Disc Medicine Announces Exclusive Licensing Agreement with Mabwell Therapeutics for Novel Anti-TMPRSS6 Monoclonal Antibodies to Modulate Iron Homeostasis
January 20 2023 - 6:00AM
Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage
biopharmaceutical company focused on the discovery, development,
and commercialization of novel treatments for patients suffering
from serious hematologic diseases, announced today that is has
entered into an agreement with Mabwell Therapeutics to obtain an
exclusive license to a portfolio of monoclonal antibodies targeting
TMPRSS6 (Transmembrane Serine Protease 6, also known as
Matriptase-2) including the phase 1-ready drug candidate MWTX-003.
Disc plans to initiate a phase 1 trial in healthy volunteers in the
second half of 2023.
MWTX-003 has the potential to address a wide range of
hematologic disorders including polycythemia vera and
beta-thalassemia by controlling iron homeostasis. Genetic studies
show that TMPRSS6 affects red blood cell formation by controlling
the level of iron that is available for erythropoiesis. Clinical
and non-clinical evidence has shown that reducing iron levels by
inhibiting TMPRSS6 has potential to treat hematologic
disorders.
“Disc has built deep expertise in the role of iron homeostasis
in hematologic disorders, and I am thrilled to expand our portfolio
with these highly complementary antibody programs.” said John
Quisel, J.D., Ph.D., Chief Executive Officer and President of Disc.
“We are delighted to be partnering with Mabwell, a company with a
strong antibody technology platform that is led by Dr. Xin Du, a
leading expert on TMPRSS6 biology. This program is in perfect
alignment with our strategy and we look forward to advancing
MWTX-003 into phase 1 studies later this year.”
Under the terms of the agreement, Disc will obtain exclusive
rights to develop and commercialize MWTX-003 and other anti-TMPRSS6
monoclonal antibodies discovered by Mabwell, in the United States,
Europe, and other territories outside of China and Southeast Asia.
MWTX-003 is phase 1-ready and received acceptance of an
Investigational New Drug (IND) application from the U.S. Food and
Drug Administration (FDA) in November 2022. Mabwell will receive an
upfront cash payment of $10.0 million, in addition to development
and commercial milestones for a total of up to $412.5 million in
eligible payments, and tiered, mid to high single digit royalties
on net sales.
The transaction is subject to customary closing conditions and
approval by the shareholders of the parent company of Mabwell
Therapeutics, Mabwell (Shanghai) Bioscience Co., Ltd.
About Disc
Disc Medicine is a clinical-stage biopharmaceutical company
committed to discovering, developing, and commercializing novel
treatments for patients who suffer from serious hematologic
diseases. We are building a portfolio of innovative, first-in-class
therapeutic candidates that aim to address a wide spectrum of
hematologic diseases by targeting fundamental biological pathways
of red blood cell biology, specifically heme biosynthesis and iron
homeostasis. For more information, please visit
www.discmedicine.com.
About Mabwell TherapeuticsMabwell Therapeutics,
Inc. is a San Diego-based biotechnology company focusing on the
discovery and development of antibody and protein-based drugs in
multiple therapeutic areas including hematological disorders, liver
disease, and neurodegenerative diseases. Mabwell Therapeutics is a
wholly-owned subsidiary of Mabwell (Shanghai) Bioscience Co., Ltd.,
a global integrated biopharmaceutical company primarily engaged in
the discovery, development, manufacturing, and commercialization of
biotherapeutics
Disc Cautionary Statement Regarding Forward-Looking
Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of
1995, including, but not limited to, express or implied statements
regarding: future product development plans and projected timelines
for the initiation and completion of preclinical and clinical
trials and other activities; the potential for the results of
ongoing preclinical or clinical trials and the efficacy of Disc’s
product candidates; future product development and regulatory
strategies, including with respect to specific indications; Disc’s
plans for Gemini’s assets; Disc’s plans for its hematology
portfolio; interactions with regulatory authorities; and Disc’s
financial position. The use of words such as, but not limited to,
“believe,” “expect,” “estimate,” “project,” “intend,” “future,”
“potential,” “continue,” “may,” “might,” “plan,” “will,” “should,”
“seek,” “anticipate,” or “could” or the negative of these terms and
other similar words or expressions that are intended to identify
forward-looking statements. Forward-looking statements are neither
historical facts nor assurances of future performance. Instead,
they are based on Disc’s current beliefs, expectations and
assumptions regarding the future of Disc’s business, future plans
and strategies, clinical results and other future conditions. New
risks and uncertainties may emerge from time to time, and it is not
possible to predict all risks and uncertainties. No representations
or warranties (expressed or implied) are made about the accuracy of
any such forward-looking statements.
Disc may not actually achieve the plans, intentions or
expectations disclosed in these forward-looking statements, and
investors should not place undue reliance on these forward-looking
statements. Actual results or events could differ materially from
the plans, intentions and expectations disclosed in the
forward-looking statements as a result of a number of material
risks and uncertainties including but not limited to: (i) the
outcome of any legal proceedings that may be instituted against the
parties and others related to the merger agreement; (ii)
unanticipated difficulties or expenditures relating to the merger,
the response of business partners and competitors to the
announcement or completion of the merger, and/or potential
difficulties in employee retention as a result of the announcement
or completion of the merger; (iii) Disc’s listing on the Nasdaq
Capital Market and operating as a public company; (iv) the adequacy
of Disc’s capital to support its future operations and its ability
to successfully initiate and complete clinical trials; (v) the
nature, strategy and focus of Disc; (vi) the difficulty in
predicting the time and cost of development of Disc’s product
candidates; (vii) Disc’s plans to research, develop and
commercialize its current and future product candidates; (viii) the
timing of initiation of Disc’s planned preclinical studies and
clinical trials; (ix) the timing of the availability of data from
Disc’s clinical trials; (x) the timing of any planned
investigational new drug application or new drug application; (xi)
the risk of cessation or delay of any ongoing or planned clinical
trials of Disc or its collaborators; (xii) the clinical utility,
potential benefits and market acceptance of Disc’s product
candidates; (xiii) Disc’s commercialization, marketing and
manufacturing capabilities and strategy; (xiv) Disc’s ability to
identify additional product candidates with significant commercial
potential and to expand its pipeline in hematological diseases;
(xv) the risk that Disc may not realize the intended benefits of
its drug discovery platform; (xvi) developments and projections
relating to Disc’s competitors and its industry; (xvii) the impact
of government laws and regulations; (xviii) the impact of public
health epidemics affecting countries or regions in which Disc has
operations or does business, such as the COVID-19 pandemic, (xix)
the timing and anticipated results of Disc’s preclinical studies
and clinical trials and the risk that the results of Disc’s
preclinical studies and clinical trials may not be predictive of
future results in connection with future studies or clinical trials
and may not support further development and marketing approval;
(xx) the timing and outcome of Disc’s planned interactions with
regulatory authorities; (xxi) findings from investigational review
boards at clinical trial sites and publication review bodies;
(xxii) Disc’s ability to protect its intellectual property
position; (xxiii) Disc’s estimates regarding future revenue,
expenses, capital requirements and need for additional financing;
(xxiv) the other risks and uncertainties described in the “Risk
Factors” section of the definitive proxy statement/prospectus dated
December 2, 2022 and filed with the SEC under Rule 424(b) and other
documents filed by Disc from time to time with the SEC, as well as
discussions of potential risks, uncertainties, and other important
factors in Disc’s subsequent filings with the Securities and
Exchange Commission; and (xxv) the post-closing integration of Disc
and Gemini. Any forward-looking statement speaks only as of the
date on which it was made. None of Disc, nor its affiliates,
advisors or representatives, undertake any obligation to publicly
update or revise any forward-looking statement, whether as result
of new information, future events or otherwise, except as required
by law.
Media Contact
Peg RusconiVerge Scientific
Communicationsprusconi@vergescientific.com
Investor Relations Contact
Christina Tartaglia (Investor)Stern Investor
Relationschristina.tartaglia@sternir.com
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