SQZ Biotech Announces Clearance of US IND Application for First Clinical Trial
First program advancing into the clinic through the SQZ-Roche collaboration in APCs for oncology
WATERTOWN, Mass., Oct. 22, 2019 (GLOBE NEWSWIRE) — SQZ Biotechnologies (SQZ), a cell therapy company developing innovative treatments for multiple therapeutic areas, today announced that the company’s Investigational New Drug (IND) application for SQZ-PBMC-HPV, a novel cellular immunotherapy of antigen presenting cells (APCs) has been cleared after submission to the U.S. Food and Drug Administration (FDA). The trial is investigating the cell therapy comprised of SQZ-engineered APCs to treat HPV+ tumors, titled SQZ-PBMC-HPV. Marking the first program to enter the clinic for the company, SQZ-PBMC-HPV is also the first trial advancing into the clinic in the SQZ-Roche collaboration developing APCs for oncology.
Armon Sharei, PhD, founder and chief executive officer of SQZ, noted, “The FDA’s clearance of our IND is a pivotal moment for the company. SQZ has potential to bring novel cell therapies to patients addressing high unmet medical needs, and this important milestone marks the first clinical translation of our platform.”
“SQZ APCs have the potential for broad impact in the oncology space. A cell therapy targeting solid tumors without the need for immune or myeloablative pre-conditioning could possibly shift the paradigm for patients,” said Oliver Rosen, MD, chief medical officer of SQZ. “The preclinical data underpinning this program have shown significant tumor reduction driven by high CD8 T cell infiltration into the tumor microenvironment, alongside a favorable preclinical safety profile. We are looking forward to translating this into potentially meaningful results for patients.”
The Phase 1 multi-center trial (NCT04084951) is sponsored by SQZ and will enroll in multiple cohorts to assess SQZ-PBMC-HPV as both monotherapy and in combination with Roche’s checkpoint inhibitor, atezolizumab. 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.
SQZ-PBMC-HPV is an autologous cell therapy product precisely engineered via SQZ’s Cell Squeeze® platform to target HPV+ cancers. It is the first product stemming from the 2018 collaboration expansion between Roche and SQZ to develop SQZ-APCs for oncology. 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 company creating innovative treatments by transforming cells into sophisticated therapeutics. Using its proprietary platform, SQZ has the unique ability to precision engineer many patient cell types and deliver multiple materials, potentially resulting in powerful, multifunctional cell therapies for a range of diseases with an initial focus on cancer. The first applications for the company leverage SQZ’s ability to generate target-specific immune responses, both in activation for the treatment of solid tumors, and immune tolerance for the treatment of immune reactions and diseases. For more information please visit www.sqzbiotech.com. SQZ Contact: Rebecca Cohen Senior Manager, Corporate Relations firstname.lastname@example.org 617-758-8672 ext. 728 Media Contact: Cait Williamson, PhD LifeSci Public Relations email@example.com 646-751-4366