Salarius Pharmaceuticals announced that two recently published animal studies in peer-reviewed journals provide additional insight into the role of inhibiting lysine-demethylase 1 (LSD1 or KDM1A), a well-validated target in hematologic and solid tumors. The company's seclidemstat (SP-2577), a first-in-class, orally bioavailable LSD1 inhibitor, is currently being evaluated in an investigator-initiated Phase 1/2 clinical study at MD Anderson Cancer Center as a potential treatment for myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML) in patients with limited treatment options.
New Research Validates LSD1 Target
The first study, titled "Histones lysine demethylase 1A inhibitors, seclidemstat and tranylcypromine, induce astrocytogenesis in rat neural stem cells," was published in Biochemical and Biophysical Research Communications by lead author Sohyeon Kim of Chung-Ang University's College of Pharmacy in Seoul, Korea. According to the abstract, the findings suggest that KDM1A is a target for regulating neural stem cells fate and provide insights into the molecular mechanisms underlying neurodevelopmental processes and epigenetics.
The second study, "Lysine-specific demethylase 1 controls key OSCC preneoplasia inducer STAT3 through CDK7 phosphorylation during oncogenic progression and immunosuppression," was published in International Journal of Oral Science by lead author Amit Kumar Chakrabouty of Boston University's Henry M. Goldman School of Dental Medicine. The study provides a deeper understanding of oral squamous cell carcinoma (OSCC) progression and highlights LSD1 as a potential therapeutic target for controlling OSCC progression from preneoplastic lesions.
Clinical Development Progress
"These animal studies show the importance of inhibiting LSD1 expression and provide further support for the potential role of SP-2577 in slowing or stopping cancer cell growth," said David Arthur, President, CEO and Director of Salarius Pharmaceuticals. Arthur reported that the MDACC investigator-initiated hematologic cancer study is active and enrolling patients, with study updates expected later this year. The study will be supported while the company evaluates strategic alternatives for seclidemstat going forward.
The ongoing clinical trial is evaluating seclidemstat in MDS and CMML patients who previously failed or relapsed after hypomethylating agent therapy, representing a patient population with significant unmet medical needs.
Strategic Merger Advances
Salarius continues to make progress on its planned merger with Decoy Therapeutics Inc., announced on January 13, 2025. Under the definitive agreement, Decoy will merge with a wholly owned subsidiary of Salarius, with the newly formed company to be named Decoy Therapeutics.
The proposed transaction is expected to facilitate multiple value-creating inflection points with Decoy's pipeline of peptide conjugate therapeutics engineered by its IMP3ACT platform, which allows for the rapid computational design and manufacturing of innovative peptide conjugate therapeutics. Decoy's product pipeline targets unmet needs in respiratory infectious diseases and gastroenterology oncology indications.
Combined Company Pipeline
The combined company intends to incorporate Salarius' oral small molecule protein degrader SP-3164 into a highly targeted peptide-based proteolysis targeting chimeras (PROTACS) drug candidate. During the next 12 months, Decoy expects to advance its lead asset, a pan-coronavirus antiviral, to the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration, and to make progress with its other programs including a broad-acting antiviral against flu, COVID-19 and respiratory syncytial virus (RSV), and a peptide drug conjugate targeting GI cancers.
Following the merger, Decoy investors would own approximately 92.4% of the outstanding shares of the merged company and Salarius stockholders would own approximately 7.6% of the outstanding shares, exclusive of any shares issued in any financing necessary to consummate the merger transaction.
The combined company will be led by Decoy's Co-founders, Chief Executive Officer Frederick "Rick" Pierce and Chief Scientific Officer Barbara Hibner, along with other key executives from both companies.
