Sana Biotechnology Announces FDA Clearance of Investigational New Drug Application for SC291, a Hypoimmune-modified, CD19-directed Allogeneic CAR T Therapy, for Patients with Lupus Nephritis, Extrarenal Lupus, and ANCA-associated Vasculitis
November 09 2023 - 3:05PM
Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on
changing the possible for patients through engineered cells, today
announced the U.S. Food and Drug Administration (FDA) has cleared
the company’s Investigational New Drug (IND) application to
initiate a study of SC291 in patients with multiple B-cell mediated
autoimmune diseases, including lupus nephritis, extrarenal lupus,
and antineutrophil cytoplasmic antibody (ANCA)-associated
vasculitis.
“Our goal is to develop SC291 for patients with multiple B-cell
mediated autoimmune diseases, and the clearance of this IND is an
important milestone,” said Doug Williams, PhD, Sana’s President of
Research and Development. “SC291 is an allogeneic CAR T cell
therapy with a scaled manufacturing process that produces hundreds
of patient doses per manufacturing run, which we believe will be
critical to addressing these large unmet needs. The use of
allogeneic cells further simplifies the treatment paradigm for
doctors and patients alike by eliminating apheresis and
individualized patient-by-patient manufacturing of the drug
product. We intend to begin treating patients in the near-term and
expect to disclose initial safety and efficacy data across multiple
diseases in 2024.”
About SC291 in B-cell mediated Autoimmune
DiseasesSC291 is a CD19-directed allogeneic CAR T cell
therapy developed using Sana’s hypoimmune platform. Our allogeneic
T cell programs utilize T cells from healthy donors to generate CAR
T therapies that, in this case, target CD19, a protein expressed on
the cell surface of B cells. It has been shown that B cells drive
disease pathology in many autoimmune diseases, and B-cell targeting
therapies from several different modalities have been efficacious
across multiple autoimmune diseases. Emerging data in the field
support the concept that deeper tissue B cell depletion can be
associated with greater efficacy and a reasonable safety profile.
CD19-directed CAR T therapy introduces a new option, where the CAR
T is the effector cell that depletes B cells in situ. Our goal is
to develop SC291 in various settings, using our existing hypoimmune
allogeneic CAR T manufacturing platform, to deliver with scale for
these large unmet needs.
About 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 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 Company’s expectations regarding the timing and significance of
data from its clinical trials; the potential significance of the
clearance of the SC291 IND in B-cell mediated autoimmune disease;
the potential significance of the manufacturing scale for SC291;
the potential benefits of using allogeneic cells with respect to
the treatment paradigm; expectations regarding the timing and scope
of the presentation of initial clinical data from the SC291 trial
in B-cell mediated autoimmune disease; the goals for and potential
benefits of the SC291 program; and the ability to use the Company’s
hypoimmune platform to evade immune recognition and overcome the
immunologic rejection of allogeneic cells and the potential
benefits associated therewith. 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.
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 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
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