RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Orphan Drug (Australia), Conditional marketing approval (European Union)

Structure/Sequence

Sequence Code 453739243

Source: *****

Clinical Trials associated with Imlifidase

NCT06518005

/ RecruitingPhase 2IIT

An Open-label, Phase 2 Trial to Evaluate the Efficacy and Safety of a Single Intravenous Administration of GNT0003 (an Adeno-associated Viral (AAV) Vector Expressing the UGT1A1 Transgene) Following Imlifidase Pre-treatment in Adult Participants With Severe Crigler-Najjar Syndrome (CNS) Requiring Daily Phototherapy and Presenting Pre-existing Anti-AAV8 Antibodies

Clinical trial rationale:
CNS is an ultra-rare (<1/1 million newborns), autosomal recessive disorder of bilirubin conjugation caused by mutation in the gene coding for uridine 5'-diphosphate glucuronosyltransferase (UGT1A1), that causes the accumulation of neurotoxic unconjugated bilirubin (UCB).
Reduction of UCB is managed with phenobarbital in mild CNS, and daily phototherapy in severe CNS.
There is no authorized curative medical treatment for CNS. Liver transplantation is currently the only curative treatment for severe CNS.
GNT0003 is a genetically modified recombinant (r) viral vector composed of the AAV8 viral capsid carrying the UGT1A1 transgene which aims to correct the dysfunction of the mutated gene by achieving durable expression of a functional copy of the affected gene.
Imlifidase (IgG-degrading enzyme) has demonstrated its efficacy in highly sensitized adult kidney transplant patients.
To give participants with pre-existing anti-AAV8 antibodies access to gene therapy treatments, this trial aims to demonstrate the safety and efficacy of GNT0003 following imlifidase pre-treatment in adult participants with severe CNS requiring daily phototherapy and presenting with pre-existing anti-AAV8 antibodies.
Primary objective: to assess efficacy of a single intravenous administration of GNT0003 following imlifidase pre-treatment in participants with severe CNS requiring phototherapy and pre-existing AAV8 antibodies
Secondary objective: to collect data on safety and tolerability of GNT0003 and imlifidase, efficacy of imlifidase, pharmacokinetic and pharmacodynamic profile of GNT0003, and Quality of Life.
The trial will include 3 parts:
* A baseline period for at least 3 months
* A treatment period
* A follow-up period:
* Initial post-treatment follow-up over 48 weeks
* Long-term follow-up for 4 additional years
This trial will be conducted in accordance with the International Conference on Harmonization Guideline for Good Clinical Practice and the Declaration of Helsinki. Participants must be consented using the approved Informed Consent Form before any procedures specified in the protocol are performed.

Start Date08 Nov 2024

Sponsor / Collaborator

Genethon

[+1]

NCT06461546

/ WithdrawnPhase 2IIT

Imlifidase in Living Donor Renal Transplantation Highly Sensitized Recipients (LIVEDES)

This is a Phase II, pilot, prospective, unicentric trial, to evaluate Imlifidase could improve the transplantability of the highly sensitized patients with good outcomes respect to survival and functionality of the graft.

Start Date22 Oct 2024

Sponsor / Collaborator-

NCT06241950

/ Enrolling by invitationPhase 1

An Open-Label, Systemic Gene Delivery Study to Evaluate the Safety, Tolerability and Expression of SRP-9001 in Association With Imlifidase in Subjects With Duchenne Muscular Dystrophy With Pre-existing Antibodies to rAAVrh74

This is a gene transfer therapy study evaluating the safety of delandistrogene moxeparvovec and delandistrogene moxeparvovec dystrophin expression in association with imlifidase, in participants with DMD with pre-existing antibodies to rAAVrh74 over a period of 104 weeks.

Start Date29 Jan 2024

Sponsor / Collaborator

Sarepta Therapeutics, Inc.

[+1]

100 Clinical Results associated with Imlifidase

100 Translational Medicine associated with Imlifidase

100 Patents (Medical) associated with Imlifidase

131

Literatures (Medical) associated with Imlifidase

01 Jul 2025·Transplantation Reviews

Spanish guidelines for kidney transplantation in highly sensitized patients with donor-specific anti-HLA antibodies

Review

Author: Mazuecos, Auxiliadora ; Paz-Artal, Estela ; González, M Francisca ; Álvarez, Antonia ; Nieto, Antonio ; Caro, José L ; Coll, Elisabeth ; Fernández, Constantino ; Diekmann, Fritz ; Crespo, Marta ; Muro, Manuel ; Segundo, David San ; Andrés, Amado ; Vilches, Carlos ; Cruzado, Josep M ; Domínguez-Gil, Beatriz ; Vega, Rocío ; Ontañón, Jesús ; Mancebo, Esther ; Palou, Eduard ; Bestard, Oriol

Highly sensitized patients awaiting kidney transplantation face substantial challenges due to the presence of potential donor-specific anti-HLA antibodies (DSA). These antibodies increase the risk of antibody-mediated rejection (ABMR), but also complicate their access to HLA compatible transplantation. Although advancements in allocation priority programs, such as the Spanish Program for the Access of Highly Sensitized Patients to Kidney Transplantation (PATHI), have introduced virtual crossmatching (v-XM) to streamline compatibility assessments, patients with >99,5 % virtual panel reactive antibodies (vPRA) often remain on waiting lists for extended periods with minimal chances of receiving a transplant. This article summarizes Spanish guidelines for a harmonized and comprehensive framework for the management of highly sensitized patients. These guidelines focus on strategies to facilitate transplantation in the presence of DSA, including a stepwise approach to delist HLA antigens, prioritizing those recognized as "less deleterious" antibodies, to expand transplant options while minimizing immunological risks. Conventional desensitization techniques are discussed, alongside the innovative use of imlifidase to enable transplants in particularly complex cases. Post-transplant monitoring protocols are also exposed, with a focus on early detection of antibody rebound and effective management of ABMR. Ultimately, this resource offers clinicians a structured framework to navigate the intricate challenges of kidney transplantation in high-risk populations, aiming to enhance access to life-saving procedures and improve patient outcomes.

01 Jun 2025·ANALYTICA CHIMICA ACTA

Online multimethod platform for comprehensive characterization of monoclonal antibodies in cell culture fluid from injection of crude sample - Incorporation of middle-up and bottom-up workflows

Article

Author: Zioga, Eirini ; Vido, Marek ; Sadighi, Raya ; Wouters, Sam ; de Kleijne, Vera H ; Gargano, Andrea F G ; Lubbers, Karin ; Somsen, Govert W ; Haselberg, Rob

BACKGROUND:

Determination of critical quality attributes (CQAs) of pharmaceutical monoclonal antibodies (mAbs) is an essential part of quality control. Commonly, for each CQA, a separate analytical method and setup is required, making assessment of multiple CQAs time-consuming and labour-intensive. This typically involves offline purification and diverse protein digestion steps, in combination with multiple liquid-chromatographic modes. We developed an integrated, fully online multidimensional platform for direct analysis of mAbs in cell culture fluid (CCF) at an intact, subunit and peptide level from a single injection.

RESULTS:

This paper focuses on the online middle-up and bottom-up workflows. The platform combines Protein A affinity chromatography (ProtA), immobilized enzyme reactors (IMERs), reversed-phase liquid chromatography (RPLC) and high-resolution mass spectrometry (MS) for characterization of mAbs. Online ProtA was used to isolate mAbs directly from CCF. Subsequent online digestion of isolated mAb was accomplished by IMERs featuring either the proteases IdeS or trypsin. Between ProtA and IMERs, buffer exchange and pH adjustment were achieved using a strong cation-exchange (SCX) trap column. RPLC-MS analysis of F(ab)'₂ and Fc/2 fragments obtained after IdeS digestion provided information on mAb glycoform compositions and the potential presence of PTMs and subunit variants. RPLC-MS/MS analysis of trypsin-digested peptides provided over 95 % coverage of the mAb's amino acid sequence, but also identification and localization of modifications related to e.g. oxidation and deamidation. Comparisons with established offline methods were made. The overall capacity of the system to perform intact, middle-, and bottom-up analyses in parallel from a single injection is demonstrated for an industrially-relevant mAb in CCF.

SIGNIFICANCE:

The developed multidimensional platform enables the simultaneous characterization of multiple fractions from a single ProtA-isolated mAb band at intact, middle-up, or bottom-up level using various LC modes at a substantially reduced analysis time.

01 May 2025·AMERICAN JOURNAL OF TRANSPLANTATION

Continued Optimism for the use of Imlifidase for Desensitization in Kidney Transplant

Letter

Author: Schinstock, Carrie A ; Stegall, Mark

News (Medical) associated with Imlifidase

14 May 2025

·www.prnewswire.com

Hansa Biopharma data at the 2025 PNS Annual Meeting demonstrates potential of imlifidase in the treatment of GBS

LUND, Sweden, May 14, 2025 /PRNewswire/ -- Hansa Biopharma AB, "Hansa" (Nasdaq Stockholm: HNSA), will present data from its 15-HMedIdeS-09 Phase 2 single arm study of imlifidase, a first in class IgG cleaving enzyme, in Guillain-Barré Syndrome (GBS) at the Peripheral Nerve Society (PNS) Annual Meeting, taking place 17-20 May in Edinburgh, Scotland. Hansa communicated the results from the 15-HMedIdeS-09 study in December 2024. Professor Shahram Attarian, Head of Department of Neuromuscular Diseases and ALS, Hopitaux Universitaires de Marseille (APHM) and International Coordinating Principal Investigator will present data from 15-HMedIdeS-09 Phase 2 study at the 2025 PNS Annual Meeting. Hitto Kaufmann, Chief R&D Officer, Hansa Biopharma said, "We are pleased to be able to share more detail around the positive data from our 15-HMedIdeS-09 Phase 2 study, which demonstrated the significant potential imlifidase could have in combination with standard of care IVIg for patients with GBS. We know that IgG is a key driver of inflammatory attacks on peripheral nerves and has been clinically linked to the severity and progression of GBS, and that there is a clear and urgent need for new and faster treatment options in GBS. This data offers meaningful insights to help advance the understanding of IgG in GBS and improve patient care." Hansa's Phase 2 15-HMedIdes-09 open-label, single arm study was performed across multi-centers in the UK, France, and the Netherlands evaluating the safety, tolerability, and efficacy of a single dose of imlifidase (0.25 mg/kg) in 30 adult GBS patients in combination with standard of care (SoC) intravenous immunoglobulin (IVIg). The administration of imlifidase prior to SoC in patients with GBS was considered to be safe and well tolerated. --- ENDS --- Contacts for more information: Evan Ballantyne, Chief Financial Officer [email protected] Stephanie Kenney, VP Global Corporate Affairs [email protected] 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 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.1 About imlifidase 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.2-4 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 Guillain-Barré Syndrome Guillain-Barré Syndrome (GBS) is a rare, acute, paralyzing, inflammatory disease of the peripheral nervous system caused by the immune system damaging nerve cells and structures. It affects 1-2 in 100,000 people annually.5 In GBS, rapid onset and progression of muscle weakness occurs and can lead to severe paralysis of the arms and legs. Approximately 25 percent of patients require mechanical ventilation for days to months and 20 percent are unable to walk after six months.6-8 Even with current standard of care - either plasma exchange or IVIg therapy - GBS is fatal in 3-7% of cases.6-8 Most GBS patients also have sensory disturbance (tingling or numbness or ataxia) and pain, and some patients have double vision or problems with swallowing. GBS may also involve the respiratory muscles, leading to intensive care unit (ICU) admission and mechanical ventilation.9 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 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 and follow us on LinkedIn. ©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 European Medicines Agency. Idefirix® summary of product characteristics. Available at: . Angum F, et al. The Prevalence of Autoimmune Disorders in Women: A Narrative Review. Cureus. 2020 May 13;12(5):e8094. doi: 10.7759/cureus.8094. Wang L, et al. Human autoimmune diseases: a comprehensive update. J Intern Med. 2015 Oct;278(4):369-95. doi: 10.1111/joim.12395. 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 McGrogan A, Madle GC, Seaman HE, de Vries CS. The epidemiology of Guillain-Barré syndrome worldwide. A systematic literature review. Neuroepidemiology. 2009;32(2):150-63. doi: 10.1159/000184748. Epub 2008 Dec 17. PMID: 19088488.Fletcher D, et al. Neurology. 2000 27;54(12):2311-5 Leonhard SE, Papri N, Querol L, Rinaldi S, Shahrizaila N, Jacobs BC. Guillain-Barré syndrome. Nat Rev Dis Primers. 2024 Dec 19;10(1):97. doi: 10.1038/s41572-024-00580-4. PMID: 39702645. Fletcher DD, Lawn ND, Wolter TD, Wijdicks EF. Long-term outcome in patients with Guillain-Barre syndrome requiring mechanical ventilation. Neurology. 2000;54(12):2311–5. van den Berg B, Walgaard C, Drenthen J, Fokke C, Jacobs BC, van Doorn PA. Guillain-Barré syndrome: pathogenesis, diagnosis, treatment and prognosis. Nat Rev Neurol. 2014 Aug;10(8):469-82. doi: 10.1038/nrneurol.2014.121. Epub 2014 Jul 15. PMID: 25023340. Willison HJ, Jacobs BC, van Doorn PA. Guillain-Barré syndrome. Lancet. 2016 Aug 13;388(10045):717-27. doi: 10.1016/S0140-6736(16)00339-1. Epub 2016 Mar 2. PMID: 26948435. This information was brought to you by Cision The following files are available for download: SOURCE Hansa Biopharma AB WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Clinical ResultDrug Approval

24 Apr 2025

·www.prnewswire.com

Hansa Biopharma Reports First Quarter and Interim January-March 2025 Financial Results

Strong product sales and key progress in pipeline catalysts LUND, Sweden, April 24, 2025 /PRNewswire/ -- Hansa Biopharma AB, "Hansa" or the "Company" (Nasdaq Stockholm: HNSA), today announced its interim report for January-March 2025. Peter Nicklin, Chairman of the Board, Hansa Biopharma said, "In Q1, the Company delivered strong growth with total revenue of 66.3 MSEK and products sales of 65.7 MSEK. This represents a 39 percent increase as compared to Q1 2024 (47.4 MSEK). While the organ allocation market remains unpredictable and directly impacts our quarterly sales, we remain confident in our ability to significantly increase revenue year on year. In Q1, we completed enrollment in the Post Authorization Efficacy and Safety (PAES) study, secured access and reimbursement in three additional European markets, and saw growing repeat utilization of IDEFIRIX® (imlifidase) in key centers across Europe. In the second half of 2025, we anticipate several key pipeline catalysts, including data readouts from Hansa's U.S. ConfIdeS Phase 3 pivotal trial in kidney transplantation and the anti-GBM Phase 3 pivotal trial." "Also, of note, following the positive full results from the 15-HMedIdeS-09 single arm Phase 2 study in Guillain Barre Syndrome (GBS) shared in December 2024, the data is set to be presented at an upcoming medical congress. Finally, the development of the Company's next generation molecule for repeat dosing, HNSA-5487, remains on track. We recently had very positive interaction with BfArM confirming the clinical development plan for HNSA-5487 in myasthenia gravis (MG)." The Company also announced Renée Aguiar-Lucander has been appointed Chief Executive Officer effective immediately. Søren Tulstrup has stepped down from his position of CEO by mutual agreement after seven years of dedicated service to the Company. Financial Performance Q1 2025 product sales of IDEFIRIX® totaled 65.7 MSEK representing a 39 percent increase over Q1 2024 (47.4 MSEK). Revenue for the first quarter 2025 totaled 66.3 MSEK. The addition of new sites using IDEFIRIX combined with growing repeat utilization contributed to the performance. Hansa expects to see continued strong year-on-year product sales growth despite continued quarterly product sales fluctuation due to variations in European kidney allocation systems, which impacts the availability of organs for patients. Pipeline Progress During the first quarter of 2025, Hansa completed enrolment of the 20-HMedIdeS-19 Post Authorization Efficacy and Safety (PAES) study. The PAES study is part of the Company's obligation following conditional authorization by the European Commission for IDEFIRIX. The study is expected to read out in the second half of 2026 and is intended to support full marketing authorization in Europe. With completed enrollment, Hansa expects increased commercial utilization of imlifidase at key centers across Europe that participated in the PAES study. Following positive data from the 15-HMedIdeS-09 Phase 2 trial and indirect treatment comparison to the International Guillain-Barré Syndrome Outcome Study (IGOS), the data has been accepted for oral presentation at an upcoming medical conference in 2025. The trial and indirect treatment comparison demonstrated imlifidase's potential to address significant unmet need in GBS. The Phase 2 trial GNT-018-IDES in collaboration with Genethon in patients with Crigler Najjar syndrome with pre-existing antibodies against adeno-associated vectors (AAV) continues to progress with enrolment currently ongoing. The 20-HMedIdeS-17 study (ConfIdeS) remains on track for a data readout in the second half of 2025. This pivotal Phase 3 trial is evaluating imlifidase as a potential desensitization therapy, compared to standard of care, to enable kidney transplantation in highly sensitized patients. Financial Summary Conference Call Details Hansa Biopharma will host a telephone conference today Thursday, 24 April, 2025, at 14:00 CEST / 8:00 am EDT. The event will be hosted by Peter Nicklin, Chairman of the Board, Evan Ballantyne, CFO, and Hitto Kaufmann, CR&DO and Renée Aguiar-Lucander. The call will include a review of the interim results and a business and pipeline update. It will be held in English. Slides used in the presentation will be live on the company website during the call under Events & Presentations and will also be made available online after the call. To participate in the telephone conference, please use the dial-in details provided below: Participant Dial In (Toll Free): 1-833-821-3542 Participant International Dial In: 1-412-652-1248 *Please ask to be joined into the Hansa Biopharma call Join the webcast here: For the full financial calendar and list of events in 2025 please visit Contacts for more information: Evan Ballantyne, Chief Financial Officer [email protected] Stephanie Kenney, VP Global Corporate Affairs [email protected] Notes to editors 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 and follow us on LinkedIn. ©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. This information was brought to you by Cision The following files are available for download: WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Financial StatementPhase 3Executive Change

21 Mar 2025

·www.prnewswire.com

Hansa Biopharma publishes 2024 Annual and Sustainability Reports

LUND, Sweden, March 21, 2025 /PRNewswire/ -- Hansa Biopharma AB, "Hansa" or the "Company" (NASDAQ Stockholm: HNSA), today published its Annual and Sustainability Reports for 2024. Peter Nicklin, Chair of the Board, Hansa Biopharma, said: "Hansa delivered several important milestones in 2024 and remains on track to advance innovative science and important new medicines. This is in large part due to the dedicated, results-driven employees, and the Company's commitment to delivering on its discovery, development and commercialization goals. In my third year as Chair of the Board of Directors, I remain inspired and excited for what is to come for Hansa." Søren Tulstrup, President and CEO, Hansa Biopharma, said, "2024 was a momentum-building year for Hansa. With year-on-year IDEFIRIX® sales growth of 83%, a successful financing round, and several critical pipeline catalysts for imlifidase and HNSA-5487, 2024 has positioned us well to advance our efforts in Autoimmune, Gene Therapy and Transplantation. 2025 promises to be an exciting and important year, marked by several data readouts and a planned BLA submission to the U.S. FDA in kidney transplantation under the accelerated approval pathway. Hansa's science-led, patients-first business model remains at the core of what we do, executed by a team of highly experienced and dedicated individuals. We remain focused on our mission to advance critical science that can address the unmet medical needs of people living with rare, immune-mediated diseases." 2024 highlights In 2024, Hansa advanced the commercialization of IDEFIRIX® (imlifidase) in Europe as a desensitization treatment for kidney transplant patients, achieving record quarterly and full year sales. The ongoing commercialization of IDEFIRIX in Europe is being driven by continued strong market access in a total of 18 markets, including the five key markets of France, Germany, Italy, Spain and the UK. A growing body of data, real-world evidence and clinical guidelines on the utilization of imlifidase as a desensitization strategy for highly sensitized kidney transplant patients has been published. The most recent guidance published in Transplant International provides specific guidelines on appropriate use of imlifidase in clinical practice to enable kidney transplants in highly sensitized patients. Preparation for commercialization in the US is progressing, with complete randomization of the pivotal Phase 3 trial - ConfIdeS - announced in May 2024. Data readout for the trial and submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) are planned in 2H 2025. In October 2024, Hansa announced full results of the NICE-01 first in human trial and 12-month follow up analysis of HNSA-5487, demonstrating that it can robustly and rapidly reduce IgG levels, has redosing potential, and a favorable safety and tolerability profile. Initial clinical development will be focused on neuro-autoimmune disease with a well characterized role of specific autoantibodies in disease pathology and recurring acute phases - specifically, myasthenia gravis (MG). The company plans to align with regulatory authorities in the first half of 2025 on a clinical development path for HNSA-5487 in MG. In Autoimmune, enrolment was completed for the GOOD-IDES-02 Phase 3 trial in anti-glomerular basement membrane (anti-GBM) disease in December, with data readout expected in the second half of 2025. In Guillain-Barré Syndrome (GBS), Hansa announced positive full results from the 15-HMedIdeS-09 single arm Phase 2 study and an indirect treatment comparison to the International Guillain-Barré Syndrome Outcome Study (IGOS) in December 2024. In Gene Therapy, Hansa and Genethon announced initiation of GNT-018-IDES, a Phase 2 trial sponsored by Genethon evaluating the efficacy and safety of a single intravenous administration of Genethon's gene therapy GNT-0003 following pre-treatment with imlifidase in patients with severe Crigler-Najjar syndrome and pre-formed antibodies to AAV8. Enrolment continues in the SRP-9001-104 Phase 1b trial evaluating the use of imlifidase as a pre-treatment to Sarepta Therapeutics Inc.'s (Sarepta) ELEVIDYS (delandistrogene moxeparvovec) gene therapy in Duchenne Muscular Dystrophy (DMD). Hansa's journey towards a more sustainable business continues Over the last three years, Hansa has continuously evolved its approach to Sustainability aligning to the changes happening within the Company and the external environment. This year's Sustainability Report outlines the continued efforts the Company has advanced and our focus for 2025. The report highlights our work to address high unmet medical need in our three core therapy areas - Autoimmune, Gene Therapy and Transplantation, as well as our continued focus on ensuring that we are operating as a transparent, ethical business. Finally, we continue to believe that a diverse, inclusive, and supportive culture is integral to the Company's success. 2024 also marked the first year Hansa conducted a Double Materiality Assessment, an opportunity to better understand the Company's impact on stakeholders and the environment as well as what opportunities influence its business. The output - a list of prioritized material topics - provided insight and perspective on the Company's sustainability strategy and areas of focus for effective risk management. Hansa uses an annual company-wide survey by Great Place to Work®, a global authority on workplace culture, to seek employee feedback with the purpose of constantly developing and refining a healthy work environment with highly engaged and motivated colleagues. In 2024, Hansa was certified as a Great Place to Work® for the fifth consecutive year, with a 95% survey participation, Read the Annual and Sustainability Reports here. This is information that Hansa Biopharma AB (publ) is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication at 15:00 CET on 21 March 2025. Contacts for more information: Evan Ballantyne, Chief Financial Officer [email protected] Stephanie Kenney, VP Global Corporate Affairs [email protected] 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 and follow us on LinkedIn. ©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. This information was brought to you by Cision The following files are available for download: SOURCE Hansa Biopharma AB WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Gene TherapyPhase 3Clinical Result

100 Deals associated with Imlifidase

External Link

KEGG	Wiki	ATC	Drug Bank
D11470	Imlifidase	L04AA41	DB15258

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Renal transplant rejection	European Union	Hansa Biopharma AB	25 Aug 2020
Renal transplant rejection	Iceland	Hansa Biopharma AB	25 Aug 2020
Renal transplant rejection	Liechtenstein	Hansa Biopharma AB	25 Aug 2020
Renal transplant rejection	Norway	Hansa Biopharma AB	25 Aug 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Anti-Glomerular Basement Membrane Disease	Phase 3	United States	Hansa Biopharma AB	22 Dec 2022
Anti-Glomerular Basement Membrane Disease	Phase 3	Austria	Hansa Biopharma AB	22 Dec 2022
Anti-Glomerular Basement Membrane Disease	Phase 3	Belgium	Hansa Biopharma AB	22 Dec 2022
Anti-Glomerular Basement Membrane Disease	Phase 3	Czechia	Hansa Biopharma AB	22 Dec 2022
Anti-Glomerular Basement Membrane Disease	Phase 3	Denmark	Hansa Biopharma AB	22 Dec 2022
Anti-Glomerular Basement Membrane Disease	Phase 3	France	Hansa Biopharma AB	22 Dec 2022
Anti-Glomerular Basement Membrane Disease	Phase 3	Germany	Hansa Biopharma AB	22 Dec 2022
Anti-Glomerular Basement Membrane Disease	Phase 3	Ireland	Hansa Biopharma AB	22 Dec 2022
Anti-Glomerular Basement Membrane Disease	Phase 3	Italy	Hansa Biopharma AB	22 Dec 2022
Anti-Glomerular Basement Membrane Disease	Phase 3	Netherlands	Hansa Biopharma AB	22 Dec 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASGCT2025	Not Applicable	HIV Seropositivity	44	Imlifidase (Seropositive Individuals)	cdelkyarrq(jtzpdknncl) = kdscivxllb lvizurjbad (ldyzmagyjv )	Positive	13 May 2025
				Clinical Trial Subjects Treated with Imlifidase	cdelkyarrq(jtzpdknncl) = uyldtfbjdk lvizurjbad (ldyzmagyjv )
NCT03943589 (15-HMedIdeS-09, CTgov)	Phase 2	Guillain-Barre Syndrome	30	Imlifidase	kdpsgojcja(dbbzftzzxw) = fazicrenwz heykffopzp (jetouprxhj, jthxdrojxa - aovwbegyvi) View more	-	09 Apr 2025
NCT05049850 (CTgov)	Phase 2	Renal transplant rejection	3	Imlifidase	auyndxuqlq = dndmmyuolz pyabvlttxn (wmixxdfwzo, wwnsvbfadf - tguotyvayk) View more	-	17 Mar 2025
NCT03943589 (15-HMedIdeS-09, PRNewswire) Manual	Phase 2	Guillain-Barre Syndrome	30	imlifidase	atxnljxbnn(huygfhhnzy) = cajzaosihr sjydgxyzdj (xyzohbhvwy ) View more	Positive	17 Dec 2024
NCT04711850 (EudraCT number: 2018-000022-66, 2020-004777-49, Pubmed \| Clin Transplant)	Not Applicable	Renal transplant rejection DSA	-	Imlifidase	nqccoozdst(vudzakydmw) = dlbudnrsqz orwakjjmdj (vwyrogvdxs ) View more	Negative	01 Jul 2024
				Imlifidase (Plasmapheresis)	nqccoozdst(vudzakydmw) = dunwzffuyb orwakjjmdj (vwyrogvdxs ) View more
NCT03897205 (16-HMedIdes-12, CTgov)	Phase 2	Antibody-mediated rejection \| Renal transplant rejection	30	Imlifidase (Imlifidase)	evnxlfujxv(aeswiqglxq) = hmtycqazyp jikziztuvg (widmbwczdf, 4) View more	-	28 Feb 2024
				Plasma Exchange (Plasma Exchange)	evnxlfujxv(aeswiqglxq) = gqrvlugzpq jikziztuvg (widmbwczdf, 26) View more
NCT03897205 (16-HMedIdes-12, PRNewswire) Manual	Phase 2	AMR Syndrome	30	imlifidase	qppbpyvnyp(uryhbiserv) = ydradgpecw vdjpkjlkwq (nrtlqmxriu ) View more	Positive	14 Dec 2023
				standard of care	qppbpyvnyp(uryhbiserv) = odfltqxvzi vdjpkjlkwq (nrtlqmxriu ) View more
NCT03943589 (15-HMedIdeS-09, Biospace) Manual	Phase 2	Guillain-Barre Syndrome	-	imlifidase+ intravenous immunoglobulin	loqvddllmx(cxsjbgrchn) = Imlifidase was safe and well tolerated vaitdwgsrr (bctmrcjnwf ) View more	Positive	07 Dec 2023
NCT03897205 (Biospace) Manual	Phase 2	Graft Rejection	30	Imlifidase	twtqkyonzo(koxgodbkkg) = With regard to safety, imlifidase was well tolerated, and no safety signals were encountered during the study wikaepmsfp (krtlmahmph )	Positive	28 Nov 2022
				plasma exchange
ESGCT2022	Not Applicable	-	-	Imlifidase	ampidbbrni(wswsdeeocl) = igyrzkurrd wejbasgafl (kzkerpbquh ) View more	-	11 Oct 2022

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis