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What new immune drugs have been approved by FDA or EMA in 2020?
What new immune drugs have been approved by FDA or EMA in 2020? In recent years, researchers and pharmaceutical companies have shown great interest in immunotherapy.
In cancer and infectious diseases, immunotherapy has achieved fewer side effects, longer survival times and higher overall survival rates by activating or suppressing the immune system, alone or in combination with radiotherapy, chemotherapy and other combined treatments.
There are many types of immunotherapy, including immunomodulators (such as cytokines, interleukins, chemokines and immunomodulators), monoclonal antibodies, immune checkpoint inhibitors, oncolytic viruses, vaccines, and immune cell therapy (CAR- T etc.).
In 2020, the FDA/EMA approved a total of 53 immunotherapy-related drugs, including 13 monoclonal antibodies (mAb), antibody-conjugated drugs (ADC) and CAR-T therapies, as shown in the table below.
10 monoclonal antibody drugs, 2 ADC drugs, and 1 CAR-T therapy approved by the FDA/EMA in 2020
Monoclonal antibody (mAb) or combination therapy with other drugs and radionuclides has been a research hotspot in the past ten years. With the increase of monoclonal antibody drugs, its preparation technology has also been developed by leaps and bounds. Monoclonal antibody technology early uses hybridoma technology to prepare by fusion of mouse spleen B lymphocytes and immortal myeloma cells. However, mouse-derived monoclonal antibodies have obvious clinical deficiencies. Therefore, humanization is carried out through chimeric technology, and a fully human monoclonal antibody preparation technology, such as a single B-cell antibody library technology, has been developed.
The 10 monoclonal antibody drugs approved in 2020 include 4 humanized monoclonal antibodies, 3 fully humanized monoclonal antibodies and 2 chimeric antibodies, as well as 1 monoclonal antibody mixed drug. These drugs are used to treat episodic migraine, high-risk neuroblastoma, blood cancer, HER-2 positive breast cancer, thyroid eye disease, CNS autoimmune disease, Ebola virus infection, etc.
Antibody-conjugated drugs (ADC) are designed to specifically deliver anti-tumor drugs to target antigens by coupling with antibodies. ADC drug design has 4 key components: target antigen, antibody construct, cytotoxic agent and linker. Currently, 8 ADCs have been approved, and 2 ADC drugs approved in 2020 can be used to treat metastatic breast cancer and multiple myeloma.
CAR-T cells are composed of T cells isolated from peripheral blood and chimeric antigen receptor CAR. The CAR molecule consists of three parts: an extracellular domain, which contains a single-chain fragment for a specific targeted antigen, which is linked to a transmembrane domain or a second costimulatory factor, and finally contains an intracellular signal domain. CAR-T drugs approved in 2020 are used to treat cell lymphoma.
It can be seen that immunotherapy has entered a stage of rapid development, and more drugs will be approved for marketing in 2021. Whether it is mAb, ADC, or CAR-T, it is inseparable from the cell culture process. Therefore, the production process of related drugs is also inseparable from the verification of the cell bank.
(source:internet, reference only)