On February 1, 2021 SQZ Biotechnologies (NYSE: SQZ), a cell therapy company developing novel treatments for multiple therapeutic areas, reported that the company’s Investigational New Drug (IND) application for SQZTM Activating Antigen Carriers (SQZ AACs) in HPV+ tumors was cleared by the U.S. Food and Drug Administration (FDA) (Press release, SQZ Biotech, FEB 1, 2021, View Source [SID1234574465]). 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.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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.