Etrolizumab Explained

Etrolizumab (rhuMAb Beta7) is a biopharmaceutical drug candidate being developed for the treatment of ulcerative colitis and Crohn's disease. It is a humanized monoclonal antibody against the β7 subunit of integrins α4β7 and αEβ7.[1] Etrolizumab was developed by Genentech[2] [3] by engineering the FIB504 antibody to include human IgGl-heavy chain and κ-light chain frameworks; it is manufactured in CHO cells.[4]

As of 2016, it was in phase III studies for induction and maintenance therapy in people with ulcerative colitis and Crohn's.[2] [5] [6] According to data of one meta-analysis efficacy of Etrolizumab is comparable with conventional therapies such as Infliximab with less adverse events.[7]

Phase III clinical trials produced mixed results; and, on October 14, 2020, Hoffmann-La Roche, the parent company of Genentech, abandoned further efforts to develop etrolizumab for ulcerative colitis, but continued development for Crohn's disease,[8] until disappointing trial results led to this being abandoned too in February 2022.[9]

Notes and References

  1. Adis Insight Etrolizumab Latest Information Update: 16 Dec 2015
  2. UK Medicines Information. etrolizumab at UKMI Page accessed May 10, 2016
  3. Web site: Genentech: Our Pipeline. www.gene.com. 2020-05-22. 2020-05-24. https://web.archive.org/web/20200524223812/https://www.gene.com/medical-professionals/pipeline. live.
  4. WO . 2012135589 . Methods of administering beta7 integrin antagonists . Genentech and Roche. For the FIB504 mAb, see Andrew DP et al. Distinct but overlapping epitopes are involved in alpha 4 beta 7-mediated adhesion to vascular cell adhesion molecule-1, mucosal addressin-1, fibronectin, and lymphocyte aggregation. Andrew DP, Berlin C, Honda S, Yoshino T, Hamann A, Holzmann B, Kilshaw PJ, Butcher EC . Distinct but overlapping epitopes are involved in alpha 4 beta 7-mediated adhesion to vascular cell adhesion molecule-1, mucosal addressin-1, fibronectin, and lymphocyte aggregation . Journal of Immunology . 153 . 9 . 3847–61 . November 1994 . 10.4049/jimmunol.153.9.3847 . 7523506 . 32434092 . as referenced in paragraph 146 of the PCT application.
  5. Makker J, Hommes DW . Etrolizumab for ulcerative colitis: the new kid on the block? . Expert Opinion on Biological Therapy . 16 . 4 . 567–72 . 2016 . 26914639 . 10.1517/14712598.2016.1158807 . 24706213 .
  6. Rosenfeld G, Parker CE, MacDonald JK, Bressler B . Etrolizumab for induction of remission in ulcerative colitis . The Cochrane Database of Systematic Reviews . 12 . CD011661 . December 2015 . 2015 . 26630451 . 10.1002/14651858.CD011661.pub2 . 8612697 .
  7. Motaghi E, Ghasemi-Pirbaluti M, Zabihi M . Etrolizumab versus infliximab in the treatment of induction phase of ulcerative colitis: A systematic review and indirect comparison. Pharmacological Research . 139 . 120–125 . January 2019 . 30395950 . 10.1016/j.phrs.2018.11.003 . 53235342 .
  8. Tong . Amber . Roche writes off ulcerative colitis portion of etrolizumab program, days after dissecting PhIII setback . Endpoints . October 15, 2020 . 2 January 2021 . 24 November 2020 . https://web.archive.org/web/20201124012928/https://endpts.com/roche-writes-off-ulcerative-colitis-portion-of-etrolizumab-program-days-after-dissecting-phiii-setback/ . live .
  9. Web site: Archived copy . Fierce Biotech . 8 March 2023 . 8 March 2023 . https://web.archive.org/web/20230308012715/https://www.fiercebiotech.com/biotech/roche-lets-go-etro-dumping-phase-3-crohn-s-prospect-18-months-after-posting-weak-colitis . live .

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