OSAKA, JAPAN & CAMBRIDGE, MASS. -- Takeda (TSE:4502/NYSE:TAK) 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.