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Fox Chase Cancer Center added to ongoing Trial for Ewing Sarcoma and FET -Rearranged Sarcomas

PHILADELPHIA (July 13, 2021)– Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing potential new medicines for patients with pediatric cancers, solid tumors, and other cancers, announced today that Fox Chase Cancer Center in Philadelphia, PA, has been added as an active trial site for the dose-expansion stage of the ongoing clinical trial evaluating the company’s lead drug candidate, seclidemstat, in patients with relapsed or refractory Ewing sarcoma and advanced FET-rearranged sarcomas.


The addition of Fox Chase expands to nine the number of active sites participating in the open label trial intended to assess seclidemstat at the recommended Phase 2 dose (RP2D). Patient recruitment is now underway at all sites, and the first patients in the dose-expansion stage of the clinical trial have been dosed.


Seclidemstat is a novel, oral, reversible inhibitor of lysine-specific histone demethylase 1 (LSD1), an enzyme that has been shown to play a key role in the development and progression of several cancers.


Per the amended protocol, the trial’s dose-expansion stage now includes three patient arms. The first arm will enroll up to 30 patients with Ewing sarcoma, a rare and deadly pediatric bone cancer, and will investigate seclidemstat in combination with topotecan and cyclophosphamide, a commonly used second- and third- line chemotherapy regimen. Salarius believes data released during ASCO 2021 demonstrated synergy in an Ewing sarcoma cell line when seclidemstat was used in combination with topotecan and cyclophosphamide. Salarius believes this treatment combination and its use as a second- and third-line therapy could greatly expand the addressable patient population for seclidemstat and improve outcomes by allowing physicians to use seclidemstat earlier in the Ewing sarcoma continuum of care.


The trial’s second patient arm will investigate seclidemstat as a single agent in up to 15 patients with myxoid liposarcoma. The third patient arm will investigate seclidemstat as a single agent in up to 15 patients with select sarcomas that share a biology similar to Ewing sarcoma, also referred to as FET-rearranged or Ewing-related sarcomas. In data released at ASCO 2021, a subset of patients with advanced FET-rearranged sarcomas treated with single-agent seclidemstat resulted in stable disease (SD) and prolonged time to progression (TTP) which Salarius believes suggests disease control, a clinically relevant endpoint for soft tissue sarcomas.


All patient arms are designed to evaluate safety and efficacy endpoints in patients with advanced disease. Salarius expects to report data in 2022 and provide earlier updates if possible.


“We are excited to be working with Salarius and look forward to exploring the potential of seclidemstat and its ability to inhibit the LSD1 enzyme,” stated Johnathan Whetstine, Ph.D., Director, Cancer Epigenetics Institute (CEI), Fox Chase Cancer Center. “Based on our extensive research into the epigenetic causes of cancer, we believe LSD1 inhibition holds great promise in the treatment of many cancers. We believe data from preclinical studies using Ewing sarcoma cell lines has demonstrated the molecule’s ability to hit two aspects of the enzyme simultaneously. This, added to clinical data showing drug activity across Ewing and other sarcomas, support the further exploration of seclidemstat in these high unmet need patient populations.” Dr. Whetstine is a consultant to Salarius and has also served in an advisory capacity.


The recently founded CEI at Fox Chase is a national hub for epigenetics study and collaboration focused on mechanisms promoting cancer and therapeutic resistance. Its mission is to facilitate academic-to-industry and academic-to-academic partnerships with the goal of promoting discovery in cancer epigenetics.


David Arthur, CEO of Salarius Pharmaceuticals, stated, “Our goal is to make a difference in the lives of patients fighting cancer, and we believe the data we have released to date has been compelling. To now be working with a cancer research center of the caliber of Fox Chase Cancer Center further affirms the potential of seclidemstat to have a meaningful impact on the treatment of Ewing sarcoma and other cancers. We look forward to providing additional updates throughout 2021.”


Trial enrollment at Fox Chase will be led by Margaret von Mehren, M.D., Chief of Sarcoma Oncology.


In addition to Fox Chase, active clinical trial site locations include, Johns Hopkins All Children’s Hospital in St. Petersburg, FL; Children’s Hospital of Los Angeles in Los Angeles, CA; Moffitt Cancer Center in Tampa, FL; Dana-Farber Cancer Institute in Boston, MA; MD Anderson Cancer Center in Houston, TX; Nationwide Children’s Hospital in Columbus, OH; Memorial Sloan Kettering Cancer Center in New York City; and the Sarcoma Oncology Center in Santa Monica, CA.

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