SQZ: EAPC Therapeutic Candidate Gets FDA Fast Track Designation To Treat HPV16+ Tumors

(RTTNews) - SQZ Biotechnologies Co. (SQZ), a clinical-stage biotechnology company focused on cell therapies, announced Tuesday that the U.S. Food and Drug Administration has granted Fast Track Designation for its Enhanced Antigen Presenting Cell or eAPC candidate for the treatment of HPV16+ advanced or metastatic solid tumors.

Fast Track Designation would accelerate the development and review of treatments for serious and life-threatening diseases where no treatment currently exists or where the treatment in discovery may be better than what is currently available.

The company noted that SQZ eAPC platform is its second-generation cell therapy platform. It simultaneously delivers five different mRNAs-each encoding for a different protein which plays a part in stimulating key T cell activation signals required to generate an immune response against tumors-to four different cell types.

The company also presented clinical data from its ongoing Antigen Presenting Cells or APC and eAPC clinical trials at the European Society for Medical Oncology Immuno-Oncology Congress.

As per the data, APC and eAPC therapeutic candidates were well-tolerated among patients treated in its trials. Manufacturing of the cell product took less than 24 hours, and the median viability of all lots, in both clinical trials, was greater than 90 percent, the company noted.

Marshelle Smith Warren, Chief Medical Officer at SQZ Biotechnologies, said, "Receiving FDA Fast Track Designation underscores the significant potential of our SQZ eAPC candidate, which is designed to generate an even more powerful immune response than our APC candidate. The initial safety and tolerability data presented at ESMO-IO today supports our recent portfolio prioritization decision to focus on our eAPC program."

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