A presentation at ASN's Kidney Week in 2018 highlights stable renal function up to 24 months after transplantation, thanks to imlifidase | Business and Finance

LUND, Sweden, Oct. 26, 2018 / PRNewswire / – Hansa Medical AB (NASDAQ Stockholm: HMED), a leading biopharmaceutical company specializing in the inhibition of immunoglobulin G (IgG) mediated immunopathologies, has announced today that the data on imlifidase under the name of IdeS), the company's IgG cleavage enzyme, was highlighted during a presentation at l 39; the 2018 kidney week of the American Society of Nephrology (ASN), to be held from October 23 to 28, 2018 in San Diego, United States.

The presentation, titled IdeS in Highly Sensitized Patients, was presented at ASN Kidney Week 2018 by Stanley C. Jordan, MD, Director of Kidney Transplantation and Transplant Immunology at the Graft Center. Kidney and Pancreas Cedars-Sinai Medical Center, Los Angeles, USA. Thursday, October 25, 2018. The presentation described the results of a Phase 2 study initiated by an American investigator, demonstrating that renal function had remained stable over time, up to 24 months after the grafting was done. possible by imlifidase.

It was a single arm open study designed to evaluate the safety and effectiveness of imlifidase in the transplantation of a deceased donor kidney. Dr. Jordan was the principal investigator of this US study, which involved 17 patients with donor-specific antibodies at the Kidney and Pancreas Transplant Center at Cedars-Sinai Medical Center, Los Angeles, USA. As previously reported, renal transplantation allowed imlifidase in 17 patients. Patients who reached 6, 12 and 24 months after transplantation to date had an estimated glomerular filtration rate (eGFR) comparable to that of non-sensitized patients.

"In long-term follow-up, imlifidase continues to demonstrate a convincing safety and efficacy profile for patients with immunologic barriers prior to renal transplantation, patients with stable renal function up to 20 years. at 24 months, "said Dr. Jordan. "In the absence of transplantation, patients are faced with long-term dialysis, badociated with high morbidity and mortality.Imlifidase can potentially change the paradigm of these patients and allow them access to a rescue procedure. "

"The data presented at ASN provide further evidence of the ability of imlifidase to allow renal transplantation through rapid and effective inhibition of IgG," said Soren Tulstrup, president and chief from the management of Hansa Medical AB.

It is information that Hansa Medical AB is obliged to make public in accordance with the EU Regulation on Market Abuse. The information has been submitted for publication via the contact person indicated below at 8:00 am (Paris time) on 26 October 2018.

About Imlifidase Imlifidase is an enzyme that specifically cleaves IgG antibodies, thereby inhibiting the immune response mediated by IgG. Hansa Medical is developing imlifidase as a patented treatment for renal transplantation in patients with an immunological barrier to transplant surgery due to the presence of donor specific antibodies (DSA). Efficacy data reported by four phase 2 studies demonstrated that imlifidase rapidly and significantly reduced these DSA, thus enabling renal transplantation. In addition to transplantation, imlifidase is being evaluated in a Phase 2 clinical trial on a disease-related anti-GBM, a rare autoimmune disease, and Imlifidase could be used in various other autoimmune diseases.

About Sensitized Patients Many patients on a waiting list for an organ transplant are carriers of anti-human leukocyte antigen (HLA), known as "sensitized". When these antibodies are targeted on the HLA of a potential donor, called DSA, the transplanted organ can be significantly compromised. Highly sensitized patients, with high levels of ADV, will have very little chance of finding a donor for whom they will not have DSA. As a result, they may not be able to receive a transplant and remain on dialysis in a debilitating condition. Current desensitization methods are not feasible for the most sensitive patients. The rapid cleavage of all IgG antibodies by imlifidase desensitises sensitized patients and thus allows for the transplantation of a deceased donor kidney. Two-thirds of kidney transplants in the United States and Europe are from deceased donors.

About Hansa Medical Hansa Medical (NASDAQ Stockholm: HMED) is a biopharmaceutical company developing novel immunomodulatory enzymes for organ transplantation and acute autoimmune diseases. The company's flagship product, imlifidase, is a patented antibody-degrading enzyme in advanced clinical development for kidney transplant patients. It has significant development potential in other solid organ transplants and in acute autoimmune indications. Hansa also has a large portfolio of preclinical projects that can form a second wave of potential drugs. Under the NiceR project name, the company is developing new enzymes separating immunoglobulins for repeated dosing in recurrent autoimmune diseases and oncology. Hansa Medical is based in Lund, Sweden.