MorphoSys AG Initiates Phase 2 Study of Anti-CD19 Antibody MOR208 in Non- Hodgkin's Lymphoma
Published: May 13, 2013
MARTINSRIED / MUNCHEN, GERMANY--(Marketwired - May 13, 2013) -
MorphoSys AG / MorphoSys Initiates Phase 2 Study of Anti-CD19 Antibody MOR208 in Non- Hodgkin's Lymphoma . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement.
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 Non- Hodgkin's Lymphoma (NHL). MOR208 is a potent Fc-optimized anti-CD19 antibody to which MorphoSys gained worldwide rights via an exclusive license and collaboration agreement with Xencor in 2010.
The open-label, multicenter, single-arm clinical trial is designed to assess the efficacy of MOR208 in patients with relapsed or refractory Non- Hodgkin's Lymphoma. Secondary outcome measures include response duration, safety and pharmacokinetics of MOR208. A total of up to 120 patients are planned to be enrolled in four separate sub-indications (FL, MCL, DLBCL and other forms of indolent NHL). More information on the trial can be found by searching for MOR208 at www.clinicaltrials.gov. The trial is to be conducted at sites across both Europe and the US.
"In MOR208 we have a very exciting cancer program with a huge potential. Evaluating MOR208 in NHL and B-ALL - building on the data we already have for CLL - should enable us to assess the therapeutic benefit and broader commercial potential of the molecule in hematological malignancies," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG. "Broadening the drug's development program into additional indications is intended to maximize the value of this compound."
MOR208 showed encouraging signs of preliminary anti-tumor activity and an acceptable safety and tolerability profile in a Phase 1/2a trial in patients with high-risk, heavily pretreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). In addition to the phase 2 trial in NHL, MorphoSys is currently evaluating the compound in a phase 2 trial in B-cell Acute Lymphoblastic Leukemia (B-ALL).
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.
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.
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Source: MorphoSys AG via Thomson Reuters ONE [HUG#1700850]
Media Release (PDF): http://hugin.info/130295/R/1700850/561416.pdf
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