SQZ Biotechnologies Receives FDA Fast Track Designation for its eAPC Therapeutic Candidate for Treatment of HPV16+ Tumors and Presents Clinical Data for Multiple Programs at the European Society for Medical Oncology Immuno-Oncology Congress

SQZ Biotechnologies Company (NYSE: SQZ) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the company’s Enhanced Antigen Presenting Cell (eAPC) candidate for the treatment of HPV16+ advanced or metastatic solid tumors. Fast Track Designation is designed to accelerate the development and review of treatments for serious and life-threatening diseases where no treatment currently exists or where the treatment in discovery may be better than what is currently available.

The SQZ eAPC platform is the company’s second-generation cell therapy platform which simultaneously delivers five different mRNAs—each encoding for a different protein which plays a part in stimulating key T cell activation signals required to generate an immune response against tumors—to four different cell types.

The company also presented clinical data from its ongoing Antigen Presenting Cells (APC) and eAPC clinical trials at the European Society for Medical Oncology Immuno-Oncology (ESMO-IO) 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 percent.

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.

“Receiving FDA Fast Track Designation underscores the significant potential of our SQZ eAPC candidate, which is designed to generate an even more powerful immune response than our APC candidate,” said Marshelle Smith Warren, M.D., Chief Medical Officer at SQZ Biotechnologies. “The initial safety and tolerability data presented at ESMO-IO today supports our recent portfolio prioritization decision to focus on our eAPC program. In addition to the clean safety profile, we were pleased to observe stable disease in two of the four evaluable patients in the eAPC trial. The team is working diligently to add more eAPC sites to our study to achieve our goal of a highest-dose monotherapy data readout by the middle of 2023.”