Clinic business

Salarius Pharmaceuticals adds two Mayo Clinic sites to its

Expands trial to 17 US sites and 25 locations
Launch of all planned U.S. test sites substantially complete

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

Seclidemstat is a new oral, reversible and targeted inhibitor of LSD1 which affects the expression of genes currently being studied in phase 1/2 clinical studies for the treatment of solid and hematological cancers where LSD1 is implicated in the progression of disease.

The Mayo Clinic Rochester site is led by Scott H. Okuno, MD, chairman of the Community Oncology Division of the Department of Oncology and chair of the Mayo Clinic Health System Cancer Committee, and the site of the Mayo Clinic in Jacksonville is led by Steven Attia, DO of the Mayo Clinic Comprehensive Cancer Center.

David Arthur, CEO of Salarius, said: “Ewing’s sarcoma and FET-rearranged sarcomas are particularly motivating for us, given the pediatric patient population affected by these diseases, and we believe seclidemstat could play a 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 that Doctors Okuno and Attia join our list of notable investigators leading the sarcoma study through United States.

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

In addition to the Mayo Clinic sites, clinical trial sites for seclidemstat include the Seattle Cancer Care Alliance; Oregon Health & Sciences in Portland, Oregon; Johns Hopkins All Children’s Hospital in St. Petersburg, Florida; Children’s Hospital of Los Angeles; Moffitt Cancer Center in Tampa, Florida; Dana-Farber Cancer Institute in Boston; MD Anderson Cancer Center in Houston; Children’s National Hospital in Columbus, Ohio; Memorial Sloan Kettering Cancer Center in New York; the Sarcoma Oncology Center in Santa Monica, California; 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 Trial in Ewing’s Sarcomas and Other FET-Rearranged Sarcomas
The Phase 1/2 trial is currently in its dose expansion phase, which includes three groups of patients. The first arm is enrolling up to 30 patients with Ewing’s sarcoma, a rare and fatal pediatric bone cancer, and will study seclidemstat in combination with topotecan and cyclophosphamide, a commonly used second- and third-line chemotherapy regimen . Salarius believes data published at ASCO 2021 demonstrated synergy in an Ewing’s sarcoma cell line when seclidemstat was used in combination with these agents. Salarius also believes that this combination of treatments and its use as second- and third-line therapy could significantly expand the addressable patient population for seclidemstat and improve outcomes by allowing physicians to introduce seclidemstat earlier in the treatment continuum. Ewing’s sarcoma care.

The second arm of the trial is studying seclidemstat as a single agent in up to 15 patients with myxoid liposarcoma. The third arm is studying seclidemstat as a single agent in up to 15 patients with selected sarcomas who share a similar biology to Ewing’s sarcoma, also called FET-rearranged or Ewing-related sarcomas. In data published at ASCO 2021, a subset of patients with advanced FET-rearranged sarcomas treated with a single agent seclidemstat resulted in stable disease and prolonged time to progression, which Salarius says suggests disease control, a clinically relevant endpoint for soft tissue sarcomas.

The three patient groups are designed to assess safety and efficacy in patients with advanced disease. Salarius expects to release interim data updates in the second half of 2022.

About Salarius Pharmaceuticals
Salarius Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing therapies for cancer patients in need of new treatment options. Salarius’ product pipeline includes seclidemstat, the company’s lead candidate, which is being investigated 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 other sarcomas that share similar biology, also called Ewing-related or FET-rearranged sarcomas. Seclidemstat has received expedited, orphan drug and rare pediatric disease designations for Ewing’s sarcoma from the United States Food and Drug Administration. Salarius is also exploring the potential of seclidemstat in several cancers with high unmet medical needs, with an investigator-initiated Phase 1/2 clinical study in hematologic cancers underway at MD Anderson Cancer Center. Salarius received financial support from the National Pediatric Cancer Foundation to advance the Ewing’s Sarcoma clinical program and received a product development award from the Cancer Prevention and Research Institute of Texas (CPRIT). For more information, 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 fact, included in this press release are forward-looking statements. These forward-looking statements may be identified by terms such as “believe”, “develop”, “expect”, “hope”, “may”, “progress”, “potential”, “could” and terms or expressions similar 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; preliminary data related to clinical trials of Salarius, including when such data is available and made public; the growth strategy of Salarius; the value of seclidemstat as a treatment for Ewing’s sarcoma, Ewing-related sarcomas and other cancers and its ability to improve the lives of patients; broaden the scope of Salarius’ research and focus on patient populations with high unmet need; milestones of current and future clinical trials of Salarius, including timing of data readouts. Salarius may not actually achieve the plans, achieve 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 that 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 adequacy of Salarius’ capital resources; Salarius’ ability and need to raise additional capital to meet Salarius’ business operational needs and to achieve its business objectives and strategy; future clinical trial results and the impact of the results on Salarius; that the results of clinical studies and trials may not be predictive of future clinical trial results; risks related to drug development and the regulatory approval process; the competitive landscape and other industry 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 that date. Salarius disclaims any intention 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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