As the hemophilia market builds and tensions fray, Shire has signed a new licensing deal targeting bispecific antibodies.
Shire and newly-acquired Baxalta have long had medications on the market for the condition, but these are under threat from Roche and its experimental hemophilia A med emicizumab.
Roche’s med is a bispecific mAb, currently in phase 3, and is designed to bring together factors IXa and X, proteins required to activate the natural coagulation cascade and restore the blood clotting process.
Some analysts see $5 billion at peak for the once-weekly injectable emicizumab, although Shire has been fighting this in the courts of late, and also in its R&D.
Today, the Ireland-based drugmaker announced a tie-up with Swiss biotech Novimmune whereby it gets its hands on a worldwide license to work on a preclinical bispecific antibody candidate for hemophilia A.
Under the R&D pact, Shire will be leading the development of the program to “optimize and evaluate” a fully-human, bispecific IgG antibody targeting FIXa and FX. It’s designed to copy the body’s natural mechanism of Factor VIII-driven coagulation.
The endgame is to create a product that is better and safer than the current Factor class, Shire said in a statement. Money terms were not provided.
“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 of global research at 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, diabetic macular edema, antibody-mediated autoimmune disease and anti-thrombotic therapy.
These are “all signatures of Shire’s new Rare Diseases Innovation Center coming to Cambridge, Massachusetts,” the company says.
Ed Holdener, chairman and CEO of Novimmune, added: “We are delighted that our research efforts have produced several promising and potentially highly differentiated leads for improving coagulation in hemophilia A.”
The European company has been developing a platform for making fully human, bispecific antibodies and has several in-house programs targeting tumor associated antigens and the immune system check point protein CD47. The biotech and Shire first struck an R&D collaboration back in 2015.