Hansa Biopharma announces upcoming presentations including a late breaking poster presentation at the 2020 American Transplant Congress

Abstract highlights

  • 2-year follow-up data demonstrates graft survival of 90% for 31 patients post imlifidase treatment with a median eGFR of 61.5 ml/min. Despite varying levels of DSA rebound among these imlifidase-desensitized patients, the AMR frequency was comparable with those reported in other studies with less sensitized patients. 
  • Reallocation of kidneys due to positive crossmatch affects the refused organ by increasing cold ischemia time and the eventual discard of kidneys.
  • Anti-HLA IgM antibodies are unaffected by imlifidase treatment.

Lund May 20, 2020. Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced that the Company’s novel IgG-degrading enzyme, imlifidase, will be highlighted in three presentations including a late breaking poster presentation at the upcoming 2020 American Transplant Congress (ATC), on May 30 to June 1, 2020.

The ATC will be moved to an all-virtual format and all presentations will be accessible in an on-demand format.  The late breaking poster, “Follow up of imlifidase (IdeS) desensitized kidney transplant recipients” will be presented by Dr. Christian Kjellman, CSO & COO at Hansa Biopharma in the category: Posters – Kidney Immunosuppression – Desensitization.

The poster will highlight the two-year follow-up data on 31 patients who received kidney transplantation after desensitization with imlifidase. The data demonstrate patient and graft survival rates of 90% after treatment. 92% of the patients with data had a satisfactory or good kidney function at 2 years with a median eGFR at 61.5 ml/min. In addition, the presentation elaborates on antibody mediated rejection (AMR) episodes as well as the dynamics of donor-specific antibodies (DSA) after transplantation.

Following imlifidase desensitization and kidney transplantation, the level of DSA started to return between 3 and 14 days. In some patients DSA return was associated with AMR. Early AMR (onset during the first month post-transplant) occurred in 28% of the crossmatch positive patients, while another 10% were identified as late AMR. The AMR frequency was comparable with those reported in other studies with less sensitized patients in crossmatch positive patients, and only one AMR episode occurred later than six months after transplantation.

The oral presentations, “The Impact of a Positive Crossmatch on KAS Patients and Organs” will be presented by Joshua Lee, MD Senior Medical Science Liaison at Hansa Biopharma in the category: Kidney Deceased Donor Allocation II.

The presentation highlights that reallocating kidneys due to positive crossmatch affects the refused organ by significantly increasing cold ischemia time and the eventual discard of approximately 25 kidneys annually. Patients were affected with longer waiting times and a significant number ending up being delisted or dying.  

The presentation concludes that technologies and therapies to reduce crossmatch-positive  refusals could potentially have a positive impact on patients and allocation.

A second oral presentation, “Anti-HLA IgM antibodies are unaffected by imlifidase (IdeS) treatment.” will be presented by Anna Runström, Scientist at Hansa Biopharma in the category: Kidney Immunosuppression - Desensitization

The presentation highlights an assessment on whether imlifidase has an effect on human anti-HLA IgM antibodies in sensitized patients with end stage renal disease. 

It is demonstrated that the reduction of anti-HLA IgM signals, which was noted after imlifidase treatment in some patients, was not observed in IgG-depleted sera. The high anti-HLA IgM signals are likely to be caused by IgG-complexed IgM on the surface of HLA beads.

 It is concluded that Human IgM is not cleaved by imlifidase, providing further evidence that imlifidase specifically cleaves only IgG.

“I am very pleased to see that the high unmet medical need for transplantation of the most sensitized patients is strongly recognized and that imlifidase is highlighted at this important conference in the US”, says Christian Kjellman CSO and COO at Hansa Biopharma. 

“We are very excited about how imlifidase potentially can increase access to transplantation and that the long-term follow-up data is in line with best expectations in this group of challenging patients with a very high medical need.”

All abstracts and presentations will be available on the ATC homepage at http://www.atcmeeting.org

For further information, please contact:
Klaus Sindahl, Head of Investor Relations
Hansa Biopharma
Mobile: +46 (0) 709-298 269
E-mail: klaus.sindahl@hansabiopharma.com 

About Hansa Biopharma
Hansa Biopharma is leveraging its proprietary immunomodulatory enzyme technology platform to develop treatments for rare immunoglobulin G (IgG)-mediated autoimmune conditions, transplant rejection and cancer. The Company’s lead product candidate, imlifidase, is a unique antibody-cleaving enzyme that potentially may enable kidney transplantation in highly sensitized patients with potential for further development in other solid organ transplantation and acute autoimmune indications. Imlifidase is currently under review for marketing authorization by EMA. Hansa’s research and development program is advancing the next generation of the Company’s technology to develop novel IgG-cleaving enzymes with lower immunogenicity, suitable for repeat dosing in relapsing autoimmune diseases and oncology. Hansa Biopharma is based in Lund, Sweden and also has operations in Europe and US.