The product consists of a recombinant humanised IgG4 kappa CD22-targeting monoclonal antibody covalently attached to calicheamicin derivative, N-acetyl-gamma-calicheamicin dimethylhydrazide.
<0.001 EU per 1 μg of the peptide by the LAL method
Indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL).
Examples of Clinical Use:
Adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL)
The product is an antineoplastic agent that targets CD22 antigen expressed on immature B-cell lymphocytes and blocks further growth of tumor cells. The drug aims to restore normal blood counts and achieve complete remission from the disease. QT interval prolongation was observed in patients receiving the product.
Mechanism of action:
Inotuzumab ozogamicin is comprised of cytotoxic antibiotic N-acetyl-gamma-calicheamicin dimethylhydrazide attached to a humanized monoclonal IgG4 antibody via 4-(4 acetylphenoxy) butanoic acid (acetyl butyrate) linker. The drug exerts a potent cytotoxic effect against CD22+ B-cell lymphoma when the antibody binds to the CD22 receptor on the surface of B cells . The drug-CD22 complex is rapidly internalized into the cell, forming an endosome which subsequently fuses with lysosomes. N-acetyl-gamma-calicheamicin dimethylhydrazide is then intracellularly released into the acidic environment. N-acetyl-gamma-calicheamicin dimethylhydrazide is a calicheamicin derivative, which is naturally produced by the bacterium Micromonospora echinospora, and is toxic to the body when not bound to the antibody. It mediates apoptosis of the cell by binding to the minor groove of DNA in a sequence-specific manner and undergoing a structural change to generate diradicals [A20354]. These changes abstract hydrogen ions from the phosphodiester bonds of double-stranded DNA, resulting in breaks and cell apoptosis.
Inotuzumab ozogamicin is a targeted therapy for cancer, which is considered to be a frontier therapy for leukemia.
What is Inotuzumab ozogamicin?
Inotuzumab ozogamicin is an antibody drug combination chemotherapy drug used to treat a specific type of leukemia, namely recurrent or refractory B-cell acute lymphoblastic leukemia (B-ALL). Its unique design can help the drug guide a semisynthesis chemotherapy drug into leukemia cells. Inotuzumab ozogamicin has been approved for the treatment of adult B-ALL, and has been approved by FDA (Food and Drug Administration) and EMA (European Medicines Agency).
Structure of Inotuzumab ozogamicin
Inotuzumab ozogamycin is a monoclonal antibody drug composed of a monoclonal antibody and a chemotherapy drug ozogamycin. The antibody portion is a humanized IgG4 antibody. The connection structure between chemotherapeutic drug ozogamicin and antibody is a hydrazide chemical bond. This connection method can help drugs transport stably in the body and maintain the specificity of chemotherapy drugs.
Research and development history of Inotuzumab ozogamicin
Inotuzumab ozogamicin was initially researched and developed by American biotechnology company Wyeth, and was certified as Orphan Drug (Orphan drug) in 2008. In 2010, Wyeth was acquired by Pfizer, and Inotuzumab ozogamicin became one of Pfizer's main drug research projects. In clinical trials, Inotuzumab ozogamicin presents many prospects, especially in the treatment of B-ALL patients. In 2017, the FDA approved the drug's launch, becoming the first antibody drug combined with chemotherapy drug to treat B-ALL in the United States.
The function of Inotuzumab ozogamicin
The main function of Inotuzumab ozogamicin is to treat B-ALL. During the treatment process, the antibody portion (Inotuzumab) targets CD22 antigen, a common antigen on the surface of B cells and B-ALL cells. Chemotherapy drugs (ozogamicin) can enter cells, damaging their DNA and RNA structures, thereby killing the cells. Due to the fact that the entry of chemotherapy drugs depends on the presence of CD22 antigen, the action of Inotuzumab ozogamicin has strong specificity and can avoid harm to healthy cells.
The mechanism of action of Inotuzumab ozogamicin
The action of Inotuzumab ozogamicin can be divided into two parts: one is to target specific antigens through antibodies, and the other is to destroy the DNA and RNA structures of cells through chemotherapy drugs.
During the treatment process, the antibody portion (Inotuzumab) targets the CD22 antigen, which is widely present in B cells, especially B-ALL cells. When the antibody binds to CD22, Inotuzumab ozogamycin is engulfed and enters the cell, releasing a portion of the chemotherapy drug (ozogamycin) into the cell, damaging the DNA and RNA structure of the cell and killing it.
Inotuzumab ozogamicin related drugs
Inotuzumab ozogamicin belongs to a class of antibody drug combination chemotherapy drugs, similar drugs include Gemtuzumab ozogamicin, Brentuximab vedotin, and Trastuzumab emtansine (T-DM1). The characteristic of these drugs is that they can help chemotherapy drugs enter tumor cells by targeting antibody molecules and release drugs within tumor cells, thereby achieving specific and efficient therapeutic effects. These drugs have extensive applications in the treatment of cancer. For example, Trastuzumab emtansine is used to treat HER2 positive breast cancer, while Brentuximab vedotin is used to treat Hodgkin lymphoma and T-cell lymphoma.
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