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Long-term follow up data from investigator-initiated Phase II study with imlifidase (IdeS) to be presented at 2018 American Transplant Congress (ATC)

Regulatory information
Hansa Medical AB (Nasdaq Stockholm: HMED), a biopharmaceutical company developing novel immunomodulatory enzymes, today announced that long-term follow up results from the ongoing investigator-initiated US study with imlifidase (IdeS) in highly sensitized patients will be presented in an oral session at the 2018 American Transplant Congress (ATC) in Seattle, U.S. on June 5.

The long-term follow up results from the study, demonstrate that patients desensitized with imlifidase (IdeS) and transplanted with HLA-incompatible kidney show good renal function and minimal evidence of antibody mediated rejection (AMR) at a mean 18.76 months post kidney transplantation. An abstract with a summary of the coming presentation of the long-term data and conclusions is available through the ATC website, http://atcmeetingabstracts.com 

The study (ClinicalTrials.gov Identifier: NCT02426684) is an investigator-initiated study conducted at Cedars-Sinai Medical Center in Los Angeles, USA with Professor Stanley Jordan as principal investigator. The study investigates the safety and efficacy of imlifidase in removing donor specific antibodies (DSAs) in patients where previous attempts of desensitization have failed.

In the study, imlifidase is investigated in combination with high dose intravenous gammaglobulin and anti-CD20 treatment and in January 2018, patient enrollment was closed with a total of 17 patients treated with imlifidase and subsequently transplanted. Patients had DSAs and a positive cross-match test prior to imlifidase treatment and kidney transplantation. Imlifidase effectively reduced the level of DSAs in all patients thereby enabling transplantation for all patients.

The abstract with the long-term results demonstrate that all patients exhibited extensive sensitization with a median cPRA of 95%. Graft and patient survival at a mean 18.76±5.6 M post-imlifidase enabled transplantation were 94%. Rebound DSA responses were rare and of low MFI values with only four patients demonstrating DSAs, all with MFIs ≤3000. Biopsies were performed in 15 patients. All but three showed no findings or findings "suspicious" for AMR (according to Banff 2017 criteria). No patient had positive C4d staining.

Results from 14 of the 17 patients were published in The New England Journal of Medicine in August 2017 (N Engl J Med 2017;377:442-53).

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 8:00 CEST on May 30, 2018.