SC262 / Sana Biotech - LARVOL DELTA

Study Evaluating SC262 in Subjects With r/r Non-Hodgkin's Lymphoma (VIVID) (clinicaltrials.gov) - P1 | N=6 | Active, not recruiting | Sponsor: Sana Biotechnology | Recruiting ➔ Active, not recruiting | N=35 ➔ 6 | Trial primary completion date: Mar 2028 ➔ Dec 2025

Enrollment change • Enrollment closed • Trial primary completion date • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Hypoimmune, Allogeneic CD22-Directed CAR T Cells That Evade Innate and Adaptive Immune Rejection for the Treatment of Large B Cell Lymphoma Patients That Are Relapsed/Refractory to CD19-Directed CAR T Cell Therapy (ASH 2023) - "Results also demonstrate that the HIP approach to generate allogeneic CAR T cells that evade innate and adaptive immune rejection can be expanded as a platform to generate CAR T cells against target antigens alternative to CD19. Collectively, the data suggest that CD22 HIP CAR T cells display a combination of antigen-specific pharmacologic activity and immune evasion that support their progression into human clinical studies for the treatment of CD19 CAR T cell-refractory patients."

CAR T-Cell Therapy • Clinical • B Cell Lymphoma • Graft versus Host Disease • Hematological Malignancies • Immunology • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • B2M • CD19 • CD22 • CD47 • CD8 • CIITA • GZMB • IFNG

Advancing our pipeline across multiple indications and modalities (Yahoo Finance) - "Expect to file IND for SG299 in a B-cell related disease 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."

IND • P1 data • Immunology • Large B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Systemic Lupus Erythematosus

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

Study Evaluating SC262 in Subjects With r/r Non-Hodgkin's Lymphoma (VIVID) (clinicaltrials.gov) - P1 | N=35 | Recruiting | Sponsor: Sana Biotechnology | Initiation date: Oct 2024 ➔ Apr 2024

Trial initiation date • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Sana Biotechnology Reports Third Quarter 2024 Financial Results and Business Updates (GlobeNewswire) - "The VIVID trial evaluates SC262, a HIP-modified CD22-directed allogeneic CAR T therapy, in patients with relapsed or refractory B-cell malignancies who have received prior CD19-directed CAR T therapy. Sana is enrolling patients and expects to share data in 2025."

Enrollment status • P1 data • Hematological Malignancies • Oncology

Study Evaluating SC262 in Subjects with R/r Non-Hodgkin's Lymphoma (VIVID) (clinicaltrials.gov) - P1 | N=35 | Recruiting | Sponsor: Sana Biotechnology | Initiation date: May 2024 ➔ Oct 2024

CAR T-Cell Therapy • Trial initiation date • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Sana Biotechnology Reports First Quarter 2024 Financial Results and Business Updates (GlobeNewswire) - "The VIVID trial evaluates SC262, a HIP-modified CD22-directed allogeneic CAR T, in patients with relapsed or refractory B-cell malignancies. The VIVID trial initially investigates SC262 in patients who have received prior CD19-directed CAR T therapy....Sana expects to share initial data in 2024."

P1 data • Diffuse Large B Cell Lymphoma

Study Evaluating SC262 in Subjects With r/r B-cell Malignancies (VIVID) (clinicaltrials.gov) - P1 | N=35 | Recruiting | Sponsor: Sana Biotechnology | Not yet recruiting ➔ Recruiting

CAR T-Cell Therapy • Enrollment open • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Study Evaluating SC262 in Subjects With r/r B-cell Malignancies (VIVID) (clinicaltrials.gov) - P1 | N=35 | Not yet recruiting | Sponsor: Sana Biotechnology

CAR T-Cell Therapy • New P1 trial • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

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 (GlobeNewswire) - "Sana Biotechnology, Inc...today announced the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application to initiate a study of SC262 in patients with relapsed or refractory B-cell malignancies, initially in patients who have received prior CD19-directed CAR T therapy....'Over the past twelve months, Sana has received three IND regulatory clearances, as well as supported the authorization of an investigator-sponsored CTA, to begin new studies utilizing our hypoimmune platform in seven different indications in oncology, B-cell mediated autoimmune diseases, and type 1 diabetes. We look forward to presenting data from all of these studies this year, including initial proof of concept data for SC262 later this year.'"

Clinical data • IND • Diabetes • Hematological Malignancies • Immunology • Metabolic Disorders • Oncology • Type 1 Diabetes Mellitus

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 (GlobeNewswire) - "Sana Biotechnology, Inc...today announced preclinical data supporting the anti-tumor and immune evasion capabilities of allogeneic CAR T cells engineered with Sana’s proprietary hypoimmune (HIP) technology were presented at the 65th American Society of Hematology (ASH) Annual Meeting in San Diego, CA...The results demonstrated that CD22 HIP CAR T cells evaded adaptive immune cell recognition and cytolysis through B2M and CIITA gene disruption and innate immune cell recognition through the overexpression of CD47...Sana submitted the investigational new drug (IND) application and intends to begin human testing of SC262 in early 2024...The data showed that candidate GPRC5D CARs elicited in vitro cytotoxicity and effector cytokine production that is comparable to clinically validated benchmark control CARs....these GPRC5D CAR T cells controlled multiple myeloma tumor cells both in vitro and in vivo, demonstrating efficacy that is on par with clinical benchmark GPRC5D CAR T cells."

New trial • Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology

Sana Biotechnology Announces Five Presentations at the 65th American Society of Hematology Annual Meeting (GlobeNewswire) - "Sana Biotechnology, Inc...today announced that five abstracts will have poster presentations at the 65^th American Society of Hematology Annual Meeting to be held December 9-12, 2023 in San Diego, CA."

Preclinical • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

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 Fourth Quarter and Full Year 2022 Financial Results and Business Updates (GlobeNewswire) - "SC262 incorporates this clinically-validated CAR with T cells manufactured using hypoimmune technology with a goal of filing an IND in 2023."

IND • Oncology