Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on
creating and delivering engineered cells as medicines, presented
data at the 63rd American Society of Hematology (ASH) Annual
Meeting and Exposition, taking place from Saturday, December 11 to
Tuesday, December 14, 2021, which highlighted further progress with
key technologies supporting Sana’s in vivo and ex vivo CAR T cell
programs.
“The data presented at ASH showcase the progress we are making
with Sana’s CAR T cell programs,” said Terry Fry, M.D., Sana’s Head
of T Cell Therapeutics. “The hypoimmune and fusogen technologies
are designed to address significant challenges that lead to
sub-optimal patient outcomes and prevent widespread utilization of
cell and gene therapies, including cell persistence and
cell-specific delivery. We continue to move these potential
therapies toward clinical trials in patients, with a goal of filing
two INDs as early as next year.”
On Saturday, December 11, Sonja Schrepfer, M.D., Ph.D., Sana’s
Head of Hypoimmune Platform, presented a poster (Abstract 1690)
titled “Engineered hypoimmune allogeneic CAR T cells exhibit innate
and adaptive immune evasion even after sensitization in humanized
mice and retain potent anti-tumor activity.” Data demonstrated
continued progress with Sana’s hypoimmune allogeneic CAR T cell
platform, showing in murine models that these gene-modified CAR T
cells targeting CD19 can evade both the innate and adaptive immune
systems without any evidence of a change in their ability to
eliminate leukemia. This immune evasion was present in naïve
subjects as well as in sensitized subjects that had previously
rejected non-hypoimmune CAR T cells. In the study, the hypoimmune
allogeneic CD19 CAR T cells did not induce activation of the
adaptive immune system, T cells or B cells, in the treated subjects
(p<0.0001 when compared to non-modified CD19 CAR T cells), and
also evaded the subjects’ innate immune responses. These findings
are an important step toward the possibility of “off-the-shelf”
allogeneic CD19 CAR T cells that persist without immunosuppression,
including in patients that have previously been treated with a CAR
T therapy.
On Sunday, December 12, Terry Fry, M.D., presented a poster
(Abstract 2769) titled “In vivo delivery of a CD20 CAR using a
CD8-targeted fusosome in Southern pig-tail macaques (M. nemestrina)
results in B cell depletion.” The presentation outlined the
potential to deliver a CAR gene to make CAR T cells in vivo. B cell
depletion in these healthy non-human primates is used as a
surrogate marker for an anti-tumor effect against B cell
malignancies such as leukemia and lymphoma. Following the infusion
of the CD8a-targeted fusosome carrying the gene for an anti-CD20
CAR into macaques, B cells were meaningfully reduced in 4 of 6
animals after 7 to 10 days. Scientists found the anti-CD20 CAR
transcripts via measurements of mRNA expression in spleen cells
isolated from treated animals; conversely, no expression was
detected in tissues from control animals. Subjects in this study
received no lymphodepleting chemotherapy. Additionally, the
fusosome treatment was well-tolerated in all animals with no
evidence of adverse effects. These findings suggest that the
fusosome technology represents a novel therapeutic opportunity to
treat patients with B cell malignancies, with the potential for in
vivo delivery of the CAR gene to CD8 T cells.
On Sunday, December 12, Sana Scientist Christie Ciarlo, Ph.D.,
presented a poster (Abstract 2942) titled “CD4-targeted fusosomes
are capable of transducing resting T helper cells to generate
highly potent CAR T cells.” The presentation highlighted the
ability of select fusosomes to effectively target the correct cells
and to deliver an integrating CAR payload that can develop CAR T
cells in vivo. CD4-targeted CD19 CAR fusosomes efficiently
transduced activated T cells (34% ± 1.5% CD4+CAR+; 0.54 ± 0.18
c/dg) and resting T cells (20% ± 0.5% CD4+CAR+; 0.28 ± 0.14 c/dg).
The data showed that these fusosomes were specific to certain T
cells based on their functionality and also that they could deliver
their payloads to helper T cells without activation, opening up new
potential pathways for in vivo cell therapies. Investigators
concluded that targeting the CD4 co-receptor through in vivo
delivery of a genetic payload can produce potent and functional CAR
T cells, with the potential to target certain cancers.
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 more than 350
people working together to create an enduring company that changes
how the world treats disease. Sana has operations in Seattle,
Cambridge, and South San Francisco. 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 filing of IND applications; and the
potential activity, uses and advantages of hypoimmune CAR T cells
and fusosome technology, including CD4-specific fusosomes and
CD8α-targeted fusosomes. 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 Annual Report on Form 10-K dated March 24, 2021 and
Quarterly Report on Form 10-Q dated November 8, 2021. Except as
required by law, the Company undertakes no obligation to update
publicly any forward-looking statements for any reason.
All product and company names herein may be trademarks of their
registered owners.
Investor Relations:Nicole
Keithinvestor.relations@sana.com
Media:Morgan Warners, Finsbury Glover
Heringmedia@sana.com
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