Keros’ elritercept has shown promising efficacy signals in myelofibrosis and myelodysplastic syndromes and could pose a formidable challenge to Bristol Myers Squibb’s Reblozyl.
Takeda Pharmaceuticals on Tuesday inked an exclusive licensing deal with Massachusetts-based biotech Keros Therapeutics to advance a potential competitor to Bristol Myers Squibb’s blockbuster injection Reblozyl (luspatercept).
At the center of Tuesday’s deal is Keros’ elritercept, a late-stage activin inhibitor being assessed for the treatment of anemia in patients with hematologic cancers such as myelofibrosis and myelodysplastic syndromes (MDS). Elritercept previously won the FDA’s Fast Track designation for very low-, low- and intermediate-risk MDS.
For the worldwide rights to develop, manufacture and commercialize elritercept, Takeda is paying Keros $200 million upfront and is pledging development, approval and commercial milestone payments “with the potential to exceed $1.1 billion,” according to Keros’ news release. The biotech will also be entitled to tiered royalties on net sales of elritercept.
Tuesday’s agreement will give Takeda control over elritercept in international markets except mainland China, Hong Kong and Macau.
“The addition of elritercept further bolsters our oncology pipeline and introduces a potential future growth driver for Takeda,” Teresa Bitetti, president of Takeda’s Global Oncology Business Unit, said in a statement. “Elritercept has the potential to make a meaningful difference for patients with blood cancers, one of our key areas of strategic focus.”
Elritercept is currently being studied in two Phase II trials—one in myelofibrosis and the other in very low-, low-, or intermediate-risk MDS.
At the 29th Annual Hybrid Congress of the European Hematology Association in June 2024, Keros touted “durable transfusion independence” in patients with lower-risk MDS after treatment with elritercept, including in those who had high transfusion burdens. In the myelofibrosis study, presented at the same conference, elritercept addressed ineffective hematopoiesis and cytopenias, while also providing other clinical benefits such as easing symptoms and reducing spleen volume.
Takeda plans to take elritercept into late-stage development, with a clinicaltrials.gov page showing that an MDS study is scheduled to start by the end of this year.
Elritercept could potentially compete with BMS’s Reblozyl, a blockbuster erythroid maturation agent indicated for MDS and beta-thalassemia. In the third quarter, Reblozyl surged 80% to bring in nearly $450 million for the pharma.
For Keros, analysts see the Takeda deal to be a big positive. Truist Securities in a Tuesday note wrote that the agreement is “a strong indication for differentiated profile of elritercept in MDS and likely [myelofibrosis],” adding that Takeda’s upfront payment will put the biotech “in a strong capital position with runway expected into 4Q 2028.”
Guggenheim Partners agreed, noting that “today’s deal helps to shore up the company’s balance sheet,” which in turn should allow it to focus its resources into the development of its Phase II asset cibotercept, being developed for pulmonary arterial hypertension. A readout for this program is expected in the second quarter of 2025.
