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SQZ Biotechnologies receives FDA Fast Track Designation for eAPC candidate
The Fly

SQZ Biotechnologies receives FDA Fast Track Designation for eAPC candidate

SQZ Biotechnologies announced that the U.S. FDA has granted Fast Track Designation for the company’s Enhanced Antigen Presenting Cell candidate for the treatment of HPV16+ advanced or metastatic solid tumors. The company also presented clinical data from its ongoing Antigen Presenting Cells and eAPC clinical trials at the European Society for Medical Oncology Immuno-Oncology Congress. Data also demonstrated that its APC and eAPC therapeutic candidates were well-tolerated among patients treated in its trials. Manufacturing of the cell product took less than 24 hours, and the median viability of all lots, in both clinical trials, was greater than 90%. In the SQZ eAPC clinical trial, scans showed stable disease as the best overall response for two out of four evaluable patients in low dose Cohort 1. A positive ELISpot response for the E7 antigen was observed in one of these patients and correlated with prolonged stable disease. This patient remains on treatment.

Published first on TheFly

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