INT230-6 Granted Fast Track Designation in Metastatic Triple-Negative Breast Cancer
Posted: Monday, April 22, 2019
The U.S. Food and Drug Administration (FDA) recently granted Fast Track designation to a development program evaluating INT230-6 for the treatment of patients with relapsed or metastatic triple-negative breast cancer who have failed to respond to at least two prior lines of therapy.
Designed for direct intratumoral injection, INT230-6 comprises two anticancer agents and a penetration enhancer molecule that helps disperse the drugs throughout tumors and diffuse into cancer cells. INT230-6 is being evaluated in a phase I/II clinical study (ClinicalTrials.gov identifier NCT03058289) in patients with various advanced solid tumors. In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor kill and recruitment of dendritic cells to the tumor microenvironment that induced anticancer T-cell activation.