SQZ Biotechnologies Presents Celiac Disease Tolerizing Antigen Carrier Preclinical Data at 2022 Federation of Clinical Immunology Societies (FOCIS) Annual Meeting
SQZ® TACs Result in the In Vitro Presentation of Antigen Associated with Celiac Disease, Supporting T Cell Tolerizing Approach
Cell Squeeze® Process Leads to TACs with Consistently High Amounts of Antigen Cargo
Findings Build on Published Type 1 Diabetes TAC Data and Further Support Planned TAC IND Submission for Celiac Disease in First Half of 2023
“We’ve now shown in different preclinical models of autoimmune disease that SQZ® TACs have the ability to utilize the immune system’s natural processes to tolerize T cells, demonstrating the flexible capabilities of this platform,” said
SQZ® TACs act as Trojan horses, utilizing the body’s natural cell clearance processes to allow for the presentation of antigen cargo that can support the tolerization of specific T cells involved in autoimmune diseases. Earlier this year in Frontiers of Immunology, the company published comprehensive preclinical research showing that SQZ® TACs loaded with type 1 diabetes (T1D) autoantigens could induce multiple key mechanisms of antigen-specific tolerance in various model systems, including deletion of autoreactive T cells, anergy, and expansion of regulatory T cells (Tregs) capable of bystander suppression. In an in vivo model of T1D, the TAC treatment was able to combat active autoimmune responses and prevent hyperglycemia.
These research findings are part of the body of work that will support the company’s anticipated
Major Findings from Autoimmune Disease Models:
- Gliadin Epitope T Cell Presentation: An in vitro assay found that TACs with deamidated gliadin cargo were taken up by dendritic cells, processed, and presented gliadin epitopes via MHC class II signaling to T cells
- Production of TAC Batches: The Cell Squeeze® process resulted in the manufacture of TACs with consistently high amounts of deamidated gliadin
Poster Presentation Details
Title: SQZ® TAC Cell Therapy Platform Induces Antigen Specific T-regs and Prevents Onset of Type 1 Diabetes in Adoptive Transfer Models
Abstract Number: Tu109
About Celiac Disease
Celiac disease is a chronic autoimmune disorder that occurs in genetically predisposed people.i ii The disease is triggered by eating foods containing gluten, which is found in wheat, barley, and rye. Disease symptoms can include abdominal pain, diarrhea, nausea, vomiting, and other common signs. When gluten is ingested, the body mounts an immune response that attacks and damages the villi that line the small intestine, which can impact nutrient absorption.iii Many people who have celiac disease have not been diagnosed,iv however population-based studies indicate that the disease affects about 2 million people in
About Type 1 Diabetes
Nearly 1.6 million Americans are living with Type 1 Diabetes (T1D), including about 1.4 million adults and 200,000 children and adolescents (<20 years). Five million people in the
About SQZ® TACs
SQZ® TACs are a red blood cell-derived engineered cell therapy candidate being developed as an antigen-specific immune tolerance platform. The platform is designed to leverage the natural process of RBC clearance by professional antigen presenting cells (APCs) in the lymphoid organs, where they engulf aged RBCs and present their components to CD4 and CD8 T cells. This physiological mechanism is tolerogenic by default, instructing the immune system to not mount an attack. SQZ® TACs are generated by engineering RBCs with disease-specific antigen using the Cell Squeeze® technology and are made to appear aged. SQZ® TACs are designed to be rapidly engulfed in vivo by the patient’s professional APCs and to act as a “Trojan horse” to drive high quantities of antigen through the tolerogenic RBC clearance process, which may ultimately induce tolerization of the patient’s T cell and antibody responses against the specific target.
Forward Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements relating to events and presentations, platform and clinical development, product candidates, preclinical and clinical activities, progress and outcomes, development plans, clinical safety and efficacy results, therapeutic potential and disease prevalence. These forward-looking statements are based on management's current expectations. Actual results could differ from those projected in any forward-looking statements due to several risk factors. Such factors include, among others, risks and uncertainties related to our limited operating history; our significant losses incurred since inception and expectation to incur significant additional losses for the foreseeable future; the development of our initial product candidates, upon which our business is highly dependent; the impact of the COVID-19 pandemic on our operations and clinical activities; our need for additional funding and our cash runway; the lengthy, expensive, and uncertain process of clinical drug development, including uncertain outcomes of clinical trials and potential delays in regulatory approval; our ability to maintain our relationships with our third party vendors; and protection of our proprietary technology, intellectual property portfolio and the confidentiality of our trade secrets. These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K and other filings with the
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i Leonard MM, Sapone A, Catassi C, et al. Celiac Disease and Nonceliac Gluten Sensitivity: A Review. JAMA 2017;318:647-656
iii Beyond Celiac website (as of
v Lionetti E, Gatti S, Pulvirenti A, et al. Celiac disease from a global perspective. Best Pract Res Clin Gastroenterol 2015;29:365-79.
vi Leonard MM, Sapone A, Catassi C, et al. Celiac Disease and Nonceliac Gluten Sensitivity: A Review. JAMA 2017;318:647-656