Salarius began enrolling for a Phase 1 trial in Ewing sarcoma in 2018. Ewing sarcoma is a devastating pediatric illness and represents a major unmet clinical need. Currently, chemotherapy, radiation and tumor resection surgery are the only options for patients, and in many cases the tumors reoccur or is in too delicate of a location to risk surgery. There is a 70-90% five-year mortality rate for patients whose tumors recur after treatment or who are initially diagnosed with metastatic disease. Translocations involving the EWS gene are the sole driver for over 85% of Ewing sarcoma, and the EWS protein must complex with LSD1 to induce a cancer phenotype. Seclidemstat blocks this LSD1-EWS interaction to reverse cancer pathology resulting in cures in animal models.
Salarius plans to begin enrolling for a phase 1 trial in advanced solid tumors in 2019. This trial will enroll patients with advanced solid tumors who have progressed on prior therapy, including patients with prostate and sarcomas. Depending on the cancer, LSD1 can associate with a myriad of proteins to drive tumor growth. For instance, in prostate cancer LSD1 can associate with the androgen receptor to activate genes that promote cancer cell growth and metastasis. Seclidemstat is able to block these interactions and reduce tumor burden.
In a separate planned phase 1 trial sponsored by the Huntsman Cancer Institute, Seclidemstat will be evaluated for the treatment of late stage triple negative breast cancer (TNBC), HER2-/ER+ breast cancer, and ovarian cancer. This trial will enroll Stage IV or locally advanced cancers, where the standard of care has failed. Preclinical and clinical data have demonstrated that LSD1 is an important driver for these advanced cancers. Additionally, Seclidemstat has shown activity in preclinical models that suggests it could inhibit tumor growth and represents a viable treatment option for patients.
LSD1 complexes with proteins to drive tumor growth. Seclidemstat blocks these interactions and reduces tumor burden across various types of cancer types.
- Phase 1
- Phase 2
SeclidemstatAdvanced Tumor Studies
SeclidemstatBreast & Ovarian