Shire has obtained exclusive worldwide rights from Novimmune for a bi-specific antibody that is currently in pre-clinical development for treating patients with the blood disorders hemophilia A and hemophilia A with inhibitors. Financial terms were not disclosed.

Under the terms of the deal, Ireland-based Shire will lead the program’s development to optimize and evaluate a fully human, bi-specific IgG antibody targeting Factor X (FX) and activated Factor IX (FIXa), which are designed to imitate the body’s natural mechanism of Factor VIII-driven coagulation. Shire said its ultimate aim is 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.”

“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,” said Fritz Scheiflinger, Shire’s head of global research.

Shire has been steadily building its monoclonal antibody (MAb) research capability and now has programs in hereditary antioedema (HAE), diabetic macular edema, antibody-mediated autoimmune disease and anti-thrombotic therapy.

Novimmune’s chairman and CEO, Ed Holdener, said the deal builds on an existing collaboration that was initiated in 2015 to assess Factor VIII-mimetic, bi-specific antibodies. The Swiss biopharma has been developing a platform for making fully human, bi-specific antibodies and has several in-house programs targeting tumor-associated antigens and the immune checkpoint protein CD47.