Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on
changing the possible for patients through engineered cells, today
announced data from four presentations at the 2023 American
Association for Cancer Research (AACR) Annual Meeting.
“Sana remains focused on improving outcomes, predictability, and
access with cell and gene therapies, and we have several programs
looking to expand on the transformative potential for CAR T cells
in treating hematological cancers,” said Terry Fry, Sana’s Senior
Vice President and Head of T Cell Therapeutics. “At AACR, we
presented data highlighting the potential of our hypoimmune
platform to “hide” allogeneic CAR T cells from immune recognition,
improving CAR T cell persistence and anti-tumor effect. Other data
highlighted the progress and potential of SG299, the first drug
candidate from our fusogen platform, in generating CD19-directed
CAR T cells with in vivo delivery. In 2023, we look forward to
initial clinical data for SC291, allogeneic CAR T cells for
patients with B cell cancers; filing an IND for SC262, allogeneic
CAR T cells for patients that have failed previous CAR T therapy;
and filing an IND for SG299, our in vivo CAR delivery program for
patients with B cell cancers.”
The poster (abstract 4091) titled “Engineered hypoimmune CAR T
cells provide lasting tumor control in immunocompetent allogeneic
humanized mice even with re-challenge” described preclinical data
on hypoimmune (HIP)-modified allogeneic CD19 directed CAR T cells.
The study results showed that HIP CD19-directed CAR T cells were
functionally immune evasive in allogeneic humanized mouse models.
The cells persisted and remained functional over multiple months in
an allogeneic immune system, even with tumor re-challenge after 90
days. In contrast, although CD19-directed CAR T cells lacking
hypoimmune edits showed an initial tumor response, they were
eliminated by the allogeneic immune system and tumor recurred after
30 days in the majority of animals.
The late-breaking poster (abstract LB311) titled “Increased
potency of CD8-targeted fusosomes enhances CAR gene delivery to
resting primary T cells” described the preclinical efficacy of a
CD8-targeted fusosome encoding a CD19 CAR transgene manufactured
using an improved process. The improved process generates fusosomes
with increased potency that result in increased in vivo CAR T
generation and increased tumor control. CD8-targeted fusosomes were
also evaluated in a clinically relevant mock extracorporeal
delivery setting, which potently generated CD19-directed CAR T
cells. A CD8-targeted fusosome delivering a CD19 CAR transgene has
the potential to provide an off-the-shelf therapeutic approach to
generate CD19-directed CAR T cells in vivo and without
lymphodepleting chemotherapy.
The poster (abstract 2735) titled “Development of a novel, fully
human anti-CD19 chimeric antigen receptor for in vivo delivery via
CD8-targeted fusosomes” compares preclinical data on a fully human
CD19-directed CAR, which comprises a human CD19 binder developed at
Sana, to a standard murine FMC63 CAR. CD19-directed CAR T cells
with the fully human CD19 CAR demonstrated comparable efficacy to
CD19-directed CAR T cells with an FMC63 CAR in both in vitro and in
vivo models. CD8-targeted fusosomes delivering this fully human
CD19 CAR into T cells demonstrated anti-tumor efficacy in vivo. The
use of a fully human CD19 binder has the potential to reduce the
immunogenicity of the CD19 CAR relative to an FMC63 CAR and has
potential applicability in both Sana’s hypoimmune CAR T cell
platform and in vivo CAR T cell platform.
The poster (abstract 2734) titled “Modulation of resting T cell
status to enhance transduction and CAR T expansion following
exposure to CD8-targeted fusosomes” highlighted the preclinical
efficacy of treatments to modulate resting T cell status to enhance
transduction and generation of CAR T cells by a with CD8-targeted
fusosomes encoding a CD19 CAR transgene, both prior to and after
delivery of such fusosomes. Although CD8-targeted fusosomes alone
were effective at transducing resting T cells, pre-treatment of
resting T cells with IL-7 increased transduction efficiency in
vitro and also increased anti-tumor efficacy in vivo. Adding
rapamycin to IL-7 in the pre-treatment setting further increased
the fusosomes’ transduction efficiency. When IL-7 was delivered
post-transduction, there was CAR T cell expansion, resulting in
improved in vitro cytotoxicity. When given systemically, IL-7
supported the expansion of in vivo fusosome-generated CAR T cells
and increased anti-tumor efficacy compared to fusosome only.
Combinations of CD8-targeted fusosomes with cytokine treatments
could be implemented to further increase transduction and CAR T
cell generation, drive CAR T cell expansion, and improve patient
outcomes.
About Sana’s Hypoimmune PlatformSana’s
hypoimmune platform is designed to create cells ex vivo that can
“hide” from the patient’s immune system to enable the transplant of
allogeneic cells without the need for immunosuppression. We are
applying hypoimmune technology to both donor-derived allogeneic T
cells, with the goal of making potent and persistent CAR T cells at
scale, and pluripotent stem cells, which can then be differentiated
into multiple cell types at scale. Preclinical data from a variety
of cell types demonstrate that these transplanted allogeneic cells
can evade both the innate and adaptive arms of the immune system
while retaining their function. Our most advanced programs using
hypoimmune technology include our allogeneic CAR T program
targeting CD19+ cancers (SC291), our allogeneic CAR T program
targeting CD22+ cancers (SC262), our allogeneic CAR T program
targeting BCMA+ cancers (SC255), and our stem-cell derived
pancreatic islet cell program for patients with type 1 diabetes
(SC451).
About Sana’s Fusogen PlatformSana’s fusogen
platform is designed to optimize in vivo cell specific delivery of
genetic material. Our goal is to be able to repair and control
genes in cells. Engineering cells in vivo requires the development
of both an appropriate delivery vehicle, as well as an active
component to effectively modify the target cell. Fusogens are
naturally occurring cell-targeting proteins. Sana reengineers these
proteins to target specific cell surface receptors, enabling
cell-specific delivery to many different types of cells. The
platform was developed to deliver an active component to any cell
in a specific, predictable, and repeatable way. This technology is
the backbone of Sana’s in vivo delivery platform and is
incorporated into various product candidates, including SG299, a
CD8-targeted fusosome that delivers a CD19 CAR to target CD19+
cancer cells.
About Sana BiotechnologySana Biotechnology,
Inc. is focused on creating and delivering engineered cells as
medicines for patients. We share a vision of repairing and
controlling genes, replacing missing or damaged cells, and making
our therapies broadly available to patients. We are a passionate
group of people working together to create an enduring company that
changes how the world treats disease. Sana has operations in
Seattle, Cambridge, South San Francisco, and Rochester. For more
information about Sana Biotechnology, please visit
https://sana.com/.
Cautionary Note Regarding Forward-Looking
StatementsThis press release contains forward-looking
statements about Sana Biotechnology, Inc. (the “Company,” “we,”
“us,” or “our”) within the meaning of the federal securities laws,
including those related to the company’s vision, progress, and
business plans; expectations for its development programs, product
candidates, and technology platforms, including its pre-clinical,
clinical, and regulatory development plans and timing expectations,
including the expected timing of IND submissions and indications
for which the Company is developing its product candidates, and
expected timing and availability of clinical data; the potential
benefits and impact of fusosomes, including in combination with
other treatments, and product candidates comprising a human CD19
binder, and potential applicability of such binder; the potential
capabilities, benefits, and impact of the hypoimmune platform,
including the potential ability to create cells ex vivo that can
“hide” from the patient’s immune system to enable the transplant of
allogeneic cells without the need for immunosuppression, and the
fusogen platform, including the potential ability to repair and
control genes in cells and deliver an active component to any cell
in a specific, predictable, and repeatable way. All statements
other than statements of historical facts contained in this press
release, including, among others, statements regarding the
Company’s strategy, expectations, cash runway and future financial
condition, future operations, and prospects, are forward-looking
statements. In some cases, you can identify forward-looking
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“believe,” “contemplate,” “continue,” “could,” “design,” “due,”
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“positioned,” “potential,” “predict,” “seek,” “should,” “target,”
“will,” “would” and other similar expressions that are predictions
of or indicate future events and future trends, or the negative of
these terms or other comparable terminology. The Company has based
these forward-looking statements largely on its current
expectations, estimates, forecasts and projections about future
events and financial trends that it believes may affect its
financial condition, results of operations, business strategy and
financial needs. In light of the significant uncertainties in these
forward-looking statements, you should not rely upon
forward-looking statements as predictions of future events. These
statements are subject to risks and uncertainties that could cause
the actual results to vary materially, including, among others, the
risks inherent in drug development such as those associated with
the initiation, cost, timing, progress and results of the Company’s
current and future research and development programs, preclinical
and clinical trials, as well as economic, market and social
disruptions, including due to the ongoing COVID-19 public health
crisis. For a detailed discussion of the risk factors that could
affect the Company’s actual results, please refer to the risk
factors identified in the Company’s Securities and Exchange
Commission (SEC) reports, including but not limited to its Annual
Report on Form 10-K dated March 16, 2023. Except as required by
law, the Company undertakes no obligation to update publicly any
forward-looking statements for any reason.
Investor Relations & Media:Nicole
Keithinvestor.relations@sana.commedia@sana.com
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