Syndax, Incyte Sign $602 Million Collab to Advance Monoclonal Antibody

Syndax Pharmaceuticals and Incyte are collaborating to develop and commercialize the former’s anti-CSF-1R monoclonal antibody, axatilimab.

Briggs Morrison, M.D., CEO of Syndax said the partnership could “significantly expand and maximize” the program advancing the antibody to treat chronic graft-versus-host disease (cGVHD).

He said the antibody is also being developed for additional indications such as idiopathic pulmonary fibrosis (IPF), a type of organ fibrosis that causes scarring of the lungs. 

Collaboration Terms

Incyte will lead global commercial activities for axatilimab across all indications. Profits from the drug in the US will be split equally between the companies, while Syndax will receive royalties in the double-digits on ex-US sales.

In return, Incyte will pay Syndax $152 million in cash, including a $117 million upfront payment and a $35 million equity investment made at $24.62 per share. Considering Syndax’s closing price of $18.80 on Friday, Incyte’s stock purchase comes at a 30% premium. Finally, Syndax could receive up to $450 million in milestone payments if regulatory, development, and sales goals are met.

“We are excited to partner with Syndax and for the opportunity to bring another potential treatment to patients with life-threatening conditions, like GVHD,” said Hervé Hoppenot, CEO of Incyte.

“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.”

Axatilimab, Anti-CSF-1R Antibody

cGVHD is a life-threatening complication that arises when stem cells from a donor (graft) attack the tissues of the recipient (host). It occurs in 40% of patients who received hematopoietic stem cell transplantation or bone marrow transplant. It is estimated that cGVHD affects around 14,000 patients in the US.

Axalitimab blocks the receptor for CSF-1 (colony stimulating factor 1), a signal that controls the proliferation of immune cells. The antibody causes a reduction in the number of immune cells that mediate disease. 

The monoclonal antibody was licensed to Syndax from UCB, a research-focused Belgian biopharma, in 2016.

Axatilimab Trials

Syndax is planning a slew of trials for its drug, most of which will take place in 2022.

The company recently completed a Phase 1/2 trial of axatilimab in patients with cGVHD. The Phase 1 part of the study showed axatilimab was well-tolerated and brought about a high level of response from patients with cGVHD. Syndax expects to present updated results from the Phase 1 portion and Phase 2 preliminary results at a medical meeting in late 2021.

The drug is also being evaluated as a monotherapy in a global pivotal Phase 2 study dubbed AGAVE-2. Data on the primary endpoint and safety profile of the drug is expected to be revealed in 2023.

An additional Phase 2 trial will pair axatilimab with an unspecified JAK inhibitor in patients with steroid-refractory cGVHD. Beyond cGVHD, Syndax plans to start a Phase 2 proof of concept trial of axatilimab in patients with IPF next year.

Current Treatments for cGVHD

Treatment with steroids and immunosuppressants like tacrolimus is the standard of care for cGVHD. When first-line treatments fail, more potent drugs like Imbruvica (ibrutinib) are used. More recently, in July, Kadmon Pharma won FDA approval for Rezurock, its ROCK2 inhibitor, as a treatment for cGvHD, when two other systemic therapies have failed.

Barely a month after Rezurock launched in the US, Kadmon got snapped up by drug giant Sanofi in a $1.9 billion buyout.

Author

Joy Lin

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