Date: 2013-12-10
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the study
Company: Morphosys (Germany)
Product: MOR208 in combination with lenalidomide (Revlimid®)
Action
mechanism: MOR208 (formerly XmAb®5574) is a potent anti-CD19 antibody with a proprietary modification to the Fc portion, that is being developed to treat B-cell malignancies.The target molecule CD19 is expressed more broadly and earlier in B-cell development than CD20, the target of the marketed cancer drug Rituxan®. Therefore targeting CD19 could potentially allow for an even broader therapeutic use of MOR208 than marketed anti-CD20 antibodies.
In June 2010, MorphoSys AG and Xencor signed a worldwide exclusive license and collaboration agreement. The agreement provided MorphoSys with an exclusive worldwide license to MOR208 for the treatment of cancer and other indications. Using Xencor\'s XmAb Fc enhancement technology, MOR208 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
Disease: chronic lymphocytic leukemia (CLL)
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: 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\".
Latest
news: * On December 10, 2013, MorphoSys 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 safetyof 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. MorphoSys will provide MOR208 drug supply for the study. 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 also conducting Phase 2 clinical trials of MOR208 in patients with non-Hodgkin's lymphoma (NHL) and B-cell acute lymphoblastic leukemia (B-ALL).
