Syndax Pharmaceuticals and Incyte have signed an exclusive global partnership and licence agreement to develop and market the former’s anti-CSF-1R monoclonal antibody, axatilimab.

The companies intend to advance the antibody as a backbone treatment for patients with chronic graft-versus-host disease (cGVHD).

Axatilimab will also be developed to treat various immune-mediated diseases, in which CSF-1R-dependent monocytes and macrophages are deemed to cause organ fibrosis.

Under the deal, Syndax will get $117m in upfront payment and an equity investment of $35m from Incyte.

In addition, Incyte will pay up to another $450m as potential regulatory, development and commercial milestone payments to Syndax.

Incyte will oversee the international commercialisation activities of axatilimab for all indications.

In the US, the companies will equally share the profit while Syndax will get double-digit royalty payments on product sales outside of the US.

Syndax also holds an option to jointly promote axatilimab for any approved indications in the US.

The development expenses linked to the international and US-specific clinical trials will be shared at a rate of 55% and 45% by Incyte and Syndax, respectively.

Incyte will handle the complete future development expenses for trials intended for markets outside the US.

The preliminary development of axatilimab in idiopathic pulmonary fibrosis (IPF) will be funded by Syndax while Incyte holds an option to co-fund late-stage development for the indication.

Syndax Pharmaceuticals CEO Briggs Morrison said: “This partnership has the potential to significantly expand and maximise the axatilimab programme across multiple lines of treatment in chronic graft-versus-host disease, as well as additional indications in which the monocyte-macrophage lineage plays a vital role in the fibrotic disease process such as idiopathic pulmonary fibrosis.”

Phase I data from the recently concluded Phase I/II trial showed axatilimab’s tolerability and increased response rate in cGVHD patients refractory to various therapeutic agents.

Subject enrolment is underway for the international Phase II AGAVE-201 trial of axatilimab as a single agent in cGVHD patients.

Topline results from this trial are expected to be reported in 2023.

In January last year, Incyte signed a collaboration and license agreement with MorphoSys to continue the global development and commercialisation of the latter’s tafasitamab (MOR208) for B-cell malignancies.