Successful Phase 2 Study of IdeS in Highly Sensitized Dialysis Patients awaiting Kidney Transplantation

Hansa Medical AB today announced preliminary data showing that IdeS has very
good efficacy in a phase 2 study with 8 highly sensitized patients on the
waiting-list for kidney transplantation. The study shows that IdeS has the
capacity to make sensitized patients eligible for transplantation by decreasing
HLA antibodies to acceptable levels. IdeS increased the probability of
compatible transplantation by reducing the percentage panel reactivity to low
levels in all patients.
Hansa Medical AB today announced preliminary data showing that IdeS has very
good efficacy in a phase 2 study with 8 highly sensitized patients on the
waiting-list for kidney transplantation. Data analysis shows that IdeS rapidly
decreases anti-HLA antibodies to levels acceptable for transplantation, thereby
increasing the probability of finding a compatible donor. This is demonstrated
by a significant reduction of percentage panel reactivity after treatment. In
addition, essentially all IgG was cleaved within 24 hours after dosing in all
patients. IdeS was considered safe and well tolerated in HLA sensitized dialysis
patients awaiting kidney transplantation.

“IdeS can be directly life-saving for patients waiting for transplantation who
have antibodies to transplantation antigens, The worst affected patients
represent about 15 % of the wait-listed patients. In addition, a further 25 % of
the patients waiting for a transplant may benefit from IdeS treatment." says
Gunnar Tufveson, Professor in Transplantation Surgery, Uppsala University
Hospital.

“The data show that IdeS swiftly and efficiently degrades the antibodies which
prevent kidney transplantation of these patients. We are highly encouraged to
pursue further investigation of IdeS for sensitized transplantation patients as
well as patients suffering from having other obstructive and pathogenic IgG.”
says Christian Kjellman, Chief Scientific Officer of Hansa Medical AB.

About the Study
The phase 2 IdeS study was a single arm, single centre, ascending dose study at
Uppsala University Hospital, Sweden. Eight sensitized dialysis patients were
included and they received 0.12 or 0.25 mg/kg body weight of intravenous IdeS
once or twice within 2 days. IgG was rapidly and efficiently cleaved within
minutes after IdeS treatment. Antibodies to HLA, measured with single-antigen
bead analysis and T- and B-cell panel reactive antibody analysis, reached levels
acceptable for transplantation within hours of treatment. IdeS had an acceptable
safety and tolerability profile in the intended category of patients; myalgia
and increased susceptibility to infection were identified as potential side
effects. Susceptibility to infection is expected in connection with
immunosuppressive treatments. Hansa Medical has previously reported about one
patient in the study who was made eligible for kidney transplantation by
treatment with IdeS and successfully transplanted with a deceased donor. IdeS
treatment converted the positive cross-match tests (both FACS-CXM and CDC-CXM)
negative, thereby making the transplantation possible. Today, the patient is
well, with a fully functional graft without any signs of rejection.

About sensitized patients
Approximately one third of the several hundred thousands of patients waiting for
organ transplantation are sensitized to human leukocyte antigen (HLA). These
patients have developed antibodies to HLA primarily as the result of allo
-immunisation from previous transplantations, blood transfusions or pregnancies.
Antibodies to HLA hamper the identification of a suitable donor and HLA
-antibodies that react to a potential donor (i.e. a positive cross-match test)
are a direct contraindication to transplantation because of the risk of antibody
-mediated rejection. Consequently, sensitized patients have extended waiting
times on dialysis and risk never being transplanted, despite highest priority.
End-stage renal disease patients can be maintained on dialysis However, kidney
transplantation is the treatment-of-choice since the patient’s life expectancy
and quality of life is dramatically increased and there are substantial cost
-savings associated with transplantation compared to dialysis.

About IdeS
IdeS, a unique molecule with a novel mechanism, is a bacterial enzyme that
cleaves human IgG antibodies. IdeS degrades all IgG specifically, swiftly and
efficiently. IdeS has been tested for safety and efficacy in numerous in vitro
and in vivo models. During 2013, a phase I clinical trial on 29 healthy subjects
was conducted, demonstrating IdeS as efficacious and well tolerated with a
favourable safety profile. During 2014, a phase II clinical trial in sensitized
patients awaiting kidney transplantation was initiated, to be reported during
2015. IdeS has potential indications within transplantation and a broad variety
of rare autoimmune diseases, where it addresses unmet medical needs. IdeS is
protected by several patents and has been published in numerous peer review
journals.

About Hansa Medical AB
Hansa Medical is a biopharmaceutical company focused
on novel immunomodulatory enzymes. Lead project IdeS is an antibody-degrading
enzyme in clinical development, with potential use in transplantation and rare
autoimmune diseases. Other projects include HBP (a market introduced diagnostic
marker for severe sepsis) and EndoS (an antibody-modulating bacterial enzyme in
pre-clinical development). The company is based in Lund, Sweden. Hansa Medical's
share (HMED) is listed on NASDAQ First North in Stockholm with Remium Nordic AB
as Certified Adviser. Major shareholders are Farstorps Gård AB and Nexttobe AB.

For further information, please contact:
Hansa Medical AB

Fredrik Lindgren, President and CEO
Mobile: +46 705 61 61 77
E-mail: fredrik.lindgren@hansamedical.com

Emanuel Björne, Corporate Development Director
Mobile: +46 707 17 54 77
E-mail: emanuel.bjorne@hansamedical.com

www.hansamedical.com