Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on
changing the possible for patients through engineered cells, today
announced it will prioritize future development activity for
SC291, the company’s CD19-directed allogeneic CAR T cell therapy,
in B-cell mediated autoimmune diseases (AID). The company will
suspend development of both SC291 in oncology and of SC379, its
glial progenitor cell program, as it seeks partnerships for these
programs. Sana will increase its investment in its type 1 diabetes
program with the cash savings from these changes.
“Early clinical data with our hypoimmune platform (HIP) suggest
HIP-modified cells evade immune detection, giving us confidence in
the potential of the platform across multiple therapeutic areas. At
the same time, we need to ensure that we are directing our
investments into the areas where we believe we can have the
greatest impact for patients,” said Steve Harr, Sana’s President
and Chief Executive Officer. “Greater focus on type 1 diabetes,
SC291 in AID, and SC262 in refractory blood cancers will enhance
our ability to present robust clinical data over the next twelve to
eighteen months. This modified strategy will also help us reduce
our cash burn but comes with the necessity of parting with some
talented and valued colleagues. We thank them for their
contributions toward building Sana and thank the patients who have
been treated in the SC291 oncology study.”
With these changes, Sana extends its expected cash runway into
2026. Payments related to ongoing activities combined with the
reduction in force may increase the 2024 operating cash burn above
prior guidance of less than $200 million.
“Since joining Sana, I have actively engaged with the team to
understand both Sana and competitor data and believe it is the
right time to prioritize where we believe we have the most
differentiated therapeutic candidates and the highest probability
of success for patients,” said Dhaval Patel, M.D., Ph.D., Chief
Scientific Officer of Sana. “Type 1 diabetes is a significant unmet
need, and we are optimistic that our program is novel and has the
potential to offer patients meaningful benefit. The decision to
prioritize SC291 in B-cell mediated autoimmune diseases is based on
early clinical data with this drug in both oncology and autoimmune
diseases, which show that therapy with SC291 can predictably lead
to the deep B cell depletion that appears to drive an immune
“reset” and significant clinical benefit in patients with B-cell
mediated autoimmune diseases such as lupus. We look forward to
generating and sharing more data from across our portfolio.”
Select Program Review
UP421 (HIP-modified primary pancreatic islet cells) in
type 1 diabetes: The 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 is active; Sana expects to share proof
of concept data in 2024 and/or 2025.
SC291 (HIP-modified CD19-directed allogeneic CAR T) in
autoimmune diseases: Sana continues enrollment in the
Phase 1 GLEAM trial for SC291 for the treatment of B-cell mediated
autoimmune diseases and expects to share clinical data in 2024
and/or 2025.
SC262 (HIP-modified CD22-directed allogeneic CAR T) in
oncology: Sana continues enrollment in the Phase 1 VIVID
study for patients with refractory B-cell malignancies who have
failed a previous CD19-directed CAR T therapy and expects to share
data in 2025.
SC451 (HIP-modified stem cell-derived pancreatic islet
cells) in type 1 diabetes: Sana continues preclinical
development of this HIP-modified, stem-cell derived therapy for
patients with type 1 diabetes.
SG299 (in vivo CAR T
with CD8-targeted fusogen delivery of a CD19-directed
CAR): Sana is continuing its preclinical development of
this program, with potential in both B-cell mediated autoimmune
diseases and oncology.
SC291 (HIP-modified CD19-directed allogeneic CAR T) in
oncology: Given alternative opportunities within its
pipeline as well as increased competition within blood cancers and
uncertainty about the best path to regulatory and commercial
success, Sana is halting enrollment and further internal investment
in the Phase 1 ARDENT trial. It is actively seeking a licensing
partner to support advancement.
SC379 (stem-cell derived glial progenitor cells) in
various CNS diseases: Sana will actively seek a partner or
opportunity to spin out this program into a new company.
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, Bothell, 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;
expectations regarding the impact of the Company’s modified
strategy on its cash burn and cash runway and its potential ability
to present clinical data for the type 1 diabetes program, SC291
program in AID and SC262 program over the next twelve to eighteen
months; expectations regarding how the Company will use the cash
savings from the changes to its business; the potential ability of
HIP-modified cells to evade immune detection; the potential of the
HIP platform across a number of therapeutic areas; expectations
regarding the Company’s cash runway; expectations regarding the
Company’s 2024 operating cash burn; expectations regarding where
the Company has the most differentiated therapeutic candidates and
the highest probability of success; expectations regarding the type
1 diabetes program and its ability to offer patients meaningful
benefits; the ability of deep B cell depletion to drive an immune
“reset” and clinically benefit patients with B-cell mediated
autoimmune diseases such as lupus; 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; and the Company’s future plans for the SC291 oncology
and SC379 programs, including its ability to partner the SC291
oncology program or partner or spin out the SC379 program into a
new company. 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 Annual Report on Form 10-Q dated
August 8, 2024. 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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