Our Equity Story

A unique immunomodulatory enzyme technology

Imlifidase is a unique IgG antibody-cleaving enzyme studied in five clinical studies.
By removing the immunological barrier, imlifidase has the potential to enable kidney transplantation in highly sensitized patients.

Patients may become sensitized after losing a first transplant or being exposed to foreign tissues through blood transfusion or pregnancy. Such sensitized patients account for roughly 30% of people on the kidney waiting lists.
HLA sensitization is a major barrier to kidney transplantation since high levels of anti-HLA antibodies are likely to target and significantly compromise a transplanted organ. The more antibodies, the lower the likelihood of finding a donor organ.
Many highly sensitized patients will indefinitely remain in a debilitating disease state on long-term dialysis treatment, which is associated with high cost, a poor quality of life and an increased mortality rate. If approved, imlifidase could potentially help highly sensitized patients getting off dialysis by enabling transplantation.
Beyond kidney transplantation, Hansa Biopharma is also working on a number of additional indications in rare autoimmune diseases with no approved treatment options, including anti-GBM, Guillain-Barré syndrome and acute Antibody Mediated Rejection (AMR) post transplantation.

Hansa Biopharma is establishing its own commercial and medical organization in Europe and the US with the capacity to reach hospitals treating highly sensitized patients awaiting kidney transplantation. Outside these core markets we will seek commercial partnerships.
We are liaising with the transplant community in Europe and the U.S., including patient advocacy groups and are preparing the building of the infrastructure needed to enable access if and once imlifidase is approved.
Since February 28th, 2019, our first Marketing Authorization Application (MAA) for imlifidase has been under review by the European Medicines Agency (EMA).
Hansa Biopharma has a broad patent coverage for its technology through 2035 and potentially beyond in key markets, and orphan drug designation for imlifidase in both EU and the US in kidney transplantation and Anti-GBM. In addition, Hansa Biopharma has obtained orphan drug designation for imlifidase in the treatment of GBS in the US. Orphan Drug Designation provides development and commercial incentives, including certain market exclusivities for 10 years in EU and 7 years in the US.

We are leveraging our proprietary immunomodulatory enzyme platform to investigate imlifidase in several phase 2 clinical studies in rare autoimmune indications including anti-GBM (Goodpasture’s disease), Guillain-Barré syndrome and acute Antibody Mediated Rejection (AMR) post transplantation, all with Orphan Drug status.
With our next generation program, NiceR, we are developing enzymes that may potentially enable repeat dosing. This program may have the potential to apply to a broad array of indications, including relapsing autoimmune diseases, chronic transplant rejection, oncology and repeat dosing of gene therapy.
We are exploring the potential to enable gene therapy in patients with Neutralizing Antibodies.