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
SQZ Biotechnologies Company (NYSE: SQZ), focused on unlocking
the full potential of cell therapies for multiple therapeutic
areas, today presented Tolerizing Antigen Carrier (TACs)
nonclinical results at the 2022 Federation of Clinical Immunology
Sciences (FOCIS) annual meeting. The new celiac disease research
found that in an in vitro assay, SQZ® TACs with deamidated gliadin,
a protein associated with celiac disease, resulted in dendritic
cell presentation of tolerizing antigens to T cells. In addition,
the early data showed that the company’s Cell Squeeze® process
could produce TACs with consistently high levels of antigen. The
findings build upon additional research showing SQZ® TACs
engineered to induce protection against type 1 diabetes could
combat active autoimmune responses and prevent hyperglycemia.
“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 Howard Bernstein,
M.D., Ph.D., Chief Scientific Officer at SQZ Biotechnologies. “We
are excited to continue progressing this promising research as we
move closer to our anticipated TAC IND submission for celiac
disease in the first half of 2023.”
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 TAC IND submission for celiac
disease, the first autoimmune disease indication for the SQZ® TAC
platform.
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 Poster Session: Tuesday, June 21, 2022,
6:15 PM – 7:45 PM PT
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 the United States and approximately 1% of the
population worldwide, with regional differences.v vi There is
currently no approved drug treatment and patients are advised to
maintain a gluten-free diet, which involves strict, lifelong
avoidance of exposure to gluten proteins. Long-term complications
of celiac disease may include malnutrition, accelerated
osteoporosis, nervous system problems and issues related to
reproduction. Rare complications can include cancer of the small
intestine, cirrhosis, and non-Hodgkin lymphoma.
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 U.S. are expected to have T1D by 2050. A
separate CDC study of T1D cases in youth showed that 60 percent of
diagnoses occur between the ages of 5 and 14. Worldwide incidence
is 15 patients diagnosed per every 100,000 people. There is no cure
for T1D, and it requires chronic disease management through
exogenous insulin therapy, insulin analogs and adjunctive
treatments for glycemic control. The life expectancy for T1D
patients is 10–15 years less than the healthy population due to
hypoglycemia events and long-term risks of cardiovascular
complications, neuropathy, kidney damage, and retinopathy. There
remains significant unmet need for disease-modifying therapeutics
that address the autoimmune-mediated attack of beta cells as a
driving factor of disease pathogenesis.
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.
About SQZ Biotechnologies SQZ Biotechnologies is a
clinical-stage biotechnology company focused on unlocking the full
potential of cell therapies to benefit patients with cancer,
autoimmune and infectious diseases. The company’s proprietary Cell
Squeeze® technology offers the unique ability to deliver multiple
biological materials into many patient cell types to engineer what
we believe can be a broad range of potential therapeutics. Our goal
is to create well-tolerated cell therapies that can provide
therapeutic benefit for patients and improve the patient experience
over existing cell therapy approaches. With accelerated production
timelines under 24 hours and the opportunity to eliminate
preconditioning and lengthy hospital stays, our approach could
change the way people think about cell therapies. The company’s
first therapeutic applications seek to generate target-specific
immune responses, both in activation for the treatment of solid
tumors and in immune tolerance for the treatment of unwanted immune
reactions and autoimmune diseases. For more information, please
visit www.sqzbiotech.com.
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 U.S.
Securities and Exchange Commission could cause actual results to
differ materially from those indicated by the forward-looking
statements. Any forward-looking statements represent management's
estimates as of this date and SQZ undertakes no duty to update
these forward-looking statements, whether as a result of new
information, the occurrence of current events, or otherwise, unless
required by law.
Certain information contained in this press release relates to
or is based on studies, publications, surveys and other data
obtained from third-party sources and our own internal estimates
and research. While we believe these third-party sources to be
reliable as of the date of this press release, we have not
independently verified, and we make no representation as to the
adequacy, fairness, accuracy, or completeness of any information
obtained from third-party sources.
i Leonard MM, Sapone A, Catassi C, et al. Celiac Disease and
Nonceliac Gluten Sensitivity: A Review. JAMA 2017;318:647-656 ii
Celiac Disease Foundation website (as of Sept 13,2021) iii Beyond
Celiac website (as of Sept 13, 2021) iv National Institute of
Diabetes and Digestive and Kidney Diseases website (as of Sept 13,
2021) 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
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version on businesswire.com: https://www.businesswire.com/news/home/20220621005151/en/
Media Contact: Erin Phelps erin.phelps@sqzbiotech.com
857-760-0920
Investor Contact: Mike Kaiser
michael.kaiser@sqzbiotech.com 857-760-0398
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