− 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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References:

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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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