On May 19, 2021 SQZ Biotechnologies Company (NYSE: SQZ), a cell therapy company developing novel treatments for multiple therapeutic areas, reported that it will present safety and tolerability, manufacturing, and antitumor activity data from its ongoing Phase 1 clinical trial of SQZ-PBMC-HPV-101 in patients with advanced or metastatic Human Papillomavirus Positive tumors at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 4-8 (Press release, SQZ Biotech, MAY 19, 2021, View Source [SID1234580309]).
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"These early data demonstrate the feasibility of our Cell Squeeze technology and how it can potentially change the way the field thinks about cell therapies," said Armon Sharei, Ph.D., Chief Executive Officer and Founder of SQZ Biotechnologies. "In this small number of patients whose cancer was very advanced, SQZ-PBMC-HPV-101 has been well-tolerated at all tested dose levels and demonstrated signals of increased immune activity. Importantly, we are also presenting evidence that we can efficiently and reproducibly manufacture our investigational therapy at scale, potentially making it more accessible to patients in need."
The Phase 1 clinical trial data of SQZ-PBMC-HPV-101 being presented at ASCO (Free ASCO Whitepaper) includes three of the four planned monotherapy dose-escalating patient cohorts. Enrollment and evaluation of the monotherapy in the highest-dose cohort is ongoing. In the next stage of the trial, it is planned to combine SQZ-PBMC-HPV-101 with immune checkpoint inhibitors. The study’s primary outcome measures in the monotherapy stage of the trial are safety, tolerability, and the definition of the recommended phase 2 dose. Secondary outcome measures include antitumor activity and manufacturing feasibility.
Trial Highlights from ASCO (Free ASCO Whitepaper) Abstract 2536
Design, Safety, Tolerability and Patient Demographics
SQZ-PBMC-HPV was given IV q 3 weeks on an outpatient basis and patients did not receive a prior conditioning regime
The median number of lines of prior therapy was four, and all but one patient had previously received an immune checkpoint inhibitor
SQZ-PBMC-HPV-101 was well-tolerated at all dose levels tested with patients receiving between two to 10 doses
No dose-limiting toxicity or Grade 3 or higher treatment-related SAEs were observed
Manufacturing
All batches of SQZ-PBMC-HPV-101 demonstrated HPV-specific CD8 T cell activation in vitro after thawing, and batch size allowed for treatment at the assigned dose regimen
Quick and efficient manufacturing with all patient batches produced in less than 24 hours
Investigational doses were released and available for administration approximately one week from the time a patient’s cells were drawn
Outcome and Biomarker
Four patients achieved stable disease
One patient who achieved stable disease remained on study for 42 weeks
Preliminary analyses on pre- and post-therapy tumor biopsies indicated increased immune activity in select patients
Poster Presentation Details
Title: Initial Results of a first-in-human, dose escalation study of a cell-based vaccine in HLA A* 02+ patients with recurrent, locally advanced or metastatic HPV16+ solid tumors
First Author: Antonio Jimeno, M.D., Ph.D., University of Colorado Cancer Center
Abstract Number: 2536
Poster Session: Developmental Therapeutics — Immunotherapy
Date and Time: A copy of the poster will be available on-demand starting Friday, June 4, 2021 at 8:00 am ET via the ASCO (Free ASCO Whitepaper) virtual meeting website.
SQZ-PBMC-HPV-101 Trial Design
SQZ-PBMC-HPV-101 is being evaluated in a Phase 1 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 stages of the trial include safety, tolerability, and to define a recommended phase 2 dose. 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 stage of the trial. The monotherapy phase of the study includes escalating dose cohorts with DLT measured over 28 days. The planned safety combination phase of the study will include SQZ-PBMC-HPV-101 and checkpoint inhibitors that have previously received regulatory approval. DLT will be measured over 42 days in the safety combination phase.
About Human Papillomavirus Positive Cancers
Human papillomavirus (HPV) is one of the most common viruses worldwide and certain strains persist for many years leading to cancer. According to the Centers for Disease Control (CDC), in the United States HPV+ tumors represent 3% of all cancers in women and 2% of all cancers in men, resulting in over 39,000 new cases of HPV+ tumors every year. HPV infection is larger outside of the U.S., and according to the International Journal of Cancer HPV+ tumors account for 4.5% of all cancers worldwide, resulting in approximately 630,000 new cases every year. According to the CDC, HPV infection plays a significant role in the formation of more than 90% of anal and cervical cancers, and most cases of vaginal (75%), oropharyngeal (70%), vulval (70%) and penile (60%) cancers.