Glossary
ADS
American Depositary Share; Galapagos has a Level 3 ADS listed on Nasdaq with ticker symbol GLPG and CUSIP number 36315X101. One ADS is equivalent to one ordinary share in Galapagos NV
ATALANTA-1
ATALANTA-1 Phase 1/2 study with the decentralized manufactured CD19 CAR-T candidate, GLPG5101, in patients with relapsed/ refractory non-Hodgkin lymphoma (R/R NHL)
ATPase
ATPase (adenosine triphosphatase) is an enzyme that catalyzes the hydrolysis of ATP (adenosine triphosphate) into ADP (adenosine diphosphate) and an inorganic phosphate. This reaction releases energy, which the cell can use to perform various functions
BCMA
B cell maturation antigen (BCMA) is a member of the tumor necrosis factor receptor superfamily that plays an important role in regulating B-cell proliferation and survival. BCMA is central to the survival of multiple myeloma cells
Biologics
Biologics, also referred to as Biologicals, are those class of medicines which are grown and then purified from large-scale cell cultures of bacteria or yeast, or plant or animal cells. Biologicals are a diverse group of medicines which includes vaccines, growth factors, immune modulators, monoclonal antibodies, as well as products derived from human blood and plasma. What distinguishes biologics from other medicines is that these are generally proteins purified from living culture systems or from blood, whereas other medicines are considered as 'small molecules' and are either made synthetically or purified from plants
CAR-T
Chimeric antigen receptor T cells (also known as CAR-T cells) are T cells that have been genetically engineered to produce an artificial T cell receptor for use in immunotherapy
Cash position
Current financial investments and cash and cash equivalents
CD19
CD19 is a protein found on the surface of B-cells, a type of white blood cell. Since CD19 is a hallmark of B-cells, the protein has been used to diagnose cancers that arise from this type of cell, notably B-cell lymphomas
Cell therapy
Cell therapy aims to treat diseases by restoring or altering certain sets of cells or by using cells to carry a therapy through the body. With cell therapy, cells are cultivated or modified outside the body before being injected into the patient. The cells may originate from the patient (autologous cells) or a donor (allogeneic cells)
Chronic Lymphocytic Leukemia (CLL)
Chronic lymphocytic leukemia is the most common leukemia in adults. It is a type of cancer that starts in cells that become certain white blood cells (called lymphocytes) in the bone marrow. The cancer (leukemia) cells originate in the bone marrow and migrate to the bloodstream
Complete Response Rate (CRR)
Term used for the absence of all detectable cancer after the treatment is completed
Compound
A chemical substance, often a small molecule with drug-like properties
Contract research organization (CRO)
Organization which provides drug discovery and development services to the pharmaceutical, biotechnology and medical devices industry
Cryopreservation
Process where biological material - cells, tissues, or organs - are frozen to preserve the material for an extended period of time
Cytokine
A category of small proteins which play important roles in signaling in processes in the body
Cytokine release syndrome (CRS)
Condition that develops when your immune system responds too aggressively to infection or after certain types of immunotherapy, such as CAR-T-cell therapy
Dermatomyositis (DM)
Dermatomyositis is a rare inflammatory disease. Common symptoms include distinctive skin rash, and inflammatory myopathy, or inflamed muscles, causing muscle weakness
Development
All activities required to bring a new drug to the market. This includes preclinical and clinical development research, chemical and pharmaceutical development and regulatory filings of product candidates
Discovery
Process by which new medicines are discovered and/or designed. At Galapagos, this is the department that oversees target and drug discovery research through to nomination of preclinical candidates
Dose-range finding study
Phase 2 clinical study exploring the balance between efficacy and safety among various doses of treatment in patients. Results are used to determine doses for later studies
EC
European Commission
Efficacy
Effectiveness for intended use
EMA
European Medicines Agency, in charge of European market authorization of new medications
End-to-end
A process that takes a system or service from beginning to end and delivers a complete functional solution, usually without strong reliance on third parties
EUPLAGIA-1
EUPLAGIA-1 Phase 1/2 study with decentralized manufactured CD19 CAR-T candidate, GLPG5201, in patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) and small lymphocytic lymphoma (R/R SLL), with or without Richter transformation (RT)
FDA
The U.S. Food and Drug Administration is an agency responsible for protecting and promoting public health and in charge of American market approval of new medications
Filgotinib
Formerly known as GLPG0634, commercial name is Jyseleca®. Small molecule preferential JAK1 inhibitor, approved in RA and UC in the European Union, Great-Britain and Japan. Phase 4 studies in both RA and UC are ongoing
FORM 20-F
Form 20-F is an SEC filing submitted to the US Securities and Exchange Commission
FSMA
The Belgian market authority: Financial Services and Markets Authority, or Autoriteit voor Financiële Diensten en Markten
FTE
Full-time equivalent; a way to measure an employee’s involvement in a project. For example, an FTE of 1.0 means that the equivalent work of one full-time worker was used on the project
G&A expenses
General & administrative expenses
GALACELA
Phase 2 study with GLPG3667 in patients with systemic lupus erythematous
Galapagos’ cell manufacturing platform
Galapagos’ decentralized, innovative cell therapy manufacturing platform has the potential for the administration of fresh, fit cells within a median vein-to-vein time of seven days, greater physician control and improved patient experience. The platform consists of an end-to-end xCellit™ workflow management and monitoring software system, a decentralized, functionally closed, automated manufacturing platform for cell therapies (using Lonza’s Cocoon®) and a proprietary quality control testing and release strategy.
GALARISSO
Phase 2 study with GLPG3667 in patients with dermatomyositis
GLPG0634
Molecule number currently known as filgotinib and Jyseleca®
GLPG3667
A TYK2 kinase inhibitor discovered by us, topline results from the Phase 1b in psoriasis reported in July 2021
GLPG5101
A second generation anti-CD19/4-1BB CAR-T product candidate currently in Phase 1/2 study in R/R NHL
GLPG5201
A second generation anti-CD19/4-1BB CAR-T product candidate currently in Phase 1/2 study in R/R CLL/SLL with or without RT
GLPG5301
A BCMA CAR-T product candidate
Immune effector cell-associated neurotoxicity syndrome (ICAN)
Clinical and neuropsychiatric syndrome that can occur in the days to weeks following administration of certain types of immunotherapy, especially immune effector cell (IEC) and T cell engaging therapy
Immunology
The study of the immune system and is a very important branch of the medical and biological sciences. The immune system protects humans from infection through various lines of defence. If the immune system is not functioning as it should, it can result in disease, such as autoimmunity, allergy, and cancer
In-/out-licensing
Receiving/granting permission from/to another company or institution to use a brand name, patent, or other proprietary right, in exchange for a fee and/or royalty
Intellectual property
Creations of the mind that have commercial value and are protected or protectable, including by patents, trademarks or copyrights
Investigational New Drug (IND) Application
An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans
JAK
Janus kinases (JAK) are critical components of signaling mechanisms utilized by a number of cytokines and growth factors, including those that are elevated in RA. Filgotinib is a preferential JAK1 inhibitor
Jyseleca®
Jyseleca® is the brand name for filgotinib
Leukapheresis
Laboratory procedure in which white blood cells are separated from a sample of blood
Lymphocyte
Type of white blood cell that is part of the immune system
MAGE-A4
MAGE-A4, melanoma-associated antigen A4, is a member of the MAGE protein family of cancer-testis antigens. In healthy adult, MAGE-A4 expression is restricted to immune-privileged sites. However, in many cancers MAGE-A4 is widely expressed including lung cancer, head and neck squamous cell cancer, synovial sarcoma(SS), ovarian cancer, urothelial cancer and melanoma
Milestone
Major achievement in a project or program; in our alliances, this is usually associated with a payment
Multiple myeloma (MM)
Multiple myeloma (MM) is typically characterized by the neoplastic proliferation of plasma cells producing a monoclonal immunoglobulin. The plasma cells proliferate in the bone marrow and can result in extensive skeletal destruction with osteolytic lesions, osteopenia, and/or pathologic fractures
Non-Hodgkin lymphoma (NHL)
Non-Hodgkin lymphoma is a type of cancer that begins in the lymphatic system, which is part of the body's germ-fighting immune system. In non-Hodgkin lymphoma, white blood cells called lymphocytes grow abnormally and form tumors throughout the body
Objective Response Rate (ORR)
The response rate is the percentage of patients on whom a therapy has some defined effect; for example, the cancer shrinks or disappears after treatment. When used as a clinical endpoint for trials of cancer treatments, this is often called the objective response rate
Oncology
Field of medicine that deal with the diagnosis, treatment, prevention, and early detection of cancer
Outsourcing
Contracting work to a third party
PAPILIO-1
Phase 1/2 study with GLPG5301 in patients with relapsed/refractory multiple myeloma
Parkinsonism
Parkinsonism is a clinical syndrome characterized by a combination of motor symptoms typically associated with Parkinson's disease. Parkinsonism can be caused by Parkinson's disease itself, but it can also result from other conditions, such as neurodegenerative diseases, medication side effects, vascular changes, infections, toxins
Phase 1
First stage of clinical testing of an investigational drug designed to assess the safety and tolerability, pharmacokinetics of a drug, usually performed in a small number of healthy human volunteers
Phase 2
Second stage of clinical testing, usually performed in no more than several hundred patients, in order to determine efficacy, tolerability and the dose to use
Phase 3
Large clinical trials, usually conducted in several hundred to several thousand patients to gain a definitive understanding of the efficacy and tolerability of the candidate treatment; serves as the principal basis for regulatory approval
Pivotal trials
Registrational clinical trials
PRAC
Pharmacovigilance Risk Assessment Committee of the European Medicines Agency, responsible for assessing all aspects of risk management of human medicines
Preclinical
Stage of drug research development, undertaken prior to the administration of the drug to humans. Consists of in vitro and in vivo screening, pharmacokinetics, toxicology, and chemical upscaling
Preclinical candidate (PCC)
A new molecule and potential drug that meets chemical and biological criteria to begin the development process
Product candidate
Substance that has satisfied the requirements of early preclinical testing and has been selected for development, starting with formal preclinical safety evaluation followed by clinical testing for the treatment of a certain disorder in humans
PROTAC
A proteolysis-targeting chimera (PROTAC) is a hetero-bifunctional molecule containing two small molecule-binding ligands joined together by a linker
R&D operations
Research and development operations; unit responsible for discovery and developing new product candidates for internal pipeline or as part of risk/reward sharing alliances with partners
Refractory
"Refractory" refers to a patient with cancer that is/has become resistant to, or does not respond to, treatment
Relapsed
"Relapsed" refers to a patient with cancer that develops cancer again after a period of improvement
Rheumatoid arthritis (RA)
A chronic, systemic inflammatory disease that causes joint inflammation, and usually leads to cartilage destruction, bone erosion and disability
Richter transformation
Richter transformation (RT) is an uncommon clinicopathological condition observed in patients with CLL. It is characterized by the sudden transformation of the CLL into a significantly more aggressive form of large cell lymphoma, and occurs in approximately 2-10% of all CLL patients
S&M expenses
Sales and marketing expenses
SEC
Securities and Exchange Commission in the US
SMARCA2
SMARCA2 (SWI/SNF related, matrix associated, actin dependent regulator of chromatin, subfamily a, member 2) is a gene that encodes a protein involved in chromatin remodeling. This protein is a part of the SWI/SNF family of proteins, which are essential for regulating gene expression by altering the structure of chromatin (the complex of DNA and proteins that forms chromosomes). Mutations or dysregulation of SMARCA2 have been implicated in various cancers. As a part of the chromatin remodeling machinery, changes in its activity can lead to altered gene expression profiles that may contribute to tumorigenesis
Solid tumor
A solid tumor is an abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumors can occur in various parts of the body and are characterized by the uncontrolled growth of cells in a specific area. They can be benign (non-cancerous) or malignant (cancerous)
Systemic lupus erythematosus (SLE)
An autoimmune disease, with systemic manifestations including skin rash, erosion of joints or even kidney failure
Target
Protein that has been shown to play a role in a disease process and that forms the basis of a therapeutic intervention or discovery of a medicine
Target discovery
Identification and validation of proteins that have been shown to play a role in a disease process
TCR-T
T-Cell Receptor Therapy; In TCR-T therapy, T cells are extracted from a patient and genetically modified in the laboratory to express a specific TCR that can recognize cancer-specific antigens. These engineered T cells are then expanded in number and infused back into the patient, where they can seek out and destroy cancer cells displaying the target antigen. This therapy is a type of adoptive cell transfer and is being researched as a potential treatment for various types of cancer
TYK
Tyrosine kinase is an enzyme that can transfer a phosphate group from ATP to the tyrosine residues of specific proteins inside a cell. It functions as an "on" or "off" switch in many cellular functions. Tyrosine kinases belong to a larger class of enzymes known as protein kinases which also attach phosphates to other amino acids such as serine and threonine. GLPG3667 is a reversible and selective TYK2 kinase domain inhibitor
Ulcerative colitis (UC)
UC is an IBD causing chronic inflammation of the lining of the colon and rectum (unlike CD with inflammation throughout the gastrointestinal tract)
uza-cel
Uza-cel is a next-generation clinical-stage engineered TCR T-cell therapy developed by Adaptimmune, targeting the MAGE-A4 cancer antigen expressed in various solid tumors. Uza-cel is engineered to express the CD8α co-receptor alongside the engineered TCR that targets MAGE-A4. Data indicate that co-expression of CD8α may broaden and increase the immune response against solid tumors