Salarius Pharmaceuticals and Nationwide Children’s Hospital Disclose Research Findings from Presentation at 2021 AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics

HOUSTON, Oct. 07, 2021 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing potential new medicines for patients with pediatric cancers, solid tumors, and other cancers, and Nationwide Children’s Hospital announced today research findings from their presentation at the 2021 AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics. The conference begins today, October 7, 2021, and runs through October 10, 2021.

The presentation, titled Targeting LSD1 protein scaffolding function in FET-rearranged sarcomas with SP-2577, disclosed preclinical research that demonstrated seclidemstat (SP-2577), Salarius’ lead drug candidate, has a differentiated mechanism of action that gives it potent activity in sarcomas compared to another LSD1 inhibitor. Previously published third-party research has revealed that LSD1 is highly expressed in various sarcoma subtypes, though not all LSD1 inhibitors show anti-tumor activity in these cancer types due to their respective mechanisms of action.

Salarius and Nationwide studied this concept by comparing seclidemstat, SP-2513 (an inactive control), and OG-L002 (representative compound of irreversible LSD1 inhibitors) in FET-rearranged sarcoma cell lines, specifically Ewing sarcoma, myxoid liposarcoma (MLS), desmoplastic small round cell tumor (DSRCT), and clear cell sarcoma (CCS). Highlights from the presentation included:

• Seclidemstat demonstrated potent activity across cell lines in vitro, while SP-2513 and OG-L002 had no/minimal activity against these cell lines.

• Preliminary in vivo assessment of seclidemstat efficacy in DSRCT patient-derived xenograft organoids resulted in a significant delay in time to event.

• Data indicates that the robust scaffolding inhibition function of seclidemstat is essential for reducing FET-rearranged driven sarcoma cell viability.
  

The presented preclinical data, in combination with results from the ongoing dose-expansion Phase 1/2 trial of seclidemstat in select sarcoma patients, demonstrate that seclidemstat’s differentiated mechanism of action gives it unique anti-cancer activity in FET-rearranged sarcomas compared to other LSD1 inhibitors. Ongoing research will focus on identifying potential biomarkers for selecting patients with increased sensitivity to seclidemstat.

“We are excited to have the opportunity to present the preclinical data that strongly supports the potential for seclidemstat in FET-rearranged sarcomas,” stated David Arthur, Chief Executive Officer for Salarius Pharmaceuticals. “Taken together, the findings detailed in the presentation demonstrate that seclidemstat’s unique inhibition of LSD1’s non-enzymatic functions is essential for reducing FET-fusion driven cancer cell viability. This data, combined with previous clinical data presented at American Society of Clinical Oncology 2021 (abstract# 3073) underscores our decision earlier this year to amend the dose-expansion stage of the ongoing Phase 1/2 sarcoma trial to include FET-rearranged sarcoma patients.”

Emily Theisen, Ph.D., principal investigator for The Center for Childhood Cancer and Blood Diseases at the Abigail Wexner Research Institute at Nationwide Children’s Hospital, stated, “The presented preclinical data demonstrate the important role that seclidemstat’s ability to inhibit LSD1’s scaffolding function plays in the drug’s anti-cancer activity. This is a promising area of research, and we look forward to future advances that bring new therapies to patients and their families.”

The full poster presentation is available on the AACR website at https://www.aacr.org/meeting/aacr-nci-eortc-international-conference-on-molecular-targets-and-cancer-therapeutics/ .

About Nationwide Children’s Hospital

Named to the Top 10 Honor Roll on U.S. News & World Report’s 2021-22 list of “Best Children’s Hospitals,” Nationwide Children’s Hospital, located in Columbus, Ohio, is one of America’s largest not-for-profit freestanding pediatric health care systems providing wellness, preventive, diagnostic, treatment and rehabilitative care for infants, children and adolescents, as well as adult patients with congenital disease. Nationwide Children’s has a staff of more than 13,000 providing state-of-the-art pediatric care during more than 1.6 million patient visits annually. As home to the Department of Pediatrics of The Ohio State University College of Medicine, Nationwide Children’s physicians train the next generation of pediatricians and pediatric specialists. The Abigail Wexner Research Institute at Nationwide Children’s Hospital is one of the Top 10 National Institutes of Health-funded freestanding pediatric research facilities. More information is available at NationwideChildrens.org.

About Salarius Pharmaceuticals

Salarius Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing cancer therapies for patients in need of new treatment options. Salarius’ lead candidate, seclidemstat, is being studied as a potential treatment for pediatric cancers, sarcomas and other cancers with limited treatment options. Seclidemstat is currently in a Phase 1/2 clinical trial for relapsed/refractory Ewing sarcoma and select additional sarcomas that share a similar biology to Ewing sarcoma, also referred to as Ewing-related or FET-rearranged sarcomas. Seclidemstat has received Fast Track Designation, Orphan Drug Designation and Rare Pediatric Disease Designation for Ewing sarcoma from the U.S. Food and Drug Administration. Salarius is also developing seclidemstat for several cancers with high unmet medical need, with a second Phase 1/2 clinical study initiated by MD Anderson Cancer Center exploring seclidemstat in hematologic cancers in combination with azacytidine. Salarius has received financial support from the National Pediatric Cancer Foundation to advance the Ewing sarcoma clinical program and was also 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 “anticipate,” “potential,” “progress,” “design,” “estimate,” “continue,” “will,” “aim,” “can,” “believe,” “plan,” “allow,” “expect,” “intend,” “goal,” “provide,” “able to,” “position,” “project,” “developing,” “look forward,” “promising,” and similar terms or expressions or the negative thereof. Examples of such statements include, but are not limited to, statements relating to the following: Salarius’ growth strategy; the value of seclidemstat as a potential treatment for Ewing sarcoma, FET-rearranged sarcomas and other cancers; the nature of research related to patients with sensitivity to seclidemstat; Salarius’ differential therapeutic activity in several cancer types; Salarius’ development of seclidemstat for several cancers with high unmet medical need; bringing new therapies to market; and Salarius’ plans to initiate additional clinical trials. 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; Salarius’ ability to project future capital needs and cash utilization and timing and accuracy thereof; the ability of Salarius to access the remaining funding available under the CPRIT grant; 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; the sufficiency of Salarius’ intellectual property protection; risks related to the drug development and the regulatory approval process; the competitive landscape and other industry-related risks; market conditions and regulatory or contractual restrictions which may impact the ability of Salarius to raise additional capital; the possibility of unexpected expenses or other uses of Salarius’ cash resources; risks related to the COVID-19 outbreak; and other risks described in Salarius’ filings with the Securities and Exchange Commission, including those discussed in Salarius’ quarterly report on Form 10-Q for the quarter ended June 30, 2021 and in Salarius’ annual report on Form 10-K for the year ended December 31, 2020. 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.

Contact:
Tiberend Strategic Advisors, Inc.
Maureen McEnroe, CFA
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Johanna Bennett (media)
(212) 375-2686
jbennett@tiberend.com