Ireland-incorporated Shire, the leader in rare diseases, has now announced its acquisition of exclusive worldwide rights to develop and commercialize an innovative, bi-specific antibody in pre-clinical development for the treatment of hemophilia A and hemophilia A patients with inhibitors, from privately-held Swiss biotech firm Novimmune.
The company aims to deliver a treatment that improves upon the strong and long-term record of efficacy and safety that has been set by the Factor class.
It is therefore leading the development of the program to optimize and evaluate a fully-human, bi-specific IgG antibody targeting FIXa and FX, designed to imitate the body’s natural mechanism of Factor VIII-driven coagulation.
The antibody candidate which is currently in preclinical stage could provide a key advantage over the current standard treatment of hemophilia A. Since more or less 30% of patients who receive recombinant factor VIII develop antibodies against it, Novimmune’s antibody which targets an alternative process, is expected to be effective in case of those who have developed these inhibitors.
“This novel program builds on our extensive monoclonal antibody (MAb) capabilities, as well as on our in-depth scientific expertise in hematology,” said Fritz Scheiflinger, Head Global Research, Shire. “While further development and clinical trials are needed to
fully evaluate this antibody, we are encouraged by the potential of the data that we have seen in early discovery and the promise it may hold for hemophilia A patients and patients with inhibitors.”“Novimmune is building on a collaboration initiated in 2015 with Shire to generate and evaluate Factor VIII-mimetic, bi-specific antibodies,” said Ed Holdener, Chairman and CEO of Novimmune. “We are delighted that our research efforts have produced several promising and potentially highly differentiated leads for improving coagulation in hemophilia A.”
Shire, along with Novo Nordisk, currently dominates the hemophilia market expected to reach €14Bn by 2024. This move in particular will help it stay on top of the myriad of innovative treatments for hemophilia progressing through the pipeline.
