MorphoSys and Galapagos Initiate Phase 1 Study in Joint Antibody Program MOR106
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MorphoSys and Galapagos Initiate Phase 1 Study in Joint Antibody Program MOR106
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MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) and
Galapagos NV (Euronext & NASDAQ: GLPG) announced today that dosing of MOR106, a
first-in-class human monoclonal antibody, in healthy volunteers has been
initiated in a phase 1 study. MOR106 was jointly discovered by MorphoSys and
Galapagos under their collaboration, and has a novel mode of action with
potential application in inflammation.
The primary objective of the phase 1 study is to evaluate the safety and
tolerability of single doses of MOR106. The study is randomized, double-blind,
placebo-controlled and conducted in a single center in at least 56 healthy
volunteers in Belgium, evaluating single ascending doses (SAD) administered as
intravenous infusion. This phase 1 study is characterized by its adaptive
design, which enables the initiation of a subsequent multiple ascending dose
(MAD) study in patients, depending on the outcome of the SAD study in healthy
volunteers.
The study's secondary objective is to characterize the pharmacokinetic profile
of MOR106 as well as monitor the occurrence of anti-drug antibodies as a measure
of immunogenicity with MOR106. Topline results of the complete study, including
the potential subsequent MAD part in patients, are expected in the second half
of 2017.
"We are delighted to see the first antibody program from our alliance with
Galapagos entering the clinical development stage. MOR106 is MorphoSys's fifth
proprietary antibody program in clinical development and the first from our
novel Ylanthia technology platform. We are excited about the growing value and
maturity of our development pipeline. The start of this very innovative clinical
development program also reflects the high value of our ongoing collaboration
with Galapagos", commented Dr. Arndt Schottelius, Chief Development Officer of
MorphoSys AG.
"The alliance with MorphoSys has produced a first-in-class candidate human
monoclonal antibody," said Piet Wigerinck, Chief Scientific Officer of
Galapagos. "MOR106 is the 10th Galapagos candidate with a new mode of action to
be brought into the clinic."
About MOR106 and the antibody collaboration
MOR106 is a human IgG1 monoclonal antibody for treatment of inflammatory
diseases. MOR106 arises from the alliance initiated by Galapagos and MorphoSys
in 2008, in which both companies contribute their core technologies and
expertise. Galapagos provides the disease-related biology including cellular
assays and targets discovered using its target discovery platform. MorphoSys
contributes its Ylanthia antibody technology to generate fully human antibodies
directed against the target and contributes full CMC development of this
compound. Galapagos and MorphoSys will continue to equally share the research
and development costs, as well as all future revenues.
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 100 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®,
100 billion high potentials®, Slonomics®, Lanthio Pharma® and LanthioPep® are
registered trademarks of the MorphoSys Group.
About Galapagos
Galapagos (Euronext & NASDAQ: GLPG) is a clinical-stage biotechnology company
specialized in the discovery and development of small molecule medicines with
novel modes of action. Our maturing pipeline comprises Phase 2, Phase 1, pre-
clinical, and discovery programs in cystic fibrosis, inflammation, fibrosis,
osteoarthritis and other indications. We have discovered and developed
filgotinib: in collaboration with Gilead we aim to bring this JAK1-selective
inhibitor for inflammatory indications to patients all over the world. Galapagos
is focused on the development and commercialization of novel medicines that will
improve people's lives. The Galapagos group, including fee-for-service
subsidiary Fidelta, has approximately 440 employees, operating from its
Mechelen, Belgium headquarters and facilities in The Netherlands, France, and
Croatia. More information at www.glpg.com.
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
Jochen Orlowski
Associate Director Corporate Communications & IR
Alexandra Goller
Senior Manager Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-404
investors(at)morphosys.com
Galapagos NV
Investors:
Elizabeth Goodwin
VP IR & Corporate Communications
Tel: +1 781 460 1784
ir(at)glpg.com
Media:
Evelyn Fox
Director Communications
Tel: +31 6 53 591 999
communications(at)glpg.com
Media Release (PDF):
http://hugin.info/130295/R/2001219/738318.pdf
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: MorphoSys AG via GlobeNewswire
[HUG#2001219]
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Datum: 07.04.2016 - 07:30 Uhr
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News-ID 462458
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