SQZ: FDA Authorizes To Proceed With Phase 1/2 Clinical Trial Of SQZ-eAPC-HPV Cell Therapy

(RTTNews) - SQZ Biotechnologies Co. (SQZ), a clinical-stage biotechnology company focused on cell therapies, announced Monday that the U.S. Food and Drug Administration has cleared the investigational new drug or IND application for SQZ-eAPC-HPV, a novel mRNA-based cell therapy for the treatment of HPV16 positive solid tumors.

The FDA now authorizes the company to proceed with initiating a Phase 1/2 clinical trial of the novel cell therapy candidate.

The company said it plans to initiate its COMMANDER-001 Phase 1/2 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.

The investigational candidate, which targets E6 and E7 oncoproteins, is being studied as a monotherapy and in combination with pembrolizumab, an immune checkpoint inhibitor.

SQZ-eAPC-HPV is created by delivering 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.

The SQZ eAPC trial is the third FDA IND clearance for a clinical candidate based on the company's Cell Squeeze technology.

Armon Sharei, Chief Executive Officer and Founder of SQZ Biotechnologies, said, "SQZ eAPCs build upon the promising preliminary monotherapy clinical activity shown by our first SQZ APC platform. Through multiplexed engineering of a patient's monocytes, B cells, T cells, and NK cells, we are able to integrate antigen presentation and enhanced immunological functions into a single clinical candidate that could become a powerful weapon against solid tumors."