Sana Biotechnology Announces Fast Track Designation for SC291 in Relapsed/Refractory Systemic Lupus Erythematosus
Sana Biotechnology (NASDAQ: SANA) announced that the FDA has granted Fast Track designation for SC291, their hypoimmune-modified CD19-directed allogeneic CAR T therapy, for treating relapsed/refractory systemic lupus erythematosus (SLE). The company is currently enrolling patients in the GLEAM trial, which evaluates SC291 in B-cell mediated autoimmune diseases including lupus nephritis, extrarenal lupus, and ANCA-associated vasculitis. Initial clinical data is expected in 2025. SC291's scaled manufacturing process can produce hundreds of patient doses per manufacturing run, positioning it as a potential universal off-the-shelf therapy.
Sana Biotechnology (NASDAQ: SANA) ha annunciato che la FDA ha concesso la designazione Fast Track per SC291, la loro terapia CAR T allogenica diretta contro il CD19 modificata per essere ipoimmune, per il trattamento del lupus eritematoso sistemico (LES) in fase di recidiva/riferimento. L'azienda sta attualmente reclutando pazienti per il trial GLEAM, che valuta SC291 nelle malattie autoimmuni mediate dalle cellule B, inclusi la nefrite lupica, il lupus extrarenale e la vasculite associata agli ANCA. Si prevede che i dati clinici iniziali siano disponibili nel 2025. Il processo di produzione scalato di SC291 può produrre centinaia di dosi per paziente per ciclo di produzione, posizionandola come una potenziale terapia universale pronta all’uso.
Sana Biotechnology (NASDAQ: SANA) anunció que la FDA ha otorgado la designación Fast Track para SC291, su terapia CAR T alogénica modificada para ser hipoinmune dirigida contra CD19, para el tratamiento del lupus eritematoso sistémico (LES) en recaída/refractario. La compañía está actualmente reclutando pacientes para el ensayo GLEAM, que evalúa SC291 en enfermedades autoinmunes mediadas por células B, incluyendo nefritis lúpica, lupus extrarrenal y vasculitis asociada a ANCA. Se espera que los datos clínicos iniciales estén disponibles en 2025. El proceso de fabricación escalado de SC291 puede producir cientos de dosis por paciente por ciclo de producción, posicionándola como una posible terapia universal lista para usar.
Sana Biotechnology (NASDAQ: SANA)는 FDA가 패스트 트랙 지정을 SC291에 부여했다고 발표했습니다. SC291은 면역 억제형 CD19 방향의 알로겐 CAR T 치료제로, 재발/난치성 전신성 홍반 루푸스(SLE) 치료를 위한 것입니다. 현재 회사는 GLEAM 시험에 환자를 등록하고 있으며, 이 시험은 SC291을 루푸스 신염, 외부 신장 루푸스 및 ANCA 관련 혈관염을 포함한 B세포 매개 자가면역 질환에서 평가합니다. 초기 임상 데이터는 2025년에 예상됩니다. SC291의 대량 생산 공정은 제조당 수백 개의 환자용 용량을 생산할 수 있어, 즉시 사용 가능한 보편적인 치료제로 자리잡을 가능성이 있습니다.
Sana Biotechnology (NASDAQ: SANA) a annoncé que la FDA a accordé la décision Fast Track pour SC291, leur thérapie CAR T allogénique modifiée avec une hypo-immunité, dirigée contre le CD19, pour le traitement du lupus érythémateux systémique (LES) en rechute/réfractaire. L'entreprise recrute actuellement des patients pour l'essai GLEAM, qui évalue SC291 dans les maladies auto-immunes médiées par les cellules B, notamment la néphrite lupique, le lupus extrarénal et la vascularite associée aux ANCA. Les premières données cliniques sont attendues en 2025. Le processus de fabrication à grande échelle de SC291 peut produire des centaines de doses par patient à chaque cycle de production, la positionnant comme une thérapie universelle prête à l'emploi.
Sana Biotechnology (NASDAQ: SANA) gab bekannt, dass die FDA die Fast-Track-Einstufung für SC291, ihre hypoimmunkorrigierte CD19-gesteuerte allogene CAR T-Therapie zur Behandlung von rückfälligem/refraktärem systemischen Lupus erythematodes (SLE), erteilt hat. Das Unternehmen rekrutiert derzeit Patienten für die GLEAM-Studie, die SC291 bei B-Zell-vermittelten Autoimmunerkrankungen, einschließlich Lupusnephritis, extrarenalem Lupus und ANCA-assoziierter Vaskulitis, bewertet. Erste klinische Daten werden für 2025 erwartet. Der skalierte Herstellungsprozess von SC291 kann Hunderte von Patientendosen pro Produktionslauf erstellen, was es als potenzielle universelle Therapie ermöglicht, die sofort verfügbar ist.
- FDA Fast Track designation received for SC291, potentially expediting development and review process
- Manufacturing capability of hundreds of patient doses per production run
- Potential to address large unmet medical need in lupus treatment
- Initial clinical data not available until 2025
- Still in early clinical development phase with uncertain outcomes
Insights
The FDA Fast Track designation for SC291 represents a significant milestone in Sana's development of CAR T therapy for lupus treatment. The designation validates the unmet medical need in treating relapsed/refractory SLE and could potentially accelerate the path to market. The scalable manufacturing process, producing hundreds of doses per run, suggests strong commercial viability if clinical trials succeed.
Key advantages of SC291 include its hypoimmune modification and allogeneic (off-the-shelf) nature, which could make it more accessible and cost-effective compared to traditional autologous CAR T therapies. The GLEAM trial's broad scope, including lupus nephritis and ANCA-associated vasculitis, indicates potential for multiple revenue streams if successful. However, with initial data expected in 2025, investors should note the extended timeline before potential commercialization.
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
FAQ
What is the Fast Track designation that SANA received for SC291?
When will SANA release initial clinical data for the GLEAM trial?
What conditions is SANA's SC291 being tested for in the GLEAM trial?
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