SG299 / Sana Biotech - LARVOL DELTA

Sana Biotechnology Reports Fourth Quarter and Full Year 2024 Financial Results and Business Updates (GlobeNewswire) - "Type 1 Diabetes – Sana continues the clinical development of gene-modified primary islet cells (UP421) and the pre-clinical development of SC451...Sana expects to share additional data in 2025 and file an IND as early as 2026....Enrolling patients in the GLEAM trial for SC291 in B-cell mediated autoimmune diseases and VIVID trial for SC262 in relapsed/refractory B-cell malignancies; expect to report clinical data from both studies in 2025....in vivo CAR T cells: Sana expects to file an IND for SG299 as early as 2026, and we look forward to developing it in a range of B-cell cancers and B-cell mediated autoimmune diseases."

Clinical data • IND • P1 data • ANCA Vasculitis • Immunology • Oncology • Systemic Lupus Erythematosus • Type 1 Diabetes Mellitus

Enabling Potent T Cell Delivery and Mitigating Key Off-Target Concerns of In Vivo CAR T Lentiviral Vectors with the Targeted Paramyxovirus Fusogen System (ASH 2024) - "Accordingly our in vivo CAR T vector, SG299, shows highly specific and potent delivery to CD8 T cells in NHPs. Thus SG299 represents a differentiated approach for enabling in vivo CAR T therapy, potentially avoiding key off-target concerns."

Preclinical • Viral vector • Gene Therapies • CD19 • CD4 • CD8

Sana Biotechnology Announces Increased Focus on...B-cell Mediated Autoimmune Diseases with the Potential to Deliver Clinical Proof of Concept Data Across Multiple Studies in 2024 and 2025 (GlobeNewswire) - "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....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."

P1 data • Preclinical • Immunology • Lupus • Systemic Lupus Erythematosus

Characterizing Insertional Oncogenic Risk of a Novel CD8-Targeted Fusosome for In Vivo CAR T Cell Generation (ASGCT 2024) - "In vitro transduction of T cells with SG299 and VSGV-LVV resulted in comparable CAR transduction as measured by VCN and CAR expression, lack of recurrent evidence for preferential SG299 LVV integration across the genome, and comparable IS profiles to VSVG-LVV used in autologous therapies. These findings suggest SG299 likely carries comparable insertional oncogenic risk to ex vivo clinical CAR T products. While FDA recently announced an evaluation of T cell malignancy risk in patients treated with autologous therapies, Levine et al."

CAR T-Cell Therapy • Preclinical • Gene Therapies • Hematological Malignancies • Lymphoma • Oncology • CD8

Preclinical Efficacy of a Novel CD8-Targeted Fusosome for In Vivo CAR T Cell Therapy (ASH 2023) - "SG299 is a CD8-targeted fusosome; a self-inactivating (SIN) lentiviral vector (LVV) pseudotyped with a CD8-targeted fusogen, which carries a transgene encoding a CD19-directed chimeric antigen receptor (CAR)...Finally, an assessment of donor-to-donor variability across five PBMC donors using a single lot of fusosome showed donor-specific variations in tumor control as measured by BLI but demonstrated a consistent protection from morbidity and mortality. Collectively, these studies demonstrate preclinical efficacy of our CD8/CD19CAR candidate, lot consistency and verify our ability to generate CD19-directed CAR T cells in vivo using a specifically targeted platform."

CAR T-Cell Therapy • Preclinical • Oncology • CD4 • CD8

Sana Biotechnology Announces Increased Focus on Hypoimmune-Related Pipeline with the Potential to Deliver Clinical Proof of Concept Data from Four Programs in 2023 and 2024 with a 2024 Operating Burn under $200M (GlobeNewswire) - "Select Program Review: (i) SC291 Oncology (HIP-modified CD19-directed allogeneic CAR T): Enrollment continues in Sana’s ARDENT Phase 1 study for the treatment of B-cell lymphomas and leukemias with clinical data expected in 2023 and 2024 ;(ii) SC262 (HIP-modified CD22-directed allogeneic CAR T): Sana expects to submit an IND in 4Q 2023 for the treatment of B-cell lymphomas and leukemias in patients who have failed CD19-directed CAR T therapies, with preliminary clinical data expected in 2024; (iii) SG299 (in vivo CAR T with CD8-targeted fusogen delivery of a CD19-directed CAR): Sana will continue its focused research on this innovative platform but not submit an IND at this time as previously planned."

Enrollment status • IND • P1 data • Leukemia • Non-Hodgkin’s Lymphoma

Sana Biotechnology Reports Second Quarter 2023 Financial Results and Business Updates (GlobeNewswire) - "Goal to submit INDs this year for...SG299 in hematologic cancers....Sana’s goal is to file an IND...for SC255 in 2024."

IND • Hematological Malignancies • Oncology

Sana Biotechnology Announces the Acceptance of Six Abstracts for Presentation at the American Society of Gene and Cell Therapy (ASGCT) 26th Annual Meeting (GlobeNewswire) - "Sana Biotechnology...announced that six abstracts highlighting preclinical data from the fusogen platform have been accepted for presentation, including two oral presentations, at the American Society of Gene and Cell Therapy (ASGCT) 26th Annual Meeting taking place May 16-20, 2023 in Los Angeles, CA."

Preclinical • Hematological Malignancies • Oncology

Sana Biotechnology Highlights Preclinical Hypoimmune Data for its Allogeneic CAR T Platform and Advancements with its In Vivo Fusogen Platform with Four Presentations at the 2023 AACR Annual Meeting (GlobeNewswire) - "Sana Biotechnology...announced data from four presentations at the 2023 American Association for Cancer Research (AACR) Annual Meeting....The poster (abstract 2735)...compares preclinical data on a fully human CD19-directed CAR, which comprises a human CD19 binder developed at Sana, to a standard murine FMC63 CAR. CD19-directed CAR T cells with the fully human CD19 CAR demonstrated comparable efficacy to CD19-directed CAR T cells with an FMC63 CAR in both in vitro and in vivo models. CD8-targeted fusosomes delivering this fully human CD19 CAR into T cells demonstrated anti-tumor efficacy in vivo."

Preclinical • Hematological Malignancies • Oncology

Sana Biotechnology Highlights Preclinical Hypoimmune Data for its Allogeneic CAR T Platform and Advancements with its In Vivo Fusogen Platform with Four Presentations at the 2023 AACR Annual Meeting (GlobeNewswire) - "Sana Biotechnology...announced data from four presentations at the 2023 American Association for Cancer Research (AACR) Annual Meeting....The late-breaking poster (abstract LB311)...described the preclinical efficacy of a CD8-targeted fusosome encoding a CD19 CAR transgene manufactured using an improved process. The improved process generates fusosomes with increased potency that result in increased in vivo CAR T generation and increased tumor control....A CD8-targeted fusosome delivering a CD19 CAR transgene has the potential to provide an off-the-shelf therapeutic approach to generate CD19-directed CAR T cells in vivo and without lymphodepleting chemotherapy."

Late-breaking abstract • Preclinical • Hematological Malignancies • Oncology

Sana Biotechnology Announces Preclinical Data Published in Nature Communications Demonstrating the Ability of its Hypoimmune Allogeneic CD19-directed CAR T Cells to Evade Immune Rejection and Produce Durable Anti-Tumor Responses (GlobeNewswire) - "Sana Biotechnology, Inc...announced that Nature Communications has published a paper titled 'Hypoimmune anti-CD19 chimeric antigen receptor T cells provide lasting tumor control in fully immunocompetent allogeneic humanized mice'. The preclinical studies published in this paper evaluated the performance of Sana’s hypoimmune (HIP) allogeneic chimeric antigen receptor (CAR) T cells versus unmodified allogeneic (allo) CAR T cells. The key findings demonstrate that HIP CAR T cells significantly outperformed unmodified allo CAR T cells in tumor studies using fully immunocompetent, humanized mice in both durability of tumor clearance as well as CAR T cell expansion and persistence. In additional in vitro assays and in vivo assays, the data demonstrate that HIP engineering does not impact CAR T cell specificity, impair cytotoxic function, accelerate T cell exhaustion, or weaken anti-tumor efficacy."

Preclinical • Oncology

Sana Biotechnology Announces the Acceptance of Four Abstracts for Presentation at the 2023 American Association for Cancer Research Annual Meeting (GlobeNewswire) - "Sana Biotechnology...announced that four abstracts, including a late-breaking abstract, highlighting preclinical data from both the hypoimmune and fusogen platforms have been accepted for poster presentation at the 2023 American Association for Cancer Research (AACR) Annual Meeting taking place April 14-19, 2023 in Orlando, FL....Late-breaking poster presentation to highlight preclinical data demonstrating that the increased potency of CD8-targeted fusosomes enhances CAR gene delivery to resting primary T cells."

Late-breaking abstract • Preclinical • Hematological Malignancies • Oncology

Sana Biotechnology Confirms Key Program Timelines and Announces Portfolio Prioritization (GlobeNewswire) - "Select Program Review: (i) SC263 (HIP-modified, CD22-targeted allogeneic CAR T) - Sana expects to file an IND in 2023....This therapy has the potential to treat patients with B cell malignancies who have failed previous CAR T therapies; (ii) 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....The company expects to study this therapy in patients with B cell malignancies; (iii) SC255 (HIP-modified, BCMA-targeted allogeneic CAR T) - Sana expects to file an IND in 2024 to treat multiple myeloma."

IND • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

Sana Biotechnology Reports Fourth Quarter and Full Year 2021 Financial Results and Business Updates (GlobeNewswire) - "Progressed Sana’s in vivo CAR T program, SG295, utilizing a CD8-targeted fusosome to deliver a CD19-targeted CAR; IND expected as early as this year"

IND • Oncology • Solid Tumor