October 05, 2012 / 7:30 am, CET
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today that its collaboration partner OncoMed Pharmaceuticals has advanced the HuCAL antibody OMP-59R5 into the next stage of clinical development. OMP-59R5, which is part of OncoMed's Notch pathway collaboration with GlaxoSmithKline, is now being evaluated in a Phase 1b/2 trial in the US in first-line advanced pancreatic cancer patients.
"We are excited to see this innovative HuCAL program advancing into the next stage of clinical development. Today's news further underlines that MorphoSys's pipeline has matured substantially and is today well balanced with several compounds in mid- to late-stage clinical development," commented Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys AG. "OMP-59R5 represents the most advanced HuCAL-based antibody program targeting a validated cancer stem cell pathway. Cancer stem cells potentially offer one of the most attractive targets for attacking a range of tumor types, making this program an exciting addition to the overall pipeline of HuCAL-based drugs."
In the Phase 1b/2 "ALPINE" trial (Antibody therapy in first-Line Pancreatic cancer Investigating anti-Notch Efficacy and safety), OMP-59R5 is being tested in combination with gemcitabine in first-line advanced pancreatic cancer patients. Following a Phase 1b safety run-in, a randomized Phase 2 clinical trial will proceed in these patients to compare the efficacy of standard-of-care gemcitabine either with OMP-59R5 or with placebo. The primary endpoints of the Phase 2 part of the trial will be progression-free survival (PFS) in OMP-59R5 arms compared to a placebo arm. The two primary endpoints will examine PFS in all patients, as well as in patients who have a particular biomarker. Key secondary and exploratory endpoints include overall survival, response rate, and safety, and these endpoints will be assessed in all patients, as well as in the biomarker positive subset of patients.
MorphoSys's clinical pipeline now comprises one program in phase 2/3 clinical development, nine in phase 2 and eleven in phase 1. Of these, four are proprietary, as yet un-partnered programs, namely MOR103, which has successfully completed a phase 1b/2a trial in rheumatoid arthritis and a phase 1b trial in multiple sclerosis, MOR208, which has completed a phase 1 trial for chronic lymphocytic leukemia and MOR202, which is in a phase 1/2a trial for multiple myeloma.
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. The company's AbD Serotec unit uses HuCAL and other antibody technologies to generate superior monoclonal antibodies for research and diagnostic applications.
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® and 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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