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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
Additional agreements around reimbursement from H2 2021.

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 enrollment (64 patients) in H2 2022.

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

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Next anticipated milestones
Pivotal Phase 3 study expected to commence in 2022 (50 patients).

Status
Clinical Phase 2 completed.
Clinical Phase 3 planned.

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)

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Next anticipated milestones
Completion of enrollment (30 patients) in H1 2022.

Status
Clinical Phase 2 ongoing.

Guillain-Barré syndrome (GBS)

Guillain-Barré syndrome (GBS)

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Status
Clinical Phase 2 ongoing.

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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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 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)

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Status
Preclinical research ongoing.

NiceR

Recurring treatment in autoimmune disease, transplantation and oncology

Recurring treatment in autoimmune disease, transplantation and oncology

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Next anticipated milestones
Completion of GLP toxicology studies in 2022.

Status
Preclinical research ongoing.

EnzE

Cancer immunotherapy

Cancer immunotherapy

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Status
Research phase.

Ongoing
Completed
Planned
Conditional approvement based on Phase 2 data

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.

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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