Pipeline

With our clinical and preclinical research programs we evaluate imlifidase across a wide spectrum of both potential disease areas and indications in an effort to address significant unmet medical needs.

Our broad pipeline spans pre-kidney transplantation desensitization, post-transplantation antibody-mediated organ rejection (AMR), rare IgG-mediated autoimmune conditions such as anti-glomerular basement membrane disease (anti-GBM), and Guillain-Barré Syndrome (GBS), as well as cancer. Full details on clinical program are available at: www.clinicaltrials.gov.

In preclinical development, we are also evaluating the use of imlifidase to potentially enable gene therapy treatment in patients with pre-existing neutralizing antibodies. Beyond imlifidase, we are developing our next generation IgG-cleaving enzyme program, NiceR, for repeat dosing. Finally, our EnzE program could potentially enhance the potency of oncology treatments.
Research

Broad pipeline in transplantation and autoimmune conditions

	Preclinical	Phase 1	Phase 2	Phase 3	Marketing authorization	Marketed
Imlifidase
EU: Kidney transplantation in highly sensitized patients							EU: Kidney transplantation in highly sensitized patients Close Next anticipated milestones EU: Additional agreements around reimbursement / Post approval study to be completed by 2025 Status Commercialization ongoing based on approval. Notes Results from the Phase 1 study have been published, Winstedt el al. (2015) PLOS ONE 10(7) Lorant et al, American Journal of Transplantation and 03+04 studies (Jordan et al New England Journal of Medicine) The EU Commission has granted conditional approval for imlifidase in highly sensitized kidney transplant patients. As part of the conditional approval Hansa has committed to do a post-approval study
US: Kidney transplantation in highly sensitized patients							US: Kidney transplantation in highly sensitized patients Close Next anticipated milestones Completion of enrollment: H1 2023 Complete randomization (64 patients): H2 2023 For more information: NCT04935177 Status Clinical Phase 3 ongoing. Notes Results from the Phase 1 study have been published, Winstedt el al. (2015) PLOS ONE 10(7) Lorant et al, American Journal of Transplantation and 03+04 studies (Jordan et al New England Journal of Medicine)
Anti-GBM disease							Anti-GBM disease Close Next anticipated milestones First patient enrolled (50 patients): H1 2023 Status Clinical Phase 3 ongoing. Notes Investigator-initiated study by Mårten Segelmark, Professor at the universities in Linköping and Lund
Antibody mediated kidney transplant rejection (AMR)							Antibody mediated kidney transplant rejection (AMR) Close Next anticipated milestones Full data read-out: H2 2023 Status Clinical Phase 2 ongoing.
Guillain-Barré syndrome (GBS)							Guillain-Barré syndrome (GBS) Close Next anticipated milestones Topline data: H2 2023 Comprative efficacy analysis to IGOS data in 2024. Status Clinical Phase 2 ongoing.
ANCA-associated vasculitis							ANCA-associated vasculitis Close Next anticipated milestones Complete enrollment (10 patients) Notes Phase 2, first patient enrolled Investigator-initiated study by Dr. Adrian Schreiber and Dr. Philipp Enghard, at Charité Universitätsmedizin, Berlin, Germany
Pre-treatment ahead of gene therapy in Duchenne Muscular Dystrophy (Partnered with Sarepta)							Pre-treatment ahead of gene therapy in Duchenne Muscular Dystrophy (Partnered with Sarepta) Close Next anticipated milestones Initiate clinical study of imlifidase as pre-treatment in DMD 2023 Status Preclinical research ongoing.
Pre-treatment ahead of gene therapy in Limb-Girdle Muscular Dystrophy (Partnered with Sarepta)							Pre-treatment ahead of gene therapy in Limb-Girdle Muscular Dystrophy (Partnered with Sarepta) Close Status Preclinical research ongoing.
Pre-treatment ahead of gene therapy in Pompe disease (Partnered with AskBio)							Pre-treatment ahead of gene therapy in Pompe disease (Partnered with AskBio) Close Status Preclinical research ongoing.
Pre-treatment ahead of gene therapy in Crigler-Najjar syndrome (Partnered with Genethon)							Pre-treatment ahead of gene therapy in Crigler-Nailar syndrome (Partnered with Genethon) Close Status Preclinical research ongoing.
HNSA-5487
Lead molecule from second-generation lgG antibody cleaving enzymes (NiceR)							Lead molecule from second-generation lgG antibody cleaving enzymes (NiceR) Close Next anticipated milestone Read out of phase 1 in healthy subjects. Status Clinical phase 1 ongoing.

Ongoing

Completed

Planned

Post approval study running in parallel with commercial launch

Interested in being involved?

If you are interested in getting involved in a clinical study, please talk to your physician. They will be able to advise you on whether you would be eligible to enroll into a study and if participation could be right for you.

Compassionate use

Hansa Biopharma is committed to putting patients first while advancing important science in areas of high unmet need with the goal of providing life-saving treatment options to patients and clinicians. At this time, we are unable to offer access to unauthorized treatments via a compassionate use program. Physicians seeking more information can contact medinfo@hansabiopharma.com. For information regarding Hansa clinical trials, please visit clinicaltrials.gov.

Hansa Biopharma global access program policy

At this time, we are unable to offer access to unauthorized treatments via a compassionate use program that will provide an equitable and sustainable option for patients. However, we will evaluate and respond to each individual access request on a case-by-case basis. Clinicians considering suitability of their patients for access to clinical trials, can visit clinicaltrials.gov to see which Hansa trials are recruiting patients and where.

Pipeline

Broad pipeline in transplantation and autoimmune conditions

Interested in being involved?

Compassionate use

Hansa Biopharma global access program policy

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