Hansa Biopharma is a biopharmaceutical company with headquarter in Lund, Sweden. The company develops and commercializes treatments for patients with immunological conditions and rare immunoglobulin G (IgG)-mediated autoimmune conditions. The company’s product candidate, imlifidase, is an antibody-cleaving enzyme designed to work within a few hours and thereby inactivating the part of the immune system represented by IgG. The IgG is the most common antibody and are very important in fighting autoimmune reactions, where the body’s immune system is activated to attack its own organs and tissues. Due to its mechanism of action, imlifidase therefore has therapeutic potential in diseases caused by an unwanted activation of the immune system or in situations where IgGs constitute barriers to treatment such as by transplantation.
imlifidase gives new hope for kidney patients
Finding a kidney match for transplantation, due to excessive levels of IgG antibodies, can be a difficult if not almost impossible challenge for sensitized patients. This means that many of these patients have to remain on dialysis with no real hope of finding a matching kidney, which leads to a degraded quality of life with no prospect of returning to the labor market, a higher mortality rate as well as being a more expensive solution for society compared to transplantation.
Hansa Biopharma’s enzyme imlifidase (trade name: Idefirix) has been shown to be extremely effective and safe in inactivating IgG antibodies and enabling transplantation in highly sensitized patients with results and survival, in line with what might be expected for non-sensitized patients.
Last year Imlifidase obtained conditional approval in Europe based on four phase II studies in 46 patients and is now commercially available in the first countries as a pre-treatment for highly sensitized patients before a transplant. Full approval is expected upon completion of a post-marketing study which is expected to begin shortly.
Moreover, Hansa plans to bring imlifidase to the US in the same indication and has just initiated a phase III study in 64 highly sensitized patients supportive of a filing for approval in 2024 Imlifidase is also being investigated in phase II to treat antibody-mediated rejection of transplanted kidneys.
Several disease indications under development
Other rare autoimmune disease indications under development includes:
- Anti-GBM (Goodpasture’s Disease) (Phase II), an acute autoimmune disease in which the body, for unknown reasons, produces antibodies against the basement membrane of the kidneys and lungs, causing severe damage to the kidneys and lungs and can cause patients to lose the renal function and end up in dialysis.
- Guillain-Barré syndrome (GBS) (Phase II), also an acute autoimmune condition that occurs in the central nervous system as a result of a viral infection or similar. The inflammation starts with hitting the muscles in the feet and lower legs, then involving muscles in the thighs, hips, body and less frequently the arms. Only the fewest patients will recover completely on top of a GBS attack.
- Finally, Hansa has a partnership with Sarepta Therapeutics in gene therapy for the pretreatment of patients with Limb-girdle muscular dystrophy (LGMD) and Duchenne muscular dystrophy (DMD). Hansa receives all earnings from the sale of imlifidase as pre-treatment and furthermore receive royalties and milestone payments from Sarepta.
KICKBACKS IN THE SHARE DURING 2021 BUT GOOD CHANCES FOR A COMEBACK
Throughout most of 2021, the stock has underperformed just like the rest of the biotech sector and is currently down by -62% for the year (December 9, 2021) We expect that the decline mainly is driven by the sector rotation due to to Covid-19, which has led many generalist investors to shift their focus from growth- and biotech shares to value and consumer-oriented shares. In addition, Hansa has had a less significant news flow compared to 2020, where the company’s technology experienced a triple validation within transplantation, autoimmune diseases, and gene therapy. However, nothing has changed, and we therefore see good opportunities for a comeback to the share, once the most significant reimbursement agreements are in place and the major transplant centers have treated the first patients.