Each human being, starting with oneself, is a DNA sequence, which is the molecule that stores all the genetic information that makes up a living being and is “written” with a combination of four molecules that are represented by the letters: G , A, T, C. Each of us is configured with 3.2 billion of these letters.
Well, the order in which these four basic elements are arranged forms the different genes and each gene contains the necessary instructions to form a specific protein. The genes of a specific cell can be active or inactive, depending on the function and needs of that cell. Once a gene is activated, the information it contains is used to synthesize or express the protein it encodes. Many diseases are due to incorrectly turned on or off genes.
Convinced that the cure for disease lies within each of us, the founders of biotech Amgen took advantage of this knowledge of molecular biology to differentiate themselves from other pharmaceutical companies. They decided, at first, to focus their efforts on analyzing the complexities of diseases and better understanding their origin, and later on discovering innovative therapies that could improve the lives of patients. All this thanks to an innovative use of biotechnology.
Today, Amgen is at the forefront of the latest biological treatments. Using state-of-the-art science and state-of-the-art technology, it harnesses the enormous potential of molecular biology and advanced human genetics to study billions of biological compounds, with the aim of discovering therapies that are changing the course of some of the more serious diseases or respond to unmet treatment needs in areas such as oncology, hematology, cardiology, nephrology, cardiovascular diseases, inflammatory diseases and bone metabolism.
Biological drugs
30% of the drugs in our health system are already biological, and despite the fact that some of them, such as insulin and some vaccines, have been used for several decades, they are still largely unknown to the general population. Biological drugs are molecules similar or identical to proteins and other complex substances that our bodies depend on to stay healthy. They are produced in live cell lines cultivated in bioreactors and acquire the modality of therapeutic recombinant proteins, monoclonal antibodies and fusion proteins, among other modalities.
Biological drugs are too large and complex to be produced exclusively by chemical methods. Specifically, they are 200 to 1000 times the size of a chemically synthesized drug (such as tablets or capsules) and highly sensitive. This makes your characterization and manufacturing processes complex. In addition, they must be injected or infused into the body to prevent their complex structure from being degraded during digestion, which would occur if they were administered orally.
Applying the power of omics sciences to R&D
In recent decades, technological advances have also transformed scientific research through the large-scale study of many genes, proteins and metabolites, allowing the creation of genomics (science that studies the genome or DNA), proteomics (responsible for studying proteins present in a sample), metabolomics (technology that determines global changes in the concentration of metabolites present in a fluid, tissue or organism in response to genetic variation, a physiological or pathological stimulus), transcriptomics (science which studies the expression of transcripts that come from different genes) and epigenomics (a set of processes through which the transcription of genes is regulated without affecting the DNA sequence). Each of these omics sciences has contributed to a better understanding of the origin of certain diseases.
In this context, Amgen has been applying omics sciences to its R&D for years. In its effort to transform the way drugs are discovered and developed, its scientists have discovered essential genetic factors underlying dozens of cardiovascular diseases and various types of cancer, thanks to the contribution of its subsidiary, CODE Genetics, a world leader in research. genetics, which published the most accurate map of the human genome in 2019.
Amgen uses deCODE’s unique expertise in human genetics combined with its growing knowledge of population transcriptomics and proteomics to find meaningful links between these two data sets. The purpose of understanding the genetics of the disease is to use all that information to create new methods of diagnosis, treatment and prevention of the disease.
In fact, these omics sciences and technologies are providing researchers with a better understanding of the cause of certain diseases. “There is enough raw information in a single human genome to fill a small library. The data that flows from various branches of omics are like pixels that can be put together to build a clearer picture of how the disease takes root and develops ”, comments Fina Lladós, Amgen’s general director for Spain and Portugal.
These technologies have the potential to offer new biomarkers for the earlier diagnosis of some diseases and facilitate faster and more successful clinical trials by drastically reducing their size and duration. All of this is making it possible for drugs to be approved and reach patients who need them much earlier. In addition, with genetics and other human data, it will be possible to predict how a patient’s disease will evolve and improve the ability to prevent diseases before they become more serious.
Thus, omics sciences will allow Amgen to approach an increasingly targeted medicine , according to genetic information and the individual characteristics of each patient. “We are convinced that the next scientific advances will take place in the area of biological sciences through the study of human genetics, which are already demonstrating its ability to solve humanity’s most important challenges. Genetics continues to be one of the most powerful tools that we can apply to understand how nature works ”, points out the General Director of Amgen for Spain and Portugal.
A radical change in drug design
The paradigm that has governed drug discovery for the past decades is ushering in a new era of innovation marked by the emergence of genetic engineering, the cornerstone of modern biotechnology.
In the field of oncology, for example, epigenomics is probably one of the omics sciences that is playing a more relevant role , due to the large number of genetic alterations that tumors present. Amgen researchers have managed to discover an effective inhibitor of a mutation subtype of the KRAS gene, present in one in eight new diagnoses of non-small cell lung cancer (NSCLC), a type of lung cancer that represents up to 85 % of cases, the discovery of which could lead to new specific treatment options for this type of tumor.
In addition, genetic engineering allows Amgen scientists to manufacture complex molecules , which would be impossible to obtain through chemical synthesis. While the first biotechnological drugs were modified versions of human proteins, today complex molecular structures can already be designed thanks to the study of the molecular machinery of cells and the use of sophisticated technologies.
One area of research where unprecedented innovations are being achieved is immuno-oncology, which specifically harnesses the power of T cells, crucial for the immune system. Amgen has been researching new ways to fight cancer using immunotherapy for years, a new class of biological therapies aimed at increasing the immune system’s ability to detect and destroy cancer cells. This is the case with the innovative technology platform developed by Amgen (BiTE®), a type of immunotherapy that can help the immune system detect and attack only tumor cells.
Amgen’s response to COVID-19
In April this year, following the onset of the pandemic, deCODE Genetics, a subsidiary of Amgen, decided to use its DNA sequencing capabilities to address the pandemic by tracking the spread of the coronavirus by studying genetic mutations in SARS-CoV-2 and measuring the durability of human antibodies against the virus.
The objective of the study was to obtain a complete map of the molecular epidemiology of COVID-19 in Iceland, headquarters of this company, in order to provide scientific data to the whole world, which would help health authorities to take the necessary measures to stop the spread of the disease. It was intended to offer a vision, as comprehensive as possible, on how the virus spreads among the population and how containment measures such as early and mass diagnosis, case monitoring or isolation could help curb the disease. Thus, the results confirmed the concern about the effect that asymptomatic people have on the spread of the virus.
The company
Amgen is the world’s largest independent pharmaceutical biotechnology company. Based in Thousand Oaks, California (USA), it was born in 1980 a few years after the discoveries that led to modern biotechnology. It was one of the first companies to realize the potential of this new field and to discover and develop biological treatments.
The work of more than 23,000 Amgen employees in more than 100 countries has enabled more than 20 million patients to improve their health and quality of life . Currently, the company has more than 139 international clinical trials underway, essential to convert the fifty molecules under development into effective and safe biological drugs.
Amgen started its activity in Spain in 1990, with which this year it is celebrating its 30th anniversary. Based in Barcelona, Amgen Spain is the fifth largest market in the world for the company and the third in Europe. It markets a dozen innovative drugs in addition to 3 biosimilars. R&D activity in Spain is one of the most important of the company worldwide, with 44 clinical trials underway in a wide spectrum of therapeutic areas, in collaboration with various health centers in the country. The workforce is made up of more than 340 employees, of which more than 60% are women, a percentage that is above the national average. The general director, Fina Lladós, is a member of the ‘Women of Health’ initiative.
