SQZ Biotechnologies Announces FDA Clearance of IND Application to Allow for Clinical Trial with SQZ Activating Antigen Carriers (SQZ AACs) in Patients with HPV+ Tumors

SQZ AACs generated from red blood cells are designed to leverage a patient’s professional antigen-presenters to drive T cells to attack tumors

WATERTOWN, Mass.--(BUSINESS WIRE)--SQZ Biotechnologies (NYSE: SQZ), a cell therapy company developing novel treatments for multiple therapeutic areas, today announced that the company’s Investigational New Drug (IND) application for SQZ^TM Activating Antigen Carriers (SQZ AACs) in HPV+ tumors was cleared by the U.S. Food and Drug Administration (FDA). The clinical trial will investigate SQZ-AAC-HPV, a cell therapy candidate generated from red blood cells (RBCs) engineered with tumor-specific antigen to treat HPV+ tumors. This trial, SQZ-AAC-HPV-101, marks the first clinical program from the company’s wholly-owned SQZ AAC platform.

SQZ AACs are a novel cellular immunotherapy candidate designed to transport tumor-specific antigen and TLR agonists to the patient’s endogenous, professional, antigen presenting cells in vivo. These antigen presenting cells are capable of potent T cell activation that could potentially drive an anti-tumor effect. In preclinical studies, SQZ AACs in mouse models have demonstrated robust immune responses, CD8 T cell infiltration, and correlated tumor reduction.

“Advancing our SQZ AAC program into the clinic is a significant milestone for our team,” said Armon Sharei, PhD, founder and chief executive officer of SQZ Biotechnologies. “This program further illustrates the broad cell engineering capabilities of our core technology and the diversity of our pipeline. SQZ AACs potentially open another dimension of biology where SQZ cell therapy candidates could drive patient impact.”

The Phase 1 multi-center trial will enroll multiple cohorts to assess SQZ-AAC-HPV as both monotherapy and in combination with other immunoncology therapies. 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.

“We are dedicated to leveraging our unique capabilities and novel cell therapy candidates to try to improve patients’ lives by offering them potential outcomes that they need and deserve. SQZ AACs are our next approach for a potential differentiated cell therapy targeting solid tumors that could represent an exciting evolution in the cancer patient experience,” said Oliver Rosen, MD, chief medical officer.

About SQZ-AAC-HPV

SQZ AACs are generated by squeezing red blood cells (RBCs) with an antigen and activating adjuvant. The process is tuned to make the engineered RBCs appear aged. Once administered to patients, SQZ AACs aim to be rapidly taken up by professional antigen presenting cells through a natural process to destroy aged RBCs in the body known as eryptosis. To take advantage of this process, SQZ AACs are designed to act as a “Trojan horse” to deliver significant quantities of antigen and activation factors to the professional, endogenous antigen presenting cells in the lymphoid organs and drive subsequent activation of T cells specific to HPV+-tumors. SQZ-AAC-HPV is the first product candidate from the SQZ AAC platform.

About SQZ Biotechnologies

SQZ Biotechnologies is a clinical-stage biotechnology company developing transformative cell therapies for patients with cancer, infectious diseases, and other serious conditions. Using its proprietary technology, SQZ Biotechnologies offers the unique ability to deliver multiple materials into many patient cell types to engineer what we believe can be an unprecedented range of potential therapeutics for a variety of diseases. SQZ Biotechnologies has the potential to create well-tolerated cell therapies that can provide therapeutic benefit for patients and to improve the patient experience over existing cell therapy approaches. With accelerated production timelines under 24 hours and the opportunity to eliminate preconditioning and lengthy hospital stays, our goal is to use the SQZ approach to establish a new paradigm for cell therapies. Our first therapeutic applications aim to leverage the potential to generate target-specific immune responses, both in activation for the treatment of solid tumors and immune tolerance for the treatment of unwanted immune reactions and autoimmune diseases. For more information please visit www.sqzbiotech.com.

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SQZ Biotechnologies IR Contact:
Rebecca Cohen
Corporate and Investor Relations
rebecca.cohen@sqzbiotech.com
617-758-8672 ext. 728

Media Contact:
Kate Contreras
kcontreras@w2ogroup.com
617-229-5960