Annual Report 2015
Engineering the Medicines
of Tomorrow

Nearly one million people
worldwide were
diagnosed with blood
cancer in 2015.

our research: fighting blood cancer

Antibodies attack
blood cancer cells in
a targeted manner.

our antibody mor208: mode of action

New developments
in the treatment
of blood cancer benefiting
patients.

the mor208 antibody in clinical development

MOR208 – the investigational antibody in cancer patients

With MOR208, its most advanced antibody against blood cancer, MorphoSys is exploiting combination therapies with other cancer drugs.

Based on its specific mode of action and good tolerability shown so far, MOR208 is considered a promising potential combination partner with other cancer drugs.

Planned clinical combination studies with MOR208 in blood cancer indications

In a phase 2a clinical trial, MOR208 has been administered as a single agent to 92 patients with different subtypes of non-Hodgkin's lymphoma (including DLBCLDLBCL: diffuse large B cell lymphoma, a subform of NHL) and has shown promising efficacy and good tolerability.

MOR208 is also being evaluated in combination with the cancer drugs lenalidomide and ibrutinib in CLLCLL: Chronic lymphocytic leukemia; most common type of cancer of the blood and bone marrow, affecting the B cells patients in an ongoing investigator-initiated phase 2 clinical trial conducted by researchers at Ohio State University.

The next step is to evaluate MOR208 in a number of clinical trials in combination with other drugs to examine the efficacy and safety profile of the combination in patients.

MorphoSys is therefore planning to initiate three combination clinical trials with MOR208 in 2016.

  1. MOR2018 + Lenalidomide in DLBCl
  2. Mor208 + Idelalisib in CLL
  3. Mor208 + Bendamustine in DLBCL
  1. MOR208 will be evaluated in a phase 2 trial in combination with the compound lenalidomide in around 80 patients with diffuse large B cell lymphoma (DLBCL) to study safety and efficacy of the combination therapy. Immunomodulators such as lenalidomide have been proven to increase the activity of natural killer cells (NK cellsNK cells: Natural killer cells of the body’s immune system; cells capable of recognizing and killing abnormal cells, e.g. tumor cells) of the body’s own immune system. MOR208 binds specifically to the tumor cell and attracts NK cells, which should facilitate an efficacious and specific killing of tumor cells. The potential additive and/or synergistic effects of the two agents in combination, will be investigated in this clinical study in DLBCL patients.

  2. In a further phase 2 trial, MOR208 is planned to be evaluated in combination with the drug idelalisib in up to 120 patients with chronic lymphocytic leukemia (CLL). This study is designed to treat patients who have experienced a relapse in prior treatment with the cancer drug ibrutinib and/or another Btk inhibitor. This patient group has no existing alternative treatment options. It is aimed to investigate if the combined administration of an antibody such as MOR208 targeted specifically against malignant B cells with a novel oral cancer drug such as idelalisib targeting B cell malignancies can be of benefit to these patients.
  3. In the second half of 2016, MorphoSys plans to launch a combination trial with MOR208 and the chemotherapeutic agent bendamustine in DLBCL. This study will initially begin with a safety evaluation, and is planned to transition into a phase 3 trial with approximately 320 patients in 2017. Bendamustine has proven itself in years of clinical practice as a combination partner for blood cancer therapies. Now a pivotal trial is planned to investigate the combination with the MOR208 antibody, which has shown promising activity and has been well tolerated as a monotherapy in clinical trials.
  1. MOR208: Study centers worldwide
  2. MOR208: Patient numbers worldwide
  1. MOR208 is being developed in clinical studies worldwide. There are hospitals and study centers from four continents currently participating in these studies, and their number is expected to grow.
  2. MOR208’s safety and efficacy are being evaluated in a number of upcoming clinical trials in cancer patients. The number of patients participating in these studies is expected to increase substantially over the next several years.

Interview

Dr. Wojciech Jurczak Associated Professor, DEP. of Hematology, Jagiellonian University, Krakow, Poland
Principle clinical investigator for MOR208

Dr. Jurczak, why does MOR208 lend itself so well to combination therapies?
MOR208 has been very well tolerated in clinical trials as a single agent and has shown a clear and targeted efficacy profile. This makes it an interesting candidate for new combination therapies. The idea behind such therapies is to attack tumor cells from multiple sides to significantly increase the therapeutic benefit hoped for. For instance, in combination with a chemotherapeutic agent that has a different mechanism of action against blood cancer, the two compounds are intended to complement or, in an ideal case, even mutually reinforce each other. We want to further evaluate this in the planned clinical combination trials with MOR208 in lymphoma and leukemia patients.
Which indications are targeted with MOR208 in the upcoming clinical trials?
MOR208 is being developed to treat B cell malignancies of the lymphatic system. This could be a promising approach because MOR208 binds to the CD19CD19: Therapeutic target for the treatment of B cell lymphomas and leukemias antigen, which is expressed on malignant B cells. There are currently only few therapies available for patients suffering from relapsed and refractory diffuse large B cell lymphoma (DLBCL) and chronic lymphocytic lymphoma (CLL). Therefore, we see a high medical need for new, effective and well-tolerated combination therapies with an antibody such as MOR208 in these indications.
What is the clinical situation for DLBCL patients?
Currently, there are not many effective treatment alternatives available to patients diagnosed with relapsed or refractory DLBCL, the most common form of non-Hodgkin’s lymphoma. Aside from standard cytotoxic chemotherapies, most of the therapies that have been approved for this type of lymphoma are antibody therapies directed against the CD20CD20: Therapeutic target for the ­treatment of B cell lymphomas and ­leukemias target molecule. The CD19 antigen that MOR208 binds to, however, is very strongly expressed on B cells, and therefore seems to be a promising target molecule, in particular for those patients where a prior CD20-directed therapy has failed. MOR208 has already shown promising efficacy and good tolerability as a single agent in a phase 2a clinical trial in non-Hodgkin’s lymphoma, particularly in DLBCL. We will now test MOR208’s potential in combination with other anti-cancer drugs in this indication hoping to be able to offer patients new and effective treatment options.
What are you expecting from MOR208 in CLL?
CLL can currently be treated relatively successfully for a certain period with so-called Btk inhibitors such as ibrutinib. There is, however, a high unmet medical need for CLL patients after ending their therapy with ibrutinib. There are no approved therapies available to this patient group, and the life expectancy on average for these patients is very short. MOR208 could be a promising therapeutic combination partner in this indication, especially given the scientific findings that show MOR208’s ability not only to facilitate tumor cell killing, but also to potentially sensitize cancer cells, making them more susceptible to certain combination drug treatments. This will now be clinically tested in a planned combination trial with the cancer drug idelalisib in CLL patients after a failure of Btk inhibitor therapy.
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