MorphoSys AG has announced that the Ohio State University (OSU), Department of Internal Medicine led by Prof. Dr. John Byrd, Director Division of Hematology, initiated an investigator sponsored trial to evaluate the efficacy and safety of MOR208 in combination with lenalidomide (Revlimid®) in patients with chronic lymphocytic leukemia (CLL).
The trial is being conducted by the sponsor investigator Dr. Jennifer Woyach, Assistant Professor of Internal Medicine at the OSU, and is expected to enroll up to 20 treatment naïve and 20 relapsed/refractory CLL patients.
The open-label, multi-dose, double-arm trial is entitled "A Phase II Study of MOR00208 in Combination with Lenalidomide for Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL), Prolymphocytic Leukemia (PLL) or Patients with Untreated CLL/SLL/PLL".
MorphoSys will provide MOR208 drug supply for the study. More information on the trial can be found by searching for MOR208 on www.clinicaltrials.gov.
"We are very pleased that Dr. Jennifer Woyach has chosen to initiate this trial. This first investigator-sponsored trial evaluating MOR208 underscores the growing interest we are seeing in this innovative antibody molecule within the medical community. MOR208 has been shown to act synergistically with the immunomodulator lenalidomide in non-clinical models. In contrast to other potential combination partners, lenalidomide leaves the FcR-stimulated NK cell function, specifically ADCC, intact, preserving the anti-lymphoma efficacy of both agents. This combination could provide a chemotherapy-free alternative for CLL patients with limited treatment options," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG.
MOR208 is a humanized monoclonal antibody that targets the antigen CD19 for treatment of B cell malignancies and autoimmune diseases. The antibody has been engineered to possess significantly enhanced antibody-dependent cell-mediated cytotoxicity (ADCC), thus improving a key mechanism for tumor cell killing and offering potential for enhanced efficacy compared to traditional antibodies for the treatment of cancer.
Preclinical work conducted by MorphoSys indicates that lenalidomide may be a powerful combination partner for the therapeutic antibody MOR208. Lenalidomide enhances T cell and natural killer (NK) cell activity in pre-clinical models. MOR208 in combination with lenalidomide has shown an increased cytotoxicity as compared to MOR208 alone, indicating that the two substances act synergistically.
In a Phase 1/2a trial MOR208 has shown encouraging signs of preliminary anti-tumor activity and an acceptable safety and tolerability profile in patients with high-risk, heavily pretreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
The study results have shown an overall response rate of 29.6% (according to IWCLL 2008 criteria) based on the safety population of the trial (n=27). MorphoSys is conducting Phase 2 clinical trials of MOR208 in patients with non-Hodgkin's lymphoma (NHL) and B-cell acute lymphoblastic leukemia (B-ALL).