Hansa Biopharma to attend 2025 J.P. Morgan Healthcare Conference
Hansa Biopharma has announced its attendance at the 43rd Annual J.P. Morgan Healthcare Conference, following significant achievements across three therapeutic areas in the past 12 months. In Autoimmune, the company reported positive data from the Phase 2 trial in Guillain Barre Syndrome and completed enrollment for the Phase 3 anti-GBM trial. Their second-generation IgG cleaving molecule, HNSA-5487, showed promising 12-month analysis results.
In Gene Therapy, Hansa initiated two significant trials: a Phase 1b trial in Duchenne Muscular Dystrophy with Sarepta Therapeutics and a Phase 2 trial in Crigler-Najjar Syndrome with Genethon. The Transplantation segment saw completion of ConfIdeS trial randomization and record-breaking IDEFIRIX quarterly sales of 69.5 MSEK in Q3 2024.
Key 2025 milestones include data readouts from multiple trials and a planned BLA submission to the FDA in the second half of the year. The company continues to develop novel immunomodulating therapies based on its proprietary IgG cleaving platform.
Hansa Biopharma ha annunciato la sua partecipazione alla 43ª Conferenza Annuale sulla Salute J.P. Morgan, dopo importanti traguardi in tre aree terapeutiche negli ultimi 12 mesi. In Autoimmune, l'azienda ha riportato dati positivi dalla sperimentazione di Fase 2 nella Sindrome di Guillain Barre e ha completato l'arruolamento per la sperimentazione di fase 3 anti-GBM. La loro molecola di seconda generazione IgG cleaving, HNSA-5487, ha mostrato risultati promettenti nell'analisi a 12 mesi.
Nel settore della Gene Therapy, Hansa ha avviato due sperimentazioni significative: una sperimentazione di Fase 1b nella Distrofia Muscolare di Duchenne con Sarepta Therapeutics e una sperimentazione di Fase 2 nella Sindrome di Crigler-Najjar con Genethon. Il segmento Trapianto ha visto il completamento della randomizzazione nello studio ConfIdeS e vendite trimestrali record di IDEFIRIX pari a 69,5 MSEK nel terzo trimestre del 2024.
Tra i principali traguardi del 2025 ci sono letture di dati provenienti da più sperimentazioni e una prevista presentazione della BLA all'FDA nella seconda metà dell'anno. L'azienda continua a sviluppare nuove terapie immunomodulanti basate sulla sua piattaforma proprietaria IgG cleaving.
Hansa Biopharma ha anunciado su asistencia a la 43ª Conferencia Anual de Atención Sanitaria J.P. Morgan, tras logros significativos en tres áreas terapéuticas en los últimos 12 meses. En Autoinmunidad, la compañía reportó datos positivos del ensayo de Fase 2 en el Síndrome de Guillain Barre y completó la inscripción para el ensayo de Fase 3 anti-GBM. Su molécula de segunda generación que corta IgG, HNSA-5487, mostró resultados prometedores en el análisis a 12 meses.
En Terapia Génica, Hansa inició dos ensayos significativos: un ensayo de Fase 1b en Distrofia Muscular de Duchenne con Sarepta Therapeutics y un ensayo de Fase 2 en Síndrome de Crigler-Najjar con Genethon. El segmento de Transplante vio la finalización de la aleatorización del ensayo ConfIdeS y ventas trimestrales récord de IDEFIRIX de 69,5 MSEK en el tercer trimestre de 2024.
Los hitos principales de 2025 incluyen la presentación de datos de múltiples ensayos y una presentación planificada de BLA a la FDA en la segunda mitad del año. La empresa sigue desarrollando nuevas terapias inmunomoduladoras basadas en su plataforma de corte de IgG propietaria.
한사 바이오파마는 지난 12개월 동안 세 가지 치료 분야에서 중요한 성과를 거둔 후, 제43회 JP 모건 헬스케어 컨퍼런스에 참석한다고 발표했습니다. 자가면역 분야에서 이 회사는 길리안 바레 증후군에 대한 2상 시험에서 긍정적인 데이터를 보고했으며, 3상 anti-GBM 시험의 모집을 완료했습니다. 그들의 2세대 IgG 절단 분자인 HNSA-5487은 12개월 분석 결과가 유망하다는 것을 보여주었습니다.
유전자 요법 분야에서 한사는 두 가지 중요한 시험을 시작했습니다: 사렙타 테라퓨틱스와 함께하는 두셴 근육 위축증에 대한 1b상 시험과 제네톤과 함께하는 크리글러-나자르 증후군에 대한 2상 시험입니다. 이식 분야에서는 ConfIdeS 시험의 무작위배정 완료 및 2024년 3분기 IDEFIRIX의 분기 매출 69.5 MSEK로 신기록을 세웠습니다.
주요 2025년 이정표에는 다수의 시험에서 자료 발표 및 올해 하반기에 FDA에 BLA 제출이 계획되어 있습니다. 이 회사는 자사의 고유한 IgG 절단 플랫폼을 기반으로 새로운 면역조절 치료제를 개발하고 있습니다.
Hansa Biopharma a annoncé sa participation à la 43ème Conférence Annuelle sur la Santé de J.P. Morgan, après des réalisations significatives dans trois domaines thérapeutiques au cours des 12 derniers mois. Dans le domaine Auto-immun, la société a annoncé des données positives d'un essai de phase 2 sur le syndrome de Guillain-Barré et a complété l'inscription pour l'essai de phase 3 anti-GBM. Leur molécule de deuxième génération de clivage des IgG, HNSA-5487, a montré des résultats prometteurs lors de l'analyse à 12 mois.
Dans le domaine de la Thérapie Génique, Hansa a lancé deux essais significatifs : un essai de phase 1b sur la dystrophie musculaire de Duchenne avec Sarepta Therapeutics et un essai de phase 2 sur le syndrome de Crigler-Najjar avec Genethon. Le segment Transplantation a vu l'achèvement de la randomisation de l'essai ConfIdeS et des ventes trimestrielles record d'IDEFIRIX de 69,5 MSEK au troisième trimestre de 2024.
Les jalons clés de 2025 comprennent la publication de données issues de plusieurs essais et une soumission prévue de BLA à la FDA dans la seconde moitié de l'année. L'entreprise continue de développer de nouvelles thérapies immunomodulatrices sur la base de sa plateforme de clivage des IgG propriétaire.
Hansa Biopharma hat ihre Teilnahme an der 43. Jahreskonferenz der J.P. Morgan Healthcare bekannt gegeben, nachdem sie in den letzten 12 Monaten bedeutende Erfolge in drei therapeutischen Bereichen erzielt hat. Im Bereich Autoimmunität berichtete das Unternehmen über positive Daten aus der Phase-2-Studie zur Guillain-Barré-Syndrom und schloss die Rekrutierung für die Phase-3-Studie zu anti-GBM ab. Ihr IgG-spaltendes Molekül der zweiten Generation, HNSA-5487, zeigte vielversprechende Ergebnisse in einer 12-Monats-Analyse.
Im Bereich der Gen-Therapie hat Hansa zwei bedeutende Studien initiiert: eine Phase-1b-Studie zur Duchenne-Muskeldystrophie mit Sarepta Therapeutics und eine Phase-2-Studie zum Crigler-Najjar-Syndrom mit Genethon. Im Bereich Transplantation wurde die Randomisierung der ConfIdeS-Studie abgeschlossen und IDEFIRIX erzielte im dritten Quartal 2024 einen Rekordumsatz von 69,5 MSEK.
Wichtige Meilensteine 2025 umfassen Datenveröffentlichungen aus mehreren Studien und die geplante Einreichung eines BLA bei der FDA in der zweiten Jahreshälfte. Das Unternehmen entwickelt weiterhin neuartige immunmodulierende Therapien auf Basis seiner proprietären IgG-spaltenden Plattform.
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The Company has achieved several key milestones in the last 12-months across its three key therapeutic areas: Autoimmune, Gene Therapy and Transplantation.
In Autoimmune, the company announced positive data from the 15-HMedIdeS-09 Phase 2 trial in Guillain Barre Syndrome (GBS) and indirect treatment comparison to the International Guillain-Barré Syndrome Outcome Study (IGOS) demonstrating the potential of imlifidase, the Company's first-generation IgG cleaving molecule, to address a significant unmet need in GBS. Additionally, the GOOD-IDES-02 (Phase 3 trial in anti-GBM) completed enrolment and positive results from the NICE-01 Phase 1 trial and additional 12-month analysis for HNSA-5487, the Company's second-generation IgG cleaving molecule, demonstrated rapid and robust IgG reduction and redosing potential.
In Gene Therapy, the Company initiated two trials with gene therapy partners: SRP-9001-104 Phase 1b trial in Duchenne Muscular Dystrophy (DMD) with Sarepta Therapeutics, Inc. (Nasdaq: SRPT) and GNT-018-IDES Phase 2 trial in Crigler-Najjar Syndrome with Genethon. In both trials, imlifidase is being evaluated as a pre-treatment to gene therapy in patients with anti-AAV antibodies.
In Transplantation, randomization of the ConfIdeS (pivotal US Phase 3 trial in kidney transplantation) trial was completed. The Company had four consecutive quarters of strong IDEFIRIX (imlifidase) sales across
In 2025, the Company has several key milestones:
- Data read out of the pivotal US Phase 3 ConfIdeS trial for imlifidase and submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) in 2H 2025
- Data read out of Sarepta Therapeutics' Phase 1b trial SRP-9001-104 in DMD (2H 2025)
- Data read out of the GOOD-IDES-02 Phase 3 trial in anti-GBM
- HNSA-5487 development pathway alignment with regulatory agencies in neuro-autoimmune diseases (1H 2025) with an initial focus in myasthenia gravis (MG)
Hansa is developing novel immunomodulating biologic therapies based on its proprietary, first in class IgG cleaving platform and is focused on IgG-driven immune mediated diseases. The Company has two IgG cleaving compounds including imlifidase, a first generation, first in class, single dose therapy with proven efficacy and safety and HNSA-5487, a second-generation IgG cleaving molecule with redosing potential. Imlifidase is conditionally approved in the EU for desensitization in kidney transplantation, with late-stage trials in autoimmune diseases where IgG is a driver of disease, and as a pre-treatment to gene therapy in patients with anti-AAV antibodies.
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 Imlifidase
Imlifidase is a unique antibody-cleaving enzyme originating from Streptococcus pyogenes that specifically targets IgG and inhibits IgG-mediated immune response.1 It has a rapid onset of action, cleaving IgG-antibodies and inhibiting their activity within hours after administration. Imlifidase is conditionally approved in
About HNSA-5487
HNSA-5487 is Hansa Biopharma's second-generation IgG-cleaving enzyme with the potential to prolong the IgG-low window and redosing potential. In the NICE-01 Phase 1b trial, HNSA-5487 demonstrated rapid and highly robust reduction of IgG levels by more than 95 percent within a few hours post treatment. In a 12-month follow up analysis IgG levels returned to normal range six months after initial dosing. This confirms that HNSA-5487 mirrors the extremely high efficacy of imlifidase, the Company's first-generation IgG-cleaving enzyme, in reducing total IgG levels. No serious adverse events were observed and as previously communicated HNSA-5487 is safe and well tolerated.
About Hansa and Kidney Transplantation
Kidney disease can progress to kidney failure or End-Stage Renal Disease (ESRD), identified when a patient's kidney function is less than
Highly sensitized kidney transplant 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.4 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.5,6 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.7,8 Across the
Imlifidase is a promising new strategy for desensitization of transplant patients with donor-specific anti-HLA (Human Leukocyte Antigens) antibodies (DSAs).11 Highly sensitized patients have high levels of these preformed antibodies that can bind to the donor organ and damage the transplant.4 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.10-13 Hansa is collecting further clinical evidence and will submit additional efficacy and safety data based on one observational follow-up study and one post authorization efficacy study (PAES).
About Hansa and Autoimmune Diseases
Autoimmune diseases form a group of serious diseases caused by the immune system attacking the body. In many autoimmune diseases the immune system mistakenly recognizes the body's own proteins, as foreign and mounts an immune response, creating antibodies to attack the body's own cells and tissues.14-16 Pathogenic IgG can contribute to a broad spectrum of autoimmune diseases.
Hansa Biopharma is exploring how imlifidase and HNSA-5487 may be able to prevent or slow the progression of these diseases and their debilitating, life-threatening symptoms. Imlifidase is currently being studied in the following autoimmune diseases: anti-glomerular basement membrane (anti-GBM) disease and Guillain-Barré Syndrome (GBS). HNSA-5487 is moving quickly into the clinical phase focusing on patients with myasthenia gravis (MG) and potentially other neuro-autoimmune diseases.
About Hansa and Gene Therapy
Imlifidase is currently being evaluated as a pre-treatment to gene therapy in areas of high unmet need. Many gene therapies are based on the use of Adeno Associated Viruses (AAV) vectors.17-19 In some patients the immune system carries antibodies that counteract the gene therapy treatment preventing its success.18-24 Pre-treatment with imlifidase prior to AAV-based gene therapy treatment has the potential to inactivate antibodies and thereby enable gene therapy in patients with pre-existing antibodies to AAV-based gene therapies.23 It is estimated that anti-AAV antibodies on average prevent 1 in 3 people from benefiting from gene therapy treatments.18-21
About Hansa Biopharma
Hansa Biopharma 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 second-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
1. 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.
2. NIH (2018). What is kidney failure? Available at: https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/what-is-kidney-failure.
3. Newsletter Transplant 2022. International figures on donation and transplantation. Available at: Newsletter Transplant - latest edition I Freepub (edgm.eu) Accessed: May 2024.
4. Eurostam Report (A
5. 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.
6. 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/
7. 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/
8. 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/
9. Organ Procurement and Transplantation Network (OPTN) and Scientific Registry of Transplant Recipients (SRTR). OPTN/SRTR 2022 Annual Data Report.
10. 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.
11. Jordan SC, et al. IgG Endopeptidase in Highly Sensitized Patients Undergoing Transplantation. N Engl J Med 2017;377:442-453. DOI: 10.1056/NEJMoa16125
12. 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.
13. 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.
14. Angum F, et al. The Prevalence of Autoimmune Disorders in Women: A Narrative Review. Cureus. 2020 May. 12(5):e8094. doi: 10.7759/cureus.8094.
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16. Ma H, Murphy C, Loscher CE and O'Kennedy R (2022) Autoantibodies – enemies, and/or potential allies? Front. Immunol. 13:953726. doi: 10.3389/fimmu.2022.953726
17. Lundstrom K. Viral Vectors in Gene Therapy: Where Do We Stand in 2023? Viruses. 2023 Mar 7;15(3):698. doi: 10.3390/v15030698. PMID: 36992407; PMCID: PMC10059137.
18. Boutin S, et al. Prevalence of serum IgG and neutralizing factors against adeno-associated virus (AAV) types 1, 2, 5, 6, 8, and 9 in the healthy population: implications for gene therapy using AAV vectors. Hum Gene Ther. 2010 Jun;21(6):704-12. doi: 10.1089/hum.2009.182. PMID: 20095819.
19. Calcedo R, Wilson JM. Humoral Immune Response to AAV. Front Immunol. 2013 Oct 18;4:341. doi: 10.3389/fimmu.2013.00341. PMID: 24151496; PMCID: PMC3799231.
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