Submission of Investigational New Drug application expected in the second quarter of 2023 with start of Phase 1 trial expected in second half of 2023

HOUSTON, TX, USA I May 01, 2023 I 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 completion of two Good Laboratory Practice (GLP) toxicology studies with its targeted protein degrader SP-3164, with no unexpected safety findings during the course of either study. These GLP toxicology reports will be included in the Investigational New Drug (IND) application the company plans to submit to the U.S. Food and Drug Administration (FDA) in the second quarter of 2023.

“We are encouraged by the successful completion of these GLP toxicology studies, which represents another significant milestone in the development of SP-3164. Based on preclinical research completed to date, we believe SP-3164 has potential to address several types of lymphomas and other cancers both as monotherapy and in combination with approved standard of care therapies,” said David Arthur, president and chief executive officer of Salarius. “These results reinforce our belief that SP-3164 holds significant promise to improve the treatment paradigm for blood cancers.”

Salarius held a pre-IND meeting with the FDA in May 2022 and is in the process of completing activities that will allow it to commence a Phase 1 study in the second half of this year.

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 non-Hodgkin Lymphomas (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 for Hematology Annual Meeting showed compelling SP-3164 activity in lymphoma models and supports SP-3164’s potential for the Phase 1 clinical trial in NHL planned to initiate in 2023. Additional supporting data were presented in April 2023 at the American Association for Cancer Research Annual Meeting showing SP-3164 demonstrates compelling antitumor activity in animal models of follicular lymphoma and multiple myeloma.

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. 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 or follow Salarius on Twitter and LinkedIn.

SOURCE: Salarius Pharmaceuticals