Sana Biotechnology Announces FDA Clearance of Investigational New Drug Application for SC262, a Hypoimmune-modified, CD22-directed Allogeneic CAR T Therapy, for Patients with Relapsed or Refractory B-cell Malignancies
January 05 2024 - 9:00AM
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 SC262 in patients with relapsed or refractory
B-cell malignancies, initially in patients who have received prior
CD19-directed CAR T therapy.
Engineered CAR T cell therapies for B-cell malignancies use
binders to target proteins expressed on the surface of
B cells. One such protein, CD19, has been the target of all
approved autologous CAR T therapies for B-cell lymphoma and B-cell
acute lymphoblastic leukemia to date. Unfortunately, incomplete
responses or relapses occur in approximately 60% of CD19 CAR
T-treated patients. CD22, which is also a B-cell surface protein,
has emerged as an alternative to address failure to achieve durable
complete responses with CD19-directed CAR T therapy. SC262
expresses the same CAR, including the same CD22 binder, used in
CD22-directed CAR T therapies tested in multiple academic clinical
trials. To date, these trials have shown durable complete responses
in a substantial number of patients in the relapse setting
following treatment with a CD19-directed CAR T therapy.
“Patients who have failed a CD19-directed CAR T therapy
represent a significant unmet need, and this population is growing
as more patients receive these therapies,” said Doug Williams, PhD,
Sana’s President of Research and Development. “SC262 represents an
important potential option for these patients and is the next step
in building Sana’s hypoimmune CAR T therapy platform. Over the past
twelve months, Sana has received three IND regulatory clearances,
as well as supported the authorization of an investigator-sponsored
CTA, to begin new studies utilizing our hypoimmune platform in
seven different indications in oncology, B-cell mediated autoimmune
diseases, and type 1 diabetes. We look forward to presenting data
from all of these studies this year, including initial proof of
concept data for SC262 later this year.”
About SC262 in B-cell MalignanciesSC262 is a
hypoimmune, CD22-directed allogeneic CAR T cell therapy derived
from healthy donor CD4+ and CD8+ T cells. SC262 is developed with
Sana’s hypoimmune platform, which is designed to overcome the
immunologic rejection of allogeneic cells and may result in longer
CAR T cell persistence and a higher rate of durable complete
responses for patients with B-cell malignancies. CD22 is expressed
on lymphoma and leukemia cells in most patients with these
diseases, including those that have failed CD19- and/or a
CD20-directed therapies. SC262 is initially being explored in
patients that have failed a previous CD19-directed therapy. 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 SC262 as a therapeutic for patients with B-cell
malignancies.
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 of CD22-directed CAR T
therapies to address failure to achieve durable complete responses;
expectations regarding the growth of the potential patient
population for SC262; the potential significance of the IND
clearance for SC262; the ability to use the Company’s hypoimmune
platform to evade immune recognition and overcome the immunologic
rejection of allogeneic cells without immunosuppression and the
potential benefits associated therewith; the potential of SC262 as
a therapeutic for patients with B-cell malignancies; and the
ability to apply the HIP technology to donor-derived allogeneic T
cells to make potent and persistent CAR T cells at scale and
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 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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