Hansa Medical AB announces the formation of a medical advisory board for IdeS in anti-GBM disease

Hansa Medical AB today announces the appointment of leading experts to their
newly formed medical advisory board for IdeS in anti-GBM disease. The board will
assist the company in developing IdeS as a treatment for patients with anti-GBM
disease.
The members of the medical advisory board for anti-GBM disease include:

Dr Mårten Segelmark, M.D. is Head of the Division of Drug Research (LÄFO) and
Professor in Nephrology at the Department of Medical and Health Sciences (IMH),
Linköping University. Dr. Segelmark received his medical degree from Lund
University and completed fellowship at University of North Carolina at Chapel
Hill before being appointed associate professor in Clinical Nephrology and
senior consultant in Nephrology at Lund University Hospital. Dr Segelmark’s
research is focused on the role of autoantibodies for the diagnosis and
pathogenesis of glomerulonephritis and systemic vasculitis and he is a leading
expert in anti-GBM disease. He has published more than 100 peer-reviewed journal
articles, book chapters, and reviews.

Dr Wladimir Szpirt, MD is a specialist in nephrology at Copenhagen University
hospital, Denmark. Dr Szpirt received his degree and internal fellowship at
Copenhagen University hospital. He is a member of ethical committees, steering
committees and GCP societies as well as a number of professional societies
within kidney-and autoimmune disease, including becoming the president for the
International Society for Apheresis. Dr Szpirt’s research interest is in
vasculitis, kidney disease and clinical trials and he has an extensive list of
publications within this field.

Dr. David RW Jayne, MD is Director of the Vasculitis and Lupus Clinic and Reader
in Vasculitis at the University of Cambridge, UK. Dr. Jayne received his
bachelor of surgery degree and medical degree from Cambridge University, England
and postgraduate training at several London hospitals and Harvard University. He
is on the editorial board of 7 journals and serves as a referee for 45 journals.
He is a medical advisor to UK, US and EU regulatory bodies, patient groups, and
professional organizations and has published more than 200 peer-reviewed journal
articles, book chapters, and reviews. Dr Jayne’s research is focused on clinical
evaluation of newer immunotherapeutics in vasculitis, lupus and immune-mediated
renal disease and he coordinates international clinical research vasculitis
network (EUVAS) and multi-center randomized controlled trials.

About anti-GBM disease (Goodpasture’s Disease)
Rapidly progressive glomerulonephritis and bleeding from the lungs became known
as Goodpasture’s syndrome, based on a case report from 1919 by the pathologist
Ernest William Goodpasture (1). Goodpasture’s syndrome or anti-GBM disease is a
rare autoimmune disease (incidence 0.5-1 per million) in which IgG antibodies
bind to the glomerular basement membrane resulting in rapidly progressive
glomerulonephritis often associated with pulmonary hemorrhage (2). The diagnosis
of anti-GBM disease is based on the detection of anti-GBM antibodies in
conjunction with clinical symptoms. Anti-GBM disease has a poor prognosis and
rapidly progressive glomerulonephritis combined with lung hemorrhage often
results in death of the patient if not treated. Despite treatment less than 30%
of the patients survive with a preserved kidney function and among the surviving
patients a majority end up in dialysis waiting for kidney transplantation. Early
diagnosis and rapid treatment are important to stabilize kidney function and
decrease lung bleeding. Current treatment aims to remove antibodies from the
blood (plasmapheresis), to slow the production of anti-GBM antibodies
(chemotherapy) and halt inflammation (glucocorticoids), thereby lowering disease
activity.

(1) Goodpasture EW. (1919) Am J Med Sci;158:863.
(2) Hellmark T, Segelmark M. (2014) J Autoimmun.;48-49:108–12.

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
favorable safety profile. During 2014, a phase II clinical trial in sensitized
patients awaiting kidney transplantation was initiated, to be reported during
2015. In addition to transplantation, IdeS has potential indications within a
variety of rare autoimmune diseases including anti-GBM disease. IdeS is
protected by several patents and has been published in numerous peer review
journals.
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

Christian Kjellman, Ph.D
Chief Scientific Officer
Mobile: +46 705 717417
E-mail:
christian.kjellman@hansamedical.com

www.hansamedical.com
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.