MorphoSys Initiates Phase 2 Study of Anti-CD19 Antibody MOR208 in B-cell Acute Lymphoblastic Leukemia

MorphoSys AG (FSE: MOR; Prime Standard Segment; TecDAX) announced today that it has dosed the first patient in a Phase 2 clinical trial of MOR208 in B-cell acute lymphoblastic leukemia (B-ALL). MOR208 is a potent monoclonal Fc optimized anti-CD19 antibody to which MorphoSys gained worldwide access via an exclusive license and collaboration agreement with Xencor in 2010.
The US-based study is an open-label, multicenter, single-arm clinical trial designed to assess the efficacy of MOR208 in patients suffering from relapsed or refractory B-ALL. Secondary outcome measures include response duration, safety and pharmacokinetics of MOR208. In total, 30 patients are planned to be enrolled. More information on the trial can be found by searching for MOR208 at www.clinicaltrials.gov.
"Due to its high expression levels on non-Hodgkin's lymphomas and B-cell leukemias CD19 represents a particularly attractive immunotherapy target for hematological cancers," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG. "What is unique about MOR208 is that the antibody comprises only a very minor change to the Fc part of the molecule leading to significantly increased potency."
MOR208 has shown in a Phase 1/2a trial 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). In addition to the Phase 2 trial in B-ALL MorphoSys is about to start a second Phase 2 trial in Non-Hodgkin's Lymphoma (NHL).
B-cell malignancies, such as B-ALL, NHL and CLL affect more than one hundred and fifty thousand patients in the seven major markets each year. 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.
 
 
About MorphoSys:
MorphoSys developed HuCAL, the most successful antibody library technology in the pharmaceutical industry. By successfully applying this and other patented technologies, MorphoSys has become a leader in the field of therapeutic antibodies, one of the fastest-growing drug classes in human healthcare.
Together with its pharmaceutical partners, MorphoSys has built a therapeutic pipeline of more than 70 human antibody drug candidates for the treatment of cancer, rheumatoid arthritis, and Alzheimer's disease, to name just a few. With its ongoing commitment to new antibody technology and drug development, MorphoSys is focused on making the healthcare products of tomorrow. MorphoSys is listed on the Frankfurt Stock Exchange under the symbol MOR. For regular updates about MorphoSys, visit http://www.morphosys.com.
 
HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay®, RapMAT®, arYla®, Ylanthia® and 100 billion high potentials® are registered trademarks of MorphoSys AG.
Slonomics® is a registered trademark of Sloning BioTechnology GmbH, a subsidiary of MorphoSys AG.
 
This communication contains certain forward-looking statements concerning the MorphoSys group of companies. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve risks and uncertainties. Should actual conditions differ from the Company's assumptions, actual results and actions may differ from those anticipated. MorphoSys does not intend to update any of these forward-looking statements as far as the wording of the relevant press release is concerned.
 
 
For more information, please contact:
MorphoSys AG
Dr. Claudia Gutjahr-Löser
Head of Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-122
 
Mario Brkulj
Associate Director Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-454
 
Alexandra Goller
Specialist Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-332
 
investors@morphosys.com
MorphoSys Initiates Phase 2 Study of Anti-CD19 Antibody MOR208 in B-cell Acute Lymphoblastic Leukemia

MorphoSys AG (FSE: MOR; Prime Standard Segment; TecDAX) announced today that it has dosed the first patient in a Phase 2 clinical trial of MOR208 in B-cell acute lymphoblastic leukemia (B-ALL). MOR208 is a potent monoclonal Fc optimized anti-CD19 antibody to which MorphoSys gained worldwide access via an exclusive license and collaboration agreement with Xencor in 2010.
The US-based study is an open-label, multicenter, single-arm clinical trial designed to assess the efficacy of MOR208 in patients suffering from relapsed or refractory B-ALL. Secondary outcome measures include response duration, safety and pharmacokinetics of MOR208. In total, 30 patients are planned to be enrolled. More information on the trial can be found by searching for MOR208 at www.clinicaltrials.gov.
"Due to its high expression levels on non-Hodgkin's lymphomas and B-cell leukemias CD19 represents a particularly attractive immunotherapy target for hematological cancers," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG. "What is unique about MOR208 is that the antibody comprises only a very minor change to the Fc part of the molecule leading to significantly increased potency."
MOR208 has shown in a Phase 1/2a trial 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). In addition to the Phase 2 trial in B-ALL MorphoSys is about to start a second Phase 2 trial in Non-Hodgkin's Lymphoma (NHL).
B-cell malignancies, such as B-ALL, NHL and CLL affect more than one hundred and fifty thousand patients in the seven major markets each year. 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.
 
 
About MorphoSys:
MorphoSys developed HuCAL, the most successful antibody library technology in the pharmaceutical industry. By successfully applying this and other patented technologies, MorphoSys has become a leader in the field of therapeutic antibodies, one of the fastest-growing drug classes in human healthcare.
Together with its pharmaceutical partners, MorphoSys has built a therapeutic pipeline of more than 70 human antibody drug candidates for the treatment of cancer, rheumatoid arthritis, and Alzheimer's disease, to name just a few. With its ongoing commitment to new antibody technology and drug development, MorphoSys is focused on making the healthcare products of tomorrow. MorphoSys is listed on the Frankfurt Stock Exchange under the symbol MOR. For regular updates about MorphoSys, visit http://www.morphosys.com.
 
HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay®, RapMAT®, arYla®, Ylanthia® and 100 billion high potentials® are registered trademarks of MorphoSys AG.
Slonomics® is a registered trademark of Sloning BioTechnology GmbH, a subsidiary of MorphoSys AG.
 
This communication contains certain forward-looking statements concerning the MorphoSys group of companies. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve risks and uncertainties. Should actual conditions differ from the Company's assumptions, actual results and actions may differ from those anticipated. MorphoSys does not intend to update any of these forward-looking statements as far as the wording of the relevant press release is concerned.
 
 
For more information, please contact:
MorphoSys AG
Dr. Claudia Gutjahr-Löser
Head of Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-122
 
Mario Brkulj
Associate Director Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-454
 
Alexandra Goller
Specialist Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-332
 
investors@morphosys.com

Posted: April 2013

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