Bioverativ completes acquisition of True North Therapeutics

Strengthens leadership in rare blood disorders with first-in-class candidate to treat cold agglutinin disease, a chronic autoimmune hemolytic anemia with no approved therapies.

“We are excited to welcome the talented True North team and combine their deep understanding of complement biology with our expertise in hematology to develop innovative therapies for people with rare blood disorders,” said John Cox, CEO of Bioverativ. “This acquisition strengthens our pipeline, expands our scientific competencies, and provides a significant opportunity to meaningfully impact people living with cold agglutinin disease. We also believe it has the potential to create significant long-term value for our shareholders.”

With the acquisition, Bioverativ adds TNT009, a first-in-class monoclonal antibody in development for cold agglutinin disease (CAgD), to its pipeline of novel, investigational therapies for the treatment of rare blood disorders, including hemophilia, sickle cell disease and beta thalassemia. There are no approved treatments for CAgD, which is a rare and chronic autoimmune hemolytic condition that often leads to severe anemia. People living with CAgD can suffer with a significant disease burden, including frequent blood transfusions, crippling fatigue, and an increased risk of life-threatening thrombotic events such as pulmonary embolism and stroke.

TNT009 has received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of hemolysis in patients with primary CAgD, and orphan drug designation from the FDA and the European Medicines Agency. Late-stage clinical development planning for TNT009, including a registrational program, is underway.

The acquisition also includes TNT020, a discovery-stage, follow-on monoclonal antibody that targets activated C1s with the potential for less frequent dosing and subcutaneous administration.