Update (02/06/2017): MorphoSys has successfully completed Phase II with MOR208 in combination with bendamustine and the Phase III part of the study is now open for enrollment.
Originally published on 07/09/2016
MorphoSys is shooting to bring a new non-Hodgkin’s lymphoma drug through Phase II and III in one swoop with a new monoclonal antibody.
MorphoSys had a rough couple of bumps: the company had to scrap its antibody collaboration with Celgene last year and go to court to defend related patent rights from Janssen earlier this year. But the German biotech is back on the horse as its latest therapy, MOR208, enters a dual-armed Phase 2/3 trial for relapsed or refractory Diffuse Large B Cell Lymphoma (DLBCL), the most common form of non-Hodgkin’s lymphoma.
The company reports that its first patient of 330 has been dosed with a combination of MOR208 with the chemotherapeutic agent bendamustine, in a global study to evaluate the safety and tolerability. In addition to the disease criteria, patients must have had one to three previous (failed) treatments, including at least one anti-CD20 targeting therapy, and be ineligible for autologous stem cell transplantation.
The primary endpoint of the study is progression-free survival, but objective response rate, duration of response, overall survival, disease control rate and time to progression will also be evaluated as secondary outcome measures. The broader goal of the study is to transition into MorphoSys’s first pivotal Phase III study of an antibody, starting as early as 2017.
MorphoSys chose CD19 as a target because it is homogeneously expressed across all B cell malignancies and enhances B cell receptor signaling for the cell’s survival. MorphoSys developed MOR208 as an Fc-enhanced monoclonal antibody to target this receptor and induce direct apoptosis, as well as antibody-dependent cell-mediated cytotoxicity and cellular phagocytosis. This mechanism will hopefully improve tumor cell extermination.
So far, the biotech has not independently brought any of its therapies the whole way through the clinic, but it has had great success with its antibody library, dubbed, ‘HuCAL‘. MorphoSys claims that its platform is the most successful of its kind in the pharmaceutical industry: indeed, it is an integral part of the company’s antibody drug pipeline targeting a range of diseases including cancer, rheumatoid arthritis, and Alzheimer’s disease. This pipeline has funneled over 100 monoclonal antibodies into the clinic!
Check out what the company’s CEO has to say about its strategy and outlook in our interview with him last year.