Company:Immudex

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Immudex
TypePrivate
IndustryReagents and Diagnostics
PredecessorDako
Founded2009
Headquarters
Copenhagen
,
Denmark
Key people
Helene Kähler Hjenner (CEO)

Liselotte Brix (CSO)

Henrik Martin Pfundheller(CCO)
BrandsDextramer®,dCODE Dextramer®, Klickmer®,U-Load
DivisionsImmudex USA, LLC
Websitewww.immudex.com

Immudex is a Danish life science company established in 2009 that specializes in developing reagents for cellular immune monitoring. The company develops and commercializes research and diagnostic tools based on their trademarked technology Dextramer®, a versatile molecule with multiple binding sites and fluorophores that ensures a reliable detection of cells involved in the immune response[1] (T cells, B cells, non-conventional T cells and other immune cells like iNKT). Immudex has its headquarters in the Greater Copenhagen Area (Denmark), with a branch office in Virginia (US).

History

In 2001, the Danish diagnostic company Dako invented Dextramer®, an MHC multimer for detecting antigen-specific T-cells. Jørgen Schøller was an employee of Dako at the time and a co-inventor of Dextramer®.

In 2005, immunologist Liselotte Brix joined Dako. Brix and Schøller shared an interest in T-cells and antigen-specific immune responses. Together, Brix and Schøller launched the Immudex Division, a branch under Dako. The Immudex Division utilized Dextramer® to identify immune cells active in infectious diseases and transplantation. Sensing the Dextramer® MHC multimer had much-unrealized potential in immuno-oncology and for a wide variety of infectious diseases, Brix, Schøller and Henrik Pedersen, also a coworker at Dako, spun out Immudex ApS as an independent company in 2009.[2]

In 2011, Ernst & Young awarded the prestigious "Entrepreneur of the Year 2011" award in the Life Sciences category to Immudex for its commitment to bettering results for practitioners and patients.[3]

Immudex became the provider of MHC Multimer and Elispot Proficiency Panels Service in 2013.[4] Laboratories worldwide can evaluate their immune monitoring performance with either MHC Multimer or T-cell ELISpot assays.

Also, in 2013, Immudex partnered with JPT Peptide Technologies to co-distribute and co-promote some of their immunolimmunogical product lines.[5]

As of February 20, 2017, Helene Kähler Hjenner was appointed the new CEO of Immudex, succeeding Henrik Pedersen in the role.[6]

Immudex also entered a partnership with 10xGenomics in 2018.[7] This collaboration combines dCODE Dextramer® reagents with the 10xGenomics Single Cell Immune Profiling Solution.

Entering 2020, Immudex relocated its headquarters from Copenhagen to Virum, Denmark.[8] In that same year, Immudex started collaborating with BD (Becton, Dickinson and Company) to create dCODE® Dextramer a reagent compatible with their BD Rhapsody™ Single-Cell Analysis System.[9]

In June 2021, Immudex and ImmunAware announced a business collaboration aimed at broadening the availability of immunAware’s easYmer® product portfolio through Immudex’ global sales channels and integrating the easYmer® monomers into Immudex’ product offerings.[10]

Dextramer® technology

Dextramer® reagents were designed to help researchers and clinicians worldwide to obtain high-quality results.[11] They contain multiple binding sites and numerous fluorophores to boost avidity in binding antigen-specific T cells to isolate populations even when these are rare or have low-affinity receptors.

That same configuration is at the core of other Immudex products that enable multiplexing and expand the types of cells that can be targeted to unravel complex immune responses. The advantage of the long dextran is that it can easily flex and bend to bind multiple T-cell receptors across the cell surface. Also, the high number of fluorophores on the dextran enhance staining intensity and improve resolution.

Dextramer® multimers lengthen binding times and strengthen signals enable the detection of low-affinity T-cell receptors while providing reproductible results through the whole workflow.

Applications

Immudex technologies allow in-depth examination of disease-specific immunity to reveals granular details about the composition of the cellular immune response, how immunity changes over time, and how it is impacted by therapeutic treatments.

Focus on insights

  • Cellular immune monitoring: accurately quantify target immune cells by flow cytometry
  • Single-cell multi-omics: to discover and characterize antigen-specific T-cell epitopes at single-cell resolution
  • In-situ immune monitoring: to track the spatial distribution of antigen-specific immune cells in tissue by direct or indirect staining
  • Clinical grade reagents: source GMP-grade and clinical reagents for monitoring of one or more epitope-specific immune cell populations

Focus on diseases

  • Immuno-oncology: understand how treatments impact immune response and uncover markers of successful outcomes
  • Infectious disease: informed research on disease progression and vaccines, including novel viruses like SARS-CoV-2
  • Autoimmunity: find signatures of immune cell activity that reveal mechanisms of autoimmune conditions
  • Transplantation: evaluate immune reconstitution in organ transplant patients

Products

Basic Research

  • MHC I Dextramer®: designed to identify antigen-specific CD8+ T cells by flow cytometry.
  • MHC II Dextramer®: designed to identify antigen-specific CD4+ T-cell subsets by flow cytometry.
  • CD1d Dextramer®: CD1d Dextramer® are flow cytometry reagents that can identify CD1d restricted NKT cells.
  • Dextramer® Disease Panels: predefined MHC Dextramer® panels for flow cytometry to detect T-cell populations in cancer and infectious diseases like melanoma, cancer testis, COVID-19, EBV, CMV and others.
  • Dextramer® In-Situ Staining: MHC Dextramer® reagents combined with immunohistochemistry to provide information about the abundance, spatial distribution, and localization of T cells within the tissue .
  • dCODE Dextramer®: dCODE Dextramer® adds a unique DNA barcode to the MHC Dextramer® reagent to detect antigen-specific T cells using PCR, followed by next-generation sequencing. It is available for multi-omics analysis of antigen-specific T cells and TCR sequencing using 10x Chromium Single Cell Gene Expression and BD Rhapsody™ Single-Cell Analysis System.
  • Klickmer®: dextran backbone carrying multiple acceptor sites able to bind any biotinylated molecule, used for the detection of B cells, simulating antigen presentation, antibody discovery and much more (Read more). Klickmer® is also available in a DNA barcode labeled version, dCODE® Klickmer, for multi-omics analysis.
  • U-Load Dextramer®: loadable Dextramer® technology, allowing the combination of customized MHC-peptide complexes from the lab .
  • easYmer®: Immudex is the global distributor of the high-quality easYmer® MHC I monomers manufactured by immunAware. easYmer® products contains the reagents necessary to load peptides into MHC creating peptide-monomer complexes and cover 40 human and 2 mouse allotypes for MHC I.
  • U-Load MHC II: MHC II monomers that contain the reagents necessary to load peptides into MHC creating peptide-monomer complexes with U-Load Dextramer®, covering 4 human allotypes for MCH II.

Clinical

Immudex provides Dextramer® Reagents that meet clinical-grade quality requirements (ISO 123485 and FDA GMP (21 CFR 820). Clinical-grade Dextramer® Reagents undergo rigorous quality control checks throughout and after manufacturing to ensure batch consistency, stability, and performance robustness.

Immudex Services

Customer Solutions

Immudex develops customized products to meet specific workflow or experimental setup requirements. Such tailored products include:

  • Monomers or Dextramer® Reagents with MHC I or MHC II alleles not available as a predefined product.
  • Clinical-Grade Dextramer® Reagents in compliance with good manufacturing practices (GMP) for clinical trials.
  • Dextramerization service with Dextramer® or dCODE Dextramer® backbone: clients provide a protein that Immudex binds to a dextran molecule to create a customized multimer.
  • Customized dCODE Dextramer® products

Proficiency Panels

The US Cancer Immunotherapy Consortium of the Cancer Research Institute (CIC of CRI) and the European Association for Cancer Immunotherapy (CIMT) established a proficiency panel program to standardize immune monitoring among laboratories.[4] In 2013, Immudex became a provider of proficiency test to interested individual laboratories worldwide. Immudex offers two proficiency tests, with CLIA and ISO 15189 recommendations for routine clinical labs:

  • MHC Multimer Proficiency Panels: a laboratory determines the number of antigen-specific CD8+ T cells present in provided samples using MHC multimer reagents and flow cytometry.
  • T cell ELISpot Proficiency Panels: a laboratory determines the number of antigen-specific T cells secreting IFN-g in provided samples using enzyme-linked immunospot (ELISpot) assay.

Participating laboratories can evaluate and benchmark their immune monitoring performance against a collaborative standard. Results of the proficiency panels are posted annually for review and self-assessment.

Partnerships and Collaborations

In 2011, Immudex entered a strategic agreement with ImmunoSite, a provider of immune monitoring services. ImmunoSite utilizes Dextramer® technologies to validate the effectiveness of potential drugs and vaccines.[15]

Immudex has been under agreement with the US Cancer Immunotherapy Consortium (CIC of CRI) and the European Cancer Immunotherapy Consortium (CIMT) since 2013 to provide proficiency tests.[4]

In 2013, Immudex began collaborating with JPT Peptide Technologies to co-distribute and co-promote some of their immunological product lines.[5] JPT is a provider of high-performance peptide tools and services. Clients can select suitable PepMix™ Peptide Pool and MHC Dextramer® reagents as a set.

In 2018, Immudex entered a partnership with 10x Genomics, a research-specific gene sequencing technology manufacturer.[7] The combination of dCODE Dextramer® Reagents with the 10x Genomics Single-Cell Immune Profiling Solution was a first example of Immundex innovations used on a commercially available single-cell analysis system. The combination enables direct information of structural T-cell receptor specificity, cell surface phenotype, and gene expression in a single cell.

In 2020, Immudex started collaborating with BD (Becton, Dickinson and Company).[9] The outcome was the dCODE Dextramer® (RiO) reagents, which are DNA-barcoded MHC Dextramer® Reagents compatible with the BD Rhapsody™ Single-Cell Multi-Omic Analysis System.

In 2021, Immudex began co-distributing the easYmer® MHC I and MHC II monomers made by immunAware.[10] The easYmer® monomers cover 40 human and 2 mouse allotypes worldwide. By combining U-Load Dextramer® and easYmer® monomers, users can monitor a broader range of human immune diversity.

References

  1. ↑ Batard, Pascal; Peterson, Daniel A.; Devêvre, Estelle; Guillaume, Philippe; Cerottini, Jean-Charles; Rimoldi, Donata; Speiser, Daniel E.; Winther, Lars et al. (March 2006). "Dextramers: New generation of fluorescent MHC class I/peptide multimers for visualization of antigen-specific CD8+ T cells". Journal of Immunological Methods 310 (1-2): 136–148. doi:10.1016/j.jim.2006.01.006. ISSN 0022-1759. http://dx.doi.org/10.1016/j.jim.2006.01.006. 
  2. ↑ "Immudex, a new spin-out from Dako" (PDF) (Press release). Immudex ApS. October 9, 2009. Archived (PDF) from the original on January 3, 2014.
  3. ↑ Ernst & Young, Nov. 24th, 2011. "Immudex wins the category of Life Sciences Entrepreneur Of The Year 2011". Copenhagen, DK.
  4. ↑ 4.0 4.1 4.2 Press release “Immudex becomes the provider of MHC multimer and ELISpot proficiency panel services” April 2013.
  5. ↑ 5.0 5.1 Press release. “JPT and Immudex Announce Partnership Agreement” November 5, 2013.
  6. ↑ Press release. “Helene Kähler Hjenner is the New CEO of Immudex” February 2017.
  7. ↑ 7.0 7.1 Press release. “Immudex partners with 10x Genomics to further enhance applications of its dCODE® DNA Barcode Technology”. September 2018.
  8. ↑ Press release. “Innovation Requires Space. New Headquarters”. February 2020.
  9. ↑ 9.0 9.1 Press release. “Immudex Collaborates with BD to Create Improved Solutions for T Cell Multi-Omics Research” June 2020.
  10. ↑ 10.0 10.1 Press release. “Immudex and immunAware enter partnership”. June 2021
  11. ↑ Dolton, G.; Lissina, A.; Skowera, A.; Ladell, K.; Tungatt, K.; Jones, E.; Kronenberg‐Versteeg, D.; Akpovwa, H. et al. (July 2014). "Comparison of peptide–major histocompatibility complex tetramers and dextramers for the identification of antigen‐specific T cells" (in en). Clinical & Experimental Immunology 177 (1): 47–63. doi:10.1111/cei.12339. ISSN 0009-9104. PMC 4089154. https://onlinelibrary.wiley.com/doi/10.1111/cei.12339. 
  12. ↑ Tario, Joseph D.; Chen, George L.; Hahn, Theresa E.; Pan, Dalin; Furlage, Rosemary L.; Zhang, Yali; Brix, Liselotte; Halgreen, Charlotte et al. (2014-10-23). "Dextramer reagents are effective tools for quantifying CMV antigen-specific T cells from peripheral blood samples". Cytometry Part B: Clinical Cytometry 88 (1): 6–20. doi:10.1002/cyto.b.21196. ISSN 1552-4949. PMC 4376327. http://dx.doi.org/10.1002/cyto.b.21196. 
  13. ↑ TF1000.07 Dextramer CMV Kit Package Insert US (IVD), Immudex.
  14. ↑ TF1010.07 Dextramer CMV Kit Package Insert EU (CE-IVD), Immudex.
  15. ↑ Press release. “ImmunoSite Technologies allies with Immudex for more effective T cell response monitoring”. September 2011.

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