SQZ Biotechnologies Receives FDA Fast Track Designation for its Lead Cell Therapy Candidate for the Treatment of HPV16+ Tumors
SQZ Biotechnologies (NYSE: SQZ) announced that the FDA has granted Fast Track Designation for its lead therapy candidate, SQZ-PBMC-HPV, aimed at treating HPV16+ advanced solid tumors. This designation may accelerate development and review processes for treatments for serious diseases. The candidate has shown promise in early clinical data, demonstrating potential anti-tumor activity and favorable tolerability. The ongoing Phase 1/2 clinical trial includes monotherapy and combination therapy evaluations, targeting significant treatment opportunities in oncology.
- FDA Fast Track Designation granted for SQZ-PBMC-HPV therapy candidate.
- Promising clinical data showing anti-tumor activity in HPV16+ advanced solid tumors.
- Continued patient enrollment in Phase 1/2 clinical trial indicates ongoing development progress.
- None.
Designation Creates Potential to Bring Important New Therapy to Patients Earlier
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
Data presented at the
SQZ-PBMC-HPV-101 Trial Design
SQZ-PBMC-HPV is being evaluated in a Phase 1/2 clinical trial for the treatment of HPV16+ advanced or metastatic solid tumors. Patients must be positive for the human leukocyte antigen serotype HLA-A*02. The investigational candidate, which targets E6 and E7 oncoproteins, is being studied as a monotherapy and in combination with immuno-oncology agents. The study’s primary outcome measures in the monotherapy and combination phases of the trial include safety and tolerability. Antitumor activity is a secondary outcome measure in both the monotherapy and combination stages of the trial, and manufacturing feasibility is a secondary outcome measure in the monotherapy phase of the trial. The monotherapy phase of the study includes escalating dose cohorts with a dose-limiting toxicity (DLT) window of 28 days and is designed to identify a recommended phase 2 dose. The planned combination phase of the study will include SQZ-PBMC-HPV and checkpoint inhibitors. DLT will be measured over 42 days.
About Human Papillomavirus Positive Cancers
Human papillomavirus (HPV) is one of the most common viruses worldwide and certain strains persist for many years, often leading to cancer. According to the
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