Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on
changing the possible for patients through engineered cells, today
announced that Nature Biotechnology has published a paper titled
“Hypoimmune induced pluripotent stem cells survive long term in
fully immunocompetent, allogeneic rhesus macaques.” The preclinical
studies published in this paper used Sana’s hypoimmune (HIP)
technology to engineer HIP-modified allogeneic cells to escape
immune detection in the absence of immune suppression. In vivo
studies in fully immunocompetent non-human primates (NHPs)
demonstrated that HIP-modified allogeneic cells survived without
immunosuppression for the length of the studies (16 weeks and
>40 weeks). An additional humanized mouse study showed that
HIP-modified induced pluripotent stem cells (iPSCs) that are
differentiated into pancreatic islet cells were immune evasive and
ameliorated diabetes in vivo.
“We have demonstrated in numerous preclinical studies that our
hypoimmune-engineered cells persist and function without eliciting
an immune response,” said Doug Williams, PhD, Sana’s President of
Research and Development. “These published data in rigorous
translational models that closely imitate the human immune system
support our previous findings, most importantly that HIP-modified
allogeneic cells avoid immune recognition and rejection without
immune suppression. We are incorporating the HIP technology into
multiple therapeutic candidates in our pipeline and look forward to
reporting our first human clinical data later this year.”
Allogeneic HIP Cells Avoid Immune Activation and Escape
Systemic Immune Rejection in NHPsNHP iPSCs were engineered
using HIP technology to generate HIP-modified iPSCs. A cross-over
study was performed where NHP HIP iPSCs (HIPallo) were administered
to NHPs previously sensitized to non-engineered NHP iPSCs (wtallo)
and wtallo cells were administered to NHPs previously transplanted
with HIPallo cells. In NHPs first receiving HIPallo cells, no
cellular immune activation or killing of HIPallo cells was observed
after cell transplantation. Subsequent injection of wtallo cells
into these NHPs induced strong cellular immune responses similar to
those observed in the group receiving wtallo cells first. The
HIPallo cells survived with no evidence of immune recognition
despite this immune response to wtallo cells. In contrast, NHPs
initially transplanted with wtallo cells showed rapid immune
sensitization, including strong T cell activation and killing of
the wtallo cells. Subsequent transplantation of HIPallo cells
showed survival and no cellular immune response to HIPallo cells
despite the previous immune activation to and killing of wtallo
cells.
In all instances, administration of HIPallo cells did not
generate de-novo antibodies and no antibody-related killing of
HIPallo cells was observed, regardless of the order of
administration. In contrast, administration of wtallo cells
provoked a vigorous antibody and killing response against these
cells.
In a separate study using human iPSCs, hypoimmune-modified human
iPSCs (HIPxeno iPSCs) and unmodified human iPSCs (wtxeno iPSCs)
were transplanted into NHPs. Similar results were observed and
demonstrated the ability of HIPxeno iPSCs to avoid immune
activation and recognition, whereas wtxeno iPSCs induced a strong
immune response.
Human HIP iPSCs Differentiated into All Three Germ
Layers, Collectively Avoiding Immune Recognition; HIP Primary Islet
Cells Survive for Over 40 Weeks in NHPIn the allogeneic
setting following transplantation into the NHP, iPSCs
differentiated in vivo and gave rise to cells from all three germs
layers (endoderm, medoderm, and ectoderm). These HIP-modified cells
avoided immune recognition, survived, and engrafted in
immunocompetent NHPs, supporting the notion that cells remain
hypoimmune through differentiation and that the various HIP
derivatives are protected from immune recognition even after
differentiation.
In another study, HIP-modified allogeneic primary islet cells
achieved long-term survival after transplantation for over 40 weeks
and evaded immune recognition without the use of immunosuppression
in one NHP. An additional study in immunocompetent allogeneic
humanized mice demonstrated that human HIP iPSC-derived islet cells
are functional and ameliorated diabetes following
transplantation.
Only Transgenic CD47 Overexpression Provided Widespread
Protection Against the Innate Immune Response The
depletion of class I and II human leukocyte antigens (HLA) is an
engineering strategy aimed at broadly avoiding recognition by the
adaptive immune system. This depletion, however, triggers
recognition by the innate system, including a killing response by
NK cells and macrophages. Head-to-head comparisons of strategies to
counteract this response were conducted and data showed that
strategies using HLA-E, HLA-G, or PD-L1 did not prevent innate
immune recognition. Only CD47 overexpression prevented both
adaptive and innate immune recognition in vitro and in vivo.
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, our allogeneic CAR T program targeting
CD22+ cancers, our allogeneic CAR T program targeting BCMA+
cancers, and our stem-cell derived pancreatic islet cell program
for patients with type 1 diabetes.
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.
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 expectations for
availability and timing of clinical data; and 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. 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 economic,
market, and social disruptions, including due to the 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
Quarterly Report on Form 10-Q dated May 8, 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
Sana Biotechnology (NASDAQ:SANA)
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Sana Biotechnology (NASDAQ:SANA)
過去 株価チャート
から 5 2023 まで 5 2024