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Top-line clinical results from US study with lead candidate IdeS to be presented at the American Transplant Congress

Regulatory information
Hansa Medical AB (Nasdaq Stockholm: HMED), a biopharmaceutical company developing novel immunomodulatory enzymes, today announced that top-line clinical results from the ongoing investigator initiated US study will be presented in an oral session at the 2017 American Transplant Congress (ATC) in Chicago, U.S. on 30 April.  The top-line results from the study, demonstrate that treatment with IdeS completely eliminates donor specific antibodies (DSAs) and enables transplantation of HLA incompatible patients. An abstract with the top-line data and conclusions is available through the ATC website http://atcmeeting.org 

The abstract, titled “Experience with The Bacterial Enzyme IdeS (IgG Endopeptidase) for Desensitization of Highly-HLA Sensitized (HS) Kidney Allograft Recipients“ concludes that: 1. IdeS completely eliminates donor specific antibodies in HLA incompatible patients. 2. IdeS is generally well tolerated with acceptable adverse events and 3. IdeS may provide a more rapid and durable method to desensitize HLA sensitized patients, offering them the benefits of life-saving transplantation. IdeS, IgG degrading enzyme of Streptococcus pyogenes, is an enzyme that depletes IgG antibodies fast and effectively. Hansa Medical is developing IdeS as a proprietary treatment to enable kidney transplantation in sensitized patients.   In the US study, 15 highly sensitized patients with mean cPRA 95% received IdeS 4-6 hours prior to incompatible kidney transplantation. The IdeS treatment resulted in total IgG and HLA antibody elimination. Fourteen of 15 patients were successfully transplanted without discernible adverse events. Antibody mediated rejection episodes occurred in four patients and all four responded to anti-rejection treatment. One graft loss occurred due to non-HLA IgM and IgA antibodies. A comparison of the levels of donor specific antibodies before IdeS treatment and one month after IdeS treatment shows a significant reduction.  

The abstract supports the company’s conviction that IdeS could become the first therapy to enable highly HLA sensitized kidney disease patients to be transplanted. HLA sensitization impacts approximately 30% of patients with kidney disease and is a major barrier to kidney transplantation.

The title, timing and location of the presentations are as follows:

Abstract#166
Authors:S Jordan, MD1, J Choi, PharmD1, C Kjellman, PhD2, L Winstedt, PhD2,   X Zhang, PhD4, S Louie, MPh1, A Kang, BS1, M Haas, MD, PhD3 and A Vo,   PharmD1. 1Comprehensive Transplant Center, Cedars-Sinai Medical Center, Los   Angeles, CA, United States; 2Hansa Medical, Lund, Sweden; 3Dept of Pathology,   Cedars-Sinai Medical Center, Los Angeles, CA, United States and 4HLA,   Cedars-Sinai Medical Center, Los Angeles, CA, United States.
Title:Experience with The Bacterial Enzyme IdeS   (IgG Endopeptidase) for Desensitization of Highly HLA Sensitized (HS) Kidney   Allograft Recipients
Day/Date: 30 April 2017
Location:Room E354B
Time: 4.30-6 pm
Session: Concurrent   Session: Novel Immunosupression – DSA Monitoring
Session Type:  Oral presentations

This information is information that Hansa Medical AB (publ) is obliged to make public pursuant to the Financial Instruments Trading Act. The information was submitted for publication on March 29, 2017 at 10.15 CET.