Abzena’s partner True North Therapeutics subject of US$825m take-over

According to the agreement, Bioverativ will pay US$400m upfront and up to US$425m in milestone payments to acquire all assets of True North Therapeutics(TNT), including the worldwide rights to the company’s lead candidate, TNT009, a first-in-class monoclonal antibody to treat cold agglutinin disease (CAD), using Composite Human Antibody  technology licenced from Abzena.

CAD is a rare and chronic haemolytic condition that often leads to severe anaemia, requiring numerous transfusions, and can result in life-threatening thrombotic events. There are no approved therapies for the orphan disease, which occurs in approximately 16 people per million globally, including an estimated 5,000 people in the United States. In May 2017, the U.S. Food and Drug Administration (FDA) granted TNT009 breakthrough therapy designation for the treatment of hemolysis in patients with primary CAD, and plans for the full clinical development programme, including a registrational programme, are underway.

The FDA decision was based on data from a Phase Ib trial, which showed that TNT009 normalised haemoglobin levels in six of six study participants with primary CAD, increasing haemoglobin by an average of 4g/dL and resolving their anaemia. All participants were transfusion free while on treatment. TNT009 was generally well tolerated. As of December 21, 2016, five of six participants (83.3%) with primary CAD experienced at least one adverse event; all were mild to moderate in severity and no adverse event was assessed as related to TNT009 by the investigator. 

TNT009 was created using Abzena’s Composite Human Antibody technology and falls within the Abzena Inside portfolio of products being clinically developed by Abzena’s partners.