MUNICH—MorphoSys AG, a clinical-stage biopharmaceutical focused on battling cancer, is on a fast track with its antibody MOR208 toward FDA approval and marketing in the United States due to recent updates on L-MIND and B-MIND, its two ongoing clinical trials of the investigational Fc-enhanced anti-CD19 antibody MOR208 in patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL) who are not eligible for high-dose chemotherapy and autologous stem cell transplantation.
Top-line results of the MOR208 clinical trials are expected to be released at a medical conference in mid-2019. MorphoSys released updates March 6 on its L-MIND and B-MIND trials, and on March 14, the company hosted a conference and webcast for investors on the highlights of 2018 and its goals into 2019 and beyond.
The L-MIND trial, the company’s single-arm, open-label study investigating MOR208 in combination with lenalidomide, has completed enrollment, and data are currently being analyzed.
The top priority is to bring MOR208 plus lenalidomide in r/r DLBCL to approval as fast as possible.
On the regulatory front, MorphoSys plans to complete the submission of the Biologics License Application to the U.S. Food and Drug Administration for approval of MOR208 by year’s end. The company is continuing the pivotal Phase 3 B-MIND study, evaluating MOR208 plus bendamustine versus rituximab plus bendamustine in r/r DLBCL and conduct a preplanned, event-driven, interim analysis of B-MIND, which is projected to take place in the second half of 2019. Simon Moroney, MorphoSys’ CEO, referred to 2018 as “an outstanding year” for the company, with 2018 revenues “exceeding expectations.”
“Our highest priority has been MOR208, where we have made great progress,” Moroney said. “Our goal is to bring MOR208 to market as soon as possible, including plans to commercialize MOR208 in the U.S.”
Malte Peters, chief development officer of MorphoSys, also spoke to investors about the “remarkable progress” of MOR208 and the L-MIND and B-MIND investigational trials. “Our goal is to make MOR208 available to every patient who needs it,” Peters said, with 70 percent of a hospital patient sample on the treatment showing no disease progression in 12 months. MorphoSys has also initiated discussions with the European regulatory authorities to explore the possibility of using the L-MIND study as the basis for the submission of a potential marketing authorization application (MAA) in Europe.
If the European Medicines Agency agreed to accept a potential MAA based on L-MIND, submission of an MAA could occur earlier than originally anticipated, according to the company.
The B-MIND study, which compares MOR208 in combination with bendamustine vs. rituximab plus bendamustine, continues as originally designed, Peters said. Additionally, during the first quarter of 2019 and in agreement with the FDA, MorphoSys implemented an amendment of the B-MIND study, with the scientific rationale based on published literature as well as MorphoSys’s own preclinical data, indicating that MOR208 might be particularly active in patients characterized by the presence of a certain biomarker.
Depending on the outcome of the interim analysis of B-MIND, an increase from 330 to 450 patients may be required, in which case an event-driven primary analysis of the study is expected in the first half of 2021.
“The amended B-MIND trial enables us to test the hypothesis that MOR208 shows enhanced activity in patients who can be identified using the biomarker, while allowing us to test efficacy in the unselected patient population as originally planned,” Peters added.
Moroney surprised some investors by announcing he would not be renewing his contract as a member of the company’s management board. He will step down as CEO on expiry of his current contract on June 30, 2020, or when a successor is appointed, whichever comes sooner.
After having dedicated 27 years to MorphoSys, Moroney said he wanted the chance “to do something else and explore new opportunities,” adding he has left the company in good shape, declaring, “MorphoSys, today, is stronger than it has ever been.”
MOR208 is an investigational monoclonal antibody directed against the antigen CD19, which is broadly expressed on the surface of B cells. It is therefore considered as an important factor for the treatment of B cell malignancies such as non-Hodgkin’s lymphoma, diffuse large B cell lymphoma and chronic lymphocytic leukemia.
