Sana Biotechnology's SC291 receives FDA Fast Track designation for treating relapsed/refractory systemic lupus erythematosus, with initial data expected in 2025.
Quiver AI Summary
Sana Biotechnology, Inc. announced that the FDA has granted Fast Track designation for its SC291 therapy, aimed at treating relapsed/refractory systemic lupus erythematosus (SLE) and other B-cell mediated autoimmune diseases. This designation aims to expedite the development and regulatory review processes for critical treatments. SC291 is a modified allogeneic CAR T therapy designed to target B cells, which play a significant role in the pathology of autoimmune diseases. The company is currently enrolling patients for its GLEAM trial and expects to report initial clinical data in 2025. Sana's Chief Scientific Officer highlighted SC291's potential as a scalable, off-the-shelf therapy to address unmet medical needs in this area.
Potential Positives
- Fast Track designation from the FDA for SC291 recognizes the urgent need for new treatments for patients with relapsed/refractory systemic lupus erythematosus (SLE).
- Enrollment in the GLEAM trial for SC291 indicates ongoing progress in clinical development, with initial data expected to be reported in 2025.
- SC291 has the potential to be a universal off-the-shelf therapy, addressing a significant unmet medical need in B-cell mediated autoimmune diseases.
- The hypoimmune platform used to develop SC291 allows for scaled manufacturing, which could lead to enhanced availability of the therapy for patients.
Potential Negatives
- The press release emphasizes the need for new treatment options for patients with relapsed/refractory systemic lupus erythematosus (SLE), which may indicate the current inadequacy of existing treatments, reflecting negatively on the company's previous pipeline.
- Initial clinical data from the GLEAM trial is not expected until 2025, suggesting a long timeline before potential market entry, which could lead to investor concern about the company's future revenue generation.
- The cautionary note regarding forward-looking statements highlights inherent risks and uncertainties in drug development, which may undermine confidence in the company's future success and profitability.
FAQ
What is Fast Track designation for SC291?
Fast Track designation is an FDA process to expedite the development and review of drugs treating serious conditions.
Which conditions is SC291 targeting?
SC291 is aimed at treating relapsed/refractory systemic lupus erythematosus (SLE) and related B-cell mediated autoimmune diseases.
When will initial clinical data for SC291 be available?
Sana Biotechnology expects to report initial clinical data from the GLEAM trial in 2025.
What is the purpose of the GLEAM trial?
The GLEAM trial evaluates the efficacy of SC291 in B-cell mediated autoimmune diseases, including lupus nephritis and extrarenal lupus.
How does SC291 work as a therapy?
SC291 is a hypoimmune, CD19-directed CAR T therapy that aims to deplete B cells involved in autoimmune diseases.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$SANA Insider Trading Activity
$SANA insiders have traded $SANA stock on the open market 2 times in the past 6 months. Of those trades, 0 have been purchases and 2 have been sales.
Here’s a breakdown of recent trading of $SANA stock by insiders over the last 6 months:
- RICHARD MULLIGAN has traded it 2 times. They made 0 purchases and 2 sales, selling 300,000 shares.
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$SANA Hedge Fund Activity
We have seen 73 institutional investors add shares of $SANA stock to their portfolio, and 89 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- FMR LLC added 4,438,949 shares (+16.3%) to their portfolio in Q3 2024
- T. ROWE PRICE INVESTMENT MANAGEMENT, INC. removed 1,184,060 shares (-76.0%) from their portfolio in Q3 2024
- DUQUESNE FAMILY OFFICE LLC removed 984,000 shares (-100.0%) from their portfolio in Q2 2024
- BLACKROCK, INC. added 771,847 shares (+7.0%) to their portfolio in Q3 2024
- INTEGRAL HEALTH ASSET MANAGEMENT, LLC added 600,000 shares (+50.0%) to their portfolio in Q3 2024
- DIMENSIONAL FUND ADVISORS LP added 556,155 shares (+106.4%) to their portfolio in Q3 2024
- OCTAGON CAPITAL ADVISORS LP removed 360,800 shares (-100.0%) from their portfolio in Q2 2024
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
Fast Track designation is designed to expedite clinical development and regulatory review timelines
Enrolling patients in the GLEAM trial for SC291 in B-cell mediated autoimmune diseases, including systemic lupus erythematosus; expect to report initial clinical data in 2025
SEATTLE, Dec. 02, 2024 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for SC291 in relapsed/refractory systemic lupus erythematosus (SLE), which includes extrarenal lupus and lupus nephritis. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
SC291, a hypoimmune (HIP)-modified CD19-directed allogeneic CAR T therapy, is being evaluated in Sana’s GLEAM trial in patients with B-cell mediated autoimmune diseases including lupus nephritis, extrarenal lupus, and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. Sana is enrolling patients in this study and expects to share initial data in 2025.
“We are pleased to receive Fast Track designation from the FDA for SC291, which highlights the need for new treatment options for patients with relapsed/refractory SLE,” said Dhaval Patel, M.D., Ph.D., Chief Scientific Officer of Sana. “As a HIP-modified allogeneic CAR T therapy with a scaled manufacturing process that produces hundreds of patient doses per manufacturing run, SC291 has the potential to serve as a universal off-the-shelf therapy that can address this large unmet need. We look forward to sharing initial data from the ongoing GLEAM trial.”
About SC291 in B-cell mediated Autoimmune Diseases
SC291 is a CD19-directed allogeneic CAR T cell therapy developed using Sana’s hypoimmune platform. Our allogeneic T cell programs use T cells from healthy donors to generate CAR T therapies that, in this case, target CD19, a protein expressed on the cell surface of B cells. B cells drive disease pathology in many autoimmune diseases, and therapies that target B cells have been efficacious across multiple autoimmune diseases. Emerging data in the field support the concept that deeper tissue B cell depletion can be associated with greater efficacy and a reasonable safety profile. CD19-directed CAR T therapy introduces a new option, in which the CAR T is the effector cell that depletes B cells
throughout the body. Our goal is to develop SC291 in various settings, using our existing hypoimmune allogeneic CAR T manufacturing platform, to deliver with scale for these large unmet needs.
About Sana Biotechnology
Sana 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, WA, Cambridge, MA, South San Francisco, CA, Bothell, WA and Rochester, NY. 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 technology platforms, including its preclinical, clinical and regulatory development plans and timing expectations; the potential of SC291 to serve as a universal off-the-shelf therapy for patients with relapsed/refractory SLE; expectations regarding the timing of initial data from the GLEAM trial; the association between deeper tissue B cell depletion and greater efficacy and a reasonable safety profile; and the ability to develop SC291 in various settings, using the Company’s existing hypoimmune allogeneic CAR T manufacturing platform, to deliver with scale for B-cell mediated autoimmune diseases. 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 November 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 Keith
investor.relations@sana.com
media@sana.com
This article was originally published on Quiver News, read the full story.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
