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.”
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.
DISCLOSURE NOTICE: This release contains forward-looking information that are based on company management’s current beliefs and expectations and are subject to currently unknown information, risks and circumstances and actual results may vary from what is being currently projected. In addition, from time to time, Syntrix or its representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should”, “could” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause Syntrix’s actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause Syntrix’s actual activities or results to differ materially from the activities and results anticipated in such forward-looking statements. Syntrix does not undertake any obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise.
Media Contact: Aaron Schuler, PhD, 253-833-8009, x21
