SQZ Biotechnologies Company

• US
• SQZ Biotechnologies Company
• Health-Care

SQZ

We are a clinical-stage biotechnology company developing transformative cell therapies for patients with cancer, infectious diseases and other serious conditions. We use our proprietary technology, Cell Squeeze, to physically squeeze cells through a microfluidic chip, temporarily opening the cell membrane and enabling biologic material of interest, or cargo, to diffuse into the cell. This technology allows us to create a broad pipeline of product candidates for different diseases. We believe our Cell Squeeze technology has the potential to create well-tolerated cell therapies that can provide therapeutic benefit for patients. Our potential benefits include accelerated timelines with production time under 24 hours, compared to four to six weeks for other existing cell therapies, improved patient experience by eliminating the need for pre-conditioning or lengthy hospital stays, and broadened therapeutic impact.

Our goal is to use the SQZ approach to establish a new paradigm for cell therapies. We are using Cell Squeeze to create multiple cell therapy platforms focused on directing specific immune responses. Our most advanced platform in development, SQZ Antigen Presenting Cells (SQZ APC), is currently in a Phase 1 trial in HPV+ tumors. Our additional platforms currently in development are SQZ Activating Antigen Carriers (SQZ AAC) and SQZ Tolerizing Antigen Carriers (SQZ TAC). We are leveraging each of these platforms to create differentiated product candidates that have applicability across multiple disease areas.

Our SQZ APC platform is focused on generating robust CD8+ T cell responses, which are known to be critical to powerful immune responses. We believe that the keys to driving responses are the quantity, quality and specificity of the CD8+ T cells that are generated. In preclinical studies, the SQZ APC platform has shown approximately 1,000 times more efficient CD8+ T cell activation compared to other cancer vaccines and has also shown that these T cells are specific to the target antigen. SQZ APCs have shown encouraging anti-tumor activity and the ability to elicit protective memory preclinically, indications of the quality of the CD8+ T cells produced. We have also shown in preclinical studies the ability of SQZ APCs to elicit specific immune responses for multiple target antigens, including highly immunogenic (HPV) and less immunogenic (mutant KRAS) antigens.

Our lead product candidate, SQZ-PBMC-HPV, from our SQZ APC platform, is a targeted cancer vaccine that has been designed to generate antigen-specific CD8+ T cell (CD8, CD8 T cell) responses to attack HPV+ tumors. We believe there remains significant unmet need in HPV+ cancers, with over 630,000 new cases every year globally.

We are evaluating SQZ-PBMC-HPV in a Phase 1 clinical trial as a monotherapy and in combination with other immuno-oncology agents for the treatment of HPV16+ advanced or metastatic solid tumors, including cervical, head-and-neck, anal, penile, vulvar and vaginal cancer.

The primary objectives of the trial are to evaluate safety and tolerability and to determine the maximum tolerated dose, if any, or maximum administered dose and to define a dose for the expansion cohort and future studies. We are currently dosing patients in the monotherapy cohorts and as of August 31, 2020 have enrolled 8 patients, 3 in the low-dose monotherapy cohort and 5 in the high-dose monotherapy cohort. We expect to initiate the combination portion of the trial in the first half of 2021 and expect initial data in the second half of 2021. The total number of patients enrolled will depend on safety and observed immunogenic effects. We have the ability to expand the trial to treat additional cohorts of patients or expand cohorts that show clinical benefit. If we expand the trial, we may enroll up to a total of 200 patients.

Unlike certain other oncology cell therapies, patients in the clinical trial receive no pre-conditioning and we plan for the treatment to be administered without post-treatment hospitalization. There have been no treatment-related grade 3 or higher adverse events and no dose limiting toxicities, or DLTs, observed. All doses in the trial have been manufactured in under 24 hours, with no batch failures. We are encouraged by the safety data and manufacturing we have seen to date as well as the initial biomarker data from the low-dose cohort, which showed early signs of intratumoral immune activity. We expect to present more comprehensive data from patients in the monotherapy cohorts in the first half of 2021. 

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