Allogeneic CD22-Directed CAR T Cell Therapy (SC262) by Sana Biotechnology: A Comprehensive Overview

I. Introduction

Chimeric Antigen Receptor (CAR) T cell therapy represents a significant advancement in cancer treatment, particularly for hematological malignancies. Autologous CAR T therapies, which utilize a patient's own T cells engineered to target cancer antigens like CD19, have demonstrated remarkable efficacy in B-cell cancers.[1] However, the widespread application of autologous CAR T faces considerable challenges, including complex and lengthy patient-specific manufacturing processes, potential for manufacturing failures due to poor patient T cell quality, and treatment delays that can be critical for patients with aggressive disease.[1]

Allogeneic, or "off-the-shelf," CAR T therapies derived from healthy donors offer potential solutions to these limitations, promising immediate availability, manufacturing scalability, and product consistency.[1] Despite these advantages, the development of allogeneic CAR T cells has been significantly hampered by fundamental immunological barriers. The recipient's immune system readily recognizes donor T cells as foreign, leading to their rapid rejection (host-versus-graft rejection), which curtails therapeutic persistence and efficacy.[1] Conversely, the infused donor T cells can attack the recipient's healthy tissues, causing potentially fatal graft-versus-host disease (GvHD).[1] Current strategies to mitigate these issues often rely on intensive patient immunosuppression, which introduces substantial risks of infection and other complications.[3]

Sana Biotechnology, a company focused on engineering cells as medicines [5], is developing technologies aimed at overcoming these core challenges. Central to their strategy is the Hypoimmune (HIP) platform, designed to render allogeneic cells immunologically "invisible".[3] SC262 is Sana's investigational allogeneic CAR T cell therapy candidate engineered using this HIP platform.[4] It specifically targets the CD22 antigen, a protein expressed on B cells.[5] SC262 is being developed initially for patients with relapsed or refractory (r/r) B-cell malignancies who have previously failed treatment with CD19-directed CAR T therapies, addressing a growing and significant unmet medical need.[2] The development of SC262 serves not only as a potential new therapy but also as a critical clinical test for Sana's HIP platform, aiming to validate its potential to enable safe and effective "off-the-shelf" cell therapies without requiring long-term immunosuppression.

II. SC262: Therapeutic Candidate Profile

SC262 is defined as an investigational, allogeneic CAR T cell therapy developed by Sana Biotechnology.[5] It comprises a balanced mixture of CD4+ and CD8+ T cells sourced from healthy donors, which are subsequently engineered to express a CD22-directed CAR and incorporate modifications from Sana's proprietary Hypoimmune (HIP) platform.[5]

Target Antigen: CD22

The therapeutic target for SC262 is CD22, a transmembrane sialoglycoprotein belonging to the SIGLEC family, which is typically expressed on the surface of mature B lymphocytes and most B-cell malignancies, including various forms of lymphoma and leukemia.4

The selection of CD22 as a target is strategically significant, particularly in the context of CAR T therapy sequencing. CD19-directed CAR T therapies, while highly effective initially for many patients, are associated with relapse rates around 60%.[2] One major mechanism of resistance is the loss or downregulation of the CD19 antigen on the cancer cell surface. However, CD22 expression often persists on these malignant B cells even after CD19-targeted treatment failure.[2] This makes CD22 an attractive subsequent target for patients whose disease has progressed.

Notably, the CAR construct employed in SC262 utilizes a CD22 binder that has already undergone clinical investigation in academic settings. These prior studies demonstrated that CD22-directed CAR T cells using this binder could induce durable complete responses in a significant proportion of patients who had relapsed after CD19 CAR T therapy.[4] By incorporating a clinically validated targeting moiety, Sana aims to leverage existing efficacy signals for the CAR component, allowing a focused evaluation of the performance and safety of the allogeneic HIP platform itself.

Modality: Allogeneic "Off-the-Shelf" CAR T

As an allogeneic product, SC262 is manufactured using T cells from qualified healthy donors rather than the patient's own cells.1 This "off-the-shelf" approach is intended to overcome key limitations of autologous CAR T therapies, including:

• Accessibility: Potentially available immediately for treatment without patient-specific manufacturing delays.
• Consistency: Manufactured in batches, allowing for greater product uniformity and quality control.
• Scalability: Potential for large-scale production to treat broader patient populations.[5]
• Overcoming Patient T Cell Issues: Avoids challenges related to poor T cell health or insufficient T cell numbers in heavily pre-treated patients.

The successful implementation of SC262 relies heavily on the ability of the integrated HIP platform modifications to prevent immune rejection and GvHD, which are detailed in the following section.

III. The Hypoimmune (HIP) Platform Technology

Sana Biotechnology's Hypoimmune (HIP) platform is a cornerstone of its therapeutic strategy, designed to engineer allogeneic cells capable of evading rejection by the recipient's immune system without the need for continuous, systemic immunosuppression.[1] This platform involves multiple genetic modifications aimed at rendering the cells immunologically quiescent, or "cloaked," from both the innate and adaptive immune systems.

Key Genetic Modifications:

The HIP platform employs CRISPR-Cas12b gene editing technology to introduce specific modifications to the donor T cells 4:

1. Disruption of MHC Class I and Class II Expression:

• The platform involves knocking out the B2M (Beta-2 microglobulin) gene, which is essential for the surface expression of MHC class I molecules, and the CIITA (Class II Major Histocompatibility Complex Transactivator) gene, which controls the expression of MHC class II molecules.[4]
• Rationale: MHC molecules present peptides to T cells and are the primary targets for adaptive immune recognition of foreign cells. Eliminating MHC I and II expression is intended to prevent the recipient's CD8+ and CD4+ T cells, respectively, from recognizing the allogeneic CAR T cells as non-self, thereby evading adaptive immune rejection.[5]

2. Overexpression of CD47:

• The HIP platform engineers the cells to overexpress CD47, a transmembrane protein ubiquitously expressed on healthy cells.[4]
• Rationale: MHC-deficient cells are normally targeted for elimination by innate immune cells, particularly macrophages and Natural Killer (NK) cells, through "missing-self" recognition. CD47 acts as a "don't eat me" signal by binding to SIRPα receptors on macrophages and other phagocytes, inhibiting their activation.[4] Overexpressing CD47 is designed to protect the MHC-deficient HIP-engineered cells from this innate immune clearance, allowing them to persist.[3] Preclinical and early clinical data suggest anti-CD47 antibodies could potentially serve as a safety switch to eliminate the engineered cells if needed.[15]

3. Disruption of the Endogenous T Cell Receptor (TCR):

• The platform includes knocking out the TRAC gene, which encodes the constant region of the T cell receptor alpha chain.[4]
• Rationale: Eliminating the endogenous TCR prevents the allogeneic T cells from recognizing the recipient's tissues as foreign. This step is crucial for mitigating the risk of GvHD, a potentially lethal complication where donor T cells attack the host.[4]

Platform Validation Strategy:

Sana is strategically applying the HIP platform across diverse programs, including SC262 (CD22 CAR T), SC291 (CD19 CAR T for autoimmune diseases and oncology), and SC451 (stem cell-derived pancreatic islets for Type 1 Diabetes).1 This multi-pronged approach aims to demonstrate the platform's robustness and versatility across different cell types and therapeutic contexts. Extensive preclinical work, including studies in non-human primates, has provided foundational evidence supporting the HIP platform's ability to enable allogeneic cell engraftment and function while evading immune destruction.5 The simultaneous pursuit of these programs underscores the platform's central importance to Sana's overall mission. The combination of MHC knockout, CD47 overexpression, and TCR knockout represents a comprehensive strategy to address the multifaceted challenges of allogeneic cell therapy, potentially offering a significant advantage over approaches that tackle only specific aspects of immune rejection.

IV. Preclinical Evidence for SC262

A substantial body of preclinical work has been conducted to validate the characteristics and potential of SC262, specifically focusing on its immune evasion capabilities, anti-tumor efficacy, and safety profile.

Immune Evasion:

Preclinical studies confirmed that the HIP modifications endowed SC262 cells with the intended immune-evasive properties 4:

• In vitro cytotoxicity assays using xCelligence technology demonstrated that CD22 HIP CAR T cells (SC262) were protected from killing mediated by both NK cells and macrophages. In contrast, control T cells engineered with MHC knockouts but lacking CD47 overexpression were rapidly eliminated by these innate immune effectors, highlighting the critical role of the CD47 "don't eat me" signal for survival of MHC-deficient cells.[4]
• The knockout of B2M and CIITA genes is designed to prevent recognition by adaptive immune cells (T cells and B cells/antibodies).[4]

Anti-Tumor Efficacy:

Crucially, the complex genetic engineering involved in creating HIP CAR T cells did not appear to compromise their fundamental anti-tumor functionality 4:

• In vitro, SC262 cells exhibited potent, dose-dependent killing of various CD22-positive B-cell leukemia and lymphoma cell lines (including NALM, RAJI, and K562 engineered to express CD22). This cytotoxic activity was comparable to that of control allogeneic CD22 CAR T cells that overexpressed CD47 but retained MHC expression.[4]
• Significantly, SC262 demonstrated efficacy against target cells engineered to be CD19-negative (CD22+/CD19-), directly supporting the clinical strategy of using SC262 in patients who have relapsed after CD19-targeted therapies.[4]
• In vivo, SC262 treatment led to significant reductions in tumor burden and prolonged survival in mice bearing CD19-knockout NALM or RAJI tumors, compared to mock-treated controls.[4] The in vivo anti-tumor activity was dose-dependent and comparable to that of the non-HIP allogeneic CD47-CD22CAR T cell controls.[4]
• SC262 activation, measured by cytokine production (IFNγ, IL-2) and proliferation, was shown to be antigen-specific, requiring the presence of CD22-positive target cells.[4]

Safety Profile:

Preclinical data suggested a favorable safety profile for SC262 4:

• SC262 cells exhibited low baseline levels of cytokine secretion (IFNγ, Granzyme B, IL-2) when cultured alone or with CD22-negative cells, indicating minimal off-target activation.[4]
• The knockout of the endogenous TCR (TRAC gene disruption) is specifically designed to abrogate the risk of GvHD.[4] Consistent with this, preclinical in vivo studies reported in the ASH 2023 abstract summary indicated that SC262 was well tolerated with no signs of GvHD.[14]

Collectively, these preclinical findings provide essential proof-of-concept, demonstrating that SC262 cells can successfully evade key innate and adaptive immune rejection pathways while retaining their ability to specifically recognize and eliminate CD22-positive tumor cells, including those that have lost CD19 expression. This preclinical package supported the advancement of SC262 into clinical development.

V. Clinical Development Program: The VIVID Trial (NCT06285422)

Based on the encouraging preclinical data, Sana Biotechnology initiated the first-in-human clinical evaluation of SC262 in the VIVID trial.

Trial Identification and Design:

• Identifier: NCT06285422 [18]
• Protocol ID: SC262-101 [18]
• Title: A Phase 1 study evaluating SC262, a hypoimmune, allogeneic CD22-directed CAR T cell therapy, in relapsed and/or refractory non-Hodgkin's lymphoma (VIVID) [18]
• Phase: Phase 1 [9]
• Design: Open-label, multicenter, dose-escalation and expansion study [18]
• Sponsor: Sana Biotechnology, Inc. [20]

Objectives and Endpoints:

• Primary Objective: To assess the safety and tolerability profile of SC262, characterize dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D).[18] The primary outcome measure is the incidence of adverse events and DLTs.[18]
• Secondary Objectives: To evaluate the preliminary anti-tumor efficacy of SC262, including Objective Response Rate (ORR), Duration of Response (DOR), Progression-Free Survival (PFS), and Overall Survival (OS). Additional secondary objectives include characterizing the cellular kinetics (pharmacokinetics) and assessing the immunogenicity (development of anti-SC262 antibodies).[1]

Target Patient Population:

The trial enrolls adult patients (ages 18-80) diagnosed with specific subtypes of relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL), including Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL), and Primary Mediastinal Large B-cell Lymphoma (PMBCL).18 A critical inclusion criterion is that patients must have received and failed prior treatment with a CD19-directed CAR T cell therapy.15 Key exclusion criteria include prior CD22-targeted CAR T therapy, active central nervous system (CNS) lymphoma, and recent allogeneic hematopoietic stem cell transplantation.19 This selection focuses the trial on a population with high unmet need and tests SC262's ability to overcome resistance to prior CAR T treatment.

Intervention:

Participants receive lymphodepleting chemotherapy, typically consisting of cyclophosphamide and fludarabine, to prepare the immune environment for the CAR T cells. This is followed by a single intravenous infusion of SC262.1 The study employs a dose-escalation design, starting at a dose of 90 million CAR T cells.3

Status, Timelines, and Locations:

• Status: Currently recruiting participants.[19]
• Start Date: April 18, 2024.[20]
• Estimated Completion: Primary completion date is estimated as March 2028, with the overall study completion also estimated for March 2028.[20]
• Data Readout: Sana Biotechnology has indicated expectations to report initial clinical data from the VIVID trial during 2025.[15]
• Enrollment Target: Approximately 35 participants.[20]
• Locations: Known recruiting sites include the Fred Hutchinson Cancer Center (Seattle, WA), Swedish Cancer Institute (Seattle, WA), and The University of Kansas Hospital (Kansas City, KS).[19]

VIVID Trial (NCT06285422) Summary Table:

Parameter	Detail	Source Snippets
NCT ID	NCT06285422	18
Official Title	A Phase 1 study evaluating SC262, a hypoimmune, allogeneic CD22-directed CAR T cell therapy... (VIVID)	18
Phase	Phase 1	9
Status	Recruiting	19
Sponsor	Sana Biotechnology, Inc.	20
Conditions	Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (DLBCL, FL, MCL, MZL, PMBCL)	18
Key Eligibility	Adults 18-80 yrs; Prior CD19 CAR T therapy failure	15
Intervention	Lymphodepletion (Cy/Flu) followed by single IV infusion of SC262	1
Primary Objective	Evaluate safety, tolerability, DLTs, MTD/RP2D	18
Key Secondary Objectives	Preliminary efficacy (ORR, DOR, PFS, OS), PK, immunogenicity	1
Enrollment Target	~35	20
Start Date	April 18, 2024	20
Est. Primary Completion	March 2028	20
Est. Study Completion	March 2028	20
Expected Initial Data	2025	15

The initiation and ongoing enrollment in the VIVID trial mark a crucial step for SC262. Evaluating the therapy in patients who have already failed a prior CAR T treatment sets a high efficacy bar but directly addresses the intended clinical niche. The primary focus on safety in this Phase 1 study is paramount, particularly regarding the potential for GvHD (expected to be mitigated by TCR knockout) and typical CAR T-related toxicities (Cytokine Release Syndrome, Immune Effector Cell-Associated Neurotoxicity Syndrome). Observation of SC262 cell persistence and preliminary signs of anti-tumor activity in this challenging patient population during the 2025 data readout will be critical indicators of the HIP platform's translational success in humans.

VI. Target Indications and Unmet Medical Need

The primary clinical focus for SC262 development is patients with relapsed or refractory (r/r) B-cell malignancies who have experienced treatment failure with prior CD19-directed CAR T cell therapy.[3] This specific patient population represents a significant and growing unmet medical need. As CD19 CAR T therapies become more widely used in earlier lines of treatment, the number of patients who relapse or are refractory is increasing.[2] Outcomes for these patients are generally poor, with limited effective therapeutic options available.[3] SC262 aims to fill this gap by providing an alternative cellular therapy targeting CD22, an antigen often retained on malignant cells after CD19 loss.[5]

While the initial VIVID trial focuses on NHL subtypes [18], the expression of CD22 on other B-cell malignancies suggests broader potential applicability. Sana's pipeline overview includes Acute Lymphoblastic Leukemia (ALL) and Chronic Lymphocytic Leukemia (CLL) as potential indications for SC262.[9] The preclinical data showing efficacy against CD19-negative targets further supports its potential utility beyond resistance driven solely by CD19 antigen loss.[4]

Beyond targeting a specific malignancy or resistance mechanism, SC262 embodies the potential advantages of an effective allogeneic CAR T therapy. If the HIP platform successfully prevents immune rejection and GvHD without requiring significant immunosuppression, SC262 could offer:

• Immediate Availability: An "off-the-shelf" product ready for infusion when needed.[1]
• Manufacturing Consistency: Reduced variability compared to patient-derived products.[1]
• Broader Patient Access: Overcoming limitations related to patient T cell fitness or manufacturing failures inherent in autologous approaches.[1]

Therefore, the success of SC262 has implications beyond the treatment of CD22+ malignancies. It serves as a clinical test case for a platform technology aiming to make effective allogeneic cell therapies a practical reality, potentially shifting treatment paradigms not only in oncology but also in autoimmune diseases and regenerative medicine where Sana is also applying the HIP platform.

VII. Regulatory Landscape

The regulatory journey for SC262 is in its early stages, marked by a key milestone allowing clinical investigation.

Investigational New Drug (IND) Clearance:

Sana Biotechnology announced that the U.S. Food and Drug Administration (FDA) cleared the IND application for SC262 in January 2024.5 This clearance permitted the initiation of the Phase 1 VIVID clinical trial (NCT06285422) in patients with r/r B-cell malignancies.

Expedited Designations (Orphan Drug, Fast Track, RMAT):

Based solely on the information contained within the provided research snippets, there is no indication that SC262 has received specific expedited regulatory designations such as Orphan Drug Designation, Fast Track Designation, or Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA or the European Medicines Agency (EMA).5

It is important to note the context of these designations:

• Orphan Drug Designation is granted to therapies intended for rare diseases (affecting fewer than 200,000 people in the US or <5 in 10,000 in the EU) to incentivize development.[25] While specific subtypes of NHL or ALL might qualify, the initial broad indication of r/r B-cell malignancies may not meet the prevalence criteria without further stratification.
• Fast Track Designation is intended to expedite the development and review of drugs for serious conditions with unmet medical needs.[28] SC262 targets such a condition, but designation requires demonstrating potential to address the unmet need, often based on preclinical or early clinical data. Sana's CD19-targeted CAR T, SC291, received Fast Track for SLE.[32]
• RMAT Designation is specific to regenerative medicine therapies (like cell therapies) for serious conditions, requiring preliminary clinical evidence suggesting the potential to address unmet needs.[29] SC262 would likely need positive Phase 1 data before being eligible for RMAT designation.

The absence of these designations for SC262 at the IND clearance stage is not uncommon. Companies often apply for such designations later in development, once sufficient data is available to meet the specific criteria set by regulatory agencies. The primary regulatory achievement for SC262 thus far is the successful IND clearance, enabling human clinical trials to commence.

VIII. Future Directions and Conclusion

SC262 represents a significant program for Sana Biotechnology, embodying both a potential therapeutic solution for a challenging patient population and a critical validation effort for its underlying Hypoimmune (HIP) platform technology.

Anticipated Milestones and Future Steps:

The most immediate and critical milestone for the SC262 program is the readout of initial clinical data from the ongoing Phase 1 VIVID trial (NCT06285422), which Sana anticipates reporting in 2025.15 This initial dataset will provide the first human insights into the safety, tolerability, and persistence of SC262 HIP CAR T cells. Key aspects to monitor will include the incidence and severity of CAR T-related toxicities (CRS, ICANS), any signs of GvHD (expected to be absent due to TCR knockout), evidence of immune rejection (or lack thereof), and preliminary signals of anti-tumor activity (response rates) in this heavily pre-treated patient cohort. Positive results would likely lead to dose expansion within the VIVID trial and planning for subsequent Phase 2 studies.

Platform Validation:

The clinical performance of SC262 is intrinsically linked to the validation of Sana's HIP platform. Demonstrating that these multi-edited allogeneic cells can safely engraft, persist, and mediate clinical efficacy without requiring ongoing immunosuppression in humans would be a landmark achievement. Success with SC262, alongside parallel data from the SC291 (CD19 HIP CAR T) and SC451/UP421 (HIP Islet Cell) programs, would significantly de-risk the platform and bolster confidence in its potential applicability across a wide range of cell types and diseases.3

Competitive Context:

SC262 enters a competitive field of next-generation cell therapies. While specific competitors are not detailed in the provided materials, the program competes broadly within the space of allogeneic CAR T development and specifically among therapies targeting CD22 or other antigens for post-CD19 relapse. The success of SC262 will depend not only on its efficacy and safety but also on how its profile compares to other emerging autologous and allogeneic approaches. The unique potential advantage lies in the comprehensive immune evasion strategy of the HIP platform.

Conclusion:

In summary, Sana Biotechnology's SC262 is an investigational allogeneic CAR T cell therapy targeting CD22, engineered with the company's proprietary Hypoimmune (HIP) platform. It is designed to overcome the fundamental challenges of immune rejection and GvHD associated with allogeneic cell therapies. Preclinical studies have demonstrated promising immune evasion and antigen-specific anti-tumor efficacy, supporting its advancement into the clinic. The ongoing Phase 1 VIVID trial (NCT06285422) is currently evaluating SC262 in patients with relapsed/refractory B-cell malignancies following prior CD19 CAR T therapy, addressing a significant unmet medical need. The initial clinical data expected in 2025 represents a crucial inflection point, holding the potential to validate not only SC262 as a therapeutic candidate but also the broader applicability of the HIP platform for creating "off-the-shelf" engineered cell medicines.

Works cited

1. For Patients - Sana Biotechnology, accessed May 9, 2025, https://sana.com/for-patients/
2. Sana Biotech's SC262, a CD22-targeted CAR T cell therapy for resistant B-cell cancers, gains US regulatory approval - Patsnap Synapse, accessed May 9, 2025, https://synapse.patsnap.com/blog/sana-biotechs-sc262-a-cd22-targeted-car-t-cell-therapy-for-resistant-b-cell-cancers-gains-us-regulatory-approval
3. Corporate Presentation - Sana Biotechnology, accessed May 9, 2025, https://ir.sana.com/static-files/5a479cfb-b1b9-473a-be99-3dc6529df354
4. Hypoimmune, Allogeneic CD22-Directed CAR T Cells That Evade ..., accessed May 9, 2025, https://ashpublications.org/blood/article/142/Supplement%201/3437/503884/Hypoimmune-Allogeneic-CD22-Directed-CAR-T-Cells
5. Sana Biotechnology Announces FDA Clearance of Investigational New Drug Application for SC262, a Hypoimmune-modified, CD22-directed Allogeneic CAR T Therapy, for Patients with Relapsed or Refractory B-cell Malignancies, accessed May 9, 2025, https://ir.sana.com/news-releases/news-release-details/sana-biotechnology-announces-fda-clearance-investigational-new-1/
6. Sana Biotechnology Announces Positive Clinical Results from Type 1 Diabetes Study of Islet Cell Transplantation Without Immunosuppression - GlobeNewswire, accessed May 9, 2025, https://www.globenewswire.com/news-release/2025/01/07/3005841/0/en/Sana-Biotechnology-Announces-Positive-Clinical-Results-from-Type-1-Diabetes-Study-of-Islet-Cell-Transplantation-Without-Immunosuppression.html
7. Sana Biotechnology: Home, accessed May 9, 2025, https://sana.com/
8. Our Science - Sana Biotechnology, accessed May 9, 2025, https://sana.com/our-science/
9. Our Pipeline - Sana Biotechnology, accessed May 9, 2025, https://sana.com/our-pipeline/
10. Sana regains some of its shine | ApexOnco - Clinical Trials news and analysis, accessed May 9, 2025, https://www.oncologypipeline.com/apexonco/sana-regains-some-its-shine
11. Why Sana Biotechnology, Inc.'s (SANA) Stock Is Up 7.80% | AAII, accessed May 9, 2025, https://www.aaii.com/investingideas/article/279422-why-sana-biotechnology-inc8217s-sana-stock-is-up-780
12. Why Sana Biotechnology, Inc.'s (SANA) Stock Is Up 12.46% | AAII, accessed May 9, 2025, https://www.aaii.com/investingideas/article/256298-why-sana-biotechnology-inc8217s-sana-stock-is-up-1246
13. What is the research and development focus of Sana Biotechnology? - Patsnap Synapse, accessed May 9, 2025, https://synapse.patsnap.com/article/what-is-the-research-and-development-focus-of-sana-biotechnology
14. Sana Biotechnology Highlights Preclinical Data Supporting Tumor Control and Immune Evasion Capabilities of Hypoimmune-Modified Allogeneic CAR T Cells in Presentations at the American Society of Hematology Annual Meeting, accessed May 9, 2025, https://ir.sana.com/news-releases/news-release-details/sana-biotechnology-highlights-preclinical-data-supporting-tumor/
15. Sana Biotechnology Reports Fourth Quarter and Full Year 2024 Financial Results and Business Updates - SEC.gov, accessed May 9, 2025, https://www.sec.gov/Archives/edgar/data/1770121/000095017025040241/sana-ex99_1.htm
16. Sana Biotechnology Reports Fourth Quarter and Full Year 2024 Financial Results and Business Updates, accessed May 9, 2025, https://ir.sana.com/news-releases/news-release-details/sana-biotechnology-reports-fourth-quarter-and-full-year-2024/
17. Sana Biotechnology Reports Fourth Quarter and Full Year 2024 Financial Results and Business Updates - GlobeNewswire, accessed May 9, 2025, https://www.globenewswire.com/news-release/2025/03/17/3044084/0/en/Sana-Biotechnology-Reports-Fourth-Quarter-and-Full-Year-2024-Financial-Results-and-Business-Updates.html
18. Study Evaluating SC262 in Subjects with R/?r Non-Hodgkin`s ..., accessed May 9, 2025, https://www.fredhutch.org/en/research/clinical-trials/trial-details.fh_trial_id_15144.study-evaluating-sc262-in-subjects-with-r-r-non-hodgkin-s-lymphoma-vivid.html
19. CAR T cells (SC262) to treat B-cell non-Hodgkin lymphoma (B-NHL) that has come back (relapsed) or not gotten better with treatment (refractory) - Jason Carter Clinical Trial Search and Support, accessed May 9, 2025, https://www.ctsearchsupport.org/clinical-trials/study-evaluating-sc262-in-subjects-with-r-r-b-cell-malignancies-vivid
20. Trial Eligibility - HealthTree Foundation, accessed May 9, 2025, https://healthtree.org/dlbcl/community/clinical-trials/list/NCT06285422
21. Sana Biotechnology Announces FDA Clearance of Investigational New Drug Application for SC262 | Innovation Ventures, accessed May 9, 2025, https://innovation.ucsf.edu/news/sana-biotechnology-announces-fda-clearance-investigational-new-drug-application-sc262
22. Allogeneic CD22 CAR Cleared for First-in-Human Trial in B-Cell Malignancies - CGTLive®, accessed May 9, 2025, https://www.cgtlive.com/view/allogeneic-cd22-car-sc262-cleared-first-trial-b-cell-malignancies
23. SC-262 - Drug Targets, Indications, Patents - Patsnap Synapse, accessed May 9, 2025, https://synapse.patsnap.com/drug/61047d9fdc9540f7b9e133c4301295d9
24. FDA Grants Priority Review for Biologics License Application (BLA) and EMA Accepts Marketing Authorisation Application (MAA) for Apitegromab as a Treatment for Spinal Muscular Atrophy - FirstWord Pharma, accessed May 9, 2025, https://firstwordpharma.com/story/5944570
25. Which of these orphan drug designations is right for you? - TMC Pharma, accessed May 9, 2025, https://tmcpharma.com/fda-vs-ema-orphan-drug-designation/
26. Applying for orphan designation | European Medicines Agency (EMA), accessed May 9, 2025, https://www.ema.europa.eu/en/human-regulatory-overview/research-development/orphan-designation-research-development/applying-orphan-designation
27. FDA Grants Priority Review for Biologics License Application (BLA) and EMA Accepts Marketing Authorisation Application (MAA) for Apitegromab as a Treatment for Spinal Muscular Atrophy - Business Wire, accessed May 9, 2025, https://www.businesswire.com/news/home/20250325289782/en/FDA-Grants-Priority-Review-for-Biologics-License-Application-BLA-and-EMA-Accepts-Marketing-Authorisation-Application-MAA-for-Apitegromab-as-a-Treatment-for-Spinal-Muscular-Atrophy
28. Fast Track Designation Requests - FDA, accessed May 9, 2025, https://www.fda.gov/drugs/ind-activity/fast-track-designation-requests
29. Beacon Therapeutics Granted FDA Regenerative Medicine Advanced Therapy (RMAT), accessed May 9, 2025, https://www.beacontx.com/news-and-events/beacon-therapeutics-granted-fda-regenerative-medicine-advanced-therapy-rmat/
30. Fate Therapeutics Receives Regenerative Medicine Advanced Therapy (RMAT) Designation from FDA for FT819 to Treat Moderate to Severe Systemic Lupus Erythematosus (SLE), accessed May 9, 2025, https://ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-receives-regenerative-medicine-advanced
31. FDA Grants RMAT Designation to ATSN-201 Gene Therapy for XLRS - HCPLive, accessed May 9, 2025, https://www.hcplive.com/view/fda-grants-rmat-designation-to-atsn-201-gene-therapy-for-xlrs
32. Sana Biotechnology Announces Fast Track Designation for SC291 in Relapsed/Refractory Systemic Lupus Erythematosus, accessed May 9, 2025, https://ir.sana.com/news-releases/news-release-details/sana-biotechnology-announces-fast-track-designation-sc291/