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European Biopharmaceutical Review

Engineering Antibodies

Antibody-drug conjugates (ADCs) are a novel class of treatment agents that combine the selectivity of targeted treatment with the cytotoxic potency of chemotherapy drugs. Compared to chemotherapy, ADCs have a more favourable therapeutic index. As of today, four ADCs have been approved. However, development is still ongoing to improve the therapeutic window of ADCs further and to expand their landscape of targets and toxic payloads. The challenges of ADCs and the strategies pursued to overcome these are described. During their evolution, three generations of ADCs can be distinguished, each overcoming certain limitations.

ADCs combine the target specificity of monoclonal antibodies and the high efficacy of a cytotoxic compound. Each of the components has its limitations: lack of direct pharmacological effect of antibodies and no selectivity of the toxic effect of a chemotherapeutic for cancer cells. The promise of ADCs has been to make use of the advantages of both components and to get rid of the limitations.

The Beginning of ADCs

The ADC era began in 1993 with BR96 doxorubicin − a monoclonal antibody linked to approximately eight doxorubicin molecules, which is directed against the Lewis-Y antigen. The clinical development was stopped due to poor clinical responses. Mylotarg was the only first generation of ADC being approved by the FDA in 2000 for use in patients over the age of 60 with relapsed acute myelogenous leukemia. However, its medical use was limited by severe side effects. Within the first year after approval, the FDA required a black box warning be added to packaging. Despite attempts to resolve this, in June 2010 Mylotarg was withdrawn from the market at the request of the FDA. Notably, it was reapproved in July 2017 using dose fractionation to circumvent side effects.

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Professor Andreas Pahl has served as Chief Scientific Officer of Heidelberg Pharma since June 2016 and Chief Scientific Officer of Heidelberg Pharma Research since September 2012. Prior to his position at Heidelberg Pharma, he was Head of Late Pharmacology at Nycomed and Takeda Pharmaceuticals. After graduating in chemistry from the University of Berlin, Germany, he spent several years lecturing at TU Berlin and the University of Erlangen-Nuremberg FAU, at which he was also appointed Professor of Pharmacology and Toxicology. He still performs his teaching duties at FAU.
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Professor Andreas Pahl
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