WILMINGTON – Biopharmaceutical giant Incyte Corp. announced Monday that it has bought into a new collaboration deal on a monoclonal antibody, paying about $152 million to Massachusetts-based clinical stage company Syndax Pharmaceuticals.
The exclusive worldwide collaboration and licensing agreement covers the development and commercialization of axatilimab, Syndax’s anti-CSF-1R monoclonal antibody, a drug that is in a global Phase 2 trial to treat chronic graft-versus-host disease.
That disease is an immune response of the donor-derived blood or blood plasma cells against recipient tissues. It is a serious, potentially life-threatening complication, of some stem cell transplants, which can last for years.
An estimated 40% of transplant recipients develop chronic graft-versus-host disease, affecting about 14,000 patients in the U.S. annually. It typically manifests across multiple organ systems, with skin and mucosa being commonly involved, and is characterized by the development of fibrotic tissue.
Axatilimab is being developed under a 2016 exclusive worldwide license entered into between Syndax and Belgian biopharma firm UCB. It has been granted Orphan Drug Designation by the FDA.
Incyte and Syndax plan to initiate additional patient trials of axatilimab in 2022, including a Phase 2 trial in combination with a JAK inhibitor – which Incyte specializes in – in patients with steroid-refractory chronic graft-versus-host disease.
Under the collaboration deal, Incyte will pay Syndax $117 million upfront and make a $35 million equity investment in the clinical-stage company. Incyte had more than $2 billion in cash on hand as of June 30, according to a U.S. Securities and Exchange report.
Syndax will also be eligible to receive up to an additional $450 million in potential milestone payments under the deal.
Incyte will lead global commercial activities for axatilimab across all indications, while Syndax will retain the option to co-promote axatilimab for any approved indications in the U.S. The companies will share U.S. profits and Syndax will receive double-digit royalties on sales outside of the U.S.
“We are excited to partner with Syndax and for the opportunity to bring another potential treatment to patients with life-threatening conditions, like graft-versus-host disease,” said Hervé Hoppenot, CEO of Incyte, in a statement announcing the deal. “Collaborations between companies like Incyte and Syndax, who are both dedicated to scientific advancement, contribute to the development of new innovative medicines that may benefit patient communities around the world.”
Incyte is no stranger to graft-versus-host disease, with its banner drug Jakafi approved just last week by the U.S. Food & Drug Administration in the treatment of the steroid-refractory version that the impending trial would target in combination with axatilimab.
The companies will share development costs associated with global and U.S.-specific trials for all agreed upon trials at a rate of 55% (Incyte) and 45% (Syndax), with Incyte responsible for 100% of future development costs for trials that are specific to ex-U.S. countries. Syndax will also fund the initial development of axatilimab in a serious lung disease, idiopathic pulmonary fibrosis, while Incyte will have the option to co-fund its late-stage development.
“This partnership has the potential to significantly expand and maximize the axatilimab program 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,” said Dr. Briggs W. Morrison, CEO of Syndax, in a statement. “Incyte is a proven leader in the development and commercialization of many important innovative therapies, including a treatment for graft-versus-host disease. We are thrilled to be working alongside this talented and determined team to combine our expertise as we strive to provide new treatment options for patients in desperate need of effective interventions.”
