Cell Squeeze® Platform Offers Advantages for
GMP Engineering of Multiple Cell Types and Reduced Manufacturing
Time and Cost through its Point-of-Care System
mRNA Constructs Encoding Multiple Linked
Antigens Could Allow for a Multiantigen-Specific CD8+ T Cell
Response
SQZ® eAPCs Contain Five mRNAs Encoding for
Proteins Stimulating the Key T Cell Activation Signals to
Potentially Mount Potent Immune Response Against Tumors
SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full
potential of cell therapies for multiple therapeutic areas, will
present preclinical research demonstrating the potential of its
Cell Squeeze® technology to multiplex engineer a diverse set of
cell types, including hematopoietic stem cells (HSCs) and induced
pluripotent stem cells (iPSCs), to potentially support the creation
of new therapeutic candidates. This capability builds upon the GMP
capable system and SQZ® Point-of-Care system that can process more
than 10 billion cells per minute. The data will be presented at the
37th Annual Meeting of the Society for Immunotherapy of Cancer
(SITC) being held November 8-12, 2022, in Boston, MA.
“Our presentation at SITC demonstrates the broad potential of
our Cell Squeeze® technology to reliably deliver materials into
cells without disrupting cell function, reduce manufacturing times,
improve the safety of cell therapies, and support the creation of
new therapies,” said Jonathan Gilbert, Ph.D., Vice President of
Exploratory Research at SQZ Biotechnologies.
The company will also present a COMMANDER-001 Phase 1/2 Trial in
Progress poster demonstrating how its Enhanced Antigen Presenting
Cell (eAPC) therapeutic candidate is designed to leverage the
delivery of five mRNAs encoding for proteins stimulating the key T
cell activation signals required to generate an immune response
against tumors, including membrane-bound IL-2 and IL-12. By
presenting all three canonical signals, the eAPC approach can
potentially amplify the T cell response. Additionally, the ability
to deliver E6 and E7 mRNA encoding full-length proteins to eAPCs
removes the HLA restriction for trial screening, increasing the
addressable patient population by two-to-three times when compared
to the company’s Antigen Presenting Cell (APC) program.
Lastly, the company will present preclinical research outlining
a potential new therapeutic approach linking multiple antigens
together to create a single mRNA and delivering it into eAPCs to
generate a personalized neoantigen medicine for mutations like the
KRAS mutation.
“One of the latest examples of our platform’s potential is its
capability to deliver multiple linked antigens to eAPCs, which
could potentially be used to develop bespoke vaccines for patients
based on their cancer’s specific mutations or vaccines for a larger
set of patients with a shared mutation such as KRAS,” said
Marshelle Warren, M.D., Chief Medical Officer at SQZ
Biotechnologies. “Additionally, we are presenting our eAPC Trial in
Progress and look forward to sharing our initial data by the end of
the year.”
Major Findings from Research:
Poster #224: Generation of Cell Therapies for Diverse
Applications Using Microfluidic Cell Squeeze® Manufacturing
Technology Date: Friday, November 11, 2022
- The Cell Squeeze® system can be leveraged to engineer a diverse
set of cell types, including HSCs and iPSCs, and potentially allows
for improved product quality and manufacturing cost relative to
other common cell therapy approaches. Advantages include limited
required rest time after the engineering step, faster
proliferation, and fewer operator hours needed
- Transient engineering of a broad set of cell types with
membrane-bound cytokines could lead to new therapeutic approaches
for cell therapy. Preclinically, we show the ability to potentially
improve safety by eliminating cytokine support as well as increase
the frequency of a desirable cell phenotype
- SQZ® Point-of-Care (POC) system enables more cell engineering
possibilities while demonstrating a >90% reduction in operator
hours with total process time under six hours. The POC system also
offers the potential to eliminate the need for an ISO 7 clean
room
Poster #321: Single mRNA Constructs Encoding Multiple
Linked Antigens Allow for a Multiantigen-Specific CD8+ T Cell
Response Driven by SQZ® eAPCs Date: Thursday, November 10,
2022
- Using Cell Squeeze® technology, investigators successfully
generated SQZ® eAPCs with mRNA encoding for up to 10 linked antigen
fragments, including E6, E7, KRAS G12V, and KRAS G12D
- SQZ® eAPCs engineered with linked antigen mRNA constructs
containing KRAS antigens drove KRAS-specific T cell responses in
vitro, suggesting a potential model for a personalized neoantigen
medicine for KRAS mutations
- mRNA constructs encoding multiple linked antigens drove
increased CD8+ T cell response, further enhancing the versatility
of the Cell Squeeze® technology to potentially target multiple
tumor-associated neoantigens in a single mRNA construct
Poster #638: COMMANDER-001: A Phase 1/2, First-in-Human,
Multicenter, Open Label Study of SQZ-eAPC-HPV as Monotherapy and
with Pembrolizumab in Patients with HPV16+ Recurrent, Locally
Advanced, or Metastatic Solid Tumors (Trial in Progress)
Date: Friday, November 11, 2022
- SQZ-eAPC-HPV is an enhanced SQZ® clinical therapeutic candidate
with no HLA restrictions, which increases the eligible patient
population by 2-3 times compared to the company’s SQZ-PBMC-HPV
clinical candidate
- SQZ® Enhanced Antigen Presenting Cells (eAPCs) are engineered
by using the Cell Squeeze® technology to simultaneously deliver
five mRNAs encoding for full-length HPV16 E6 and E7 proteins
(signal 1), CD86 (signal 2), and membrane-bound (mb) IL-2 and
mbIL-12 cytokines (signal 3)
- Eligible patients undergo a single leukapheresis, from which
all doses have been manufactured in under 24 hours. Patients do not
require a preconditioning regimen prior to receiving the
therapeutic candidate
About SQZ-eAPC-HPV SQZ® Enhanced Antigen Presenting Cells
(eAPC) are derived from peripheral blood mononuclear cells (PBMCs),
which are primarily composed of monocytes, T cells, B cells, and NK
cells, and engineered with various mRNA encoding for multiple
target antigens and immuno-stimulatory signals, including CD86 and
membrane-bound IL-2 and IL-12. The company has presented
preclinical findings showing that SQZ® eAPCs have generated robust
T cell responses in human in vitro and in vivo models.
Additionally, it was demonstrated that HPV16-encoding mRNA delivery
to PBMCs stimulated CD8+ T cells across a range of HLA haplotypes,
supporting eAPC clinical development in broader HPV16+ patient
populations.
COMMANDER-001 Trial Design SQZ-eAPC-HPV is being
evaluated in a Phase 1/2 clinical trial (COMMANDER-001) for the
treatment of HPV16+ advanced or metastatic solid tumors. The
clinical candidate, which targets E6 and E7 oncoproteins, is being
studied as a monotherapy and in combination with pembrolizumab, an
immune checkpoint inhibitor. The study consists of two parts. The
first part is designed to assess safety and tolerability of
multiple doses of SQZ-eAPC-HPV in treatment-experienced patients,
following a dose-escalation scheme for monotherapy, and a dose
de-escalation for the combination with pembrolizumab. The second
part of the study will assess clinical response of SQZ-eAPC-HPV in
combination with pembrolizumab in immune checkpoint inhibitor
treatment-naïve patient populations.
About Human Papillomavirus Positive Cancers Human
papillomavirus (HPV) is one of the most common viruses worldwide
and certain strains persist for many years, often leading to
cancer. According to the Centers for Disease Control (CDC), in the
United States HPV+ tumors represent 3% of all cancers in women and
2% of all cancers in men, resulting in over 39,000 new cases of
HPV+ tumors every year. HPV infection is larger outside of the
U.S., and according to the International Journal of Cancer, HPV+
tumors account for 4.5% of all cancers worldwide resulting in
approximately 630,000 new cases every year. According to the CDC,
HPV infection plays a significant role in the formation of more
than 90% of anal and cervical cancers, and most cases of vaginal
(75%), oropharyngeal (70%), vulval (70%) and penile (60%)
cancers.
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 immune 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 Statements 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, manufacturing
capabilities, clinical safety and efficacy results, and therapeutic
potential. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20221110005244/en/
SQZ Biotechnologies Investor Relations: Mike Kaiser
michael.kaiser@sqzbiotech.com 857-760-0398
SQZ Biotechnologies Media: Erin Phelps
erin.phelps@sqzbiotech.com 857-760-0920
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