The FDA has given the German biotech’s blood cancer antibody combination Breakthrough Therapy Designation on the back of good preliminary Phase II results.
MorphoSys is one of Germany’s biggest biotechs, which hopes to generate optimized antibodies for the treatment of serious diseases. It has been granted Breakthrough Therapy Designation by the FDA for its most advanced blood cancer antibody, MOR208, in combination with lenalidomide – a current first-line drug for lymphoma. It is currently undergoing Phase II and III trials, and the fast track will help MorphoSys to bring its first antibody to the market without the help of any partners, allowing it to join Genmab and Actelion in the very exclusive club of commercial biotechs in Europe.
Diffuse large B-cell lymphoma is the most common malignant lymphoma worldwide, accounting for around 30% of all non-Hodgkin lymphomas. Between 30% and 40% of all patients with DLBCL either fail to respond to or show a relapse to initial therapy, highlighting the need for new and effective treatments.
MOR208 is a Fc-engineered monoclonal antibody against CD19. In preclinical studies, the candidate demonstrated its ability to induce apoptosis of cancer cells upon binding CD19. It comes up against hefty competition in the blood cancer field, including Novartis’ CAR-T therapy, Kiadis Pharma’s T cell immunotherapy and Adaptimmune’s NY-ESO-specific T cells.
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