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 Thera

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HOUSTON, Oct. 7, 2021 (GLOBE NEWSWIRE) — Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing potential new drugs for patients with childhood cancer, solid tumors and other cancers, and Nationwide Children’s Hospital today announced research results 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 will run through October 10, 2021.

The presentation, titled Targeting LSD1 protein scaffolding function in FET-rearranged sarcomas with SP-2577, revealed preclinical research that showed that Salarius’ lead drug candidate seclidemstat (SP-2577) has a differentiated mechanism of action that gives it potent activity. in sarcomas compared to another LSD1 inhibitor. Previously published third-party research has shown that LSD1 is highly expressed in several sarcoma subtypes, although not all LSD1 inhibitors exhibit antitumor 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, especially Ewing sarcoma, myxoid liposarcoma (MLS) , desmoplastic small round cell tumor (DSRCT), and clear cell sarcoma (CCS). Highlights from the presentation included:

Seclidemstat showed 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 the efficacy of seclidemstat in xenograft organoids derived from DSRCT patients resulted in a significant delay in time to event. Data indicate that the robust scaffold 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 Phase 1/2 dose-expansion trial of seclidemstat in selected sarcoma patients, demonstrate that the differentiated mechanism of action of seclidemstat gives it a unique anticancer 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 pleased to have the opportunity to present the preclinical data that strongly support the potential for seclidemstat in FET-rearranged sarcomas,” said David Arthur, Chief Executive Officer of Salarius Pharmaceuticals. Taken together, the findings in the presentation demonstrate that the unique inhibition of the non-enzymatic functions of LSD1 by seclidemstat is essential for reducing cancer cell viability by FET fusion. These data, combined with previous clinical data presented at the American Society of Clinical Oncology 2021 (abstract #3073), underscore our decision earlier this year to alter the dose-expansion phase of the ongoing Phase 1/2 sarcoma study to allow FET-rescheduled sarcoma patients. to include. .”

Emily Theisen, Ph.D., principal investigator of the Center for Childhood Cancer and Blood Diseases at the Abigail Wexner Research Institute at the Nationwide Children’s Hospital, stated, “The preclinical data presented demonstrate the important role that seclidemstat’s ability to enhance scaffold function of LSD1 plays in the anticancer activity of the drug. This is a promising area of ​​research and we look forward to future developments that will 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 the national 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 nonprofit freestanding pediatric health care systems that promote wellness, preventive, diagnostic, treatment and rehabilitation care for infants, children and adolescents, as well as adult patients with congenital disease. Nationwide Children’s has more than 13,000 employees who provide state-of-the-art pediatric care during more than 1.6 million patient visits per year. Home to the Ohio State University College of Medicine’s Department of Pediatrics, National Pediatricians educate 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 under investigation as a potential treatment for childhood cancer, sarcomas and other cancers with limited treatment options. Seclidemstat is currently in a Phase 1/2 clinical trial for relapsed/refractory Ewing sarcoma and is selecting additional sarcomas that have a similar biology to Ewing sarcoma, also known as Ewing-related or FET rearranged sarcomas. Seclidemstat has received the Fast Track Designation, Orphan Drug Designation, and Rare Pediatric Disease Designation for Ewing sarcoma from the US Food and Drug Administration. Salarius is also developing seclidemstat for several cancers with high unmet medical need, with a second Phase 1/2 clinical trial initiated by MD Anderson Cancer Center investigating seclidemstat in hematologic cancers in combination with azacytidine. Salarius has received funding from the National Pediatric Cancer Foundation to advance the clinical program for Ewing sarcoma and also 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, contained in this press release are forward-looking statements. These forward-looking statements can be identified by terms such as “anticipate”, “potential”, “progress”, “design”, “estimate”, “continue”, “will”, “aim”, “may”, “believe “. , “plan”, “allow”, “expect”, “plan”, “goal”, “bid”, “can”, “position”, “project”, “develop”, “look ahead”, “promising” , and similar terms or expressions or the negative thereof.Examples of such statements include, but are not limited to, statements regarding the following: Salarius’ growth strategy; the value of seclidemstat as a potential treatment for Ewing’s sarcoma, FET rearranged sarcomas and other cancers; the nature of research in patients with susceptibility to seclidemstat; Salarius’ differential therapeutic activity in different cancers; Salarius’ development of seclidemstat for various cancers with high unmet medical need; new therapies; and Salarius’ plans to initiate additional clinical trials Salarius may not actually realize the plans, the i intentions or meet the expectations or objectives set forth 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’ operational needs and achieve its business objectives and strategy; Salarius’ ability to project future capital needs and cash use and their timing and accuracy; Salarius’ ability to access the remaining funding available under the CPRIT grant; future clinical trial results and impact of the results on Salarius; that the results of studies and clinical trials may not be predictive of future results of clinical trials; the adequacy of Salarius’ intellectual property protection; risks associated with drug development and the regulatory approval process; the competitive landscape and other industry-related risks; market conditions and legal or contractual restrictions that may affect Salarius’ ability to raise additional capital; the possibility of unexpected expenses or other uses of Salarius’ funds; risks associated with 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 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 intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date they are made.

Contact:Tiberend Strategic Advisors, Inc. Maureen McEnroe, CFA(212) 375-2664 mmcenroe@tiberend.com

Johanna Bennett (media)(212) 375-2686 jbennett@tiberend.com

Source: Salarius Pharmaceuticals, Inc.

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