Sana Biotechnology Confirms Key Program Timelines and Announces Portfolio Prioritization
29 November 2022 - 10:05PM
Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on
creating and delivering engineered cells as medicines, today
announced a portfolio prioritization designed to optimize the
development of programs at or nearing clinical development,
continue investments in our core research platforms and innovation,
and maintain a strong balance sheet with an expected cash runway
into 2025. The resulting changes include focusing its second
HIP-modified allogeneic CAR T program on targeting CD22 for CD19
CAR T failures, halting further internal investment in its SC187
program (cardiomyocytes for heart failure), and stage-gating
certain platform investments based upon clinical progress in
humans. The prioritization and restructuring reduced the company’s
headcount by approximately 15%, which gives the company the
expected runway to invest in its key clinical programs over the
next several years. Timelines for the company’s lead programs,
including time to IND and clinical data, are not expected to be
impacted.
“We are making significant progress with our platforms to
address two of the fundamental opportunities to enable greater
utilization of cell engineering to treat serious diseases –
overcoming immune rejection of allogeneic cells and in vivo
delivery of gene modification reagents in a cell-specific manner.
We look forward to generating human proof of concept starting next
year and are positioning the company to invest fully based upon the
clinical data,” said Steve Harr, Sana’s President and CEO. “Losing
talented and valued colleagues is painful, and we thank them for
their contributions to Sana’s mission. Prioritization is important,
and we will continue to make decisions based upon internal data,
external evolution of the field, and the company’s needed
capabilities to deliver on the promise of our pipeline with
important medicines for patients.”
Select Program Review
- SC291 (HIP-modified, CD19-targeted allogeneic CAR T) – Sana
remains on track to file an IND this year with initial clinical
data expected in 2023. Preclinical data continue to highlight the
potential for the HIP platform to hide our allogeneic cells from
immune detection, creating the potential for longer CAR T cell
persistence and higher durable complete response rates in cancer
patients. The company intends to study this therapy in a number of
B cell malignancies.
- SC263 (HIP-modified, CD22-targeted allogeneic CAR T) – Sana
expects to file an IND in 2023. Over 50% of patients treated with
approved autologous CD19-targeted CAR T cell products either
relapse after a complete response or never reach a complete
response. CD22, which is also a B cell surface protein, has emerged
as a target to address patients that fail to achieve durable
complete responses with a CD19-directed CAR T therapy. The
CD22-directed CAR construct we are developing has led to a complete
response in over 50% of treated CD19-failure patients. SC263
incorporates this clinically-validated CAR with T cells
manufactured using our HIP platform. This therapy has the potential
to treat patients with B cell malignancies who have failed previous
CAR T therapies.
- SG295 (in vivo CAR T with CD8-targeted fusogen delivery of a
CD19-targeted CAR) – Sana remains on track to file an IND in 2023.
This program has the potential to generate CAR T cells in vivo
(inside the patient), eliminating the need for conditioning
chemotherapy and complex CAR T cell manufacturing. The company
expects to study this therapy in patients with B cell
malignancies.
- SC451 (HIP-modified, stem-cell derived pancreatic islet cell
therapy for patients with type 1 diabetes) – Sana remains on track
to file an IND in 2024. Preclinical data continue to highlight the
potential for HIP modifications to allow these cells to evade both
allogeneic and autoimmune rejection in type 1 diabetes. The goal of
this therapy is to transplant hypoimmune islet cells with no
immunosuppression into patients with type 1 diabetes so that these
cells produce insulin in a physiologic manner in response to
glucose.
- SC255 (HIP-modified, BCMA-targeted allogeneic CAR T) – Sana
expects to file an IND in 2024 to treat multiple myeloma. BCMA has
been validated as a target for autologous CAR T therapy in relapsed
and/or refractory multiple myeloma. This program will incorporate a
clinically-validated CAR and T cells manufactured using our HIP
platform, with the goal of offering greater persistence of CAR T
cells and the scalable manufacturing of our allogeneic process for
patients with multiple myeloma.
- SC379 (stem-cell derived GPCs) – The glial progenitor cell
(GPC) program aims to deliver healthy allogeneic GPCs, the
precursors to both astrocytes and oligodendrocytes. This program
has the potential to treat myelin and glial-based disorders, which
represent a broad group of debilitating neurological disorders,
including genetic disorders of dysfunctional oligodendrocyte or
astrocyte production and more common diseases such as progressive
multiple sclerosis. The company’s goal is to begin GLP toxicology
studies in 2023.
- SG418 (Fusogen HSC program) - Sana is developing a
hematopoietic stem cell (HSC)-targeted fusosome with the ability to
deliver gene editing material in vivo to repair genetic
abnormalities such as those that cause sickle cell disease and
beta-thalassemia. The company’s goal is for preclinical proof of
concept in 2023.
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 expected cash
runway, including the potential impact of the Company’s portfolio
prioritization on its expected cash runway; the potential impact of
the prioritization and restructuring on the Company’s operations
and development timelines; the ability to use the Company’s cell
engineering platforms to overcome immune rejection of allogeneic
cells and provide in vivo delivery of gene modification reagents in
a cell-specific manner; the Company’s expectations regarding the
timing, substance, and impact of the data from its clinical trials;
the Company’s expectations with respect to the potential
therapeutic benefits and impact of its development programs; the
potential ability of the Company’s HIP platform to make genomic
modifications to allogeneic cells to hide them from immune
detection and the potential benefits associated therewith; the
potential capabilities of the Company’s manufacturing process for
its SC291 program; the potential of the Company’s SG295 program to
generate CAR T cells in vivo; the potential advantages of the
second-generation manufacturing process for the Company’s SG295
program; and the potential ability of the Company’s HIP platform to
make genetic modifications to islet cells to allow them to evade
both allogeneic and autoimmune rejection in type 1 diabetes. 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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