Omeros Corporation (Nasdaq: OMER) today announced two
presentations that will be featured at the 2025 Tandem Meetings –
the Transplantation & Cellular Therapy Meetings of the American
Society for Transplantation and Cellular Therapy and the Center for
International Blood and Marrow Transplant Research, to be held
February 12-15, 2025 in Honolulu, Hawaii.
Both presentations report real world outcomes from patients with
hematopoietic stem cell transplant-associated thrombotic
microangiopathy (TA-TMA) treated with narsoplimab supplied by
Omeros under an expanded access program, also referred to as
compassionate use.
The first reports overall survival of 128 allogeneic transplant
patients with TA-TMA treated with narsoplimab under the expanded
access program and will be featured as a podium presentation by
Michelle Schoettler, M.D., Assistant Professor of Pediatric
Oncology and Hematopoietic Cellular Therapy at Emory University
School of Medicine.
The second reports on a single-center cohort of adult TA-TMA
patients who were treated with narsoplimab after failing eculizumab
treatment. The abstract will be featured in a poster session and
presented by Piyatida Chumnumsiriwath, M.D., of the Hematopoietic
Stem Cell Transplantation and Cellular Therapy Program at the
University of California, Irvine.
The presentation abstracts are available now on the Tandem
Meetings website. Details of the presentations and links to each
abstract follow:
Narsoplimab Treatment for Hematopoietic Cell Transplant
Associated Thrombotic Microangiopathy – Real World Outcomes from an
Expanded Access Program
Presentation Session: Toxicity and Supportive
Care (Oral Abstract Session D) Date: Thursday, February 13, 2025
Presentation Time: 3:15 - 3:30 p.m. HST Location: Ballroom A (HCC)
Presenting Author: Michelle Schoettler, M.D. Abstract Link
Narsoplimab for Refractory Transplantation-Associated
Thrombotic Microangiopathy in Adult Patients Receiving Allogeneic
Hematopoietic Stem Cell Transplantation
Poster Session: Late Effects, Quality of Life
and Accelerated Aging Date: Thursday, February 13, 2025
Presentation Time: 6:45 - 7:45 p.m. HST Location: Exhibit Hall 3
(HCC) Presenting Author: Piyatida Chumnumsiriwath, M.D. Abstract
Link
The poster and presentation materials are expected to be made
available on Omeros’ website at investor.omeros.com shortly after
the meeting presentations.
About Narsoplimab
Narsoplimab, also known as “OMS721,” is an investigational fully
human monoclonal antibody targeting mannan-binding
lectin-associated serine protease-2 (MASP-2), a novel
pro-inflammatory protein target and the effector enzyme of the
lectin pathway of complement. Importantly, inhibition of MASP-2 has
been demonstrated to leave intact the antibody-dependent classical
complement activation pathway, which is a critical component of the
acquired immune response to infection. A biologics license
application (BLA) is pending before the FDA for use of narsoplimab
in the treatment of hematopoietic stem cell transplant-associated
thrombotic microangiopathy (TA-TMA). Omeros will resubmit the BLA
for narsoplimab in TA-TMA followed by our planned submission of the
corresponding European marketing authorisation application (MAA) in
2025. FDA has granted narsoplimab breakthrough therapy and orphan
drug designations for TA-TMA and orphan drug status for the
prevention (inhibition) of complement-mediated thrombotic
microangiopathies. The European Medicines Agency (EMA) has granted
orphan drug designation to narsoplimab for treatment in
hematopoietic stem-cell transplant.
About Hematopoietic stem cell transplant-associated
thrombotic microangiopathy (TA-TMA)
Hematopoietic stem cell transplant-associated thrombotic
microangiopathy (TA-TMA) is a significant and often lethal
complication of stem cell transplantation. This condition is a
systemic, multifactorial disorder caused by endothelial cell damage
induced by conditioning regimens, immunosuppressant therapies,
infection, graft-versus-host disease, and other factors associated
with stem cell transplantation. Endothelial damage, which activates
the lectin pathway of complement, plays a central role in the
development of TA-TMA. The condition occurs in both autologous and
allogeneic transplants but is more common in the allogeneic
population. In the United States and Europe, approximately 30,000
allogeneic transplants are performed annually. Recent reports in
both adult and pediatric allogeneic stem cell transplant
populations have found an approximately 40-percent incidence of
TA-TMA, and high-risk features may be present in up to 80 percent
of these patients. In severe cases of TA-TMA, mortality can exceed
90 percent and, even in those who survive, long-term renal sequalae
(e.g., dialysis) are common. There is no approved therapy or
standard of care for TA-TMA.
About Omeros Corporation
Omeros is an innovative biopharmaceutical company committed to
discovering, developing and commercializing first-in-class
small-molecule and protein therapeutics for large-market and orphan
indications targeting immunologic disorders, including
complement-mediated diseases and cancers, as well as addictive and
compulsive disorders. Omeros’ lead MASP-2 inhibitor narsoplimab
targets the lectin pathway of complement and is the subject of a
biologics license application pending before FDA for the treatment
of hematopoietic stem cell transplant-associated thrombotic
microangiopathy. Omeros’ long-acting MASP-2 inhibitor OMS1029 has
successfully completed Phase 1 single- and multiple-ascending dose
clinical studies. Zaltenibart, Omeros’ inhibitor of MASP-3, the key
activator of the alternative pathway of complement, is advancing
toward Phase 3 clinical trials for paroxysmal nocturnal
hemoglobinuria and complement 3 glomerulopathy. Funded by the
National Institute on Drug Abuse, Omeros’ lead phosphodiesterase 7
inhibitor OMS527 is in clinical development for the treatment of
cocaine use disorder. Omeros also is advancing a broad portfolio of
five novel cellular and molecular immuno-oncology programs. For
more information about Omeros and its programs, visit
www.omeros.com.
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 “aim,” “anticipate,” “believe,” “could,” “estimate,”
“expect,” “goal,” “intend,” “likely,” “look forward to,” “may,”
“objective,” “plan,” “potential,” “predict,” “project,” “should,”
“slate,” “target,” “will,” “would” and similar expressions and
variations thereof. Forward-looking statements, including
statements regarding the anticipated resubmission of the BLA for
narsoplimab in the United States and the submission of a marketing
authorization application with the EMA, the timing and outcomes of
regulatory events, the availability and outcomes of additional
analyses, the prospects for obtaining FDA or EMA approval of
narsoplimab in any indication, expectations regarding future cash
expenditures, and expectations regarding the sufficiency and
availability of our capital resources to fund current and planned
operations, including the potential commercialization of
narsoplimab if it is approved by FDA or the EMA, 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, unfavorable, unexpected or inconclusive results
of our statistical analyses relating to an external registry of
TA-TMA patients, potential differences between the diagnostic
criteria used in our pivotal trial and in the external registry,
and whether FDA and the EMA determine the registry used in our
statistical analysis is sufficiently representative of TA-TMA
patients, unanticipated or unexpected outcomes of regulatory
processes in relevant jurisdictions, unproven preclinical and
clinical development activities, our financial condition and
results of operations, regulatory processes and oversight,
challenges associated with manufacture or supply of our products to
support clinical trials, regulatory inspections and/or commercial
sale following any marketing approval, changes in reimbursement and
payment policies by government and commercial payers or the
application of such policies, intellectual property claims,
competitive developments, litigation, and the risks, uncertainties
and other factors described under the heading “Risk Factors” in our
Annual Report on Form 10-K filed with the Securities and Exchange
Commission on April 1, 2024, and in our subsequently filed
Quarterly Reports on Form 10-Q. Given these risks, uncertainties
and other factors, you should not place undue reliance on these
forward-looking statements, and we assume no obligation to update
these forward-looking statements, whether as a result of new
information, future events or otherwise, except as required by
applicable law.
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version on businesswire.com: https://www.businesswire.com/news/home/20250210383381/en/
Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations IR@omeros.com
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