Syntrix today announced that it has opened an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to initiate a Phase 1/2 trial of SX-682. SX-682 is an oral allosteric small-molecule inhibitor of CXCR1 and CXCR2 (CXCR1/2) and the first clinical-stage asset from Syntrix’s myeloblockade immuno-oncology program directed at depleting the tumor microenvironment of immunosuppressive myeloid cells. CXCR1/2 are a “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. 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.
The IND will initiate 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. 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.
“Opening of this IND is an important milestone for our myeloblockade strategy in solid tumors,” said John Zebala, M.D., Ph.D., CEO of Syntrix. “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. Clinical studies in melanoma and other solid tumors have shown a direct correlation between serum levels of CXCR1/2 ligands and disease progression. 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.”
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