Hansa Biopharma presents positive outcomes of five-year follow-up study of imlifidase in kidney transplantation at ESOT Congress 2025 in London
Hansa Biopharma (Nasdaq Stockholm: HNSA) presented positive five-year follow-up data from the 17-HMedIdeS-14 study of imlifidase in kidney transplantation at the 2025 ESOT Congress in London. The extended pooled analysis demonstrated sustained positive outcomes in highly sensitized patients who received imlifidase-enabled kidney transplants.
Key findings include a 90% patient survival rate at five years (with three deaths occurring between six months and one year) and a death-censored graft survival rate of 82%. The mean estimated glomerular filtration rate (eGFR) at five years was 50 mL/min/m2, indicating favorable kidney function compared to typical post-transplant outcomes where eGFR usually ranges between 40-60 ml/min per 1.73 m2 at three years with continued decline at five years.
The presentation by Dr. Massimo Mangiola from NYU Langone Transplant Institute builds on previously published data in the American Journal of Transplantation, confirming imlifidase as a viable option for HLA-incompatible transplantation with long-term benefits comparable to standard kidney transplants.
Hansa Biopharma (Nasdaq Stoccolma: HNSA) ha presentato dati positivi a cinque anni di follow-up dello studio 17-HMedIdeS-14 sull'imlifidase nel trapianto di rene al Congresso ESOT 2025 di Londra. L'analisi estesa ha mostrato risultati duraturi e favorevoli nei pazienti altamente sensibilizzati che hanno ricevuto trapianti renali abilitati dall'imlifidase.
I risultati chiave includono un tasso di sopravvivenza dei pazienti del 90% a cinque anni (con tre decessi verificatisi tra sei mesi e un anno) e un tasso di sopravvivenza del graft, censurato per decesso, del 82%. La media del tasso di filtrazione glomerulare stimato (eGFR) a cinque anni era di 50 mL/min/m2, indicando una funzione renale favorevole rispetto ai tipici esiti post-trapianto, dove l'eGFR generalmente varia tra 40-60 mL/min per 1,73 m2 a tre anni con un declino continuo a cinque anni.
La presentazione del Dr. Massimo Mangiola del NYU Langone Transplant Institute si basa su dati già pubblicati sull'American Journal of Transplantation, confermando l'imlifidase come opzione valida per il trapianto incompatibile HLA con benefici a lungo termine comparabili ai trapianti renali standard.
Hansa Biopharma (Nasdaq Estocolmo: HNSA) presentó datos positivos de seguimiento a cinco años del estudio 17-HMedIdeS-14 sobre imlifidasa en trasplante de riñón en el Congreso ESOT 2025 en Londres. El análisis combinado extendido mostró resultados sostenidos y favorables en pacientes altamente sensibilizados que recibieron trasplantes renales habilitados con imlifidasa.
Los hallazgos clave incluyen una tasa de supervivencia del paciente del 90% a cinco años (con tres muertes ocurridas entre seis meses y un año) y una tasa de supervivencia del injerto censurada por muerte del 82%. La tasa media estimada de filtración glomerular (eGFR) a cinco años fue de 50 mL/min/m2, lo que indica una función renal favorable en comparación con los resultados típicos post-trasplante donde la eGFR suele oscilar entre 40-60 ml/min por 1,73 m2 a los tres años con un declive continuo a cinco años.
La presentación del Dr. Massimo Mangiola del NYU Langone Transplant Institute se basa en datos previamente publicados en el American Journal of Transplantation, confirmando que la imlifidasa es una opción viable para el trasplante incompatible con HLA con beneficios a largo plazo comparables a los trasplantes renales estándar.
한사 바이오파마(Nasdaq 스톡홀름: HNSA)는 2025년 런던에서 열린 ESOT 총회에서 신장이식에서 이믈리피다제(imlifidase)를 사용한 17-HMedIdeS-14 연구의 5년 추적 관찰 긍정적 데이터를 발표했습니다. 확장된 통합 분석 결과, 이믈리피다제 기반 신장이식을 받은 고감작 환자들에서 지속적인 긍정적 결과가 확인되었습니다.
주요 결과로는 5년 환자 생존율이 90%였으며(6개월에서 1년 사이에 3명 사망), 사망을 제외한 이식편 생존율은 82%였습니다. 5년 시점의 평균 추정 사구체 여과율(eGFR)은 50 mL/min/m2로, 일반적인 이식 후 결과에서 3년차에 보통 40-60 mL/min/1.73m2 범위이며 5년차에 지속적으로 감소하는 것과 비교해 양호한 신장 기능을 나타냅니다.
NYU 랭곤 이식 연구소의 마시모 만지올라 박사가 발표한 이 자료는 American Journal of Transplantation에 이전에 발표된 데이터를 기반으로 하며, 이믈리피다제가 장기적인 이점이 표준 신장이식과 유사한 HLA 부적합 이식에 유효한 옵션임을 확인합니다.
Hansa Biopharma (Nasdaq Stockholm : HNSA) a présenté des données positives à cinq ans issues de l'étude 17-HMedIdeS-14 sur l'imlifidase en transplantation rénale lors du congrès ESOT 2025 à Londres. L'analyse groupée étendue a démontré des résultats positifs durables chez des patients hautement sensibilisés ayant reçu des greffes de rein rendues possibles grâce à l'imlifidase.
Les résultats clés incluent un taux de survie des patients de 90% à cinq ans (avec trois décès survenus entre six mois et un an) et un taux de survie du greffon censuré au décès de 82%. Le débit de filtration glomérulaire estimé moyen (eGFR) à cinq ans était de 50 mL/min/m2, indiquant une fonction rénale favorable comparée aux résultats post-transplantation typiques où l'eGFR se situe généralement entre 40 et 60 ml/min par 1,73 m2 à trois ans, avec une diminution continue à cinq ans.
La présentation du Dr Massimo Mangiola de l'Institut de transplantation NYU Langone s'appuie sur des données déjà publiées dans l'American Journal of Transplantation, confirmant que l'imlifidase constitue une option viable pour la transplantation incompatible HLA avec des bénéfices à long terme comparables à ceux des transplantations rénales standard.
Hansa Biopharma (Nasdaq Stockholm: HNSA) präsentierte positive Fünfjahres-Follow-up-Daten der Studie 17-HMedIdeS-14 zur Anwendung von Imlifidase bei Nierentransplantationen auf dem ESOT-Kongress 2025 in London. Die erweiterte gepoolte Analyse zeigte anhaltend positive Ergebnisse bei hochsensibilisierten Patienten, die Imlifidase-unterstützte Nierentransplantationen erhielten.
Wesentliche Ergebnisse sind eine Patientenüberlebensrate von 90% nach fünf Jahren (mit drei Todesfällen zwischen sechs Monaten und einem Jahr) sowie eine graftüberlebensrate, zensiert nach Tod, von 82%. Die mittlere geschätzte glomeruläre Filtrationsrate (eGFR) nach fünf Jahren betrug 50 mL/min/m2, was auf eine günstige Nierenfunktion im Vergleich zu typischen posttransplantativen Ergebnissen hinweist, bei denen die eGFR üblicherweise zwischen 40-60 ml/min pro 1,73 m2 nach drei Jahren liegt und nach fünf Jahren weiter abnimmt.
Die Präsentation von Dr. Massimo Mangiola vom NYU Langone Transplant Institute baut auf zuvor veröffentlichten Daten im American Journal of Transplantation auf und bestätigt Imlifidase als eine praktikable Option für HLA-inkompatible Transplantationen mit langfristigen Vorteilen, die mit Standard-Nierentransplantationen vergleichbar sind.
- None.
- Three patient deaths occurred between six months and one year post-transplant
Insights
Hansa's 5-year kidney transplant data shows durable benefits for highly sensitized patients who previously had limited options.
The extended pooled analysis for imlifidase in kidney transplantation demonstrates impressive durability of therapeutic effect in highly sensitized patients. At the 5-year mark, patient survival reached
For context, kidney transplant recipients typically show eGFR values between 40-60 mL/min/m² at 3 years post-transplant, with continued functional decline expected thereafter. Maintaining this level of kidney function at the 5-year mark suggests imlifidase-enabled transplants provide sustainable renal function.
This data has significant clinical implications. Highly sensitized patients often remain trapped on dialysis with limited transplant options due to preformed antibodies against potential donors. By enabling HLA-incompatible transplantation, imlifidase creates a pathway for these difficult-to-transplant patients to receive organs they would otherwise reject. The long-term viability shown in this analysis supports imlifidase as a desensitization strategy that delivers durable outcomes comparable to standard kidney transplants.
The validation through presentation at ESOT and publication in the American Journal of Transplantation strengthens the clinical credibility of these findings. For transplant physicians, this extended data provides greater confidence in considering imlifidase for their highly sensitized patients who might otherwise face indefinite dialysis – a treatment associated with lower quality of life and higher mortality compared to successful transplantation.
Massimo Mangiola, PhD, NYU Langone Transplant Institute, will present the outcomes of the extended pooled analysis including data from the 17-HMedIdeS-14 study, presented at the American Transplant Congress (ATC) 2024, and published as a letter to the editor in the American Journal of Transplantation.1
The extended pooled analysis, including data from the 17-HMedIdeS-14 study, showed sustained positive outcomes out to five years of highly sensitized patients who received an imlifidase-enabled kidney transplant. After five years, the patient survival rate was
eGFR is a measure of how well the kidneys are working in the body – higher eGFR indicates better kidney function.3 For many kidney transplant recipients three years post-transplant the mean eGFR is anywhere between 40-60 ml/min per 1.73 m2 with continued decline of eGFR function at five years post-transplant.4
Hitto Kaufmann, Chief R&D Officer, Hansa Biopharma said, "We are very pleased to see that the 17-HMedIdeS-14 extended pooled analysis data continue to excite the clinical community. This study demonstrated for the first time that HLA-incompatible transplantation following desensitization with imlifidase is a viable option for patients who need it, with long term benefit comparable to standard kidney transplants, providing a life changing alternative to remaining on dialysis."
Speaker | Abstract Title | Presentation Details |
Massimo Mangiola, PhD | "Five years follow up of imlifidase desensitized kidney transplant recipients" – Oral presentation | Monday 30 June, 11:10 - 11:20 BST. Part of the FOS_04 session: Innovation in solid organ transplantation |
17-HMedIdeS-14 is part of the HMedIdeS clinical program for imlifidase. The program includes four global phase 2 trials (13-HMedIdeS-02, 13-HMedIdeS-03, 14-HMedIdeS-04 and 15-HMedIdeS-06), one US open-label phase 3 trial (ConfIdeS), a long-term follow up study (17-HMedIdeS-14) and a post-authorization efficacy and safety study in
The 17-HMedIdeS-14 study included patients who consented to long-term follow-up and had previously received an imlifidase-enabled transplant in Hansa's phase 2 studies. The 5-year extended pooled analysis is a continuation of the analysis at 3-years of crossmatch positive only patients published in the American Journal of Transplantation.1
--- ENDS ---
Contacts for more information:
Evan Ballantyne, Chief Financial Officer
IR@hansabiopharma.com
Stephanie Kenney, VP Global Corporate Affairs
media@hansabiopharma.com
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.5 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.6.7 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.8,9 Across the
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.12 It has a rapid onset of action, cleaving IgG-antibodies and inhibiting their activity within hours after administration.
Imlifidase has conditional marketing approval in
Imlifidase is a promising new strategy for desensitization of transplant patients with donor-specific anti-HLA (Human Leukocyte Antigens) antibodies (DSAs).13 Highly sensitized patients have high levels of these preformed antibodies that can bind to the donor organ and damage the transplant.5 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.11,13-15 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.
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
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
©2025 Hansa Biopharma AB. Hansa Biopharma, the beacon logo, IDEFIRIX, and IDEFIRIX flower logo are trademarks of Hansa Biopharma AB,
References
- Jordan SC, et al. Long-term outcomes at 5 years posttransplant in imlifidase-desensitized kidney transplant patients. Am J Transplant. 2025 Apr;25(4):878-880. doi: 10.1016/j.ajt.2024.11.029. Epub 2024 Dec 4. PMID: 39643005.
- Kjellman C, et al. Outcomes at 3 years posttransplant in imlifidase-desensitized kidney transplant patients. Am J Transplant. 2021 Dec;21(12):3907-3918. doi: 10.1111/ajt.16754. Epub 2021 Jul 19. PMID: 34236770; PMCID: PMC9290474.
- American Kidney Fund. Blood test: eGFR (estimated glomerular filtration rate). Available at: https://www.kidneyfund.org/all-about-kidneys/tests/blood-test-egfr. Accessed May 2025.
- Huang Y, Tilea A, Gillespie B, Shahinian V, Banerjee T, Grubbs V, Powe N, Rios-Burrows N, Pavkov M, Saran R. Understanding Trends in Kidney Function 1 Year after Kidney Transplant in
the United States . J Am Soc Nephrol. 2017 Aug;28(8):2498-2510. doi: 10.1681/ASN.2016050543. Epub 2017 Mar 7. PMID: 28270413; PMCID: PMC5533222. - 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. - 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.
- 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/
- Alelign T, Ahmed MM, Bobosha K, Tadesse Y, Howe R, Petros B. Kidney Transplantation: The Challenge of Human Leukocyte Antigen and Its Therapeutic Strategies. J Immunol Res. 2018 Mar 5;2018:5986740. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5859822/
- Heidt S, et al. Highly Sensitized Patients are Well Serves by Recieving a Compatible Organ Offer Based on Acceptable Mismatches. Front Immunol. 2021;12:687254. Available at: https://pubmed.ncbi.nlm.nih.gov/34248971/
- 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 May 2024. - 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: 10.1097/TP.0000000000003496.
- 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.
- Jordan SC, et al. IgG Endopeptidase in Highly Sensitized Patients Undergoing Transplantation. N Engl J Med 2017;377:442-453. DOI: 10.1056/NEJMoa16125
- 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 Therapeutic Opportunity. PLoS One. 2015 Jul 15;10(7):e0132011. doi: 10.1371/journal.pone.0132011. PMID: 26177518; PMCID: PMC4503742.
- 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.
- NIH (2018). What is kidney failure? Available at: https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/what-is-kidney-failure.
- Newsletter Transplant 2022. International figures on donation and transplantation. Available at: Newsletter Transplant - latest edition I Freepub (edgm.eu) Accessed: May 2025
This information was brought to you by Cision http://news.cision.com
The following files are available for download:
250630 - Hansa Biopharma at ESOT 2025 |
View original content:SOURCE Hansa Biopharma AB
FAQ
What are the 5-year survival rates for Hansa Biopharma's imlifidase kidney transplant study?
What is the kidney function (eGFR) in patients treated with Hansa Biopharma's imlifidase after 5 years?
How many patients died in Hansa Biopharma's imlifidase kidney transplant study?
Where was Hansa Biopharma's 5-year imlifidase data presented?
What clinical trials are included in Hansa Biopharma's HMedIdeS program for imlifidase?
