January 24, 2022 -- SQZ Biotechnologies announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for SQZ-eAPC-HPV, authorizing the company to proceed with initiating a phase I/II clinical trial of the novel cell therapy candidate. The company plans to initiate its Commander-001 Phase I/II clinical trial of SQZ-eAPC-HPV in patients who have HPV16 solid tumors, including head and neck, cervical, and anal cancers, and have progressed following standard therapies.
SQZ-eAPC-HPV is designed to deliver five different mRNAs into a patient's monocytes, B cells, T cells, and NK cells -- engineering four cell types with five functions in a single step. In preclinical models, SQZ e antigen-presenting cells (eAPCs) have been shown to generate robust CD8 T-cell responses against multiple antigens, including HPV16 proteins, through simultaneous expression of antigens, CD86, membrane-bound IL-2, and membrane-bound IL-12.
By focusing on engineering physiological mechanisms, SQZ cell therapies do not require patient preconditioning and have well tolerated in clinical study, according to the company. SQZ eAPCs can be manufactured in under 24 hours and have the potential for future implementation on SQZ's point-of-care platform.
The SQZ eAPC trial is the third FDA IND clearance for a clinical candidate based on the company's Cell Squeeze technology.