Takeda Pharmaceuticals has entered into an exclusive licensing agreement with Keros Therapeutics to develop and commercialize elritercept, a late-stage activin inhibitor, for the treatment of anemia in patients with hematologic cancers. The deal, announced Tuesday, positions elritercept as a potential competitor to Bristol Myers Squibb’s blockbuster drug Reblozyl (luspatercept).
Licensing Agreement Details
Under the terms of the agreement, Takeda will pay Keros $200 million upfront and is obligated to potential development, regulatory, and commercial milestone payments that could exceed $1.1 billion. Additionally, Keros will receive tiered royalties on net sales of elritercept. The agreement grants Takeda exclusive global rights to elritercept, excluding mainland China, Hong Kong, and Macau.
Teresa Bitetti, President of Takeda’s Global Oncology Business Unit, stated, “The addition of elritercept further bolsters our oncology pipeline and introduces a potential future growth driver for Takeda. Elritercept has the potential to make a meaningful difference for patients with blood cancers, one of our key areas of strategic focus.”
Elritercept's Clinical Development
Elritercept is currently being evaluated in two Phase II clinical trials for myelofibrosis and very low-, low-, or intermediate-risk myelodysplastic syndromes (MDS). The FDA has granted Fast Track designation to elritercept for very low-, low-, and intermediate-risk MDS.
Data presented at the European Hematology Association (EHA) Congress in June 2024 highlighted elritercept's potential to achieve durable transfusion independence in patients with lower-risk MDS, including those with high transfusion burdens. In the myelofibrosis study, elritercept demonstrated improvements in ineffective hematopoiesis and cytopenias, along with symptomatic relief and spleen volume reduction.
Takeda plans to initiate a Phase III trial for elritercept in MDS by the end of the year, according to a listing on clinicaltrials.gov.
Potential Impact and Analyst Perspectives
Analysts view the Takeda-Keros deal positively. Truist Securities noted that the agreement indicates a differentiated profile for elritercept in MDS and potentially myelofibrosis. Guggenheim Partners highlighted that the deal strengthens Keros’s balance sheet, allowing the company to focus on developing its Phase II asset, cibotercept, for pulmonary arterial hypertension.
About Myelodysplastic Syndromes and Myelofibrosis
Myelodysplastic syndromes (MDS) are a group of diverse blood cancers characterized by insufficient production of healthy blood cells in the bone marrow. Approximately 20,000 new cases are diagnosed annually in the United States. A majority of MDS patients experience anemia, impacting their quality of life and overall survival. 75% of people living with MDS have low-risk MDS, with a median survival of approximately three to 10 years. Many low-risk MDS patients require frequent red blood cell transfusions, which can increase over time and negatively impact quality of life.
Myelofibrosis (MF) is a rare and life-threatening blood cancer marked by scar tissue accumulation in the bone marrow, impairing normal blood cell production. Approximately 3,000 new cases of MF are diagnosed each year in the United States. 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.
