MorphoSys and Emergent BioSolutions Initiate Phase 1 Clinical Study to Evaluate the Novel Oncology Immunotherapeutic MOR209/ES414 for Prostate Cancer
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MorphoSys AG /
MorphoSys and Emergent BioSolutions Initiate Phase 1 Clinical Study to Evaluate
the Novel Oncology Immunotherapeutic MOR209/ES414 for Prostate Cancer
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The issuer is solely responsible for the content of this announcement.
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX, OTC: MPSYY) and Emergent
BioSolutions Inc. (NYSE: EBS) today announced the initiation of a Phase 1
clinical study to evaluate the safety, tolerability, and clinical activity of
MOR209/ES414 in patients with metastatic castration-resistant prostate cancer
(mCRPC). Under the terms of the companies' co-development and commercialization
agreement, the achievement of this milestone triggers a payment of US $ 5
million by MorphoSys to Emergent.
MOR209/ES414 is an immunotherapeutic protein developed by Emergent using its
proprietary ADAPTIR(TM) (modular protein technology) platform. Preclinical in
vitro and in vivo studies have shown MOR209/ES414 redirects T-cell cytotoxicity
towards cells expressing prostate specific membrane antigen (PSMA), an antigen
commonly found on prostate cancer cells.
Arndt Schottelius, Chief Development Officer of MorphoSys, said: "MOR209/ES414
has the potential to address a clear unmet medical need in prostate cancer. We
are thus delighted to see this compound moving into the clinic as expected in
early 2015. This is the fourth clinical candidate in our growing proprietary
portfolio of compounds and increases the total number of clinical programs in
our pipeline to 23."
Barry Labinger, Executive Vice President and President Biosciences Division at
Emergent BioSolutions added: "Emergent is pleased to announce the dosing of our
first patient in this Phase 1 clinical study. Prostate cancer is the most common
cancer in men, and there is a significant need for improved treatment options.
We believe that the immunotherapeutic approach represented by MOR209/ES414
offers the promise of meaningfully improved outcomes for patients with mCRPC. We
are excited to work with our partner MorphoSys, to evaluate the potential of
MOR209/ES414 in the clinic."
The study will be conducted in two stages. The primary objective of stage 1 is
to identify the maximum tolerated dose (MTD) of MOR209/ES414 administered
intravenously, with weekly dosing for three months and bi-weekly thereafter, to
patients with mCRPC. The secondary objectives are to evaluate the tolerability,
pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, cytokine response,
and clinical activity of MOR209/ES414. Within stage 2, the primary objective is
to evaluate clinical activity in patients that have or have not received prior
chemotherapy, while secondary objectives are to further characterize the safety
profile, PK, PD, and immunogenicity of MOR209/ES414.
This open-label phase 1 clinical study will be conducted in the U.S. and
Australia, with a planned enrollment of up to 130 patients. More information can
be found on clinicaltrials.gov.
About MOR209/ES414
MOR209/ES414 is a targeted immunotherapeutic protein, which activates host T-
cell immunity specifically against cells expressing Prostate Specific Membrane
Antigen (PSMA), an antigen commonly overexpressed on prostate cancer cells. The
MOR209/ES414 molecule was constructed using Emergent's ADAPTIR technology
platform and selectively binds to the T-cell receptor on cytotoxic T-cells and
PSMA on tumor cells. MOR209/ES414 contains two pairs of binding domains, each
targeting a unique antigen, linked to opposite ends of an immunoglobulin Fc
domain to extend the half-life and enable use of a purification process typical
of lg-based molecules. In preclinical studies, MOR209/ES414 has been shown to
redirect T-cell cytotoxicity towards prostate cancer cells expressing PSMA.
About the ADAPTIR(TM) Platform
ADAPTIR bispecific proteins are modular, single chain polypeptides that comprise
two separate binding domains, a hinge segment, and an effector domain (huFc).
They have a differentiated structure from monoclonal antibodies and can generate
a unique signaling response. Some ADAPTIR molecules, like MOR209/ES414, may
mediate T-cell cytotoxicity by redirecting T-cells against tumor cells. In
addition, monospecific ADAPTIR proteins may mediate complement dependent
cytotoxicity and Fc dependent cytotoxicity, similar to monoclonal antibodies.
ADAPTIR and any and all Emergent BioSolutions Inc. brand, product, service and
feature names, logos, and slogans are trademarks or registered trademarks of
Emergent BioSolutions Inc. or its subsidiaries in the United States or other
countries. All rights reserved.
About Prostate Cancer
Prostate cancer is the most common cancer in men with approximately 230,000 new
cases annually in the United States or 900,000 new cases annually worldwide.
Screening, radiation, surgery and hormone ablation therapy have greatly improved
the detection and treatment of early stage prostate cancer. However, the new
therapies only improve life expectancy by a few months for patients with
metastatic castration-resistant prostate cancer.
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 90 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.
About Emergent BioSolutions
Emergent BioSolutions is a global specialty biopharmaceutical company seeking to
protect and enhance life by offering specialized products to healthcare
providers and governments to address medical needs and emerging health threats.
Additional information about us may be found at www.emergentbiosolutions.com.
Follow us on twitter: (at)emergentbiosolu.
ADAPTIR(TM) is a trademark of Emergent BioSolutions.
MorphoSys Safe Harbor Statement
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.
Emergent BioSolutions Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Any statements, other than
statements of historical fact, are forward-looking statements. Forward-looking
statements in this press release include statements about the potential and
therapeutic opportunity of the MOR209/ES414 molecule and potential milestone and
royalty payments for development, regulatory approval and sales of the product
candidate. These forward-looking statements are based on our current intentions,
beliefs and expectations regarding future events. We cannot guarantee that any
forward-looking statement will be accurate. Investors should realize that if
underlying assumptions prove inaccurate or unknown risks or uncertainties
materialize, actual results could differ materially from our expectations.
Investors are, therefore, cautioned not to place undue reliance on any forward-
looking statement. Any forward-looking statement speaks only as of the date of
this press release, and, except as required by law, we do not undertake to
update any forward-looking statement to reflect new information, events or
circumstances.
There are a number of important factors that could cause the company's actual
results to differ materially from those indicated by such forward-looking
statements, including the success of clinical trials for MOR209/ES414; the
timing of and our ability to obtain and maintain regulatory approvals for
MOR209/ES414; the rate and degree of market acceptance and clinical utility of
MOR209/ES414 as a product; and our commercialization, marketing and
manufacturing capabilities and strategy with respect to MOR209/ES414. The
foregoing sets forth many, but not all, of the factors that could cause actual
results to differ from our expectations in any forward-looking statement.
Investors should consider this cautionary statement, as well as the risk factors
identified in our periodic reports filed with the SEC, when evaluating our
forward-looking statements.
For more information, please contact:
MorphoSys AG Emergent BioSolutions
Dr. Claudia Gutjahr-Löser
Head of Corporate Communications & IR Investors Contact:
Robert G. Burrows
Mario Brkulj Vice President, Investor Relations
Associate Director Corporate Communications Tel: +1 301-795-1877
& IR
BurrowsR(at)ebsi.com
Alexandra Goller
Media Contact:
Manager Corporate Communications & IR
Tracey Schmitt
Vice President, Global Public
Jessica Rush Affairs and Corporate Responsibility
Manager Corporate Communications & IR Tel: +1 301-795-1847
Tel: +49 (0) 89 / 899 27-404 SchmittT(at)ebsi.com
investors(at)morphosys.com
Media Release (PDF):
http://hugin.info/130295/R/1900060/675215.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#1900060]
Unternehmensinformation / Kurzprofil:
Datum: 09.03.2015 - 07:30 Uhr
Sprache: Deutsch
News-ID 376868
Anzahl Zeichen: 12431
contact information:
Town:
Martinsried / Munich
Kategorie:
Business News
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