Newly Established Center Will Focus on
Complement and Inflammation
Omeros Corporation (Nasdaq: OMER) today announced that it has
entered into a research collaboration with the University of
Cambridge, establishing the Omeros Center at Cambridge for
Complement and Inflammation Research (OC3IR). The OC3IR currently
is focusing on research related to OMS721, Omeros’ lead human
monoclonal antibody targeting mannan-binding lectin-associated
serine protease-2 (MASP-2), the effector enzyme of the complement
system’s lectin pathway, and to OMS906, Omeros’ lead human
monoclonal antibody targeting MASP-3, the key activator of the
complement system’s alternative pathway. OMS721 is currently in
three Phase 3 clinical programs – stem cell transplant-associated
thrombotic microangiopathy, IgA nephropathy and atypical hemolytic
uremic syndrome – and OMS906 is planned to enter the clinic in
early 2020. Omeros holds proprietary positions around both MASP-2
and MASP-3.
The OC3IR will be led by Professor Wilhelm Schwaeble, DSc,
Director of Research, working in close collaboration with other
Cambridge complement researchers, including Sir Peter Lachmann, ScD
FRS FMedSci, Emeritus Sheila Joan Smith Professor of Immunology at
the University of Cambridge. One of the Center’s priorities will be
to characterize further the role and response of the complement
system in endothelial injury, which is implicated in a wide range
of diseases including thrombotic microangiopathies, kidney diseases
and central nervous system disorders. The Center will also
facilitate collaborative links between Omeros and other leading
academic research laboratories in the field of complement and
inflammation research. Any intellectual property resulting from
Omeros-sponsored research at the OC3IR will be owned by Omeros, and
Omeros will have an exclusive option to acquire all rights to
intellectual property that is jointly supported by other funding
sources.
“The University of Cambridge has a longstanding history of
groundbreaking complement research, and we are excited to join
forces with Omeros to continue advancing the translation of
complement science,” said Professor Patrick Maxwell, DPhil FRCP
FMedSci, Regius Professor of Physic at the University of
Cambridge. “MASP-2 and MASP-3 are unique targets and hold
significant advantages over other complement enzymes targeted by
investigational or marketed drugs. MASP-2 and MASP-3 are
increasingly implicated in an expanding array of severe disorders,
and we look forward to working with Omeros for the betterment of
patients.”
“This partnership represents a tremendous opportunity to benefit
from the renowned complement and inflammation expertise at
Cambridge,” stated Gregory A. Demopulos, MD, chairman and chief
executive officer of Omeros. “Our prior work with Professor
Schwaeble proved extremely fruitful, and we expect that this
renewed collaboration with him, Professor Lachmann and their
colleagues will enhance and broaden Omeros’ complement franchise of
therapeutic targets, antibodies and small molecules. The result, we
expect, will be good for Omeros, Cambridge and, most importantly,
patients.”
About Omeros’ MASP Programs
Omeros controls the worldwide rights to MASP-2 and all
therapeutics targeting MASP-2, a novel pro-inflammatory protein
target involved in activation of the complement system, which is an
important component of the immune system. The complement system
plays a role in the inflammatory response and becomes activated as
a result of tissue damage or microbial infection. MASP-2 is the
effector enzyme of the lectin pathway, one of the principal
complement activation pathways. Importantly, inhibition of MASP-2
does not appear to interfere with the antibody-dependent classical
complement activation pathway, which is a critical component of the
acquired immune response to infection, and its abnormal function is
associated with a wide range of autoimmune disorders. MASP-2 is
generated by the liver and is then released into circulation.
Gene-targeted MASP-2-deficient mice and humans with MASP-2 gene
polymorphisms that affect MASP-2 serum levels and MASP-2 functional
activity are generally healthy with no obvious adverse
phenotype.
Phase 3 clinical programs are in progress for OMS721 in atypical
hemolytic uremic syndrome (aHUS), in immunoglobulin A (IgA)
nephropathy and in hematopoietic stem cell transplant-associated
thrombotic microangiopathy (HSCT-TMA). Also, two Phase 2 trials are
ongoing. One is continuing to enroll IgA nephropathy patients and
has already generated positive data in patients with IgA
nephropathy and with lupus nephritis; the other is enrolling and
has reported positive data in patients with HSCT-TMA and in
patients with aHUS. OMS721 can be administered both intravenously
and subcutaneously, and Omeros expects to commercialize each
formulation of OMS721 for different therapeutic indications. In
parallel, Omeros is developing small-molecule inhibitors of MASP-2.
Based on requests from treating physicians, Omeros has established
a compassionate-use program for OMS721, which is active in both the
U.S. and Europe. The FDA has granted OMS721 breakthrough therapy
designation for IgA nephropathy and for high-risk HSCT-TMA, orphan
drug status for the prevention (inhibition) of complement-mediated
thrombotic microangiopathies and for the treatment of IgA
nephropathy, and fast track designation for the treatment of
patients with aHUS.
Omeros also has identified MASP-3 as responsible for the
conversion of pro-factor D to factor D and as a critical activator
of the human complement system’s alternative pathway. The
alternative pathway is linked to a wide range of immune-related
disorders. In addition to its lectin pathway inhibitors, the
company is advancing its development of antibodies and
small-molecule inhibitors against MASP-3 to block activation of the
alternative pathway. Omeros has initiated the manufacturing
scale-up process of its MASP-3 antibodies in preparation for
clinical trials.
About Omeros Corporation
Omeros is a commercial-stage biopharmaceutical company committed
to discovering, developing and commercializing small-molecule and
protein therapeutics for large-market as well as orphan indications
targeting inflammation, complement-mediated diseases and disorders
of the central nervous system. The company’s drug product OMIDRIA®
(phenylephrine and ketorolac intraocular solution) 1% / 0.3% is
marketed for use during cataract surgery or intraocular lens (IOL)
replacement to maintain pupil size by preventing intraoperative
miosis (pupil constriction) and to reduce postoperative ocular
pain. In the European Union, the European Commission has approved
OMIDRIA for use in cataract surgery and other IOL replacement
procedures to maintain mydriasis (pupil dilation), prevent miosis
(pupil constriction), and to reduce postoperative eye pain. Omeros
has multiple Phase 3 and Phase 2 clinical-stage development
programs focused on: complement-associated thrombotic
microangiopathies; complement-mediated glomerulonephropathies;
cognitive impairment; and addictive and compulsive disorders. In
addition, Omeros has a diverse group of preclinical programs and a
proprietary G protein-coupled receptor (GPCR) platform through
which it controls 54 new GPCR drug targets and corresponding
compounds, a number of which are in preclinical development. The
company also exclusively possesses a novel antibody-generating
platform.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934, which are
subject to the “safe harbor” created by those sections for such
statements. All statements other than statements of historical fact
are forward-looking statements, which are often indicated by terms
such as “anticipate,” “believe,” “could,” “estimate,” “expect,”
“future”, “goal,” “intend,” “likely”, “look forward to,” “may,” “on
track”, “plan,” “potential,” “predict,” “project,” “prospects,”
“should,” “slated,” “will,” “would” and similar expressions and
variations thereof. Forward-looking statements are based on
management’s beliefs and assumptions and on information available
to management only as of the date of this press release. Omeros’
actual results could differ materially from those anticipated in
these forward-looking statements for many reasons, including,
without limitation, risks associated with product commercialization
and commercial operations, unproven preclinical and clinical
development activities, regulatory oversight, intellectual property
claims, competitive developments, litigation, and the risks,
uncertainties and other factors described under the heading “Risk
Factors” in the company’s Quarterly Report on Form 10-Q filed with
the Securities and Exchange Commission on November 8, 2018. Given
these risks, uncertainties and other factors, you should not place
undue reliance on these forward-looking statements, and the company
assumes no obligation to update these forward-looking statements,
even if new information becomes available in the future.
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version on businesswire.com: https://www.businesswire.com/news/home/20181211005212/en/
Jennifer Cook WilliamsCook Williams Communications, Inc.Investor
and Media Relations360.668.3701jennifer@cwcomm.org
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