Salarius Pharmaceuticals Adds Two Mayo Clinic Sites to its Ongoing Phase 1/2 Trial of Seclidemstat as a Treatment for Ewing’s Sarcoma and FET-Rearranged Sarcomas

Expands Trial to 17 U.S. Sites and 25 Locations 
Initiation of All Anticipated U.S. Trial Sites Largely Completed

HOUSTON, Aug. 22, 2022 (GLOBE NEWSWIRE) — Salarius Pharmaceuticals, Inc. (NASDAQ: SLRX), a clinical-stage biopharmaceutical company developing therapies for patients with cancer in need of new treatment options, announces the addition of the Mayo Clinic to its open-label Phase 1/2 trial with seclidemstat in Ewing’s sarcoma and FET-rearranged sarcomas. Mayo Clinic locations in Rochester, Minnesota, and Jacksonville, Florida are now supporting trial enrollment.

Seclidemstat is a novel oral, reversible, targeted LSD1 inhibitor that affects gene expression currently being studied in Phase 1/2 clinical studies for the treatment of solid and hematologic cancers where LSD1 is implicated in disease progression.

The Mayo Clinic site in Rochester is being led by Scott H. Okuno, M.D., Chair of the Division of Community Oncology for the Department of Oncology and Chair of the Mayo Clinic Health System Cancer Committee, and the Mayo Clinic site in Jacksonville is being led by Steven Attia, D.O. of the Mayo Clinic Comprehensive Cancer Center.

David Arthur, chief executive officer of Salarius, said, “Ewing’s sarcoma and FET-rearranged sarcomas are particularly motivating for us, given the pediatric patient population effected by these diseases, and we believe that seclidemstat could play an important role as a potential treatment for these sarcomas. The addition of these prestigious Mayo Clinic sites to our list of trial sites is deeply gratifying and we are grateful to have Dr.’s Okuno and Attia joining our roster of notable investigators leading the sarcoma study across the U.S.”

“We expect to report interim data from this trial in the second half of the year and are hopeful that seclidemstat, either alone or in combination with standard chemotherapy, will have a positive impact on the lives of these patients,” Mr. Arthur added.

In addition to the Mayo Clinic sites, seclidemstat clinical trial sites include Seattle Cancer Care Alliance; Oregon Health & Sciences in Portland, Ore.; Johns Hopkins All Children’s Hospital in St. Petersburg, Fla; Children’s Hospital of Los Angeles; Moffitt Cancer Center in Tampa, Fla.; Dana-Farber Cancer Institute in Boston; MD Anderson Cancer Center in Houston; Nationwide Children’s Hospital in Columbus, Ohio; Memorial Sloan Kettering Cancer Center in New York City; the Sarcoma Oncology Center in Santa Monica, Calif.; Virginia Cancer Specialists in Fairfax, Virginia; the Cleveland Clinic in Cleveland, Ohio; Washington University in St. Louis; Oncology Consultants in Houston; and Fox Chase Cancer Center in Philadelphia.

About the Phase 1/2 Ewing’s and other FET-rearranged sarcomas trial
The Phase 1/2 trial currently is in its dose-expansion stage, which includes three patient arms. The first arm is enrolling up to 30 patients with Ewing’s 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 a Ewing’s sarcoma cell line when seclidemstat was used in combination with these agents. Salarius also 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 introduce seclidemstat earlier in the Ewing’s sarcoma continuum of care.

The trial’s second arm is investigating seclidemstat as a single agent in up to 15 patients with myxoid liposarcoma. The third arm is investigating seclidemstat as a single agent in up to 15 patients with select sarcomas that share a similar biology to Ewing’s sarcoma, also referred to as FET-rearranged or Ewing’s-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 and prolonged time to progression, which Salarius believes suggests disease control, a clinically relevant endpoint for soft tissue sarcomas.

All three patient arms are designed to evaluate safety and efficacy in patients with advanced disease. Salarius expects to report interim data updates in the second half of 2022.

About Salarius Pharmaceuticals
Salarius Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing therapies for patients with cancer in need of new treatment options. Salarius’ product portfolio includes seclidemstat, the company’s lead candidate, which is being studied as a potential treatment for pediatric cancers, sarcomas and other cancers with limited treatment options, and SP-3164, an oral small molecule protein degrader. Seclidemstat is currently in a Phase 1/2 clinical trial for relapsed/refractory Ewing’s sarcoma and certain additional sarcomas that share a similar biology, also referred to as Ewing’s-related or FET-rearranged sarcomas. Seclidemstat has received fast track, orphan drug and rare pediatric disease designations for Ewing’s sarcoma from the U.S. Food and Drug Administration. Salarius is also exploring seclidemstat’s potential in several cancers with high unmet medical need, with an investigator-initiated Phase 1/2 clinical study in hematologic cancers underway at MD Anderson Cancer Center. Salarius has received financial support from the National Pediatric Cancer Foundation to advance the Ewing’s sarcoma clinical program and was a recipient of a Product Development Award from the Cancer Prevention and Research Institute of Texas (CPRIT). For more information, please visit salariuspharma.com or follow Salarius on Twitter and LinkedIn.

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These forward-looking statements may be identified by terms such as “believe,” “developing,” “expect,” “hopeful,” “may,” “progress,” “potential,” “could,” and similar terms or expressions or the negative thereof. Examples of such statements include, but are not limited to, statements relating to the following: the impact that the addition of new clinical sites will have on the development of Salarius’ product candidates; interim data related to Salarius’ clinical trials, including the timing of when such data is available and made public; Salarius’ growth strategy; the value of seclidemstat as a treatment for Ewing sarcoma, Ewing-related sarcomas, and other cancers and its ability to improve the life of patients; expanding the scope of Salarius’ research and focus to high unmet need patient populations; milestones of Salarius’ current and future clinical trials, including the timing of data readouts. Salarius may not actually achieve the plans, carry out the intentions or meet the expectations or objectives disclosed in the forward-looking statements. You should not place undue reliance on these forward-looking statements. These statements are subject to risks and uncertainties which could cause actual results and performance to differ materially from those discussed in the forward-looking statements. These risks and uncertainties include, but are not limited to, the following: the sufficiency of Salarius’ capital resources; the ability of, and need for, Salarius to raise additional capital to meet Salarius’ business operational needs and to achieve its business objectives and strategy; future clinical trial results and impact of results on Salarius; that the results of studies and clinical trials may not be predictive of future clinical trial results; risks related to the drug development and the regulatory approval process; the competitive landscape and other industry-related risks; and other risks described in Salarius’ filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as revised or supplemented by its Quarterly Reports on Form 10-Q and other documents filed with the SEC. The forward-looking statements contained in this press release speak only as of the date of this press release and are based on management’s assumptions and estimates as of such date. Salarius disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made.

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