Syntrix announced today the award of a $2.3 million grant from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) to perform a Phase 1/2 clinical study investigating the treatment of newly diagnosed metastatic melanoma with SX-682 in combination with the anti-PD1 agent, pembrolizumab. In 2016, it was estimated there were 76,380 new cases of melanoma in the United States, with 10,130 deaths from the disease. The Phase 1/2 trial will be conducted in collaboration with Dr. Keith Flaherty at the Termeer Center for Targeted Therapies at the Massachusetts General Hospital Cancer Center.
In mouse models of melanoma, SX-682 exhibited single-agent activity and potently synergized with anti-PD1 therapy. John Zebala, M.D., Ph.D., CEO of Syntrix, said that “Metastatic melanoma exhibits the greatest response to anti-PD1 therapy of any solid tumor type, yet still only about 30% of patients initially respond to pembrolizumab and only about 10% are progression free at one year. Our preclinical data suggest that combining SX-682 with pembrolizumab in metastatic melanoma may afford enhanced efficacy compared to pembrolizumab monotherapy. If successful, SX-682 could be a promising new addition to the treatment landscape in metastatic melanoma.”
The trial is an open-label 3+3 escalation and expansion design. Correlative studies will examine immune biomarkers in the tumor microenvironment and in the circulation.
ABOUT SX-682: SX-682 is a clinical-stage oral allosteric small-molecule inhibitor of CXCR1 and CXCR2 (CXCR1/2). Inhibiting both human isoforms is believed essential. CXCR1/2 are a combined “master switch” of the tumor microenvironment, where they control tumor cell metastasis, the epithelial to mesenchymal transition, the influx of immunosuppressive MDSCs and neutrophils and angiogenesis. Clinical studies in melanoma, breast, ovarian, prostate and colon cancer have shown a direct correlation between serum levels of CXCR1/2 ligands and disease progression. SX-682 has been validated in all major solid tumor models, where it exhibits mono-agent anti-tumor activity, blocks metastasis, depletes immunosuppressive myeloid cells, activates tumor killing by effector cells, reverses chemo-resistance, and potently synergizes with anti-CTLA-4 and anti-PD1.
ABOUT SYNTRIX: Syntrix is a pharmaceutical company committed to discovering and delivering innovative therapies by doing things differently. We innovate in discovery and clinical trials, engineer risk prospectively, integrate IP strategy creatively, and leverage non-dilutive capital to solve the most difficult clinical problems. Convergent Science & Strategy. Breakthrough Medicines.
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Media Contact: Aaron Schuler, PhD, 253-833-8009, x21