Sana Biotechnology Publishes Early Clinical Data Showing that SC291, a CD19-directed Allogeneic CAR T Therapy, Evades Immune Detection in Presence of Intact Immune System
December 01 2023 - 4:05PM
Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on
changing the possible for patients through engineered cells, today
announced the publication in Blood of an abstract providing
initial clinical data from the first patient treated at the lowest
dose in the ongoing ARDENT Phase 1 clinical trial with SC291, a
hypoimmune (HIP)-modified allogeneic CD19-directed CAR T cell
therapy. SC291 appeared safe and well tolerated, evaded immune
detection, and induced a partial response in a patient with chronic
lymphocytic leukemia (CLL). ARDENT is a Phase 1 study evaluating
safety and tolerability of SC291 in patients with CLL and
non-Hodgkin lymphoma. Treatment in this dose escalation study is
ongoing, and the company expects to present more data from this
study at a later date in an appropriate venue.
“These are the first clinical data demonstrating that our HIP
technology can engineer allogeneic cells to evade adaptive and
innate immune detection and rejection in the context of an intact
immune system, overcoming the key challenge in unlocking the
potential of allogeneic cells,” said Gary Meininger, MD, Sana’s
Chief Medical Officer. “These data suggest the potential of SC291
to persist and attack cancer cells in a manner consistent with
autologous cells, which combined with scaled manufacturing,
encourage us about both the opportunity for SC291 and our other
HIP-modified cells to provide clinical benefit for patients. The
data were published as part of an abstract submitted over the
summer, and we look forward to sharing more data from this ongoing
clinical trial that we expect will more clearly outline SC291’s
profile.”
The full abstract is available for online viewing at
https://doi.org/10.1182/blood-2023-179441.
About SC291 in B-cell Lymphomas or
LeukemiasSC291 is a hypoimmune, CD19-directed allogeneic
CAR T cell therapy derived from healthy donor CD4+ and CD8+ T cells
that are genetically engineered. SC291 is developed with Sana’s
hypoimmune platform, which is designed to overcome the immunologic
rejection of allogeneic cells, which if true for SC291 may result
in longer CAR T cell persistence and a higher rate of durable
complete responses for patients with B-cell lymphomas or leukemias.
The hypoimmune technology includes disruption of major
histocompatibility (MHC) class I and MHC class II expression to
allow cells to evade the adaptive immune system, which includes
antibody and T cell responses, as well as overexpression of CD47 to
evade 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 and the potential
of SC291 as a therapeutic for patients with B-cell malignancies.
SC291 is being evaluated in a Phase 1 study called ARDENT for
patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin
lymphoma (NHL).
About Hypoimmune PlatformSana’s hypoimmune
platform is designed to create cells ex vivo that can evade the
patient’s immune system to enable the transplant of allogeneic
cells without the need for immunosuppression. We are applying the
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 published in
peer-reviewed journals demonstrate across a variety of cell types
that these transplanted allogeneic cells are able to evade both the
innate and adaptive arms of the immune system while retaining their
activity. Our most advanced programs utilizing this platform
include an allogeneic CAR T program targeting CD19+ cancers,
an allogeneic CAR T program for B-cell mediated autoimmune
diseases, an allogeneic CAR T program targeting CD22+ cancers, and
stem-cell derived pancreatic islet cells 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
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;
the significance of initial data from the first patient treated in
the ARDENT Phase 1 clinical trial; the Company’s expectations
regarding the timing and substance of future data from the ARDENT
trial; the ability to use the HIP platform to create cells ex vivo
that can evade a patient’s immune system and enable the transplant
of allogeneic cells without the need for immunosuppression and the
potential benefits associated therewith; and the ability to apply
the HIP technology to allogeneic T cells to make potent and
persistent CAR T cells at scale and to pluripotent stem cells,
which can then be differentiated into multiple cell types at scale.
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
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Investor Relations & Media:Nicole
Keithinvestor.relations@sana.commedia@sana.com
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