- The stock price of Syndax Pharmaceuticals Inc (NASDAQ: SNDX) increased by over 14% pre-market today. This is why it happened.
The stock price of Syndax Pharmaceuticals Inc (NASDAQ: SNDX) increased by over 14% pre-market today. Investors are responding positively to Syndax Pharmaceuticals and Incyte (Nasdaq: INCY) announcing today that they have entered into an exclusive worldwide collaboration and license agreement to develop and commercialize axatilimab — which is Syndax’s anti-CSF-1R monoclonal antibody.
Syndax and Incyte are looking to develop axatilimab as a backbone therapy for patients with cGVHD as well as in additional immune-mediated diseases where CSF-1R-dependent monocytes and macrophages are believed to contribute to organ fibrosis. And Syndax recently completed a Phase 1/2 trial of axatilimab in patients with cGVHD. The data from the Phase 1 portion of the trial highlighting the tolerability and high response rate of axatilimab in cGVHD patients refractory to multiple therapeutic agents were reported during an oral presentation at the American Society of Hematology Annual Meeting in December 2020. Updated results from the Phase 1 portion and preliminary results from the Phase 2 expansion portion of the study, which evaluated 1 mg/kg of axatilimab every two weeks, are expected to be presented at a medical meeting in the fourth quarter of 2021.
Enrollment is continuing in the ongoing global pivotal Phase 2 AGAVE-201 trial of axatilimab monotherapy in patients with cGVHD, with topline data expected in 2023. And the companies also plan to initiate additional trials of axatilimab in patients with cGVHD in 2022, including a Phase 2 trial in combination with a JAK inhibitor in patients with steroid-refractory cGVHD.
Beyond cGVHD, Syndax is planning to commence a Phase 2 proof of concept trial of axatilimab early next year in patients with IPF, a serious, life-limiting orphan disease for which axatilimab could represent a much-needed treatment option with a novel mechanism of action.
Under the terms of the agreement, Incyte is going to lead global commercial activities for axatilimab across all indications. And the companies will participate in a 50:50 profit share in the U.S., and Syndax will receive double-digit royalties on sales outside of the U.S. Syndax will retain the option to co-promote axatilimab for any approved indications in the U.S.
In connection with the agreement, Syndax is going to receive an upfront payment of $117 million plus a $35 million equity investment, which will be purchased at $24.62 per share — a 30% premium to the volume weighted average price over the 10 days prior to September 24, 2021. Plus Syndax will also be eligible to receive up to an additional $450 million in potential regulatory, development and commercial milestone payments.
The companies are going to 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. And Syndax will fund the initial development of axatilimab in IPF and Incyte will have the option to co-fund late-stage development for this indication.
“This partnership has the potential to significantly expand and maximize the axatilimab program across multiple lines of treatment in chronic graft-versus-host Disease (cGVHD), 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). Incyte is a proven leader in the development and commercialization of many important innovative therapies, including a treatment for GVHD. 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.”
— Briggs W. Morrison, M.D., Chief Executive Officer of Syndax
“We are excited to partner with Syndax and for the opportunity to bring another potential treatment to patients with life-threatening conditions, like GVHD. 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.”
— Hervé Hoppenot, Chief Executive Officer of Incyte
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