Syndax, Incyte Announce Positive Topline Results From AGAVE-201 Trial Of Axatilimab

(RTTNews) - Syndax Pharmaceuticals Inc. (SNDX) and Incyte Corporation (INCY) announced on Monday positive topline data from their AGAVE-201 trial.

AGAVE-201 is a global pivotal phase II trial of drug candidate Axatilimab in adult and pediatric patients with chronic graft-versus-host disease (GVHD) who have undergone two or more prior lines of therapy.

The trial achieved its primary end point across all cohorts when patients were treated with Axatilimab at doses of 0.3 mg/kg every two weeks, 1.0 mg/kg every two weeks and 3.0 mg/kg every four weeks demonstrating overall response rates within the first six months at 74 percent, 67 percent and 50 percent, respectively.

Syndax has an exclusive worldwide collaboration and license agreement with Incyte that was signed in September 2021 to develop and commercialize Axatilimab.

The companies intend to submit a Biologics License Application to the FDA for Axatilimab by the end of this year.

"The results from the AGAVE-201 study are extremely compelling and underscore the potential benefits axatilimab may offer appropriate patients facing the serious complications associated with chronic GVHD," said Steven Stein, Chief Medical Officer of Incyte.

GVHD is an immune response of the donor-derived hematopoietic cells against recipient tissues. About 40% of transplant recipients are said to develop GVHD, affecting roughly 14,000 patients in the U.S.

Chronic GVHD typically manifests across multiple organ systems, with skin and mucosa being commonly involved, and is characterized by the development of fibrotic tissue.

In pre-market activity, shares of Syndax are trading at $23.50, up 10.54% on Nasdaq and shares of Incyte are trading at $64.82 up 1.04%