Takeda Enhances Oncology Pipeline with Elritercept via Keros Therapeutics License Deal

Takeda, a prominent pharmaceutical company based in Osaka, Japan, and Cambridge, Massachusetts, has entered into an exclusive licensing agreement with Keros Therapeutics. This collaboration focuses on the further development, manufacturing, and global commercialization of elritercept, an investigational drug, outside of mainland China, Hong Kong, and Macau.

Elritercept is a late-stage investigational activin inhibitor designed to treat anemia linked to certain hematologic cancers, such as myelodysplastic syndromes (MDS) and myelofibrosis (MF). This drug has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of very low-, low-, and intermediate-risk MDS. These conditions are often marked by insufficient blood cell production, leading to severe anemia that impacts patients' health and quality of life. Elritercept targets activin A and B proteins, thought to play a significant role in anemia-related diseases, and has shown promising results in early clinical studies, both as a monotherapy for MDS and in combination with standard treatments for MF.

Teresa Bitetti, President of the Global Oncology Business Unit at Takeda, expressed optimism about elritercept’s potential to make a meaningful difference for patients with blood cancers, underscoring its strategic importance to Takeda's oncology pipeline. Bitetti emphasized the company's commitment to advancing the innovative work initiated by Keros Therapeutics.

Currently, elritercept is being evaluated in two Phase 2 clinical trials, one for patients with very low-, low-, or intermediate-risk MDS, and another for patients with MF. Additionally, a Phase 3 RENEW trial aimed at assessing elritercept in adult patients with transfusion-dependent anemia with very low-, low-, or intermediate-risk MDS will soon commence enrollment. Takeda plans comprehensive evaluations of elritercept across different patient segments and lines of therapy for these cancers.

Jasbir S. Seehra, Ph.D., Chair and CEO of Keros Therapeutics, highlighted the valuable partnership with Takeda, citing Takeda’s global reach and expertise in oncology and hematology as critical in realizing elritercept’s potential. Seehra pointed out that elritercept’s unique mechanism of action targets a broad range of pathways in blood cell production, showing promise for patients unresponsive to standard therapies.

Under the agreement, Takeda will receive an exclusive worldwide license to develop, manufacture, and commercialize elritercept for all indications and territories outside mainland China, Hong Kong, and Macau. Takeda will also handle all development, manufacturing, and commercialization activities from the effective date of the agreement. Keros Therapeutics will receive an upfront payment of $200 million, along with potential payments related to regulatory, development, and commercial milestones, as well as royalties on net sales. The agreement is subject to customary closing conditions, including antitrust reviews.

Myelodysplastic syndromes (MDS) are a group of diverse blood cancers characterized by the bone marrow's failure to produce sufficient healthy blood cells. Annually, about 20,000 new MDS cases are diagnosed in the United States. Most MDS patients experience anemia, significantly impacting their quality of life and survival. Approximately 75% of MDS patients are classified as low-risk, with a median survival of three to ten years. These patients often require frequent red blood cell transfusions, which can worsen their quality of life over time. Despite advancements, there is a need for new therapeutic options to improve life quality and anemia symptoms, especially for patients with high transfusion needs.

Myelofibrosis (MF) is a rare, life-threatening blood cancer characterized by the accumulation of scar tissue in the bone marrow, disrupting normal blood cell production. In the United States, around 3,000 new MF cases are diagnosed annually. MF patients commonly experience anemia, an enlarged spleen, and other symptoms that significantly affect their quality of life. While standard treatments can reduce spleen size and improve symptoms, they often worsen anemia and reduce platelet counts.

Elritercept, as an investigational activin inhibitor, targets activin A and B proteins, believed to be crucial in anemia-associated diseases. It is currently under evaluation in two Phase 2 clinical trials for very low-, low-, or intermediate-risk MDS and MF. The upcoming Phase 3 RENEW trial will assess its efficacy in adult patients with transfusion-dependent anemia in the same risk categories. The FDA has granted Fast Track designation to elritercept for this indication.