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Hansa Biopharma
HNSA (, %) SEK
Hansa Biopharma
Scientist pipetting vials

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

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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

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Next anticipated milestones
Completion of randomization (64 patients) mid 2024

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 (investigator sponsored trial)

Anti-GBM disease

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Next anticipated milestones
Complete enrollment (50 patients)

Status
Clinical Phase 3 ongoing.

Notes

  • Investigator sponsored trial by Mårten Segelmark, Professor at Lund University

Antibody mediated kidney transplant rejection (AMR)

Antibody mediated kidney transplant rejection (AMR)

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Next anticipated milestones
Publication in peer-reviewed journal

Status
Clinical Phase 2 ongoing.

Guillain-Barré syndrome (GBS)

Guillain-Barré syndrome (GBS)

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Next anticipated milestones
Comparative efficacy analysis 2024

Status
Clinical Phase 2 ongoing.

ANCA-associated vasculitis (investigator sponsored trial)

ANCA-associated vasculitis

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Next anticipated milestones
Complete enrollment (10 patients)

Notes

  • Phase 2, first patient enrolled
  • Investigator sponsored trial (IST) 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)

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Next anticipated milestones
First patient treated in clinical study

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)

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Status
Preclinical research.

Pre-treatment ahead of gene therapy in Pompe disease (Partnered with AskBio)

Pre-treatment ahead of gene therapy in Pompe disease (Partnered with AskBio)

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Status
Preclinical research.

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)

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Status
Commence clinical study

HNSA-5487

Lead molecule from second-generation lgG antibody cleaving enzymes (NiceR)

Lead molecule from second-generation lgG antibody cleaving enzymes (NiceR)

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Next anticipated milestone
Further analysis around endpoints from Phase 1 to be completed in 2024 incl. selection of lead indication.

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.

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