SQZ Biotechnologies focused on unlocking the full potential of cell therapies for multiple therapeutic areas, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the company’s lead cell therapy candidate, SQZ-PBMC-HPV, 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.
“We are thrilled to receive FDA Fast Track Designation for our SQZ Antigen Presenting Cells product candidate,” said Armon Sharei, Ph.D., Chief Executive Officer and Founder at SQZ Biotechnologies. “This designation adds to our exciting clinical data presented at ESMO-IO last year where we first demonstrated the potential of our Cell Squeeze technology to drive clinical benefit while maintaining favorable tolerability. The FDA Fast Track program can potentially expedite future review processes and accelerate the registrational path for SQZ-PBMC-HPV.”
Data presented at the ESMO Immuno-Oncology Congress 2021 has shown that the company’s lead APC cell therapy candidate induced radiographic, symptomatic and immune response as monotherapy in a post-checkpoint HPV16+ solid tumor patient. The company continues to enroll patients in its highest dose monotherapy cohort and is simultaneously enrolling patients for combination therapy in the company’s Phase 1/2 SQZ-PBMC-HPV-101 clinical trial.