Takeda has entered into a licensing agreement with Keros Therapeutics for elritercept in a deal worth up to $1.1bn for global development and commercialisation.

This partnership focuses on developing, manufacturing, and commercialising elritercept globally, excluding mainland China, Hong Kong, and Macau.

Elritercept is a late-stage investigational activin inhibitor aimed at treating anaemia linked to haematologic cancers like myelodysplastic syndromes (MDS) and myelofibrosis (MF).

The US Food and Drug Administration (FDA) has granted fast track designation for its development in very low-, low-, and intermediate-risk MDS.

Early clinical trials have shown promising results, with a manageable safety profile, both as a monotherapy for MDS and in combination with standard care for MF.

The experimental therapy is currently being assessed in two Phase 2 clinical trials. It is being tested in patients with very low-, low-, or intermediate-risk MDS, and another for patients with MF.

The Phase 3 RENEW trial, which will assess elritercept in adult patients with transfusion-dependent anaemia in very low-, low-, or intermediate-risk MDS, will begin enrolment soon.

Japan-based Takeda plans to evaluate elritercept across various patient segments and treatment lines for these cancers.

Takeda global oncology business unit president Teresa Bitetti said: “Elritercept has the potential to make a meaningful difference for patients with blood cancers, one of our key areas of strategic focus.

“The addition of elritercept further bolsters our oncology pipeline and introduces a potential future growth driver for Takeda.”

As per the agreement, Takeda will assume responsibility for all development, manufacturing, and commercialisation activities.

Keros Therapeutics will receive an upfront payment of $200m. This will come with potential milestone payments related to regulatory, development, and commercial sales, plus royalties on net sales, that could reach up to $1.1bn.

The agreement is subject to customary closing conditions, including antitrust reviews.

Keros Therapeutics chair and CEO Jasbir Seehra said: “With a differentiated mechanism of action targeting a broad range of pathways in blood cell production, elritercept has shown promise for patients who have not responded to standard therapies.

“This collaboration will accelerate development of elritercept for patients in need and offer new insights into these complex hematologic conditions.”

Keros Therapeutics is a Nasdaq-listed biopharmaceutical company developing novel therapeutics targeting TGF-ß protein signalling. Its pipeline also includes cibotercept for pulmonary hypertension, and KER-065 for obesity and neuromuscular diseases.