What are Monoclonal Antibodies?
Monoclonal antibodies are laboratory-produced molecules that can restore, enhance or mimic the immune system's attack on cells. Each monoclonal antibody is specific for one particular antigen. An antigen is generally a foreign substance that stimulates the body to produce antibodies against it. Monoclonal antibodies function by latching onto cancer cells in a way that stimulates the immune system to destroy those cells.
Development of Monoclonal Antibody Technology
The technology to produce Cancer Monoclonal Antibodies was first developed in 1975 by scientists Georges Köhler and César Milstein. They found a way to immortalize a single immune B cell, allowing it to produce monoclonal antibodies of a single type that recognize and bind to a specific antigen. This provided a renewable supply of identical antibodies against a selected target. Over time, advances in hybridoma technology have allowed researchers to develop targeted monoclonal antibodies to attach to tumor cells with increased precision and fewer side effects.
Types of Monoclonal Antibodies Used in Cancer Treatment
There are several types of monoclonal antibodies that are being used to treat different forms of cancer:
- Naked monoclonal antibodies directly bind to cancer cells and stimulate the immune system to destroy those cells. Examples include trastuzumab for HER2-positive breast cancer and cetuximab for head and neck and colorectal cancers.
- Antibody-drug conjugates link powerful cytotoxic chemotherapy drugs to monoclonal antibodies. The antibodies deliver the chemotherapy directly to cancer cells while sparing healthy cells. Examples include ado-trastuzumab emtansine for HER2-positive breast cancer and polatuzumab vedotin-piiq for lymphoma.
- Bispecific T-cell engagers are monoclonal antibodies engineered with two binding domains to link T-cells to tumor cells. Examples include blinatumomab for some forms of leukemia.
- Chimeric antigen receptor (CAR) T-cell therapy genetically engineers a patient's own T-cells to produce CARs on their surface that specifically target tumors. Approved CAR T-cell therapies include axicabtagene ciloleucel and tisagenlecleucel.
Clinical Success and Commercial Growth
The success of monoclonal antibody therapies Herceptin, Rituxan and Avastin in treating certain cancers paved the way for rapid growth in this class of drugs. Global sales of monoclonal antibodies have grown over nine-fold since 2009 to reach $123 billion in 2019. Multiple large pharmaceutical companies now generate over $10 billion annually from monoclonal antibody drugs alone.
While initially more expensive than chemotherapy, many monoclonal antibody treatments have proven highly cost-effective by extending life expectancies and delaying more toxic late-stage cancer treatments. Their relatively favorable side effect profiles compared to chemotherapy also improve quality of life for patients. As more antibody drugs receive approval against new cancer targets, these novel immunotherapies are becoming a mainstay of cancer care.
Challenges and Future Opportunities
Despite all the progress, many challenges remain for monoclonal antibody therapy. Not all patients respond due to tumor heterogeneity and development of resistance. High development costs of over $1 billion per drug mean new antibodies often launch with very high list prices. Access remains an issue in some healthcare systems. Scientific challenges also include increasing tumor penetration ability of antibodies into solid tumors, improving T-cell activation efficacy and reducing CAR T-cell manufacturing complexity.
Future areas of focus include combination therapies using multiple antibodies and chemotherapy, enhancing antibodies for intracellular cancer targets, developing new antibody formats, and expanding applications beyond oncology into other diseases. With continued research and investment, monoclonal antibodies possess significant promise to transform the treatment of cancer and other diseases in the decades to come.
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