Sana Biotechnology Announces FDA Clearance of Investigational New Drug Application for SC291, a Hypoimmune-modified, CD19-targeted Allogeneic CAR T Therapy for Patients with B-Cell Malignancies
26 Januar 2023 - 10:05PM
Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on
creating and delivering engineered cells as medicines, today
announced the U.S. Food and Drug Administration (FDA) has cleared
the company’s Investigational New Drug (IND) application to
initiate a first-in-human study of SC291 in patients with various
B-cell malignancies.
SC291 is a CD19-targeted allogeneic CAR T cell therapy developed
using Sana’s hypoimmune platform. The goal of the hypoimmune
platform is 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
platform includes disruption of major histocompatibility (MHC)
class I and MHC class II expression to hide cells from the adaptive
immune system, which includes antibody and T cell responses, as
well as overexpression of CD47 to inhibit activation of 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.
“The clearance of our SC291 IND is an important milestone,
putting us closer to our goal of making an important medicine for
patients with B-cell lymphomas and leukemias,” said Steve Harr,
Sana’s President and CEO. “We look forward to understanding the
safety, potency, and persistence of these cells in patients, and we
are optimistic that SC291 can become an important medicine for
patients with these difficult cancers. Furthermore, this platform
forms the backbone for additional development of CAR T cells
targeting CD22, BCMA, and beyond. We expect initial clinical data
from the SC291 study later this year and believe insights from this
study will better inform our opportunities across the broader
platform, both for CAR T cells and for programs outside of cancer
such as our pancreatic islet cell therapy for patients with type 1
diabetes.”
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 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 targeting
CD22+ cancers, an allogeneic CAR T program targeting BCMA+ cancers,
and stem-cell derived beta 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,
including with respect to the expected timing of IND filings for
the Company’s product candidates; the Company’s expectations
regarding the timing and significance of data from its clinical
trials; the ability to use the Company’s hypoimmune platform to
overcome the immunologic rejection of allogeneic cells and the
potential benefits associated therewith; the potential benefits of
the SC291 program; and the potential to apply the hypoimmune
platform to indications outside of cancer. 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 Quarterly Report on Form 10-Q dated November 2, 2022. 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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