MorphoSys Provides an Update on its Proprietary Development Portfolio
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MorphoSys AG /
MorphoSys Provides an Update on its Proprietary Development Portfolio
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Lead Cancer Program MOR208 to be Examined in Numerous Combination Studies in
Hematological Cancers
Conference call and webcast (in English) today at 2:00pm CEST (1:00pm BST/8:00am
EDT)
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX, OTC: MPSYY) today
provided an update on the clinical development outlook for its proprietary drug
pipeline. Over the last several years, MorphoSys has built one of the broadest
and most differentiated biopharmaceutical pipelines in the biotechnology sector.
With the first partnered programs approaching the market and the Company's
proprietary portfolio gaining momentum, MorphoSys intends to commit additional
resources to advance its programs through approval-enabling studies and become a
commercial organization.
Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG commented: "MorphoSys
has successfully transitioned from a technology provider to a drug development
organization. With a robust set of proprietary drug candidates, now is the time
to scale our investment to ensure that we capture the full value of our
portfolio. We aspire to become a fully-integrated and commercial
biopharmaceutical organization with our own products on the market. Our lead
cancer compound MOR208, for which we have a comprehensive development plan, will
be at the forefront of this process."
MorphoSys's proprietary activities are currently focused on three clinical
candidates: the hemato-oncology programs MOR208 and MOR202, for which MorphoSys
holds worldwide commercial rights, and the prostate cancer program MOR209/ES414,
which is being co-developed with Emergent BioSolutions. MorphoSys is also
planning to commence clinical studies of MOR106 and MOR107 in inflammatory and
fibrotic indications respectively in 2016.
MOR208 - addressing current treatment challenges in leukemia and lymphoma
MOR208 is an Fc-enhanced antibody targeting CD19, a more widely and earlier
expressed target across multiple lymphomas and leukemias than CD20, the
therapeutic target of the most commonly used lymphoma and leukemia treatments.
By targeting CD19 and being Fc-enhanced, MOR208 could become an important and
attractive alternative to multiple current treatment options for some of the
sickest cancer patients. Based on promising results presented at the 2015 annual
meeting of the American Society of Clinical Oncology (ASCO 2015), MorphoSys will
commence two phase 2 trials of MOR208 in diffuse large B cell lymphoma (DLBCL)
and chronic lymphocytic leukemia (CLL) in the near future. In addition,
MorphoSys aims to start a pivotal study of MOR208 in DLBCL in 2017.
In DLBCL, MOR208 will be tested in combination with lenalidomide in up to 80
patients with relapsed/refractory DLBCL. The trial will be designed as an open
label, single arm study with the primary endpoint of objective response rate
(ORR) and multiple secondary endpoints, including progression-free survival
(PFS), overall survival (OS) and time to progression (TTP).
The CLL study will combine MOR208 with idelalisib and shall include 120 patients
previously treated with Bruton tyrosine kinase (BTK) inhibitor therapy. This
study will also be designed as an open label, single arm trial with the primary
endpoint of overall response rate (ORR) and multiple secondary endpoints,
including progression-free survival (PFS), overall survival (OS) and time to
progression (TTP).
In addition, MorphoSys aims to start a pivotal phase 3 trial in DLBCL in 2017,
which will test MOR208 plus bendamustine in a head-to-head setting against the
combination of rituximab and bendamustine in approximately 320 patients with
relapsed/refractory DLBCL, who are ineligible for high-dose chemotherapy (HDC)
and autologous stem cell transplantation (ASCT).
MOR208 is also being studied in two investigator-initiated trials (IIT). The
first is an ongoing phase 2 trial in CLL, which is being conducted by
MorphoSys's academic partner Dr. John Byrd, Director, Division of Hematology,
Department of Internal Medicine at Ohio State University and Dr. Jennifer Woyach
as co-investigator. This study is exploring a combination of MOR208 and
lenalidomide in treatment-naïve, older CLL patients, and relapsed/refractory CLL
patients. The second IIT is a pediatric study in ALL to be conducted in
collaboration with St. Jude Children's Research Hospital, Memphis, USA. This IIT
will test MOR208 in combination with NK-cell transplantation. Patient
recruitment for this study is anticipated to start in the first half of 2016.
Based on the positive clinical results of MOR208 in NHL which were presented at
ASCO 2015, the Company is also evaluating the possibility of commencing other
studies in B cell malignancies.
"MOR208 is an innovative, Fc-enhanced antibody which has shown great promise in
the clinic. It is one of a number of important assets for MorphoSys which we
believe can bring significant benefit to patients in need," commented Dr. Arndt
Schottelius, Chief Development Officer of MorphoSys AG. "Our goal is to
establish MOR208 as a new backbone therapy and as an ideal combination agent for
several other drugs used in a broad range of lymphomas and leukemias. Encouraged
by the promising clinical data generated so far with MOR208 and other drug
candidates, we plan to broaden our development activities."
The significantly expanded breadth of the planned and ongoing studies of MOR208
including the anticipated pivotal study in DLBCL is likely to result in
significantly higher proprietary R&D expenditure in 2016 and thereafter as
compared to previous years. MorphoSys will provide its financial guidance for
next year in early 2016.
MOR202 - generating promising data in multiple myeloma
MOR202 targets CD38, which is one of the most strongly and uniformly expressed
antigens on the surface of malignant plasma cells. Because of this expression
pattern, anti-CD38 antibodies are expected to have clinical utility as a new
therapeutic approach to multiple myeloma treatment. Initial promising efficacy
data for MOR202 was presented at ASCO 2015. A phase 1/2a study of MOR202 in
combination with dexamethasone in relapsed or refractory multiple myeloma
patients is nearing completion. Additional cohorts in which patients receive
MOR202 up to 16 mg/kg weekly in combination with pomalidomide or lenalidomide
plus dexamethasone have also commenced. Clinical data from those cohorts will be
presented at an upcoming medical conference.
MOR209/ES414 - co-development program with Emergent Biosolutions
MOR209/ES414 is a bi-specific anti-PSMA/anti-CD3 antibody being developed for
the treatment of prostate cancer. This immunotherapeutic protein activates the
patients' T-cell immunity specifically against prostate cancer cells expressing
Prostate Specific Membrane Antigen (PSMA), an antigen commonly over-expressed in
this tumor. A phase 1 study of MOR209/ES414 is ongoing, and will be conducted in
two stages. The primary objective of stage 1 of the study is to identify the
maximum tolerated dose (MTD) of MOR209/ES414 administered to patients with
metastatic castration-resistant prostate cancer (mCRPC). The primary objective
of stage 2 of the study is to evaluate the clinical activity of MOR209/ES414 in
patients who have received prior chemotherapy as well as those who are
chemotherapy-naïve. The study will enroll up to 130 patients and run through
2018. First clinical data are expected in 2016.
Continued investment in technology leadership aimed at producing additional
clinical development programs
In addition to MorphoSys's ongoing clinical studies, the Company is continuing
to progress its earlier programs including: i) the immuno-oncology focused
collaborations with Merck Serono and Immatics, ii) alliances with Heptares and
G7 Therapeutics to support development of a portfolio of therapeutic programs
targeting unique G protein-coupled receptors (GPCRs) and other transmembrane
proteins, iii) a co-development alliance with Galapagos, which, in MOR106, has
produced a first pre-clinical candidate in inflammatory diseases, iv) further
development of the lanthipeptide portfolio including MOR107 in fibrotic
diseases, and v) a growing target sourcing network with leading academic
organizations such as Temple University in Philadelphia, USA. As a result of
these efforts, MorphoSys expects to further expand its portfolio of discovery
programs and to proceed with at least two of these, namely MOR106 in
inflammation and MOR107 in fibrosis, into clinical development in 2016.
Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys AG added: "MorphoSys
has established a broad network of relationships with big pharma, biopharma
companies of various sizes and academia that could generate a stream of
attractive product opportunities. We intend to expand this network even further.
The Company's technology platforms continue to play an important role in
developing the pipeline and hence we are committed to investing in technology
development both through internal efforts and by seeking access to technology
innovations from the outside. The impact of Ylanthia, the latest antibody
library of MorphoSys, keeps increasing with 17 programs in MorphoSys's pipeline
now based on this platform. In addition, MorphoSys has established and continues
to refine platforms to generate alternative biomolecular formats including bi-
specific antibodies and constrained therapeutic peptides."
MorphoSys will hold a public conference call today at 02:00 p.m. CEST (08:00
a.m. EDT, 01:00 p.m. BST) to discuss the announcement.
Dial-in number for the Conference Call (listen-only):
Germany: +49 (0) 89 2444 32975
For U.K. residents: +44 (0) 20 3003 2666
For U.S. residents: +1 202 204 1514
Please dial in 10 minutes before the beginning of the conference.
In addition, MorphoSys offers participants the opportunity to follow the
presentation through a simultaneous slide presentation online at
http://www.morphosys.com.
A live webcast, slides, webcast replay and transcript will be made available at
http://www.morphosys.com.
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.
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
Mario Brkulj
Associate Director Corporate Communications & IR
Alexandra Goller
Manager Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-404
investors(at)morphosys.com
Media Release (PDF):
http://hugin.info/130295/R/1950334/709056.pdf
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(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
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