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2020 New Immunotherapeutic drug technology FDA/EMA approved | by Eric | Sep, 2021

Eric

2020 New Immunotherapeutic drug technology FDA/EMA approved. In 2020, among 53 products approved by the U.S. Food and Drug Administration (FDA), there are 12 antibody therapies and one CAR-T cell therapy.

Here, this review aims to explain the applications of new immunotherapeutic drugs approved by the FDA/EMA in 2020 (Table 1). They belong to 3 main categories: monoclonal antibodies (mAb), antibody-drug conjugates (ADC) and CAR -T cell therapy.

For a long time, researchers and pharmaceutical companies have developed a keen interest in immunotherapy that manages and treats a variety of diseases through multiple ways of controlling the immune system (1, 2).

In cancer and infectious diseases, immunotherapy is used to activate the immune system to eradicate evading cells, while for autoimmune diseases, transplants, allergies, and wound healing, immunotherapy aims to suppress the immune response to improve safety or tissue regeneration.

It can be divided into several categories, including:

a) immunomodulators (for example, cytokines, interleukins, chemokines, and immunomodulatory drugs),

b) monoclonal antibodies,

c) checkpoint blocking,

d) oncolytic viruses ,

E) vaccines,

f) cell therapy, such as chimeric antigen receptor (CAR) T cells (5).

In 2020, among 53 products approved by the U.S. Food and Drug Administration (FDA), there are 12 antibody therapies and one CAR-T cell therapy.

Here, this review aims to explain the applications of new immunotherapeutic drugs approved by the FDA/EMA in 2020 (Table 1). They belong to 3 main categories: monoclonal antibodies (mAb), antibody-drug conjugates (ADC) and CAR -T cell therapy.

In the past few decades, monoclonal antibodies (mAb) or their combined use with other drugs, toxins, and radionuclides have received great attention .

There are various techniques (Figure 1). They were first produced in mice using hybridoma technology, which uses the fusion of B lymphocytes from the spleen of immunized animals with an immortal myeloma cell line.

However, the clinical application of complete murine mAbs is hindered by the production of human anti-mouse antibodies, increased murine mAb clearance, and adverse allergic reactions.

Therefore, murine mAbs are transformed by chimeric technology, in which the non-human variable domain is combined with the human constant © region d.

A major advancement in humanized mAb production is through the use of complementary domain-to-determined region (CDR) grafting technology.

In this technique, non-human antibody domains are transferred to human framework sequences while retaining target specificity (10).

The technology platform has made progress to obtain fully human monoclonal antibodies.

In another technique called phage display, foreign genes are integrated into phage to generate a peptide library on the surface of phage virus particles, thereby screening the phage library to bind the target antigen (11).


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