Pipeline

SP-2577 (LSD1 inhibitor)

Salarius’ LSD1 technology was licensed from the University of Utah Huntsman Cancer Institute where it was developed in the laboratory of Dr. Sunil Sharma.

SP-2577 is being studied in an ongoing Phase 1/2 trial  treating three different patient groups with sarcomas, including Ewing Sarcoma, Myxoid Liposarcoma and additional FET-rearranged soft tissue sarcomas. These are cancers with high-unmet need and represent Salarius’ “speed-to-market strategy” given the potential for accelerated approval.

Ewing Sarcoma is a rare and deadly cancer that afflicts about 500 new patients in the US each year of which many children and adolescents. There is no standard second-line therapy for the ~40% that fail first-line cytotoxic chemotherapy therapy, highlighting the high unmet need for novel treatments. In early 2021, Salarius completed the dose escalation portion of the trial, demonstrating that SP-2577t can be given at doses that are tolerable, give adequate drug exposure, and showed preliminary signs of activity. Salarius is currently enrolling patients in the expansion portion of the trial where it is combining SP-2577with topotecan and cyclophosphamide (TC), two agents commonly given as 2^nd or 3rd line therapy, in hopes of improving patient outcomes over TC alone.

Myxoid Liposarcoma and other FET-rearranged sarcomas are other cancers with high-unmet need. There are about 1,500 new patients diagnosed each year, tripling SP-2577’s potential addressable market. Salarius is currently enrolling myxoid liposarcoma and FET-rearranged sarcoma patients and treating them with single agent SP-2577.

Salarius recently announced the initiation of an Investigator Initiated Trial studying SP-2577 in combination with Azacitidine for the treatment of patients with myelodysplastic syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML). MDS and CMML can both progress into Acute Myeloid Leukemia (AML) and data from our ongoing trial will inform development of SP-2577 in hematologic cancers (also referred to as “liquid tumors” or “blood cancers”), including AML. The American Cancer Society estimates there were almost 20,000 new cases of AML in the US alone in 2020, highlighting the potential to greatly expand SP-2577’s market. Additional research is ongoing to identify other larger market indications where SP-2577 may show efficacy.

SP-3164 (Targeted Protein Degrader)

SP-3164 is a next-generation cereblon (CRBN) binding molecular glue. Molecular glues are small molecules that commandeer the body’s normal protein degradation processes by causing proteins to stick to one another thereby inducing selective degradation of cancer-causing proteins. Derived from avadomide, SP-3164 is engineered using DECS (deuterium-enabled chiral switching), a process that replaces hydrogen atoms with deuterium to stabilize the molecule’s active enantiomer, resulting in a novel molecular entity with the potential for increased efficacy and improved safety. SP-3164 degrades transcription factors IKZF1 and IKZF3, along with other proteins, resulting in both anti-cancer and immune-modulating properties.  SP-3164 has activity in both hematologic and solid tumors and is currently in IND-enabling studies with the hope to initiate clinical trials in 2023.