Salarius Pharmaceuticals Presents SP-3164 Preclinical Data at the Inaugural Molecular Glue Drug Development Summit

Preclinical data show synergistic activity for the targeted protein degrader SP-3164 with rituximab in non-Hodgkin’s lymphomas, and significantly better performance than standard-of-care treatment

Company plans to submit an Investigational New Drug application to the U.S. Food and Drug Administration and begin a Phase 1 trial in 2023

HOUSTON, Jan. 27, 2023 (GLOBE NEWSWIRE) — Salarius Pharmaceuticals, Inc. (NASDAQ: SLRX), a clinical-stage biopharmaceutical company using protein inhibition and protein degradation to develop cancer therapies for patients in need of new treatment options, announces the presentation of preclinical data showing SP-3164’s activity in non-Hodgkin’s lymphoma (NHL) animal models. In a model of diffuse large B-cell lymphoma, SP-3164 exhibited synergistic activity with the approved anti-CD20 drug rituximab, resulting in the complete elimination of tumors in 50% of treated mice. The combination also performed significantly better than the approved regimen, lenalidomide and rituximab. These data were presented by Aundrietta Duncan, Ph.D., Salarius’ director of non-clinical development, at the inaugural Molecular Glue Drug Development Summit.

Dr. Duncan also presented data showing that SP-3164 alone demonstrated significant tumor growth inhibition compared with the control group and out-performed standard-of-care treatment in a follicular lymphoma mouse model. In the same follicular lymphoma model, the combination of SP-3164 with the standard-of-care agent showed a synergistic effect resulting in greater tumor growth inhibition than either SP-3164 or the standard-of-care agent alone.

“We are encouraged by the preclinical data generated with SP-3164 to date and look forward to commencing a Phase 1/2 clinical study in lymphoma later this year,” said David Arthur, president and chief executive officer of Salarius. “In addition, we expect to investigate SP-3164 in other hematologic malignancies while exploring the immune modulatory effects and potential combinations with existing immune-oncology drugs. We believe that SP-3164 holds significant promise to improve the treatment paradigm for blood cancers.”

Dr. Duncan’s presentation, titled “Development of the Cereblon-Binding Molecular Glue, SP-3164,” took place during the afternoon session on January 26, which was chaired by Daniela Santiesteban, Ph.D., Salarius’ director of targeted protein degradation. Dr. Duncan’s presentation is available for viewing in the Investors Events and Presentations section of Salarius’ website here.

About SP-3164
SP-3164 is an oral, next-generation molecular glue that uses Salarius’ deuterium-enabled chiral switching platform to stabilize the preferred (S)-enantiomer of avadomide, an extensively studied clinical compound that has demonstrated encouraging single-agent and combination-therapy clinical efficacy in NHL and other hematologic malignancies. The addition of deuterium at the chiral center of the molecule prevents conversion to the unwanted (R)-enantiomer, allowing for isolation and development of the preferred (S)-enantiomer into a potential new cancer treatment.

As such, SP-3164 is a new chemical entity and has been issued a U.S. composition-of-matter patent. Data presented in December 2022 at the American Society of Hematology Annual Meeting showed compelling SP-3164 activity in lymphoma models and supports SP-3164’s potential for the clinical trial in NHL planned to initiate in 2023.

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, Salarius’ 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 sarcoma and certain additional sarcomas that share a similar biology. This trial is currently on a partial clinical hold and is not enrolling new patients. Seclidemstat has received fast track, orphan drug and rare pediatric disease designations for Ewing 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 at MD Anderson Cancer Center. This trial is currently on a voluntary pause and is not enrolling new patients. Salarius has received financial support from the National Pediatric Cancer Foundation to advance the Ewing program and was a recipient of a Product Development Award from the Cancer Prevention and Research Institute of Texas (CPRIT). SP-3164 is currently in IND-enabling studies and anticipated to enter the clinic in 2023. 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 “will,” “believe,” “developing,” “expect,” “may,” “progress,” “potential,” “could,” “look forward,” “encouraging,” “might,” “should,” 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 future of the company’s Phase 1/2 trial of seclidemstat as a treatment for Ewing sarcoma and FET-rearranged sarcomas following the recently announced suspected unexpected severe adverse reaction (SUSAR) event and resulting partial clinical hold by the U.S. Food and Drug Administration (FDA); impact that the addition of new clinical sites will have on the development of Salarius’ product candidates; the timing of Salarius’ IND submissions to the FDA and subsequent timing for initiating clinical trials; 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 FDA may impose additional restrictions on the company’s Phase 1/2 trial of seclidemstat as a treatment for Ewing sarcoma and FET-rearranged sarcomas following the SUSAR, including a partial or full clinical hold; Salarius’ ability to resume enrollment in the clinical trial following its review of the available data surrounding the SUSAR; 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 the impact of such 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.

CONTACT:

LHA Investor Relations
Kim Sutton Golodetz
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