03. January 2019

Preview: Catalogue Editorial 2019



Transglutaminases in Translation

Driven by clinical programs, the transglutaminase researcher community enters an exciting and promising year. Sponsored by Dr. Falk Pharma, our tissue transglutaminase (TG2)-blocker ZED1227* entered a phase 2a proof-of-concept study for the treatment of celiac disease in mid 2018. The study aims to eventually enroll 160 patients in 20 centers all over Europe. The results of the “study on the efficacy and tolerability of a 6-week treatment with ZED1227 capsules vs. placebo in subjects with well-controlled celiac disease undergoing gluten challenge” are expected in 2019.

Targeting TG2 for the treatment of fibrotic disorders has been discussed for several years. In this regard, an anti-human tissue transglutaminase monoclonal antibody (UCB7858, “Zampilimab”) is under development. In late 2018, UCB Biopharma got approval for a phase 1/2 study “to evaluate safety/tolerability, pharmacokinetics, and efficacy of UCB7858 in adult kidney transplant recipients with chronic allograft injury” in Spain.

We are confident that, based on the outcome of such clinical trials, the transglutaminase community will profit. We anticipate that obtaining substantial data by means of target validation will increase the overall awareness of the importance of the transglutaminase field to pharmaceutical companies and to government funding agencies - resulting in more projects and increased financial support.

We would like to mention Zedira’s own research that refocuses on TG2. The 2nd generation of reversible inhibitors* has been optimized for systemic indications (e.g. fibrotic disorders), providing complementary small molecules to the monoclonal antibody approach.

A current trend in oncology and, indeed in some other areas of clinical research, is the development of antibody drug conjugates (ADCs). Such innovative biomolecules enable the targeted delivery of cytotoxic payloads to cancer cells. Enzymatic conjugation by microbial transglutaminase (MTG) is a state-of-the-art method for the production of site specifically conjugated and homogeneous ADCs with a defined drug-to-antibody ratio.
Our highly purified MTG is the product of choice for this purpose and we expect to meet the increasing requirements/demands of our customers for this enzyme, both in quantity and in conformity with stringent regulatory requirements.

Autoantibodies to TG2 (celiac disease) and TG3 (dermatitis herpetiformis) are well established biomarkers. In this context, Zedira continues to produce high quality diagnostic antigens.  Moreover, our patent protected anti-TG6-ab-ELISAs permit the detection of autoantibodies to TG6, a novel biomarker in gluten ataxia.

Factor XIII activity measurement is a diagnostic tool not only in FXIII-deficiency, but also for coagulation in routine blood tests. Our precise fluorogenic FXIII-activity assay (A101, F001) is currently adapted to a fully automated coagulation analyzer.

Finally, these and many more aspects of “Transglutaminases in Translation” will be highlighted in a special issue of Analytical Biochemistry, to be launched in early 2020: “Transglutaminases in Translation – Novel Tools and Methods Impacting on Diagnostics and Therapeutics”.
It is our pleasure to be guest editors for this special issue, and we welcome all of you in the transglutaminase field to consider submitting relevant manuscripts.

Sincerely yours,

On behalf of the entire Zedira team
Ralf Pasternack and Martin Hils

Products

  • Zedira offers a huge portfolio of reliable specialist transglutaminase related products meant to catalyze research and development, both in academia and industry.

News  

  • Team-Assistenz (w/m/d) in Teilzeit gesucht
  • imageArtikel in DZG Aktuell 01/2019 über die klinische Wirksamkeitsstudie unseres potentiellen Zöliakie Medikaments (deutsch)
  • imagePreview: Catalogue Editorial 2019
  • Press release: Dr. Falk Pharma and Zedira announce start of the phase 2a proof of concept study of ZED1227 for the treatment of celiac disease
  • Artikel in DLG-Lebensmittel – 06/2017 zur Bestimmung von Transglutaminase in Lebensmitteln (deutsch)
  • Zedira publication: Microbial Transglutaminase Used in Bread Preparation at Standard Bakery Concentrations Does Not Increase Immunodetectable Amounts of Deamidated Gliadin
  • Pressemitteilung: Dr. Falk Pharma und Zedira geben den Abschluss der Phase 1b-Studie für ZED1227 zur Zöliakie-Therapie bekannt und planen Start der Wirksamkeitsstudie
  • Press release: Dr. Falk Pharma and Zedira announce completion of phase 1b clinical trial of ZED1227 for the treatment of celiac disease and move on to proof of concept study
  • Press Release: Dr. Falk Pharma GmbH and Zedira enter a phase 1b clinical trial for a celiac disease drug
  • Zedira publication: Microbial transglutaminase has a lower deamidation preference than human tissue transglutaminase on a celiac disease relevant wheat gliadin T-cell epitope
  • Press release: Additional subsidy funding for clinical development of a celiac disease drug
  • Pressemitteilung: Zusätzliche Fördermittel für die klinische Entwicklung eines Zöliakie-Medikamentes
  • Press Release: Cooperation between Zedira and Cardiff University - Transglutaminase 6 is the focus of new research into ataxia
  • Press Release: Dr. Falk Pharma and Zedira enter phase I clinical trials for a celiac disease drug
  • Press release: Zedira receives further funding to develop Factor XIIIa-blockers for safe anticoagulation

Blog  

Events  

  • 27th ISTH Congress

    06.06.2019 - 10.06.2019
    Melbourne, Australia

  • 18th International Celiac Disease Symposium ICDS

    04.09.2019 - 07.09.2019
    Paris, France