SQZ® eAPC Platform Demonstrates that mRNA-based
Expression of Co-Stimulatory CD86 and Membrane-bound IL-2 and IL-12
Dramatically Increases Antigen-Specific CD8 T Cell Activity
T Cell Responses Shown Across Multiple Antigens
In Vitro and In Vivo Using mRNAs that Encode Infectious Disease or
Tumor-Related Antigens, including HPV (E6 and E7) and KRAS
Beyond eAPC Preclinical Advances, a SQZ AAC
Phase 1/2 Clinical Trial in Progress Presentation to be Delivered
on April 13
Data Presented at the American Association for
Cancer Research 2022 Annual Meeting
SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full
potential of cell therapies for multiple therapeutic areas, today
shared enhanced antigen presenting cell (eAPC) preclinical data
demonstrating that delivery of multiple mRNAs encoding for
disease-specific antigens together with immune stimulators (CD86
costimulatory factor and membrane bound IL-2 and IL-12 cytokines)
had a synergistic effect that substantially increased killer T
cells in humanized mouse models. The preclinical data, presented at
the American Association for Cancer Research (AACR) 2022 Annual
Meeting, showed this in vivo enhancement can be seen with a variety
of disease antigen mRNAs across a range of HLA types. The findings
indicate the potential of the company’s eAPC platform to induce a
robust killer T cell response against specific diseases, and the
opportunity to increase the number of patients who could
potentially benefit from eAPC therapeutic candidates.
The company’s first eAPC therapeutic candidate, SQZ-eAPC-HPV, is
in a Phase 1/2 clinical trial (COMMANDER-001) in patients who have
human papillomavirus positive (HPV16+) solid tumors. SQZ-eAPC-HPV
delivers mRNA for HPV-specific E6 and E7 antigens, CD86
costimulatory factor, and membrane-bound IL-2 and IL-12 cytokines.
This new platform represents sophisticated engineering that we
believe to be an advancement over the company’s APC platform
candidate, which has demonstrated promising preliminary monotherapy
clinical activity in a patient with HPV16+ solid tumors.
“Our eAPC preclinical data, both in vitro and in vivo,
demonstrate the synergistic potential of our multiple mRNA delivery
approach on activating CD8+T cells,” said Howard Bernstein, M.D.,
Ph.D., Chief Scientific Officer at SQZ Biotechnologies. “The
inclusion of disease-specific antigens, costimulatory factor, and
cytokines into a single cell therapy offers tremendous opportunity
for patient impact. With the capability to engineer all three T
cell activating signals simultaneously, we can pursue additional
preclinical activities that could extend our eAPC platform to
additional indications.”
In addition to the eAPC preclinical data, a Trial in Progress
poster presentation of the ENVOY-001 Phase 1/2 clinical trial will
be delivered by Victoria Villaflor, M.D., City of Hope Medical
Center. The presentation will summarize the ENVOY-001 study design
of SQZ-AAC-HPV, the company’s first engineered red blood cell
clinical candidate being investigated in patients with HPV16+
recurrent, locally advanced, or metastatic solid tumors.
AACR EAPC MRNA HIGHLIGHTS IN HUMANIZED
MOUSE MODEL
Synergistic Impact of Multiple mRNA T cell Stimulators
- Mice treated with human eAPCs including mRNA for CMV antigen,
CD86 costimulatory factor, and membrane-bound IL-2 and IL-12
cytokines were shown to have a dramatic increase in killer T cells
compared to APCs with mRNA for antigen alone
- Mice treated with human eAPCs including mRNA for influenza
(Flu) antigen, CD86 costimulatory factor, and membrane-bound IL-2
and IL-12 cytokines were shown to have a three-fold increase in
killer T cell compared to APCs with mRNA for antigen alone
Strong T Cell Responses Across Multiple HLA Types
- Mice treated with human eAPCs including mRNA for CMV antigen,
CD86 costimulatory factor, and membrane-bound IL-2 and IL-12
cytokines were shown to have higher killer T cells responses across
a range of HLA types (A*01, A*02, A*11, A*24, B*07, B*35) compared
to those squeezed with CMV peptide alone
AACR mRNA HIGHLIGHTS IN HUMAN PBMCs (B
cell, T cell, NK cell, Monocytes)
Expansion of CD8 T Cells & Cytokine Signaling
- Human PBMCs with antigen-encoding mRNA for CMV, Flu, HPV16 E6,
HPV16 E7 and KRAS G12V substantially increased activation of
antigen-specific T cells in vitro compared to untreated PBMCs
- Membrane-bound IL-2 and IL-12 mRNA delivery in PBMC subsets led
to surface expression of the cytokines and functional
signaling
AACR eAPC Poster
Presentation
Title: Co-delivery of antigen-encoding mRNA and signal
2/3 mRNAs to PBMCs by CellSqueeze® technology generates SQZ® eAPCs
that prime CD8 T cells in humanized mouse model Presenter:
Scott Loughhead, PhD, SQZ Biotechnologies Session Date and Time:
Tuesday, Apr 12, 2022 9:00 AM - 12:30 PM ET Poster Board Number: 19
Abstract Number: 2853
AACR Trial in Progress
Presentation
Title: ENVOY-001: A phase 1, multicenter, open-label
study of SQZ-AAC-HPV as monotherapy and in combination with immune
checkpoint inhibitors in HLA-A*02+ patients with HPV16+ recurrent,
locally advanced, or metastatic solid tumors Presenter:
Victoria M. Villaflor, MD, City of Hope Medical Center Session Date
and Time: Wednesday, April 13, 2022 9:00 AM - 12:30 PM ET Poster
Section: 35 Abstract Number: 7645
About SQZ-AAC-HPV
SQZ® Activating Antigen Carriers (AACs), derived from engineered
red blood cells (RBCs), are designed to transport tumor-specific
antigens and adjuvant to a patient’s own professional antigen
presenting cells (APCs). The APCs would then activate CD8 killer T
cells that travel to tumor sites and attack specific diseased
cells. SQZ-AAC-HPV is the company’s first AAC clinical candidate,
and it is being evaluated in a Phase 1/2 clinical trial (ENVOY-001
or SQZ-AAC-HPV-101) for the treatment of HPV16+ advanced or
metastatic solid tumors. The investigational candidate is being
studied as a monotherapy and in combination with immune checkpoint
inhibitors.
ENVOY-001 Trial Design
SQZ-AAC-HPV is being evaluated in a Phase 1/2 clinical trial
(ENVOY-001) for the treatment of HPV16+ advanced or metastatic
solid tumors. The investigational candidate, which targets E6 and
E7 oncoproteins, is being studied as a monotherapy and in
combination with immune checkpoint inhibitors. The study consists
of two parts. The first part is designed to assess the safety and
tolerability of multiple doses of SQZ-AAC-HPV monotherapy in
treatment-experienced patients. The second part of the study will
assess safety and tolerability of SQZ-AAC-HPV in combination with
nivolumab and/or ipilimumab.
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 investigational 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 monotherapy 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 Company is a clinical-stage biotechnology
company focused on unlocking the full potential of cell therapies
for patients around the world and has active programs in oncology,
autoimmune and infectious diseases, as well as additional
exploratory initiatives to support future pipeline growth. The
company’s proprietary Cell Squeeze® technology offers the unique
ability to deliver multiple biological materials into many cell
types to engineer what we believe can be a broad range of potential
therapeutics. With demonstrated production timelines under 24 hours
and the opportunity to eliminate preconditioning and lengthy
hospital stays, our approach could significantly broaden the
therapeutic range and accessibility of 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 infectious diseases, and in immune
tolerance for the treatment of 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, our platform development, our product candidates,
project funding, preclinical and clinical activities, progress and
outcomes, development plans, manufacturing, clinical safety and
efficacy results, therapeutic potential, market opportunities 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 strategic collaborators; 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 most recent 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 we undertake 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
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version on businesswire.com: https://www.businesswire.com/news/home/20220411005158/en/
SQZ Media John Lacey
781-392-5514 john.lacey@sqzbiotech.com Investors Michael Kaiser 857-760-0398
michael.kaiser@sqzbiotech.com
SQZ Biotechnologies (NYSE:SQZ)
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