Incyte has signed a collaboration and license agreement with Syndax Pharmaceuticals to develop and commercialise axatilimab for chronic graft-versus-host disease (cGVHD) and other fibrotic diseases.
Axatilimab is an experimental monoclonal antibody that acts on colony stimulating factor-1 receptor (CSF-1R), which is believed to regulate monocytes and macrophages survival and functioning.
As part of the exclusive, global agreement, the companies are planning to develop the antibody as a backbone treatment for patients suffering from cGVHD.
Additionally, axatilimab will be developed to treat patients with immune-mediated diseases in which CSF-1R-dependent monocytes and macrophages are thought to cause organ fibrosis.
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 (IPF).”
The company has recently completed a Phase I/II study in cGVHD patients, where the Phase I data showed tolerability and increased response rate of axatilimab in cGVHD patients refractory to various therapeutic agents.
The top-line results from a pivotal Phase II AGAVE-201 trial are anticipated in 2023, with more trials of the antibody being planned for cGVHD treatment.
Under the terms of the deal, Syndax will receive $117m in upfront payment along with an equity investment of $35m from Incyte.
In addition, the company will also receive up to another $450m in potential regulatory, development and commercial milestone payments from Incyte.
As per the agreement, Incyte will handle the worldwide commercialisation activities of axatilimab for all the indications.
Meanwhile, the companies will equally share the profit from the sales of axatilimab in the US while Syndax will get double-digit royalties on sales outside the US.
Furthermore, the development costs related to the international and US-specific clinical studies will be shared at a rate of 55% by Incyte and 45% by Syndax.