Initial results from the ongoing Swedish Phase II study with IdeS in sensitized kidney transplant patients will be presented at TTS 2016

Dr. Tomas Lorant, principal investigator, will present data from the ongoing
Swedish Phase II study with IdeS in sensitized kidney transplant patients at the
26thInternational Congress of the Transplantation Society in Hong Kong in August
2016. The meeting abstract published ahead of the presentation includes
preliminary data from 6 transplanted patients with HLA antibodies in the on
-going Phase II study.
The ongoing and now fully recruited Phase II study includes 10 patients that
received a single dose of IdeS (0.25 or 0.5 mg/kg) before kidney
transplantation. The study primarily evaluates safety and tolerability of the
candidate drug IdeS in sensitized kidney transplantation patients. The study is
also aimed at identifying an IdeS dose that results in anti-HLA antibody levels
acceptable for transplantation within 24 hours from dosing. These patients are
followed for six months after transplantation for safety and kidney function and
final results from the study are expected in Q4 2016.

In the published abstract, Dr. Lorant and co-authors conclude that IdeS
treatment significantly reduced the level of HLA antibodies and eliminated
complement (C1q) binding antibodies. The complement binding antibodies were
inactivated within 1 hour after IdeS treatment. Positive cytotoxic and flow
cytometry crossmatches against the donors were converted to negative by IdeS
treatment and the treatment allowed transplantation in all patients treated with
IdeS.

In addition, the abstract presents data from Hansa Medicals first Phase II study
with IdeS in sensitized patients, which was finalized in January 2015. The study
included 8 highly sensitized patients that received either 1 or 2 doses (0.12 or
0.25 mg/kg) of IdeS. The study aimed at making patients eligible for
transplantation by lowering HLA antibodies and the primary endpoint of the study
was achieved. Meeting abstract available at the TTS website:
https://confman.tts2016.org/mobis/lecture/942

By May 31, 2016 in total 21 sensitized patients have been treated with IdeS and
subsequently transplanted in three separate Phase II studies with IdeS; two
ongoing studies at Uppsala University Hospital, Karolinska University Hospital
in Huddinge and at Cedars Sinai Medical Center, Los Angeles, and one finalized
Phase II study at Uppsala University Hospital.

The information in this press release is disclosed pursuant to the Swedish
Securities Markets Act and/or the Swedish Financial Instruments Trading Act. The
information was released for public disclosure on May 31, 2016 at 08.30 CET.
For further information, please contact:
Hansa Medical AB
Göran Arvidson, CEO
Mobile: 46 70-633 30 42
E-mail: goran.arvidson@hansamedical.com
www.hansamedical.com
About Hansa Medical AB
Hansa Medical is a biopharmaceutical company focusing on novel immunomodulatory
enzymes. The lead project IdeS is an antibody-degrading enzyme in clinical
development, with potential use in transplantation and rare autoimmune diseases.
Additional projects focus on development of new antibody modulating enzymes, as
well as HBP, a diagnostic biomarker for prediction of severe sepsis at emergency
departments that is already introduced on the market. The company is based in
Lund, Sweden. Hansa Medical’s share (ticker: HMED) is listed on Nasdaq
Stockholm.