(AGENPARL) – Wed 29 October 2025 Lund, Sweden, 29 October 2025. Hansa Biopharma AB, “Hansa” (Nasdaq Stockholm:
HNSA) today announced that it will host a virtual event featuring two
distinguished transplant surgeons; Professor Robert Montgomery from NYU Langone
Transplant Institute and Professor Matthew Cooper from the Medical College of
Wisconsin, to provide deeper insights into the medical journey of highly
sensitized patients awaiting a kidney transplant and share perspectives on the
clinical relevance of the topline results from the US Phase 3 ConfIdeS study.
The event will take place on Wednesday 12 November, 2025, at  9:00 AM EST /
15:00 PM CET. Click here to join. (https://lifescievents.com/event/gl39mp2j/)
After an introduction by Renée Aguiar-Lucander, CEO, Hansa Biopharma, there will
be a presentation of the topline results from the US Phase 3 ConfIdeS trial by
Richard Philipson, CMO. Philipson will then moderate a discussion reviewing
current challenges of highly sensitized patients, the medical need and existing
clinical practice for this patient group as well as the clinical relevance of
the ConfIdes topline results, and the potential to impact current standard of
care within the US transplant community with Dr. Robert Montgomery, MD, PhD, NYU
Langone Transplant Institute, and Dr. Matthew Cooper, MD, Medical College of
Wisconsin, followed by a Q&A session.
About Robert Montgomery, MD, PhD
Dr. Robert Montgomery is Chair of the Department of Surgery and Director of the
NYU Langone Transplant Institute. As a pioneer and international expert in
desensitization, he has taken part in numerous research studies, publications,
and has received many awards for his work. Throughout his career, Dr. Montgomery
has led innovation in transplantation, credited with developing and performing
the first ‘domino paired donation’ and now leading efforts in
xenotransplantation. He is also a heart transplant recipient himself. Dr
Montgomery acted as Lead Principal Investigator for the ConfIdeS trial.
About Matthew Cooper, MD
Dr. Matthew Cooper is Chief of Transplantation, Director of Solid Organ
Transplant, and the Mark B. Adams Distinguished Professor of Surgery at the
Medical College of Wisconsin. He currently serves as a board member for the
American Society of Transplantation (AST) and the National Kidney Foundation
(NKF) and is the Surgical Director for the National Kidney Registry (NKR). Dr.
Cooper is a former President of the United Network for Organ Sharing (UNOS) and
the Organ Procurement and Transplantation Network (OPTN). He has authored over
260 peer-reviewed manuscripts, 300 abstracts, and 12 book chapters and has
received numerous awards in the field of kidney transplantation. Dr Cooper acted
as Principal Investigator for the ConfIdeS trial.
Link to Virtual Event: https://lifescievents.com/event/gl39mp2j/
— ENDS —
Contacts for more information:
Evan Ballantyne, Chief Financial Officer
Kerstin Falck, VP Global Corporate Affairs
Notes to editors
About highly sensitized patients
Highly sensitized patients have pre-formed antibodies called donor specific
antibodies (DSAs) with a broad reactivity against human leukocyte antigens
(HLAs), which can cause tissue damage and potentially transplant rejection.[1]
The presence of DSAs means that highly sensitized patients tend to have limited
or no access to transplant, as finding a compatible donor organ can be
particularly challenging.[2,3] The complexity of their immunological profile
means that highly sensitized patients spend longer time than average on
transplant waiting lists, with evidence showing that this longer time waiting
for a suitable donor relates to an increased mortality risk.[4,5] Across the
U.S. and Europe, highly sensitized patients comprise around 10-15% of the total
of patients on transplant waiting lists.[6,7]
About IDEFIRIX[®] (imlifidase)
Imlifidase is an antibody-cleaving enzyme originating from Streptococcus
pyogenes that specifically targets and cleaves immunoglobulin G (IgG) antibodies
and inhibits IgG-mediated immune response.[8] It has a rapid onset of action,
cleaving IgG-antibodies and inhibiting their activity within hours after
administration.
Imlifidase has conditional marketing approval in Europe and is marketed under
the trade name IDEFIRIX for the desensitization treatment of highly sensitized
adult kidney transplant patients with a positive crossmatch against an available
deceased donor. The use of IDEFIRIX should be reserved for patients who are
unlikely to be transplanted under the available kidney allocation system,
including prioritization programs for highly sensitized
patients.[8] IDEFIRIX was reviewed as part of the European Medicines Agency’s
(EMA) PRIority Medicines (PRIME) program, which supports medicines that may
offer a major therapeutic advantage over existing treatments or benefit patients
without treatment options.[8]
Imlifidase is a promising new strategy for desensitization of transplant
patients with donor-specific anti-HLA (Human Leukocyte Antigens) antibodies
(DSAs).[9] Highly sensitized patients have high levels of these preformed
antibodies that can bind to the donor organ and damage the transplant.[1] Once
they are inactivated with imlifidase, there is a window of opportunity for the
transplant to take place. By the time the body starts to synthesize new IgG, the
patient will be receiving post-transplant immunosuppressive therapy to reduce
the risk of organ rejection.
The efficacy and safety of imlifidase as a pre-transplant treatment to reduce
donor-specific IgG was studied in four phase 2 open-label, single-arm, six
-month clinical trials.[7,9-11 ]Hansa is collecting further clinical evidence
and will submit additional efficacy and safety data based on one observational
follow-up study and one post-approval efficacy study.
Full product information can be accessed via the initial Summary of Product
Characteristics found here (https://www.ema.europa.eu/en/documents/product
-information/idefirix-epar-product-information_en.pdf).
About kidney failure
Kidney disease can progress to kidney failure or End-Stage Renal Disease (ESRD),
identified when a patient’s kidney function is less than 15%.[12] ESRD poses a
significant health burden, affecting nearly 2.5 million patients
worldwide.[12] A kidney transplant is the treatment of choice for suitable
patients with ESRD because it offers improved survival and quality of life
benefits, and is cost savings compared to long-term dialysis. There are
approximately 170,000 kidney patients in the U.S. and Europe waiting for a new
kidney.[13]
About Hansa Biopharma
Hansa Biopharma AB is a pioneering commercial-stage biopharmaceutical company on
a mission to develop and commercialize innovative, lifesaving and life-altering
treatments for patients with rare immunological conditions. The company has a
rich and expanding research and development program based on its proprietary IgG
-cleaving enzyme technology platform, to address serious unmet medical needs in
autoimmune diseases, gene therapy and transplantation. The company’s portfolio
includes imlifidase, a first-in-class immunoglobulin G (IgG) antibody-cleaving
enzyme therapy, which has been shown to enable kidney transplantation in highly
sensitized patients and HNSA-5487, a next-generation IgG cleaving molecule with
redosing potential. Hansa Biopharma is based in Lund, Sweden, and has operations
in Europe and the U.S. The company is listed on Nasdaq Stockholm under the
ticker HNSA. Find out more at http://www.hansabiopharma.com and follow us on
LinkedIn (https://www.linkedin.com/company/hansa-medical-ab/).
©2025 Hansa Biopharma AB. Hansa Biopharma, the beacon logo, IDEFIRIX, and
IDEFIRIX flower logo are trademarks of Hansa Biopharma AB, Lund, Sweden. All
rights reserved.
References
1_Eurostam Report (A Europe-wide strategy to enhance transplantation of highly
sensitized patients on the basis of acceptable HLA mismatches.) Available
at https://cordis.europa.eu/project/id/305385/reporting.
2_Redfield RR, et al. The mode of sensitization and its influence on allograft
outcomes in highly sensitized kidney transplant recipients. Nephrol Dial
Transplant. 2016 Oct;31(10):1746-53. doi: 10.1093/ndt/gfw099.
3_Lonze BE, et al. IdeS (Imlifidase): A Novel Agent That Cleaves Human IgG and
Permits Successful Kidney Transplantation Across High-strength Donor-specific
Antibody. Ann Surg. 2018 Sep;268(3):488-496. doi: 10.1097/
4_Alelign T, Ahmed MM, Bobosha K, Tadesse Y, Howe R, Petros B. Kidney
Transplantation: The Challenge of Human Leukocyte Antigen and Its Therapeutic
5_Heidt S, et al. Highly Sensitized Patients are Well Serves by Recieving a
Compatible Organ Offer Based on Acceptable Mismatches. Front Immunol.
6_Organ Procurement and Transplantation Network (OPTN) and Scientific Registry
of Transplant Recipients (SRTR). OPTN/SRTR 2022 Annual Data Report. U.S.
Department of Health and Human Services, Health Resources and Services
Administration; 2024. Accessed [June 2024].
7_Jordan SC, et al. Imlifidase Desensitization in Crossmatch-positive, Highly
Sensitized Kidney Transplant Recipients: Results of an International Phase 2
Trial (Highdes). Transplantation. 2021 Aug 1;105(8):1808-1817. doi:
8_European Medicines Agency. Idefirix[®] summary of product characteristics.
Available at: https://www.ema.europa.eu/en/documents/product
-information/idefirix-epar-product-information_en.pdf.
9_Jordan SC, et al. IgG Endopeptidase in Highly Sensitized Patients Undergoing
Transplantation. N Engl J Med  2017;377:442-453. DOI: 10.1056/NEJMoa16125
10_Winstedt L, et al. Complete Removal of Extracellular IgG Antibodies in a
Randomized Dose-Escalation Phase I Study with the Bacterial Enzyme IdeS–A Novel
11_Lorant T, et al. Safety, immunogenicity, pharmacokinetics, and efficacy of
degradation of anti-HLA antibodies by IdeS (imlifidase) in chronic kidney
disease patients. Am J Transplant. 2018 Nov;18(11):2752-2762. doi:
10.1111/ajt.14733.
12_NIH (2018). What is kidney failure? Available at:
https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/what
-is-kidney-failure.
13_ Newsletter Transplant 2022. International figures on donation and
transplantation. Available at: Newsletter Transplant – latest edition I Freepub
(edgm.eu) Accessed: May 2024
If you would rather not receive future communications from Hansa Biopharma AB, please go to https://optout.ne.cision.com/en/2dTwhGvwt97WpADWj4Bp6JH3MMypj5TCkpq8TrRwwUkg9h1xqikE8dPQPDstjbzWeA7N68QkXFbCX3UD9Khk2uyEibCMw5dXrp49vfdxzGjRND.
Hansa Biopharma AB, Scheelevägen 22, Lund, 22362 Sweden
————————————————————
This information was brought to you by Cision http://news.cision.com
The following files are available for download:
If you would rather not receive future communications from Hansa Biopharma AB, please go to https://optout.ne.cision.com/en/2dTwhGvwt97WpADWj4Bp6JH3MMypj5TCkpq8TrRwwUkg9h1xqikE8dPQPDstjbzWeA7N68QkXFbCX3UD9Khk2uyEibCMw5dXrp49vfdxzGjRND.
Hansa Biopharma AB, Scheelevägen 22, Lund, 22362 Sweden
Report this content