SQZ Biotechnologies (NYSE:SQZ) received Fast Track Designation from he U.S. Food and Drug Administration (FDA) for its lead cell therapy candidate, SQZ-PBMC-HPV, for the treatment of HPV16+ advanced or metastatic solid tumors.
SQZ-PBMC-HPV-101 is currently being investigated in the Phase 1/2 clinical study.
The company continues to enroll patients in its highest dose monotherapy cohort and simultaneously enrolling patients for combination therapy.
Armon Sharei, Ph.D., Chief Executive Officer and Founder, stated, “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”.
FDA Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs.
SQZ Biotechnologies is trading up 29 percent at $3.57 in the after hours.
