On Tuesday, Takeda Pharmaceutical Company Limited (NYSE:TAK) 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 and myelofibrosis.
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The FDA has granted Fast Track designation for elritercept for very low-, low- and intermediate-risk MDS.
Myelodysplastic syndromes and myelofibrosis are characterized by inadequate blood cell production, often leading to severe anemia.
Elritercept targets activin A and B proteins, which are believed to be crucial 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 myelodysplastic syndromes as a monotherapy and in patients with myelofibrosis in combination with standard of care.
Elritercept is currently in two ongoing Phase 2 trials for very low-, low- or intermediate-risk myelodysplastic syndromes and myelofibrosis patients.
The Phase 3 RENEW trial evaluating elritercept in adult patients with transfusion-dependent anemia with very low-, low- or intermediate-risk myelodysplastic syndromes will begin enrollment soon.
Takeda plans to evaluate elritercept in these cancers across patient segments and lines of therapy.
Takeda will pay Keros Therapeutics an upfront payment of $200 million and is eligible to receive milestones with the potential to exceed $1.1 billion. Keros will also be eligible to receive tiered royalties on net sales.
William Blair writes that With Takeda taking responsibility for elritercept development, Keros (Outperform rating) will now have two wholly owned assets, including cibotercept in pulmonary arterial hypertension and KER-065 in obesity and neuromuscular indications, allowing Keros to narrow its focus.
The analyst notes that multiple offers for elritercept were received. Management believes that Takeda is aligned with its views on the broader opportunity for elritercept.