− Elritercept is a late-stage, potentially best-in-class
activin inhibitor designed to treat anemia associated with certain
hematologic cancers, including myelodysplastic syndromes and
myelofibrosis
− Takeda to receive exclusive global license in all
territories outside of mainland China, Hong Kong and Macau
− Transaction builds upon Takeda’s legacy in the treatment of
hematologic cancers and advances company’s global oncology
strategy
Takeda (TSE:4502/NYSE:TAK) today announced that it has entered
into an exclusive licensing agreement with Keros Therapeutics, Inc.
(Nasdaq: KROS) to further develop, manufacture and commercialize
elritercept worldwide outside of mainland China, Hong Kong and
Macau.
Elritercept is a late-stage investigational activin inhibitor
designed to treat anemia associated with certain hematologic
cancers, including myelodysplastic syndromes (MDS) and
myelofibrosis (MF). The U.S. Food and Drug Administration (FDA) has
granted Fast Track designation for the development of elritercept
for very low-, low- and intermediate-risk MDS. MDS and MF are
characterized by inadequate blood cell production, often leading to
severe anemia that significantly impacts patient health and quality
of life. Elritercept targets activin A and B proteins, which are
believed to play a crucial role in anemia-associated diseases. In
early clinical studies, elritercept has shown promising clinical
activity and a manageable safety profile in patients with very
low-, low- and intermediate-risk MDS as a monotherapy and in
patients with MF in combination with standard of care.
“Elritercept has the potential to make a meaningful difference
for patients with blood cancers, one of our key areas of strategic
focus,” said Teresa Bitetti, President of the Global Oncology
Business Unit at Takeda. “The addition of elritercept further
bolsters our oncology pipeline and introduces a potential future
growth driver for Takeda. I am excited to further advance the
pioneering work begun by the Keros Therapeutics team with the goal
of delivering this potential treatment option to patients.”
Elritercept is currently in two ongoing Phase 2 clinical trials;
one in patients with very low-, low- or intermediate-risk MDS and
one in patients with MF. The Phase 3 RENEW trial evaluating
elritercept in adult patients with transfusion-dependent anemia
with very low-, low- or intermediate-risk MDS will begin enrollment
soon. Takeda plans to evaluate elritercept in these cancers across
patient segments and lines of therapy.
“We are excited to partner with Takeda, whose global reach and
expertise in oncology and hematology will help unlock elritercept’s
potential for patients with MDS and MF,” said Jasbir S. Seehra,
Ph.D., Chair and Chief Executive Officer at Keros Therapeutics.
“With a differentiated mechanism of action targeting a broad range
of pathways in blood cell production, elritercept has shown promise
for patients who have not responded to standard therapies. This
collaboration will accelerate development of elritercept for
patients in need and offer new insights into these complex
hematologic conditions.”
Under the terms of the agreement, Takeda will receive an
exclusive worldwide license to further develop, manufacture and
commercialize elritercept in all indications and territories
outside of mainland China, Hong Kong and Macau. Takeda will be
responsible for all development, manufacturing and
commercialization as of the effective date of the agreement. Takeda
will provide Keros Therapeutics with an upfront payment of $200
million and potential payments relating to regulatory, development
and commercial sales milestones, as well as royalties on net sales.
The agreement is subject to customary closing conditions, including
completion of antitrust reviews.
About Myelodysplastic Syndromes (MDS)
Myelodysplastic syndromes (MDS) are a group of diverse blood
cancers in which the bone marrow fails to produce enough healthy
blood cells. MDS is among the most common hematologic malignancies,
with approximately 20,000 new cases diagnosed annually in the
United States.1 Most people with MDS experience anemia, or low red
blood cell counts, which impacts quality of life and mortality.2
75% of people living with MDS have low-risk MDS, with a median
survival of approximately three to 10 years.3,4 Many low-risk MDS
patients require frequent red blood cell transfusions, which can
increase over time and negatively impact quality of life.5 Despite
advances, additional therapeutic options are needed to improve
quality of life and anemia symptoms for patients with low-risk MDS,
particularly those whose disease is ringed sideroblast-negative or
who have a high transfusion need.
About Myelofibrosis (MF)
Myelofibrosis (MF) is a rare and life-threatening blood cancer
characterized by the buildup of scar tissue in the bone marrow,
which impairs its ability to produce normal blood cells. In the
United States, approximately 3,000 new cases of MF are diagnosed
each year.6 Patients with MF often experience anemia, enlarged
spleen and other symptoms that significantly affect their quality
of life. Although standard treatments can reduce spleen size and
improve symptoms, they may exacerbate anemia and lead to low
platelet counts.
About Elritercept
Elritercept is an investigational, potentially best-in-class
activin inhibitor, targeting both activin A and activin B proteins,
which are believed to play a crucial role in anemia-associated
diseases. Elritercept is currently in two ongoing Phase 2 clinical
trials; one in patients with very low-, low- or intermediate-risk
MDS and one in patients with MF. The Phase 3 RENEW trial evaluating
elritercept in adult patients with transfusion-dependent anemia
with very low-, low- or intermediate-risk MDS will begin enrollment
soon. The U.S. Food and Drug Administration (FDA) has granted Fast
Track designation for the development of elritercept for this
condition.
About Takeda
Takeda is focused on creating better health for people and a
brighter future for the world. We aim to discover and deliver
life-transforming treatments in our core therapeutic and business
areas, including gastrointestinal and inflammation, rare diseases,
plasma-derived therapies, oncology, neuroscience and vaccines.
Together with our partners, we aim to improve the patient
experience and advance a new frontier of treatment options through
our dynamic and diverse pipeline. As a leading values-based,
R&D-driven biopharmaceutical company headquartered in Japan, we
are guided by our commitment to patients, our people and the
planet. Our employees in approximately 80 countries and regions are
driven by our purpose and are grounded in the values that have
defined us for more than two centuries. For more information, visit
www.takeda.com.
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factors identified in Takeda’s most recent Annual Report on Form
20-F and Takeda’s other reports filed with the U.S. Securities and
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https://www.takeda.com/investors/sec-filings-and-security-reports/
or at www.sec.gov. Takeda does not undertake to update any of the
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Medical Information
This press release contains information about products that may
not be available in all countries, or may be available under
different trademarks, for different indications, in different
dosages, or in different strengths. Nothing contained herein should
be considered a solicitation, promotion or advertisement for any
prescription drugs including the ones under development.
References:
- Gorak E, et al. Discordant pathologic diagnoses of
myelodysplastic neoplasms and their implications for registries and
therapies. Blood Adv. 2023 Oct 24;7(20):6120-6129. doi:
10.1182/bloodadvances.2023010061.
- Haring Y, et al. MDS-Related Anemia Is Associated with Impaired
Quality of Life but Improvement Is Not Always Achieved by Increased
Hemoglobin Level. J Clin Med. 2023 Sep 9;12(18):5865. doi:
10.3390/jcm12185865.
- de Witte T, et al. Novel dynamic outcome indicators and
clinical endpoints in myelodysplastic syndrome: The European
LeukemiaNet MDS Registry and MDS-RIGHT project perspective.
Haematologica. 2020 Nov 1;105(11):2516-2523. doi:
10.3324/haematol.2020.266817.
- Sekeres M, et al. Diagnosis and Treatment of Myelodysplastic
Syndromes: A Review. JAMA. 2022 Sep 6;328(9):872-880. doi:
10.1001/jama.2022.14578.
- Wood E, et al. Outpatient transfusions for myelodysplastic
syndromes. Hematology Am Soc Hematol Educ Program. 2020 Dec
4;2020(1):167-174. doi: 10.1182/hematology.2020000103.
- Mehta J, et al. Epidemiology of myeloproliferative neoplasms in
the United States. Leuk Lymphoma. 2014 Mar;55(3):595-600. doi:
10.3109/10428194.2013.813500. Epub 2013 Jul 29.
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Media:
Japanese Media Tsuyoshi Tada tsuyoshi.tada@takeda.com
U.S. and International Media Jennifer Anderson
jennifer.anderson@takeda.com
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