Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on
creating and delivering engineered cells as medicines, shared data
in six presentations at the 64th American Society of Hematology
(ASH) Annual Meeting and Exposition, taking place from Saturday,
December 10 to Tuesday, December 13, 2022 in New Orleans, LA, which
highlighted further progress with key technologies supporting
Sana’s ex vivo allogeneic CAR T cell programs and in vivo platform.
“Our HIP platform has the potential to transform the CAR T
space, and with it, the treatment of hematologic malignancies, and
we are pleased to share data from several drug candidates before
our planned entry into the clinic in 2023,” said Terry Fry, M.D.,
Sana’s Senior Vice President and Head of T Cell Therapeutics.
“Separate oral presentations show that our HIP-modified allogeneic
CD19-targeted CAR T cells can evade immune detection and kill tumor
cells in a fully immunocompetent preclinical model, including with
serial in vivo tumor stimulation, and that our manufacturing
process is able to produce HIP-modified allogeneic CAR T cells
reproducibly at scale with high gene editing efficiency and yield.
We intend to develop this platform broadly to treat patients with
lymphoma, leukemia, and multiple myeloma with a goal of three INDs
over the next several years, including one this year for SC291
targeting CD19 positive cancers and one next year for SC263 for
patients who have failed a CD19-directed CAR T therapy.”
Transplanting cells or tissues from a donor to a different
recipient currently requires intense immunosuppression to prevent
rejection of the transplant. The goal of Sana’s hypoimmune (HIP)
platform is to eliminate the need for immunosuppression by cloaking
cells from immune recognition while at the same time generating the
manufacturing scale and reproducibility of allogeneic cells. The
challenge for the field to date in generating immune cloaked cells
has been turning off both the adaptive and innate immune system
concurrently. Sana’s platform includes disruption of major
histocompatibility (MHC) class I and MHC class II expression to
hide cells from the adaptive immune system, which includes antibody
and T cell responses, as well as overexpression of CD47 to inhibit
activation of the innate immune cell system, in particular
macrophages and natural killer (NK) cells. The company has
presented data across multiple preclinical models highlighting the
potential of this platform to cloak cells from immune recognition.
Sana’s goal is to use these HIP-modified cells to replace damaged
or missing cells in the body in a number of different diseases,
including, among others, cancer and type 1 diabetes.
On Sunday, December 11, Sonja Schrepfer, M.D., Ph.D., Sana’s
Senior Vice President and Head of Hypoimmune Platform, gave an oral
presentation (Abstract 485) titled “Engineered Hypoimmune CAR T
Cells Provide Lasting Tumor Control in Fully Immunocompetent
Allogeneic Humanized Mice.” This presentation demonstrated that
CD47 is an important mechanism to avoid innate immune rejection.
CD47 overexpression comprehensively inhibits macrophage and NK cell
killing after the disruption of MHC class I and MHC class II
expression, making it a more complete approach against innate
immune cell killing compared to other strategies. A single dose of
HIP-modified CD19-targeted CAR T cells was able to eliminate CD19+
tumors in immune competent animals, including after tumor
rechallenge, indicating that these cells may be able to persist and
maintain anti-tumor efficacy without immunosuppression.
On Sunday, December 11, Christina Chaivorapol, Ph.D., Sana’s
Vice President, Translational Technologies, gave an oral
presentation (Abstract 663) titled “Efficient and Specific
Multi-Locus Editing of Allogeneic CAR T Cells for Hypoimmunity
during Large Scale Manufacture Using Cas12b.” The presentation
outlined the use of a novel of CRISPR enzyme, Cas12b, to engineer
allogeneic hypoimmune CAR T cells at large scale in order to
prevent recognition and clearance by the host immune system while
maintaining anti-tumor efficacy. Cas12b has been highlighted in
prior studies as exhibiting a high level of on-target editing
specificity. Assessment of genome integrity of T cells manufactured
using Cas12b demonstrated highly specific editing with no
significant off-target editing and no evidence for
editing-associated structural modifications beyond those expected
from on-target cleavage. These data indicate that this scaled
manufacturing process can produce fully engineered HIP-modified
CD19-targeted allogeneic CAR T cells with high editing efficiency
and specificity.
On Saturday, December 10, Sana scientist Darin Salloum, Ph.D.,
presented a poster (Abstract 1974) titled “Functional T Cell Assays
Are Predictive of Pre-Clinical Potency to Generate Allogeneic,
Hypoimmune CD19 CAR T Cells.” The presentation highlighted the use
of several in vitro and in vivo assays to categorize T cells
derived from healthy, allogeneic donors into excellent-, good-, or
poor-performing T cells. These “stress test” assays may be used to
identify T cell quality differences which may be used to select
donors and reduce batch variability for allogeneic, HIP-modified
CAR T manufacturing. Sana’s manufacturing process appears to
create, in a replicable fashion, high quality T cells at a scale
with the potential for hundreds of doses per batch.
On Saturday, December 10, Sana scientist Adam Johnson, Ph.D.,
presented a poster (Abstract 1988) titled “A Dual-Antigen
Targeting, Hypoimmune Allogeneic CAR T to Evade Innate and Adaptive
Immune Rejection and Overcome Antigen Escape.” The presentation
showed that a dual-transduction method using lentivirus encoding
CD47-CD19CAR and CD47-CD22CAR could reproducibly generate
dual-targeted hypoimmune CAR T cells, maintain CD47 overexpression
for HIP function, and eliminate both CD19 and CD22 knockout tumor
cell lines. Sana is developing SC263, a HIP-modified, CD22-directed
CAR T with a clinically-validated CAR with the potential to treat
patients with B cell malignancies who have not responded, relapsed,
or are refractory to previous CD19-targeted CAR T therapies. The
company expects to file an IND in 2023.
On Sunday, December 11, Sana scientist Jeremy Kinder, Ph.D.,
presented a poster (Abstract 3168) titled “BCMA-Targeted,
Hypoimmune Allogeneic CAR T Cells Exhibit Potent Anti-Tumor
Activity Together with the Ability to Evade Innate and Adaptive
Immune Rejection in Pre-Clinical Tumor Models.” The presentation
showed that, in pre-clinical tumor models, HIP-modified
BCMA-directed CAR T cells with the clinically-validated CT103A CAR
construct licensed by Sana in January 2022 controlled myeloma tumor
cells equivalently to HIP-modified CAR T cells with approved BCMA
CAR constructs. In addition, HIP-modified BCMA CAR T cells showed
equal in vitro efficacy and cytokine production against BCMA+
target cells compared to non-HIP BCMA CAR T cells. These data
support advancing an allogeneic, HIP-modified BCMA-directed CAR T
product to treat myeloma. Sana expects to file an IND for product
candidate SC255 as early as 2024 to treat multiple myeloma.
On Sunday, December 11, Sana scientist Jesse Green, Ph.D.,
presented a poster (Abstract 3457) titled “CD8-Targeted,
Integrating Viral Vectors Transduce Resting T Cells and Enable
Extracorporeal Delivery (ECD) for Rapid CAR T Cell Therapies.” The
presentation highlighted that CD8-targeted CD19 CAR fusosomes are
able to specifically transduce primary, non-activated CD8+ T cells
to generate highly functional CAR T cells capable of eliminating
CD19+ tumor cells in animal models. This result was accomplished by
both a short-term ex vivo incubation with T cells followed by
infusion, termed extracorporeal delivery (ECD), or by direct IV
injection of fusosomes into animals engrafted with peripheral blood
mononuclear cells. Data generated demonstrate ECD and direct IV are
potential dosing options for patients with this fusosome for the in
vivo production of CAR T cells. The company expects to study SG295,
an in vivo CAR T with CD8-targeted fusosome delivery of a
CD19-targeted CAR, in patients with B cell malignancies. With
increased potency from a second-generation manufacturing process,
SG295 has the potential to generate a comparable number of CAR T
cells to current ex vivo manufacturing processes. The company
remains on track to file an IND in 2023.
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 with respect to the expected timing of IND filings for
the Company’s product candidates; expectations regarding the
potential impact of the Company’s technologies and therapies;
potential implications of the data presented at ASH; the potential
ability of the HIP platform to cloak cells from immune recognition;
the potential ability of HIP-modified CD19-targeted CAR T cells to
persist and maintain anti-tumor efficacy without immunosuppression;
the potential ability to manufacture fully engineered HIP-modified
CD19-targeted allogeneic CAR T cells with high editing efficiency
and specificity using Cas12b; the potential benefits of “stress
test” assays with respect to the Company’s allogeneic, HIP-modified
CAR T manufacturing process, and the potential advantages of such
manufacturing process; the potential of SC263 to treat patients
with B cell malignancies who have not responded, relapsed, or are
refractory to previous CD19-targeted CAR T therapies; and the
potential of ECD and direct IV as potential dosing options for
SG295. 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 statements by terminology such as “aim,”
“anticipate,” “assume,” “believe,” “contemplate,” “continue,”
“could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,”
“may,” “objective,” “plan,” “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 the economic,
market and social disruptions 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 SEC reports, including but not
limited to its Quarterly Report on Form 10-Q dated November 2,
2022. 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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