Trial is evaluating SQZ-PBMC-HPV as both monotherapy and in combination with a checkpoint inhibitor
Multiple doses successfully manufactured for first patient in under 24 hours
WATERTOWN, Mass., Jan. 30, 2020 (GLOBE NEWSWIRE) -- SQZ Biotechnologies (SQZ), a clinical stage company engineering innovative therapy candidates for patients with cancer and other serious diseases, today announced that the first patient in its Phase 1 clinical trial of SQZ-PBMC-HPV has received their first dose. SQZ-PBMC-HPV is an autologous cell therapy candidate comprised of SQZ-engineered antigen presenting cells (APCs) designed to induce CD8 T cell responses against HPV16. The doses for the patient were manufactured in under 24 hours, leveraging SQZ’s novel technology and rapid manufacturing process. The first dose was administered to the patient while additional doses are cryopreserved and available on-demand. This marks the first patient dosed with a cell therapy candidate developed from SQZ’s proprietary Cell Squeeze® cell engineering technology - a milestone for the company.
“It is thrilling to see our seminal discovery now implemented as the foundation of our first cell therapy treatment. This is a transformational moment for SQZ and our platform technology - bringing us a major step closer toward our mission to impact patients’ lives,” said Armon Sharei, PhD, founder and chief executive officer of SQZ.
Oliver Rosen, MD, chief medical officer of SQZ, added, “We are excited to bring our novel cell therapy to patients with HPV+ tumors. There continues to be significant unmet need in HPV+ cancers, with nearly 35,000 new cases occurring in the U.S. every year, and we are hopeful that SQZ-PBMC-HPV can help patients affected by these grievous diseases.”
The primary objectives of the Phase 1 multi-center trial (NCT04084951) are to assess safety, tolerability of different doses and booster schedules, and to determine the recommended dose of SQZ-PBMC-HPV in HPV+ tumors for subsequent treatment protocols, as both monotherapy and in combination with the checkpoint inhibitor, atezolizumab (Tecentriq™). Immunogenic effects, particularly generation of CD8 T cell responses, and efficacy of the therapy will be evaluated as secondary endpoints. HLA-A*02+ patients with recurrent, locally advanced or metastatic HPV16+ head & neck, cervical, anal, penile, vulval and vaginal cancers are all eligible for the study. The trial is sponsored by SQZ as part of the SQZ-Roche collaboration on APCs in oncology.
SQZ-PBMC-HPV is an autologous cell therapy product candidate precisely engineered via SQZ’s Cell Squeeze® technology to target HPV+ cancers. It is the first product candidate stemming from the 2018 collaboration expansion between Roche and SQZ to develop SQZ-APCs for oncology indications. The SQZ APC platform is designed to present tumor antigens to the body’s endogenous CD8 T cells. By enabling presentation of the appropriate target, this approach can potentially induce powerful CD8 T cell responses in patients to attack their tumors.
About SQZ Biotech
SQZ Biotech is a privately held, clinical stage company engineering innovative cell therapy candidates for patients with cancer and other serious diseases. Our proprietary approach to cell engineering, Cell Squeeze, physically squeezes cells through a microfluidic constriction to temporarily disrupt the cell membrane, allowing desired cargo to diffuse into the cell cytosol before the membrane reseals. We use this approach to deliver a broad range of biological material into diverse cell types to create multifunctional cell therapy candidates designed to direct specific immune responses. We believe Cell Squeeze may allow us to create cost-effective and rapidly scalable cell therapies that leverage natural physiology to improve therapeutic efficacy, safety and tolerability relative to currently approved cell therapies. For more information please visit www.sqzbiotech.com.
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Cait Williamson, PhD
LifeSci Public Relations