragments thereof in the treatment of sarcoma, lung cancer, and lymphoma, especially in the treatment of soft tissue sarcomas, preferably in the treatment of vacuolar soft tissue sarcomas. Background technique [0002] Immune escape is one of the hallmarks of cancer. Ahmadzadeh, M. et al., Blood, 114:1537-44 disclosed that tumor-specific T lymphocytes often exist in the tumor microenvironment, draining lymph nodes and peripheral blood, but due to the immunosuppressive mechanism network existing in the tumor microenvironment, their Often the progression of the tumor cannot be controlled. CD8 + Tumor-infiltrating T lymphocytes (TILs) often express activation-induced inhibitory receptors, including CTLA-4 and PD-1, while tumor cells ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395A61P35/00C12Q1/6886
CPCC07K16/2818C12Q1/6886A61P35/00A61K2039/505C12Q2600/106C12Q2600/156A61K39/00C07K2317/24C07K2317/94A61K2039/545
Inventor 姚盛冯辉武海
Owner SHANGHAI JUNSHI BIOSCI
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