Pipeline Update
Partnered Discovery
During the second quarter of 2010, MorphoSys’s partnered therapeutic antibody pipeline decreased to 64 active antibody development programs in total, with 2 programs moving into phase 1, increasing the number of programs in clinical development to 9 in total. 25 programs are in preclinical development and 30 in research (not including a co-development candidate with Novartis).
In the first six months, two partner companies, namely Centocor Ortho Biotech and Novartis, advanced HuCAL-based antibody programs into phase 1 clinical trials. Both events triggered clinical milestone payments to MorphoSys.
Centocor Ortho Biotech’s program aims at the therapeutic area of inflammatory and autoimmune diseases and is the fourth clinical trial to be reached within the collaboration with MorphoSys.
The third therapeutic antibody within the Novartis collaboration to reach clinical trials is being developed in the area of muscosceletal diseases. The first proof of concept in man of a HuCAL antibody which was achieved by the partner during the second quarter was another sign of the very successful collaboration with Novartis. This event marked an important scientific progress in proving the therapeutic benefit of HuCAL-derived antibody drugs.
Altogether, MorphoSys projects that in 2010, between four and six partnered programs could enter clinical trials.
Proprietary Development
MOR103
The phase 1b/2a clinical trial of MorphoSys’s lead drug MOR103 continues according to plan. MOR103 is a fully human HuCAL antibody directed against GM-CSF (granulocyte macrophage-colony stimulating factor), being developed in the area of inflammatory diseases such as rheumatoid arthritis (RA), where current treatment options are inadequate.
In total, the randomized, double-blind, placebo-controlled, dose-escalation trial is expected to enroll 135 patients and will be conducted in multiple centers in several European countries. The trial is currently being conducted in clinical centers in Germany, Bulgaria and the Netherlands. Enrollment is expected to be completed in the first half of 2011 with the final results expected in H1 2012.
MOR202
MOR202 is a fully human HuCAL antibody directed against CD38, a membrane-bound glycoprotein that is a promising target for the treatment of multiple myeloma. The Company expects to file a clinical trial application (CTA) before the end of 2010 and commence a phase 1/2 trial in early 2011.
Being a part of Munich’s biotechnology initiative “m4 – Personalized Medicine and Targeted Therapies”, the program has recently been awarded a research grant of the German Federal Ministry of Education and Research, BMBF. The funding of up to € 1.1 million further supports the Company’s development plans. As part of the program, the Company plans to explore relevant biomarkers for the anti-CD38 approach in collaboration with the University Hospital of Munich Technical University, thereby further differentiating this new therapeutic approach.
MOR208
In June 2010, MorphoSys added an important program to its growing product portfolio by signing a worldwide exclusive license and collaboration agreement with US-based Xencor, Inc. for an antibody in phase 1 clinical development.
Xencor’s antibody XmAb5574, which has been renamed MOR208 after the signing of the agreement, is a humanized anti-CD19 monoclonal antibody for the treatment of B-cell malignancies. It has been engineered to possess significantly enhanced antibody- dependent cell-mediated citotoxicity (ADCC), thereby maximising tumor cell killing and potentially being more efficient than traditional cancer antibodies on the market.
The FDA has approved a phase 1 trial in patients with chronic lymphocytic leukemia (CLL) in the USA, which under the terms of the agreement will be fully sponsored by Xencor. After the successful completion of this study, MorphoSys will be solely responsible for further clinical development.
Early-stage pipeline
Work with MOR104 and MOR105, two early-stage programs in inflammation, as well as with MOR205 and MOR206, two discovery programs in the therapeutic area of cancer, continues as planned.
Target Discovery
MorphoSys has selected a new target molecule in the indication of cancer, which will form the basis for the program MOR207.