Salarius Pharmaceuticals Announces Patient Enrollment to Resume in Investigator-Initiated Phase 1/2 Clinical Trial Using Seclidemstat With Azacitidine to Treat Hematologic Cancers

Salarius Pharmaceuticals, Inc. recently announced patient enrollment will resume in the investigator-initiated Phase 1/2 clinical trial evaluating seclidemstat in combination with azacitidine for the treatment of myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML). The trial is being conducted at the University of Texas MD Anderson Cancer Center (MDACC) and is listed as recruiting on clinical trials.gov – trial NCT04734990.

Seclidemstat is a novel oral reversible inhibitor of the LSD1 enzyme. Inhibiting LSD1 in preclinical in vivo hematologic models has previously demonstrated reprogramed cancer cell differentiation, reduced tumor burden and prolonged survival of treated animals studied.

As previously announced at the June 2024 European Hematology Association Annual Meeting, researchers at MDACC reported interim clinical trial results from this trial including a 43% overall response rate among 14 predominantly higher-risk MDS and CMML patients who previously failed or relapsed after hypomethylating agent therapy. In addition, researchers reported median overall survival of 18.5 months (95% CI, range 6.1-30.9 months) with median event-free survival of 7.2 months (95% CI, range 6.3-8.2 months). As reported, overall survival after failing therapy with hypomethylating agents is typically four to six months.

In July 2024 the US FDA placed the MDACC investigator-initiated trial under a partial clinical hold following a serious and unexpected adverse event. MDACC has addressed the FDA’s questions, and the partial clinical hold has been lifted.

“Coming off partial clinical hold is welcome news for Salarius stakeholders and for patients with advanced MDS and CMML, and we are excited for MDACC to enroll additional patients and build upon seclidemstat’s growing clinical database,” said David Arthur, President and CEO of Salarius Pharmaceuticals.

As announced on January 13, 2025, Salarius signed a definitive agreement under which Decoy Therapeutics, Inc. will merge with a wholly owned subsidiary of Salarius Pharmaceuticals, subject to certain closing conditions in the agreement. The newly formed company will 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 including rapid response to novel viral pathogens such as avian H5N1 flu. Decoy’s product pipeline targets unmet needs in respiratory infectious diseases and gastroenterology (GI) oncology indications.

In addition, the combined company intends to incorporate Salarius’ oral small molecule protein degrader SP-3164 into a highly targeted peptide-based proteolysis targeting chimera (PROTACS) drug candidate. The ongoing development of Salarius’ seclidemstat for hematologic cancers in the investigator-initiated Phase 1/2 clinical trial at MDACC will be supported while the company evaluates strategic alternatives for seclidemstat.

Salarius Pharmaceuticals is a clinical-stage biopharmaceutical company with two drug candidates for patients with cancer in need of new treatment options. Salarius’ product portfolio includes seclidemstat, the company’s lead candidate, which is being studied in an investigator-initiated Phase 1/2 clinical study in hematologic cancers underway at MD Anderson Cancer Center as a potential treatment for MDS and CML in patients with limited treatment options. SP-3164, the company’s IND-stage second asset, is an oral small molecule protein degrader. Salarius previously received financial support for seclidemstat for the treatment of Ewing sarcoma from the National Pediatric Cancer Foundation and was a recipient of a Product Development Award from the Cancer Prevention and Research Institute of Texas (CPRIT). For more information, please visit www.salariuspharma.com.

Decoy Therapeutics is a preclinical-stage biotechnology company that is leveraging machine learning and artificial intelligence tools alongside high-speed synthesis techniques to rapidly design, engineer and manufacture peptide conjugate drug candidates that target serious unmet medical needs. The company’s initial pipeline is focused on respiratory viruses and GI cancers. Decoy has attracted financing from institutional investors as well as significant non-dilutive capital from the Gates Foundation, the Massachusetts Life Sciences Seed Fund, the Google AI startup program and the NVIDIA Inception program. The company has also received QuickFire Challenge award funding provided by BARDA through BLUE KNIGHT, a collaboration between Johnson & Johnson Innovation – JLABS and the Biomedical Advanced Research and Development Authority within the Administration for Strategic Preparedness and Response. For more information, please visit www.DecoyTx.com.