Shire expands broad monoclonal antibody research platform

Shire obtains worldwide license to pursue development and commercialization of a novel, potentially differentiated, pre-clinical bi-specific antibody candidate for Hemophilia A.

Shire has entered into an agreement granting Shire 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. Shire is 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 company’s 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.

"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."

Shire has been steadily building its MAb research capability, which now includes MAb programs in hereditary angioedema (HAE), diabetic macular edema, antibody-mediated autoimmune disease, and anti-thrombotic therapy—all signatures of Shire’s new Rare Diseases Innovation Center coming to Cambridge, MA.

"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."

Novimmune 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 system check point protein CD47.