Takeda Enters into License Agreement with Keros Therapeutics to Expand Oncology Pipeline
Wednesday, December 04, 2024
Takeda has signed an exclusive licensing agreement with Keros Therapeutics to develop, manufacture, and commercialise elritercept outside mainland China, Hong Kong, and Macau.
Elritercept is a potential best-in-class activin inhibitor targeting activin A and B proteins. It aims to address anaemia in diseases like MDS and MF. In addition to the ongoing Phase 2 trials, Takeda plans to initiate a Phase 3 trial to explore its efficacy in patients with transfusion-dependent anaemia.
The drug's FDA Fast Track designation reflects its promise in addressing unmet needs in these conditions.
Elritercept, a late-stage investigational activin inhibitor, is being developed to treat anaemia linked to certain haematologic cancers, such as myelodysplastic syndromes (MDS) and myelofibrosis (MF).
MDS encompasses a range of blood cancers where bone marrow produces insufficient healthy blood cells. Annually, around 20,000 new cases are reported in the U.S. Most patients experience anaemia, often requiring frequent red blood cell transfusions, which can adversely affect quality of life.
MF is a rare blood cancer marked by scarring in the bone marrow, which impairs blood cell production. Around 3,000 new cases are diagnosed annually in the U.S. Common symptoms include anaemia, spleen enlargement, and fatigue, which reduce quality of life. Although current therapies improve some symptoms, they can worsen anaemia and lower platelet counts.
It has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for treating very low-, low-, and intermediate-risk MDS. Both MDS and MF are associated with insufficient blood cell production, which can result in severe anaemia and significantly impact patient health.
Elritercept targets activin A and B proteins, key contributors to these conditions. Early studies have demonstrated its potential clinical benefits and manageable safety profile in treating low- to intermediate-risk MDS and in combination with standard care for MF.
Currently, elritercept is undergoing two Phase 2 trials: one for patients with MDS and another for those with MF. A Phase 3 trial, named RENEW, will soon begin to enrol patients with transfusion-dependent anaemia and very low-, low-, or intermediate-risk MDS. Takeda aims to expand its application across different patient groups and treatment stages.
Under the agreement, Takeda gains global rights to develop and commercialise elritercept in all areas except mainland China, Hong Kong, and Macau. Keros Therapeutics will receive an upfront payment of $200 million, with potential additional payments linked to regulatory, developmental, and commercial milestones, as well as royalties on future sales. Takeda will handle all development, manufacturing, and marketing responsibilities.
This agreement reflects Takeda's commitment to expanding its oncology portfolio and addressing significant gaps in treatments for haematologic cancers.
Source: takedaoncology.com
