DRUG COMBINATION FOR GENE-IMMUNE THERAPY Russian patent published in 2023 - IPC A61K48/00 

FIELD: biotechnology.

SUBSTANCE: present invention relates to the field of biotechnology, medicine, in particular, oncology and pharmaceuticals. Two pharmaceutical combinations are described for the preparation of an injection solution for the treatment of solid malignant neoplasms by gene-immune therapy. In the first variant, the pharmaceutical combination contains two components, each of which is sealed in a container, and: the first component is sealed in the first container and is a frozen sterile solution containing hypercoiled plasmid DNA pCMV-HSVtk-hGM-CSF in a therapeutically effective amount, according to at least one pharmaceutically acceptable additive and water, the second component is sealed in the second container and is a frozen sterile solution containing the PEG-PEI-TAT peptide block copolymer in a therapeutically effective amount, at least one pharmaceutically acceptable additive and water. In the second version, the composition includes two components, each of which is sealed in a container, and: the first component is sealed in the first container and is a sterile lyophilisate containing supercoiled plasmid DNA pCMV-HSVtk-hGM-CSF in a therapeutically effective amount and at least one pharmaceutically acceptable additive, the second component is sealed in a second container and is a frozen sterile solution containing a PEG-PEI-TAT peptide block copolymer in a therapeutically effective amount, at least one pharmaceutically acceptable additive and water. A ready-made solution for injection intended for administration to a patient is prepared ex tempore by reconstituting the first component with adding water, defrosting the second component and mixing them.

EFFECT: described technical solutions demonstrate high stability and retain therapeutic efficacy for at least 18 months for the treatment of human solid malignant neoplasms.

12 cl, 1 dwg, 5 tbl, 13ex