Active immunization: Also vaccination; activation of the immune system and induction of an immune response against a certain antigen.

Active pharmaceutical ingredient (API): Is the substance in a drug that is pharmaceutically active.

Adjuvant: Pharmaceutical compound that enhances an immune response.

Affinity: A measure of the binding strength between antibody and an antigen determinant.

Allergen extract: A mixture of allergenic components. Standard doses thereof are used in conventional desensitization therapy.

Allergen tolerance: Non-reactivity to a certain allergen or reactivity only up to the level of a predefined minimal symptom score.

Allergen: A normally harmless substance that elicits a misdirected immune response.

Allergic rhinitis: A condition due to allergy that mimics a cold. “Rhinitis” means inflammation of the nasal mucous membranes.

Alum: A common adjuvant for human use.

Alzheimer’s disease: A progressive degenerative disease that alters the brain, causing impaired memory, thinking and behavior.

Ambulatory blood Pressure: Blood pressure measured by numerous readings over a 24-hour period or longer. Provides accurate and reliable information about a person’s blood pressure.

Amyloid-beta peptide: A peptide that is deposited in plaques found in the brains of Alzheimer’s disease patients.

Angiotensin II: A small peptide that is part of the rennin-angiotensin system (RAS). Induces narrowing of blood vessels and other effects to raise blood pressure.

Antibody: Class of blood proteins generated by the immune system to neutralize foreign materials such as bacteria or viruses. Can also be directed against the body’s own disease-associated molecules.

Antigen: A molecule capable of stimulating the immune system.

Antigen presenting cell: Cells of the immune system, which present antigens on their surface to other immune cells such as the T cells and this way enable proper T cell activation.

Antihypertensives: Drugs to treat high blood pressure.

Assay: An in vitro test system used to estimate the concentration or potency of a substance by measuring its biological response.

Asthma: A chronic inflammatory disorder of the airways.

Atopic dermatitis: A chronic skin disease; a type of eczema. Is thought to be associated with an allergic Th2 type immune status.

Attenuated: For vaccination, pathogenic viruses or bacteria are weakened in such a way that they don’t cause disease.

Autoimmune disease: Occurs when the immune system mistakenly recognizes the body’s own tissue as foreign and attacks it.

B cell: Immune cell that plays a central role in immunity. B cells produce antibodies.

Bacteria: Single-celled microorganisms which can exist as independent (free-living) organisms.

Bacteriophage: Viruses that infect and reproduce within bacteria.

Biogeneric: Medicine of biological origin, i.e. non-synthetic that contains the same active substance as another one already sold on the market.

Biologic: Protein- or peptide-based therapeutic (e.g. vaccines, monoclonal antibodies).

Biopharmaceutical: A drug created by means of biotechnology, especially genetic engineering.

Blood brain barrier: Physical barrier between the blood vessels in the central nervous system and the central nervous system itself. The barrier stops many substances from crossing it.

Causal treatment: A form of treatment, which addresses the cause of a disease, the underlying disease process and not only the symptoms.

Cell: An autonomous self-replicating unit. All living organisms are composed of one or more cells. In multi-cellular organisms, cells may be more or less specialized (differentiated) for particular functions.

Chemical entity: Chemical molecule.

Chemokine: Class of immune mediator that attracts and activates leukocytes.

Chronic diseases: Illnesses that are prolonged, do not resolve spontaneously, and are rarely cured completely.

Clinical: Relating to a clinic or conducted in a clinic and depending on direct observation of patients or healthy volunteers.

Compliance: Adherence of the patients to a defined drug administration/intake schedule prescribed by a doctor.

Cytokine: Regulatory protein released by cells of the immune system. Acts as intercellular mediator.

Cytotoxic T cells: Subset of T cells, also called killer cells. Mediate the direct lysis of altered cells (virus-infected or tumor cells).

DELphi™ technology: Cytos Biotechnology’s proprietary mammalian expression screening technology.

Dendritic cell: A subtype of antigen presenting cells.

Desensitization: A form of immunotherapy used to treat certain allergies.

Diastolic blood pressure: Lowest pressure within the arterial blood stream occurring with each heart beat.

Discovery: Identification of a protein or biological target linked to a particular disease. The discovery phase is followed by subsequent application of the protein as therapeutic product itself or identification of a potential drug that interacts with the protein target to help cure the disease.

Disease-modifying: In contrast to symptomatic treatment, a disease-modifying treatment aims at addressing the cause of disease and modifying the disease progression.

DNA: Desoxyribonucleic acid. The genetic information of an organism.

Double-blind: Set-up often used in clinical trials where neither the doctor nor the patient knows if placebo or the active drug substance is used.

Drug target: A defined molecule or structure within the organism, which is linked to a particular disease. For disease intervention, the drug target may either blocked/inhibited or activated by a drug (small organic molecules, antibodies, therapeutic proteins).

E.coli: Escherichia coli – gram negative bacterium widely used in microbiological and genetic research as well as in protein production.

Efficacy: Power or capacity of a drug to produce a desired therapeutic effect.

EMEA: The European Agency for the Evaluation of Medicinal Products.

Endogenous: Molecule produced within the body.

Endpoint: An outcome measure in a clinical trial.

Epidemic: Sudden disease occurrence in numbers clearly in excess of normal expectancy.

Eukaryotic: A single-celled or multi-cellular organism whose cells contain a distinct membrane-bound nucleus.

Ex vivo: Outside of the living body. Refers in this context to a procedure in which cells or tissue are isolated from a living body and used directly for biochemical/immunological laboratory analysis.

Exogenous: Originates from outside an organism.

FACS: Fluorescence Activated Cell Sorter. Complex computerized analytical instrument used for the separation, classification and quantification of cells.

FDA: Food and Drug Administration. Federal agency established to regulate the release of new foods and health-related products in the US.

Fermentation: Culturing of mammalian or bacterial cells to produce a certain substance, which often is a recombinant protein, in mass quantities.

Formulation: Method and process of selecting the components of a mixture and the product of such a process. For drugs the term usually describes the way the final drug is prepared.

Gene: Discrete units of hereditary information consisting of sections of DNA.

Gene expression: Protein synthesis from DNA via transcription and translation within a cell.

Genome: Total set of genes carried by an individual.

Glycosylation: The process of adding sugar units to a molecule.

GMP: Good Manufacturing Practice; guidelines for the manufacture of medicinal products issued by the regulatory authorities worldwide.

Half-life: The biological half-life of a substance (e.g. antibodies) is the time required for half of that substance to be eliminated from the body.

High-throughput screening (HTS): The use of automated processes to rapidly screen potential therapeutic agents e.g. antibodies.

HIV: Human immunodeficiency virus; causes AIDS.

Hypertension: Also high blood pressure; medical condition where the blood pressure is chronically elevated.

Hypertensive: Having abnormally high blood pressure.

Immune system: Complex and integrated body system of organs, tissues, cells, and cell products such as antibodies that differentiates self from non-self and protects the organism from potentially pathogenic organisms or substances.

Immunodrug™: Cytos Biotechnology’s therapeutic vaccines.

Immunogenicity/Immunogenic: Ability of a substance to evoke an immune response.

Immunostimulatory: Substance able to stimulate the immune system.

Immunotherapy/Immunotherapeutic: Therapy / product aimed at activation of the immune system to modulate a certain disease process.

In vitro: Within an artificial environment [literally “in glass”].

In vivo: Within a living organism.

Incidence: Rate of new cases of disease occurrence.

IND: Investigational New Drug Application. Request for a permission to begin testing of a certain drug in people filed with regulatory authorities like FDA.

Infectious disease: A disease that can be transmitted from person to person or from organism to organism, and is caused by e.g. viruses and bacteria.

Inflammation: A basic way in which the body reacts to infection, irritation or other injury, the key feature being redness, warmth, swelling and pain.

Inflammatory: Substance evoking inflammation.

Intradermal: Located within or between layers of skin.

Intramuscular: Within a muscle.

Intravenous: Within a vein.

Ligand: Molecule capable of binding to a receptor – may function as an agonist or an antagonist.

Lymphocyte: White blood cell.

Macrophages: A large cell that acts as a scavenger, helping the immune system to destroy foreign agents.

Malignant melanoma: The most fatal kind of skin cancer.

Median: Statistical term that relates to or constitutes the middle value in a distribution. 50% of the values are above and 50% below the median.

Melanocyte: Pigment-producing cell in the skin, hair and eye that determines their color.

Metastasis/Metastasize: Process by which cancer spreads from the place at which it first arose as a primary tumor to distant locations in the body.

Microbial: Relating to microorganisms (microbes).

mm Hg: Blood pressure values are universally stated in millimeters of mercury.

Monoclonal antibody: Antibody derived from a single clone of cells, all of which have identical antigen binding sites. Important class of biopharmaceuticals.

Monotherapy: Treatment with one drug as opposed to combination therapy. Here the term refers to treatment with QbG10 alone (i.e. CYT003-QbG10) in contrast to a treatment regimen where QbG10 is combined with a specific allergen extract (i.e. CYT005-AllQbG10).

NDA/BLA: New Drug Application or Biological License Application. The NDA / BLA contains all information that a company has gathered during the clinical trials and this application is submitted to the FDA or equivalent regulatory authorities in order to receive market approval.

Neurodegenerative diseases: Characterized by gradual loss of neural tissue / nerve cells.

Non-communicable disease: A disease that is not contagious. For instance, high blood pressure is a non-communicable disease, as would be any form of cancer.

Nucleic acids: Chain of nucleotides – includes DNA and RNA.

Open-label: Set-up used in clinical trials where the doctor and the patient know what kind of treatment is administered.

Over-expressed: Excessive expression of a gene by producing too much of its effect or product. Many cancers are supposed to arise through over-expression.

Passive Immunization: Injection of in vitro produced antibodies or immune cells recognizing a specific antigen within the body. Provides a short-lived therapeutic effect and has to be repeated frequently.

Pathogen: A disease-causing agent.

Peptide: Fragment of a protein comprised of two or more amino acids.

Phase I: Clinical trial that examines a new drug candidate’s safety profile and may involve 10–60 healthy volunteers.

Phase IIa/II: Clinical trial that examines a new drug candidate’s safety and exploratory efficacy in patients and may involve between 20 (IIa) and 500 (II) people.

Phase III: Large clinical trial that examines a new drug candidate’s safety and efficacy in a large number of patients (1,000 to 3,000 patients).

Placebo: Dummy medical treatment.

Preclinical: Phase of activities where a new drug candidate is tested in animal models.

Prevalence: The percentage of individuals within a population having a disease.

Proof-of-concept: First realization of a certain method or idea to demonstrate its feasibility. In drug development, the term is used when a new drug candidate has been effective in a small number of patients.

Prophylactic vaccination: Vaccination performed to prevent infectious diseases. Suspension of attenuated or killed viruses or bacteria or parts thereof that is capable of producing a protective immune response to such infectious agents.

Protein: Complex, high-molecular-weight organic compound. Proteins are essential to the structure and function of all living cells and viruses.

Psoriasis: Common skin disorder characterized by inflamed patches of skin topped with white scales.

Qb: Immunodrug™ carrier derived from the bacteriophage Qb.

QbG10: The Immunodrug™ Qb filled with the synthetically produced immunostimulatory DNA sequence G10.

R & D: research and development.

Receptor: Group of molecules on the surface or within a cell that deliver a signal to the cell upon stimulation.

Recombinant: Made through genetic engineering. By introducing virus, animal or plant genes into the genetic material of bacteria or yeast cells, these microorganisms can be turned into factories to produce defined proteins.

Regimen: Describes the schedule and composition according to which a drug is administered.

Renin-angiotensin system (RAS): Important system in the body that regulates blood pressure.

Rheumatoid arthritis: Chronic, inflammatory autoimmune disorder that causes the immune system to attack the body’s own joints.

Rhinoconjunctivitis: Combination of rhinitis (inflammation of the nasal mucosa) and conjunctivitis (inflammation of the conjunctiva of the eye).

RNA: Ribonucleic acid. RNA is a copy of the DNA and can function as template for protein synthesis. In certain viruses RNA rather than DNA encodes the genetic information.

Self-antigen: An antigen belonging to the organism itself.

Self-tolerance: Non-reactivity of the immune system against structures it recognizes as self.

Small molecule: Low-molecular-weight chemical compound. Many pharmaceutical drugs are small molecules.

Subcutaneous: Located / placed just beneath the skin.

Symptomatic treatment: Treatment that targets disease symptoms rather than the cause of disease. May provide short-term disease amelioration but no cure.

Systolic blood pressure: The highest pressure within the arterial blood stream occurring with each heart beat.

T cell: Immune cell that plays a central role in cell-mediated immunity. There are a number of different subgroups, such as cytotoxic T cells and T helper cells.

Th1 type immune response: A type of T helper cell response. Is induced by viral or bacterial infection or by potent vaccination to establish a protective immune response.

Th2 type immune response: A type of T helper cell response, which creates an “allergic” immune environment.

Therapeutic vaccine: Activating the immune system by using a preparation of disease-associated molecules. Induces an immune response against such antigens with the goal of modulating or interfering with an ongoing disease process.

TNF-α: Tumor necrosis factor alpha. Pro-inflammatory cytokine.

Toxicity testing: Performing controlled testing in the laboratory (in in vitro assays and in animal models) to determine the toxicity of a compound or drug to an organism at various concentrations. Is performed before testing in humans begins.

Toxicology: Branch of pharmacology concerned with the effects and treatments of poisons.

Traditional vaccine: see prophylactic vaccine.

Virus-like particle (VLP): Genetically engineered spherical protein envelope derived from a virus; does not contain viral genetic material and cannot replicate but elicits a potent immune response.