Immudex is a Danish Reagents and Diagnostics company established in 2009. The company is operating from offices located in
Copenhagen
Copenhagen ( ) is the capital and most populous city of Denmark, with a population of 1.4 million in the Urban area of Copenhagen, urban area. The city is situated on the islands of Zealand and Amager, separated from Malmö, Sweden, by the ...
, Denmark, and in
Fairfax,
Virginia
Virginia, officially the Commonwealth of Virginia, is a U.S. state, state in the Southeastern United States, Southeastern and Mid-Atlantic (United States), Mid-Atlantic regions of the United States between the East Coast of the United States ...
.
Immudex specializes in the production of
MHC Dextramers.
MHC Dextramers are chemical reagents that are designed to detect antigen-specific
T cells
T cells (also known as T lymphocytes) are an important part of the immune system and play a central role in the adaptive immune response. T cells can be distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on their ce ...
.
[Davis MM, Altman JD, Newell EW. “Interrogating the repertoire: broadening the scope of peptide-MHC multimer analysis”. Nat Rev Immunol. 2011 Jul 15;11(8):551-8. doi: 10.1038/nri3020.]
All Immudex products, whether on the marked or in development, are based on its proprietary
MHC Dextramer technology. The use of
MHC Dextramers offers a new method to accurately detect and quantify antigen-specific
CD8+ T cells
A cytotoxic T cell (also known as TC, cytotoxic T lymphocyte, CTL, T-killer cell, cytolytic T cell, CD8+ T-cell or killer T cell) is a T lymphocyte (a type of white blood cell) that kills cancer cells, cells that are infected by intracellular pa ...
.
While some of the technology is currently only sold for
Research use only (RUO), clinical applications are being actively pursued. Currently, Immudex has several development projects for clinically applicable
MHC Dextramers. Even so, the first
MHC Dextramers clinical reagent has been developed and approved for clinical in vitro diagnostics in
Europe
Europe is a continent located entirely in the Northern Hemisphere and mostly in the Eastern Hemisphere. It is bordered by the Arctic Ocean to the north, the Atlantic Ocean to the west, the Mediterranean Sea to the south, and Asia to the east ...
. Namely the CE-marked kit for enumeration of
cytomegalovirus
''Cytomegalovirus'' (CMV) (from ''cyto-'' 'cell' via Greek - 'container' + 'big, megalo-' + -''virus'' via Latin 'poison') is a genus of viruses in the order '' Herpesvirales'', in the family '' Herpesviridae'', in the subfamily '' Betaherp ...
-specific
T cells
T cells (also known as T lymphocytes) are an important part of the immune system and play a central role in the adaptive immune response. T cells can be distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on their ce ...
. Immudex primarily focuses on the identification of producing large quantities of
CD8+ T cells
A cytotoxic T cell (also known as TC, cytotoxic T lymphocyte, CTL, T-killer cell, cytolytic T cell, CD8+ T-cell or killer T cell) is a T lymphocyte (a type of white blood cell) that kills cancer cells, cells that are infected by intracellular pa ...
by the means of
MHC class I
MHC class I molecules are one of two primary classes of major histocompatibility complex (MHC) molecules (the other being MHC class II) and are found on the cell surface of all nucleated cells in the bodies of vertebrates. They also occur on ...
molecules. Even so, the research and development into the application of
MHC class II
MHC Class II molecules are a class of major histocompatibility complex (MHC) molecules normally found only on professional antigen-presenting cells such as dendritic cells, macrophages, some endothelial cells, thymic epithelial cells, and B cell ...
Dextramers might expand the technology.
History
Originally, Immudex operated as an individual division within the much larger
Danish pharmaceutical company Dako. Immudex was later spun out as a separate business, when the focus of Dako largely shifted to
cancer
Cancer is a group of diseases involving Cell growth#Disorders, abnormal cell growth with the potential to Invasion (cancer), invade or Metastasis, spread to other parts of the body. These contrast with benign tumors, which do not spread. Po ...
diagnostics.
Immudex currently have clients world wide with major markets in the United States and Europe.
Patents for the
MHC Dextramer technology were filed at Dako in 2001, and the Immudex division was launched in 2005.
In 2011, Immudex received the prestigious “Entrepreneur of the Year 2011” award in the Life Sciences category granted by
Ernst & Young
EY, previously known as Ernst & Young, is a multinational corporation, multinational professional services partnership, network based in London, United Kingdom. Along with Deloitte, KPMG and PwC, it is one of the Big Four accounting firms, Big F ...
.
Immudex received this award because of the commitment of the company, articulated in the company's "make it work and make it better" strategy to generate results for both practitioners and patients. The award is given to companies not only focused on financial growth, but also for softer values such as the entrepreneur's social responsibility and the ability to aspire an motivate the organization.
Dextramer technology
A large number of immunotherapies, currently in development, seek to induce, expand, activate or eliminate antigen-specific
T cells
T cells (also known as T lymphocytes) are an important part of the immune system and play a central role in the adaptive immune response. T cells can be distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on their ce ...
. It is therefore important to be able to quantify and characterize the
T cell
T cells (also known as T lymphocytes) are an important part of the immune system and play a central role in the adaptive immune response. T cells can be distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on their cell ...
responses before, during and after treatment in order to understand if the proposed change to the
T cells
T cells (also known as T lymphocytes) are an important part of the immune system and play a central role in the adaptive immune response. T cells can be distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on their ce ...
has been effectuated.
The process of
negative selection in the
thymus
The thymus (: thymuses or thymi) is a specialized primary lymphoid organ of the immune system. Within the thymus, T cells mature. T cells are critical to the adaptive immune system, where the body adapts to specific foreign invaders. The thymus ...
guarantees that virtually all
T cells
T cells (also known as T lymphocytes) are an important part of the immune system and play a central role in the adaptive immune response. T cells can be distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on their ce ...
have very weak affinity for
self-antigens. Therefore, the study of these lymphocytes in
autoimmune diseases
An autoimmune disease is a condition that results from an anomalous response of the adaptive immune system, wherein it mistakenly targets and attacks healthy, functioning parts of the body as if they were foreign organisms. It is estimated that ...
and
cancer
Cancer is a group of diseases involving Cell growth#Disorders, abnormal cell growth with the potential to Invasion (cancer), invade or Metastasis, spread to other parts of the body. These contrast with benign tumors, which do not spread. Po ...
has been difficult, until the fairly recent introduction of
MHC multimers.
Tetramers
A tetramer () (''tetra-'', "four" + '' -mer'', "parts") is an oligomer formed from four monomers or subunits. The associated property is called ''tetramery''. An example from inorganic chemistry is titanium methoxide with the empirical formula ...
, which are among the most popular form of these multimer complexes, have four binding sites. The
Tetramers
A tetramer () (''tetra-'', "four" + '' -mer'', "parts") is an oligomer formed from four monomers or subunits. The associated property is called ''tetramery''. An example from inorganic chemistry is titanium methoxide with the empirical formula ...
were originally developed in
Academia
An academy (Attic Greek: Ἀκαδήμεια; Koine Greek Ἀκαδημία) is an institution of tertiary education. The name traces back to Plato's school of philosophy, founded approximately 386 BC at Akademia, a sanctuary of Athena, the go ...
. Many further developments in this technology have taken place at biotechnology companies.
The Immudex
MHC Dextramers, which represent the latest advancement in this field, provide an exponentially greater probability of successful identification of antigen-specific
T cells
T cells (also known as T lymphocytes) are an important part of the immune system and play a central role in the adaptive immune response. T cells can be distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on their ce ...
. This can be done, because the
MHC Dextramers have nine, or more binding sites per
dextran
Dextran is a complex branched glucan (polysaccharide derived from the condensation of glucose), originally derived from wine. IUPAC defines dextrans as "Branched poly-α-d-glucosides of microbial origin having glycosidic bonds predominantly C-1 ...
backbone. Scientists have been optimistic about the potential of such technology, since it will help broaden the understanding of
T cell
T cells (also known as T lymphocytes) are an important part of the immune system and play a central role in the adaptive immune response. T cells can be distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on their cell ...
responses and will in the future be clinically applicable to many different antigen-specific
T cells
T cells (also known as T lymphocytes) are an important part of the immune system and play a central role in the adaptive immune response. T cells can be distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on their ce ...
.
Products
The
MHC Dextramers are fluorescent
MHC multimer reagents, developed for sensitive, specific and accurate detection of antigen-specific
T cells
T cells (also known as T lymphocytes) are an important part of the immune system and play a central role in the adaptive immune response. T cells can be distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on their ce ...
by using
Flow cytometry
Flow cytometry (FC) is a technique used to detect and measure the physical and chemical characteristics of a population of cells or particles.
In this process, a sample containing cells or particles is suspended in a fluid and injected into the ...
. The
MHC Dextramers covers human, mouse, and monkey
alleles
An allele is a variant of the sequence of nucleotides at a particular location, or locus, on a DNA molecule.
Alleles can differ at a single position through single nucleotide polymorphisms (SNP), but they can also have insertions and deletions ...
that all display disease relevant antigenic peptides. The
MHC Dextramers can thereby be used for monitoring antigen-specific
T cell
T cells (also known as T lymphocytes) are an important part of the immune system and play a central role in the adaptive immune response. T cells can be distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on their cell ...
responses.
Virus Dextramer collection 1 - provides reagents for detection, quantification and isolation of virus specific
T cell
T cells (also known as T lymphocytes) are an important part of the immune system and play a central role in the adaptive immune response. T cells can be distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on their cell ...
s. It furthermore enables detection for
CMV-,
EBV-,
influenza
Influenza, commonly known as the flu, is an infectious disease caused by influenza viruses. Symptoms range from mild to severe and often include fever, runny nose, sore throat, muscle pain, headache, coughing, and fatigue. These sympto ...
-, and
BK virus specific CD8+
T cell
T cells (also known as T lymphocytes) are an important part of the immune system and play a central role in the adaptive immune response. T cells can be distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on their cell ...
s.
Dextramer CMV kit - These
MHC Dextramers provide a method for quantification of
CMV-specific CD8+
T cell
T cells (also known as T lymphocytes) are an important part of the immune system and play a central role in the adaptive immune response. T cells can be distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on their cell ...
s in whole blood samples as an aid in predicting and monitoring patients at risk of developing
CMV-related disease.
Melanoma Dextramer collection 1 - comprises
MHC Dextramers specific for 6 different
melanoma
Melanoma is the most dangerous type of skin cancer; it develops from the melanin-producing cells known as melanocytes. It typically occurs in the skin, but may rarely occur in the mouth, intestines, or eye (uveal melanoma). In very rare case ...
-associated antigens and can be used for the detection, enumeration and isolation of
melanoma
Melanoma is the most dangerous type of skin cancer; it develops from the melanin-producing cells known as melanocytes. It typically occurs in the skin, but may rarely occur in the mouth, intestines, or eye (uveal melanoma). In very rare case ...
-specific CD8+
T cell
T cells (also known as T lymphocytes) are an important part of the immune system and play a central role in the adaptive immune response. T cells can be distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on their cell ...
s from blood or tumor tissue.
Cancer Testis Antigen CD1d Dextramer - These
MHC Dextramers are
flow cytometry
Flow cytometry (FC) is a technique used to detect and measure the physical and chemical characteristics of a population of cells or particles.
In this process, a sample containing cells or particles is suspended in a fluid and injected into the ...
reagents for the identification and sorting of
Natural killer cells (NKT), as well as an extensive range of single reagents for detection of
cancer
Cancer is a group of diseases involving Cell growth#Disorders, abnormal cell growth with the potential to Invasion (cancer), invade or Metastasis, spread to other parts of the body. These contrast with benign tumors, which do not spread. Po ...
- and viral-specific
T cell
T cells (also known as T lymphocytes) are an important part of the immune system and play a central role in the adaptive immune response. T cells can be distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on their cell ...
s. The CD1d/α-GalCer displays human CD1d molecules loaded with α-GalCer.
Development Projects
Though Immudex specializes in
MHC Dextramer technology, the company is also pursuing development projects in diagnostics for
Lyme disease
Lyme disease, also known as Lyme borreliosis, is a tick-borne disease caused by species of ''Borrelia'' bacteria, Disease vector, transmitted by blood-feeding ticks in the genus ''Ixodes''. It is the most common disease spread by ticks in th ...
/
Borreliosis
Lyme disease, also known as Lyme borreliosis, is a tick-borne disease caused by species of ''Borrelia'' bacteria, transmitted by blood-feeding ticks in the genus ''Ixodes''. It is the most common disease spread by ticks in the Northern Hem ...
, based on the detection of
Borrelia
''Borrelia'' is a genus of bacteria of the spirochete phylum. Several species cause Lyme disease, also called Lyme borreliosis, a zoonotic, vector-borne disease transmitted by ticks. Other species of ''Borrelia'' cause relapsing fever, and are ...
-specific
T cell
T cells (also known as T lymphocytes) are an important part of the immune system and play a central role in the adaptive immune response. T cells can be distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on their cell ...
s in diseased patients.
Clinical application of the CE-market
Dextramer CMV kit has been approved for the
Europe
Europe is a continent located entirely in the Northern Hemisphere and mostly in the Eastern Hemisphere. It is bordered by the Arctic Ocean to the north, the Atlantic Ocean to the west, the Mediterranean Sea to the south, and Asia to the east ...
an market. The
CMV kit will also be attempted approved for the US market through a number of clinical trials and S10K approval. The
CMV kit is intended for identification and enumerication of
CMV-specific CD8+
T cell
T cells (also known as T lymphocytes) are an important part of the immune system and play a central role in the adaptive immune response. T cells can be distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on their cell ...
s in whole blood samples. Furthermore, the
MHC Dextramer CMV kit can be used for the assessment of
CMV-specific immune status in
HLA-matched patients.
Knowledge of the level of viral-specific
T cell
T cells (also known as T lymphocytes) are an important part of the immune system and play a central role in the adaptive immune response. T cells can be distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on their cell ...
s allow evaluation of the patients preparedness for fighting the viral infection and thereby avoid unnecessary antiviral treatment.
CMV infections are often unnoticed by healthy people, but can be life threatening for immune compromised individuals, such as
HIV
The human immunodeficiency viruses (HIV) are two species of '' Lentivirus'' (a subgroup of retrovirus) that infect humans. Over time, they cause acquired immunodeficiency syndrome (AIDS), a condition in which progressive failure of the im ...
-infected persons and organ-transplant recipients.
Collaborations and partnerships
In 2013, Immudex entered into a co-distribution and co-promotional partnership with JPT Peptide Technologies. The goal of this partnership is to synergistically combine JPT's innovative peptide technologies along with existing products with Immudex's sophisticated
MHC Dextramer products. This product combination will provide a comprehensive portfolio of high quality
T cell
T cells (also known as T lymphocytes) are an important part of the immune system and play a central role in the adaptive immune response. T cells can be distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on their cell ...
relevant products and services for the immunotherapy and vaccine community.
International Proficiency Panels
Proficiency panel testing comprises an interlaboratory system for the regular testing of accuracy that the participating laboratories can achieve. The
MHC multimer panel tests the proficiency of a given laboratory in performing the
flow cytometry
Flow cytometry (FC) is a technique used to detect and measure the physical and chemical characteristics of a population of cells or particles.
In this process, a sample containing cells or particles is suspended in a fluid and injected into the ...
based
MHC multimer assay on blood and in performing an
ELISpot Assay.
In the fall of 2013 Immudex entered an agreement with the US cancer Immunotherapy consortium (CIC) and the European Association for Cancer Immunotherapy (CIMIT). The agreement dictates that Immudex will provide
MHC-peptide multimers and Elispot proficiency panels to laboratories worldwide, independently of their background and associations.
CIC and CIMT originally established proficiency panel programs to offer an external validation of assay performance and to enhance assay harmonization. Over the years, more than one hundred laboratories have participated. Not only from the cancer field, but also from other immunological fields utilizing immune monitoring. As a result, two frequently used immune monitoring methods, have now reached a high degree of harmonization.
Immudex, specialized in the detection of antigen-specific
T cell
T cells (also known as T lymphocytes) are an important part of the immune system and play a central role in the adaptive immune response. T cells can be distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on their cell ...
s has been an active participant in the proficiency panel process and is globally recognized for its expertise in immune monitoring. Thus Immudex was the logical choice as a partner for proficiency panels.
Immudex will continue the external validation program established by CIC and CIMT under the successfully implemented harmonization guidelines and will promote a more widespread use of these technologies in the development of new cancer immunotherapies and vaccines against other diseases such as
HIV
The human immunodeficiency viruses (HIV) are two species of '' Lentivirus'' (a subgroup of retrovirus) that infect humans. Over time, they cause acquired immunodeficiency syndrome (AIDS), a condition in which progressive failure of the im ...
,
TB,
diabetes
Diabetes mellitus, commonly known as diabetes, is a group of common endocrine diseases characterized by sustained high blood sugar levels. Diabetes is due to either the pancreas not producing enough of the hormone insulin, or the cells of th ...
and others.
[{{Cite news, title = Immudex takes on proficiency panels, url = http://www.immudex.com/media/29197/produktark_press.pdf]
References
Biotechnology companies of Denmark
Life science companies based in Copenhagen
Research support companies
Technology companies established in 2009
Danish companies established in 2009
Companies based in Lyngby-Taarbæk Municipality