Presentation at ASN Kidney Week 2018 Highlights Stable Renal Function at up to 24 Months Following Transplantation Enabled by Imlifidase

Lund, Sweden, October 26, 2018- Hansa Medical AB (NASDAQ Stockholm:HMED), the leading biopharma company focusing on inhibition of immunoglobulin G (IgG)-mediated immunopathologies, today announced that data on imlifidase (previously known as IdeS), the Company’s IgG cleaving enzyme, was highlighted in a presentation at the American Society of Nephrology (ASN) Kidney Week 2018, being held October 23-28, 2018 in San Diego, USA.

The presentation, titled IdeS in Highly Sensitized Patients, was presented at ASN Kidney Week 2018 by Stanley C. Jordan, M.D., Director of Kidney Transplantation and Transplant Immunology at the Kidney and Pancreas Transplant Center at Cedars-Sinai Medical Center, Los Angeles, USA on Thursday, October 25, 2018. The presentation described results from the U.S. investigator initiated Phase 2 study demonstrating continued stable renal function over time in long term follow up, up to 24 months after transplantation enabled by imlifidase.

The trial was a single-arm, open-label study designed to assess the safety and efficacy of imlifidase in deceased donor kidney transplantation. Dr. Jordan was the lead investigator in this U.S. investigator-initiated study, which enrolled 17 patients with donor specific antibodies at the Kidney and Pancreas Transplant Center at Cedars-Sinai Medical Center, Los Angeles, USA. As previously disclosed, imlifidase enabled kidney transplantation in all 17 patients. Patients reaching 6, 12 and 24 months post transplant to date showed estimated glomerular filtration rate (eGFR) comparable to non-sensitized patients.

“In long term follow up, imlifidase continues to demonstrate a compelling safety and efficacy profile for patients with previous immunological barriers to kidney transplantation, with patients showing stable renal function at up to 24 months.” said Dr. Jordan. “In the absence of transplantation, patients are confronted with long-term dialysis, which is associated with high morbidity and mortality. Imlifidase has the potential to shift the paradigm for these patients and allow access to a life-saving procedure.”

“These data presented at ASN provide further evidence of imlifidase’s ability to enable kidney transplantation through the rapid and effective inhibition of IgG,” said Soren Tulstrup, President and Chief Executive Officer of Hansa Medical AB.

This is information that Hansa Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below at 08:00am CEST on October 26, 2018.

For further information, please contact:

Company:
Emanuel Björne, Vice President Business Development and Investor Relations, Hansa Medical AB (publ)
Mobile: +46 707 175477
E-mail: emanuel.bjorne@hansamedical.com

Swedish Investor and Media Relations:
Cord Communications
Mikael Widell
+46 70-311 99 60

U.K. Investor and Media Relations
FTI Consulting
Simon Conway/ Stephanie Cuthbert 
+44 (0)20 3727 1000

U.S. Investor and Media Relations:
Argot Partners
Stephanie Marks/ David Rosen (media)
+1 212 600 1902

About imlifidase
Imlifidase (previously known as IdeS) is an enzyme that specifically cleaves IgG antibodies, thereby inhibiting the IgG-mediated immune response. Hansa Medical is developing imlifidase as a proprietary treatment to enable kidney transplantation in sensitized patients, previously unable to undergo transplant surgery due to the presence of Donor Specific Antibodies (DSAs). Efficacy data reported from four Phase 2 studies have demonstrated that imlifidase rapidly and significantly reduced these DSAs, enabling transplantation. In addition to transplantation, imlifidase is being evaluated in a clinical Phase 2 study in anti-GBM antibody disease, a rare autoimmune disorder, and imlifidase has potential applications in a variety of additional autoimmune diseases. Imlifidase is protected by a strong patent portfolio and results of studies with imlifidase have been published in multiple peer reviewed scientific journals.

About Sensitized Patients
Many patients on the waiting list for organ transplantation carry antibodies to human leukocyte antigen (HLA), which is known as being ‘sensitized’. When these antibodies are targeted towards the HLA of a potential donor, called DSAs, the transplanted organ can be significantly compromised. Patients who are highly sensitized, with high levels of DSAs, will have a very low likelihood of finding a donor towards which they will not have DSA. Therefore, they may not be able to receive a transplant at all and remain on dialysis in a debilitating disease state. Current desensitization methods are not feasible for most highly sensitized patients. Imlifidase’s rapid cleavage of all IgG antibodies, desensitizes sensitized patients, enabling deceased donors kidney transplantation. Two thirds of kidney transplantations in the U.S. and Europe are from deceased donors.

About Hansa Medical
Hansa Medical is a biopharmaceutical company developing novel immunomodulatory enzymes for organ transplantation and acute autoimmune diseases. The Company’s lead product, imlifidase (IdeS), is a proprietary antibody-degrading enzyme in late-stage clinical development for kidney transplant patients, and has significant potential for further development in other solid organ transplantation and in acute autoimmune indications. Hansa also has a strong pipeline of preclinical projects that may provide a second wave of potential drugs. Under the project name NiceR, the Company is developing novel immunoglobulin-cleaving enzymes for repeat dosing in relapsing autoimmune diseases and oncology. Hansa Medical is based in Lund, Sweden.

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About Us

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.