Galapagos and MorphoSys initiate Phase 1 study in joint antibody program MOR106
April 07 2016 - 10:13AM
Galapagos NV (Euronext & NASDAQ: GLPG) and MorphoSys AG
(FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) announced
today that dosing of MOR106, a first-in-class candidate human
monoclonal antibody, has been initiated in healthy volunteers in a
Phase 1 study. MOR106 was jointly discovered by Galapagos and
MorphoSys 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.
"The alliance with MorphoSys has produced a
first-in-class candidate human monoclonal antibody," said Piet
Wigerinck, CSO of Galapagos. "MOR106 is the 10th Galapagos
candidate with a new mode of action to be brought into the
clinic."
"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.
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.
Contacts
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@morphosys.com
Galapagos NV
Investors: Media:
Elizabeth
Goodwin
Evelyn Fox VP IR & Corporate
Communications
Director Communications +1 781 460
1784 +31
6 53 591 999
ir@glpg.com communications@glpg.com
Galapagos forward-looking statements This release may
contain forward-looking statements, including, among other things,
statements regarding the mechanism of action and profile, and
timing of clinical trials, of MOR106. Galapagos cautions the
reader that forward-looking statements are not guarantees of future
performance. Forward-looking statements involve known and
unknown risks, uncertainties and other factors which might cause
the actual results, financial condition and liquidity, performance
or achievements of Galapagos, or industry results, to be materially
different from any historic or future results, financial conditions
and liquidity, performance or achievements expressed or implied by
such forward-looking statements. In addition, even if
Galapagos' results, performance, financial condition and liquidity,
and the development of the industry in which it operates are
consistent with such forward-looking statements, they may not be
predictive of results or developments in future periods.
Among the factors that may result in differences are that
Galapagos' expectations regarding its MOR106 development program
may be incorrect, the inherent uncertainties associated with
competitive developments, clinical trial and product development
activities and regulatory approval requirements (including that
data from Galapagos' ongoing clinical research program may not
support registration or further development of MOR106 due to
safety, efficacy or other reasons), Galapagos' reliance on
collaborations with third parties (including its collaboration
partner for MOR106, MorphoSys), and estimating the commercial
potential of MOR106. A further list and description of these
risks, uncertainties and other risks can be found in Galapagos'
Securities and Exchange Commission (SEC) filings and reports,
including in Galapagos' most recent annual report on form 20-F
filed with the SEC and other filings and reports filed by Galapagos
with the SEC. Given these uncertainties, the reader is
advised not to place any undue reliance on such forward-looking
statements. These forward-looking statements speak only as of
the date of publication of this document. Galapagos expressly
disclaims any obligation to update any such forward-looking
statements in this document to reflect any change in its
expectations with regard thereto or any change in events,
conditions or circumstances on which any such statement is based or
that may affect the likelihood that actual results will differ from
those set forth in the forward-looking statements, unless
specifically required by law or regulation.
GLPG and MorphoSys initiate Phase 1 study in MOR106
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