Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on
changing the possible for patients through engineered cells, today
announced a portfolio update, including both increased focus
on its ex vivo cell therapy product candidates and an IND
submission for SC291 in autoimmune diseases. Sana is positioned to
generate clinical proof of concept from multiple programs in 2023
and 2024, with a goal of better understanding its allogeneic HIP
CAR T programs in blood cancers, allogeneic HIP CAR T program in
autoimmune diseases, and HIP pancreatic islet cells in type 1
diabetes. The company will reduce near-term spend on its fusogen
platform for in vivo gene delivery, which postpones the planned
SG299 IND and decreases its expected forward operating burn.
“We have increased confidence in the potential of
our HIP platform, and near-term, we are increasing focus on three
therapeutic areas that utilize this platform and have the potential
to address large unmet needs with curative intent – allogeneic CAR
T cells in oncology, allogeneic CAR T cells in autoimmune diseases,
and pancreatic islet cell transplantation in type 1 diabetes. We
plan to present clinical data in these areas at various times
across 2023 and 2024,” said Steve Harr, President and CEO of Sana.
“The SC291 IND submission for the treatment of autoimmune diseases
positions us to move into the rapidly emerging opportunity of
utilizing CAR T cells in these large and underserved populations,
leveraging the investments we have made to date in the HIP
platform, T cell therapeutics, and scaled manufacturing that can
produce hundreds of patient doses per run. We need to ensure that
we have a financeable cost structure with these emerging
opportunities factored in, and this strategic re-positioning
enables us to deliver significant clinical data across multiple
drug candidates with the current balance sheet. These changes
unfortunately mean that many talented and valued colleagues will
depart the company, and we thank them for their contributions and
commitment to our mission.”
Select Program Review
SC291 Oncology (HIP-modified CD19-directed
allogeneic CAR T): Enrollment continues in Sana’s ARDENT
Phase 1 study for the treatment of B-cell lymphomas and leukemias
with clinical data expected in 2023 and 2024.
SC291 Autoimmune (HIP-modified
CD19-directed allogeneic CAR T): Sana submitted an IND for
the treatment of multiple autoimmune diseases, with preliminary
clinical data expected across multiple indications in 2024.
SC262 (HIP-modified CD22-directed
allogeneic CAR T): Sana expects to submit an IND in 4Q
2023 for the treatment of B-cell lymphomas and leukemias in
patients who have failed CD19-directed CAR T therapies, with
preliminary clinical data expected in 2024.
HIP-modified primary islet cells for the
treatment of type 1 diabetes: A CTA has been submitted for
an investigator sponsored trial exploring the potential of HIP
modifications to allogeneic primary islet cells to enable immune
evasion and overcome transplant rejection in type 1 diabetes; proof
of concept data expected in 2023 and 2024.
SG299 (in vivo
CAR T with CD8-targeted fusogen delivery of a CD19-directed
CAR): Sana will continue its focused research on this
innovative platform but not submit an IND at this time as
previously planned.
2024 Operating Burn Guidance
Sana expects 2024 operating cash burn to be below
$200 million, allowing the current cash position to extend further
into 2025. The strategic re-positioning will reduce headcount by
29% while allowing the company to invest in clinical capabilities
across multiple indications in oncology, autoimmune diseases, type
1 diabetes, and central nervous system disorders. Sana will
leverage its existing allogeneic manufacturing expertise and
continue development of its GMP manufacturing facility in Bothell,
Washington.
About Sana BiotechnologySana
Biotechnology, Inc. is focused on creating and delivering
engineered cells as medicines for patients. We share a vision of
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 submissions
for the Company’s product candidates; the Company’s expectations
regarding the timing, substance, and impact of the data from its
clinical trials as well as the investigator sponsored trial
exploring HIP-modified primarily islet cells in patients with type
1 diabetes; the potential ability of HIP-modified cells to evade
immune detection and overcome allogeneic rejection; the Company’s
expected 2024 operating cash burn; the potential impact of the
Company’s reduction in its near-term spend on the fusogen program,
including on the timing of an IND submission for the SG299 program
and the Company’s forward operating burn; the Company’s
expectations with respect to the potential therapeutic benefits and
impact of its development programs and platforms, including in
various indications; the potential of SC291 to treat autoimmune
diseases; the potential impact of the portfolio update on the
Company’s clinical and manufacturing capabilities; and the
Company’s future plans with respect to its SG299 program. 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 economic,
market and social disruptions. 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 August 3, 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
Sana Biotechnology (NASDAQ:SANA)
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