Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on
changing the possible for patients through engineered cells, and
Uppsala University Hospital in Sweden today announced the Swedish
Medical Products Agency has authorized Uppsala University’s
Clinical Trial Application (CTA) to initiate an
investigator-sponsored, first-in-human study of UP421, an
allogeneic, primary islet cell therapy engineered with Sana’s
hypoimmune (HIP) technology, in patients with type 1 diabetes.
The goal of UP421 treatment is to provide proof of concept for
transplanting functional islet cells without immunosuppression.
UP421 is engineered using Sana’s hypoimmune platform modifications
with the goal of evading both allogeneic and autoimmune rejection.
The study is designed with endpoints of safety, cell survival,
immune evasion, and C-peptide production. Insights from this study
may inform development of Sana’s SC451, a hypoimmune-modified
stem-cell derived islet cell therapy for patients with type 1
diabetes.
“Islet cell transplantation has shown curative potential for
patients with type 1 diabetes, but the need for concurrent
immunosuppression has led to side effects, limited efficacy, and
decreased utilization. Sana’s hypoimmune platform has shown the
potential to evade both allogeneic and autoimmune rejection in
preclinical models, and we look forward to seeing if these insights
translate into patients, providing a path to cell transplantation
without immunosuppression,” said Steve Harr, Sana’s President and
CEO. “The team at Uppsala has significant experience in primary
islet cell manufacturing, transplantation, and clinical care of
these patients, and we look forward to seeing the results from this
clinical study and applying learnings to SC451.”
“We are pleased with the authorization of the CTA and look
forward to treating a patient with cells engineered with this novel
technology,” said Per-Ola Carlsson, Study Principal Investigator,
Senior Physician and Professor of Diabetes at Uppsala University
Hospital. “We have performed approximately 165 allogeneic, primary
islet cell transplants and have seen the benefits for patients, but
the complications of immunosuppression inhibit broader use of this
procedure. Combining Sana’s hypoimmune technology with primary
islet cell transplantation therapy can generate important
first-in-human data that may be a step to removing
immunosuppression from allogeneic cell transplant in the type 1
diabetes setting. The long-term hope is that all patients with type
1 diabetes can be cured of the disease by replacing their destroyed
insulin-producing cells with new ones.”
Primary islet cell transplantation is an established procedure
in type 1 diabetes, where allogeneic islet cells are isolated from
a cadaver and transplanted into a patient with a goal of blood
glucose control without the need for insulin. As with any organ
transplant, suppression of the recipient’s immune system is
required to prevent immune rejection of the transplanted cells. In
addition to complications from this immune suppression, inadequate
immunosuppression has limited uptake and durability of effect, as
most patients eventually reject the transplanted islets over months
to years, lose glucose control, and become insulin-dependent again,
primarily due to immune rejection of the allogeneic islets from
inadequate immunosuppression.
Sana’s hypoimmune technology seeks to overcome the immunologic
rejection of allogeneic cells via disruption of human leukocyte
antigen (HLA) class I and class II expression to allow cells to
evade the adaptive immune system, including antibody and T cell
responses, as well as overexpression of CD47 to allow cells to
evade the innate immune cell system, in particular macrophages and
natural killer (NK) cells. If UP421 successfully overcomes
immunologic rejection, it may result in engraftment, survival, and
C-peptide production in patients with type 1 diabetes
following transplantation without immune suppression. Sana’s prior
presentations across multiple preclinical models have highlighted
the potential of this platform to enable allogeneic cells to evade
immune recognition and the potential of hypoimmune-modified cells
as a therapeutic for patients.
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
Statements This 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 hypoimmune technology platform; expectations
regarding the timing and significance of data from the
investigator-sponsored clinical trial of UP421; 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 impact of insights from the UP421 study on
development of the Company’s SC451 development program; the
potential therapeutic benefits of islet cell transplantation; and
the potential ability to use the hypoimmune technology to make
potent and persistent allogeneic CAR T cells at scale and
pluripotent stem cells that can 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, 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 8,
2023. Except as required by law, the Company undertakes no
obligation to update publicly any forward-looking statements for
any reason.
Sana Investor Relations & Media:Nicole
Keithinvestor.relations@sana.commedia@sana.com
Uppsala University Hospital:Per-Ola
Carlssonper-ola.carlsson@mcb.uu.se
Sana Biotechnology (NASDAQ:SANA)
Gráfica de Acción Histórica
De Abr 2024 a May 2024
Sana Biotechnology (NASDAQ:SANA)
Gráfica de Acción Histórica
De May 2023 a May 2024