FT522 / Fate Therap - LARVOL DELTA

SAFETY AND EFFICACY OF FT522, AN OFF-THE-SHELF, IPSC-DERIVED CD19 CAR NK CELL THERAPY WITH ALLOIMMUNE DEFENSE RECEPTOR IN RELAPSED/REFRACTORY B-CELL LYMPHOMA (ICML 2025) - P1 | " In this phase I trial in patients (pts) with R/R B-cell lymphomas (ClinicalTrials.gov: NCT05950334), 3 doses of FT522 are administered after one dose of rituximab; in Regimen A following conditioning chemotherapy (fludarabine, cyclophosphamide or bendamustine) or in Regimen B with no conditioning chemotherapy. ADR-armed FT522 was well-tolerated, demonstrated activity in pts with R/R BCL in early cohorts, and did not induce alloreactive responses. Dose escalation is ongoing."

Clinical • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • IL15

Next Generation CAR-NK cell Therapy Leverages Alloimmune Defense Technology to Persist Without Conditioning Chemotherapy for the Treatment of Autoimmune Disease (EULAR 2025) - P1 | "FT522 is administered in three doses (Days 1, 4, and 8) either with CCT (fludarabine 30 mg/m 2 and cyclophosphamide 500 mg/m 2 , Days -5 to -3) or without CCT...The study is designed to assess FT522, without administration of CCT to patients, as an add-on to rituximab induction (Regimen A) and in combination with rituximab as an add-on to maintenance therapy (Regimen B)... Collectively, our preclinical and early-stage oncology clinical data in R/R BCL demonstrate that FT522 can persist, function, and function, and confer clinical benefit without the need for CCT. Furthermore, the clinical data discussed here supports the application of FT522, without CCT, for B-cell mediated autoimmune diseases."

B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Immunology • Inflammatory Arthritis • Lupus • Lymphoma • Lymphoplasmacytic Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Systemic Lupus Erythematosus • Waldenstrom Macroglobulinemia • IL15

Phase 1 Translational Assessment of an Off-The-Shelf CAR NK Cell Armed with Alloimmune Defense Technology for Conditioning-free Therapy (ASGCT 2025) - P1 | "Intense conditioning chemotherapy (CCT), often consisting of cyclophosphamide and fludarabine, is commonly administered to patients prior to treatment with CAR therapies, although CCT is associated with severe toxicities. We developed FT522, a next generation iPSC-derived CAR NK cell therapy, that is designed to confer therapeutic benefit without requiring the administration of CCT...Collectively, our preclinical and early-stage translational data from our Phase 1 study of FT522 demonstrate that ADR is capable of enabling anti-tumor activity, promoting functional persistence, and avoiding immune rejection without requiring administration of CCT to patients. Disease Focus of Abstract:Lymphoma"

P1 data • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD4 • IL15

Fate Therapeutics Announces Five Presentations on Off-the-Shelf CAR T-cell Product Platform at ASGCT Annual Meeting (GlobeNewswire) - "Fate Therapeutics...announced that five presentations of clinical and preclinical data from the Company’s induced pluripotent stem cell (iPSC) product platform will be featured at the American Society of Gene and Cell Therapy (ASGCT) 28th Annual Meeting, being held in New Orleans, Louisiana on May 13-17, 2025....The Company has been selected to deliver an oral presentation on the translational data from its Phase 1 clinical trial of FT522, an off-the-shelf, CD19-targeted CAR NK cell product candidate, in patients with relapsed / refractory B-cell lymphoma (BCL) (NCT05950334)."

Clinical data • Preclinical • Immunology • Lymphoma

Safety and Efficacy of FT522, a First-in-Class, Multi-Antigen Targeted, Off-the-Shelf, iPSC-Derived CD19 CAR NK Cell Therapy with Alloimmune Defense Receptor (ADR) in Relapsed/Refractory B-Cell Lymphoma (ASH 2024) - P1 | "Three doses of FT522 are administered in Regimen A following conditioning chemotherapy (fludarabine 30 mg/m2 and cyclophosphamide 500 mg/m2 Days -5 to -3, or bendamustine 90 mg/m2 Days -5 and -4) with rituximab (R) 375 mg/m2 (Day -4) or in Regimen B with no conditioning chemotherapy and rituximab (R) 375 mg/m2 (Day -4). Dose escalation of FT522 is ongoing, including in Regimen B without conditioning chemotherapy. Updated clinical and translational data will be presented."

Clinical • IO biomarker • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Lymphoma • Marginal Zone Lymphoma • Musculoskeletal Pain • Non-Hodgkin’s Lymphoma • Oncology • CD4 • CD8 • IL15

Development of a Multiplexed-engineered, Off-the-shelf CAR NK Cell with Unique Multi-Pathogenic Cell Targeting Capacity for the Treatment of Autoimmune Diseases in the Absence of Conditioning Chemotherapy (ACR Convergence 2024) - "In addition, FT522 in combination with rituximab and with daratumumab uniquely displayed potent ADCC against CD19neg/CD20+ and CD19neg/CD38+ cell populations, respectively. Collectively, the data highlight the unique potential of FT522 to survive and functionally persist in an allogeneic setting without CCT, and to rapidly target and eliminate both CD19+ B cells as well as other aberrant cell types that contribute to AI Dz pathophysiology. FT522 is currently being investigated in a Phase 1 clinical study in B cell lymphoma, including without administration of CCT to patients. A multi-indication investigational new drug (IND) application is being prepared for the treatment of AI Dz."

B Cell Non-Hodgkin Lymphoma • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Inflammatory Arthritis • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • IL15

Initial FT522 Phase 1 Clinical and Translational Data in Relapsed / Refractory B-cell Lymphoma (GlobeNewswire) - P1 | N=166 | NCT05950334 | Sponsor: Fate Therapeutics | "Fate Therapeutics...presented initial clinical and translational data from the Company’s Phase 1 study of FT522 in relapsed / refractory B-cell lymphoma at the American College of Rheumatology (ACR) Convergence....As of a data cutoff date of November 8, 2024, there have been no dose-limiting toxicities (DLTs)....In the study’s conditioning arm (Regimen A), at the first dose level of 300 million cells per dose (A-DL1; n=6), all three patients with indolent lymphoma achieved a complete response (CR) and one patient with mantle cell lymphoma achieved a partial response (PR), while two patients with diffuse large B-cell lymphoma (DLBCL) did not respond to treatment (1 stable disease (SD); 1 progressive disease). At the second dose level of 900 million cells per dose (A-DL2; n=3), two of three patients with DLBCL achieved an overall response (1 CR; 1 PR; 1 SD)."

P1 data • Diffuse Large B Cell Lymphoma • Indolent Lymphoma • Mantle Cell Lymphoma

Fate Therapeutics Reports Third Quarter 2024 Financial Results and Business Updates (GlobeNewswire) - "Initial Clinical Data from Phase 1 Autoimmunity Study of FT819 1XX CAR T-cell Product Candidate to be Presented in 4Q24; Second Treatment Arm Adding FT819 to Maintenance Therapy without Conditioning Chemotherapy Opened for Enrollment; FT522 Multi-indication IND Application for Conditioning-free Treatment of B Cell-mediated Autoimmune Diseases Allowed by FDA; Initial Phase 1 Clinical Data in B-cell Lymphoma to be Presented at ACR Convergence."

IND • P1 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Immunology • Lupus • Lymphoma • Oncology • Systemic Lupus Erythematosus

Fate Therapeutics Reports Second Quarter 2024 Financial Results and Business Updates (GlobeNewswire) - "FT522 iPSC-derived CAR NK Cell Program:...In its ongoing multi-center, Phase 1 clinical trial of FT522 in patients with relapsed / refractory B-cell lymphoma (BCL) (NCT05950334), the first patient has now been treated in the first three-dose cohort at 300 million cells per dose without conditioning chemotherapy (Regimen B). In addition, the first patient has now been treated in the second three-dose cohort at 900 million cells per dose with conditioning chemotherapy (Regimen A). No dose-limiting toxicities and no events of any grade of CRS, ICANS, or GvHD, have been reported in the Phase 1 study. The Company plans to present clinical and translational data from the Phase 1 study at a medical conference in the second half of 2024."

P1 data • Trial status • Non-Hodgkin’s Lymphoma

FT522 With Rituximab in Relapsed/Refractory B-Cell Lymphoma (FT522-101) (clinicaltrials.gov) - P1 | N=166 | Recruiting | Sponsor: Fate Therapeutics | N=322 ➔ 166

Combination therapy • Enrollment change • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Fate Therapeutics Announces First Lupus Patient Treated in Phase 1 Autoimmunity Study of Off-the-shelf FT819 CAR T-cell Program (GlobeNewswire) - P1 | N=322 | NCT05950334 | Sponsor: Fate Therapeutics | "Preclinical and Initial Clinical Observations for FT522 iPSC-derived CAR NK Cell Program Data...In a preclinical in vivo biodistribution study, FT522 showed dose-dependent trafficking, infiltration, and residency in secondary and tertiary tissues without cytokine support at human dose equivalency levels of 250 million cells per dose and 1 billion cells per dose (based on 20 gram mouse and 65 kilogram human allometric conversion); and....In initial clinical observations from the Company’s ongoing Phase 1 BCL study, the first two patients treated with FT522 showed rapid, deep, and sustained B-cell depletion in the periphery throughout the one-month treatment cycle...The Company intends to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in the middle of 2024 for the treatment of various autoimmune diseases with FT522..."

IND • P1 data • Preclinical • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Immunology • Non-Hodgkin’s Lymphoma • Oncology

FT522: A CAR NK Cell with the Unique Ability to Target Multiple Pathogenic Cell Types and Circumvent Lympho-conditioning in Systemic Autoimmunity (ASGCT 2024) - "Additionally, in combination with rituximab or daratumumab, FT522 elicited potent ADCC against CD20+ and CD38+ B cell populations, respectively, while primary CD19 CAR T cells failed to eliminate these same populations in the absence of CD19 expression (Fig 1B). Our data suggest that FT522 has the unique ability to elicit durable elimination of CD19+ B cells, target multiple pathogenic cell types in combination with therapeutic antibodies, and eliminate the need for conditioning chemotherapy with uncompromised effector function. Collectively, FT522 represents a promising off-the-shelf cell therapy strategy for treatment of numerous autoimmune diseases while eliminating toxicities associated with patient conditioning."

IO biomarker • Late-breaking abstract • Immunology • Infectious Disease • Inflammatory Arthritis • Oncology • CD19 • CD20 • IL15

Fate Therapeutics Announces Presentation of FT522 Preclinical Data for Autoimmune Diseases in Late-breaking Abstract at ASGCT Annual Meeting (GlobeNewswire) - "Fate Therapeutics...announced that a late-breaking abstract featuring preclinical data from its FT522 program for autoimmune diseases will be featured at the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting....Off-the-shelf, CD19-targeted CAR NK cell product candidate drives rapid and deep depletion of SLE donor CD19+ B cells. ADR technology incorporated into FT522 induces functional persistence and eliminates alloreactive host immune cells in SLE donor PBMCs."

Late-breaking abstract • Preclinical • Systemic Lupus Erythematosus

FT522 With Rituximab in Relapsed/Refractory B-Cell Lymphoma (FT522-101) (clinicaltrials.gov) - P1 | N=322 | Recruiting | Sponsor: Fate Therapeutics | Trial completion date: Dec 2039 ➔ Jun 2044 | Trial primary completion date: Dec 2024 ➔ Jun 2029

Combination therapy • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Fate Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Business Updates (GlobeNewswire) - "FT819 iPSC-derived CAR T-cell Program: CLIN2 Grant Awarded by CIRM to Fund FT819 Phase 1 Autoimmunity Study in SLE. In February, the Company was awarded $7.9 million by the California Institute for Regenerative Medicine (CIRM) to support clinical investigation of FT819 in patients with systemic lupus erythematosus (SLE)....The Company is currently conducting study start-up activities at multiple U.S. clinical sites....Preclinical Studies Ongoing to Support Expansion into Autoimmunity. The Company is conducting a preclinical assessment of the potential for FT522 to induce CD19+ B-cell depletion across a range of autoimmune diseases, including without administration of intense chemotherapy conditioning to patients."

Financing • Preclinical • Immunology • Systemic Lupus Erythematosus

FT522 With Rituximab in Relapsed/Refractory B-Cell Lymphoma (FT522-101) (clinicaltrials.gov) - P1 | N=322 | Recruiting | Sponsor: Fate Therapeutics | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Fate Therapeutics Reports Second Quarter 2023 Financial Results and Business Updates (GlobeNewswire) - "The dose-escalation stage of the study is designed to assess the safety and activity of FT522 with and without administration of intensive conditioning chemotherapy to patients. The Company is conducting Phase 1 study start-up activities at multiple sites, and plans to initiate patient enrollment with a three-dose treatment schedule at 300 million cells per dose....The Company’s Phase 1 study of FT576, its multiplexed-engineered, BCMA-targeted chimeric antigen receptor (CAR) NK cell product candidate for relapsed / refractory multiple myeloma, is currently enrolling patients in two, three-dose treatment cohorts at 1 billion cells per dose."

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

FT522 With Rituximab in Relapsed/Refractory B-Cell Lymphoma (FT522-101) (clinicaltrials.gov) - P1 | N=322 | Not yet recruiting | Sponsor: Fate Therapeutics

New P1 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Fate Therapeutics Reports First Quarter 2023 Financial Results and Business Updates (GlobeNewswire) - "Initiation of Clinical Assessment of FT522 ADR-armed, CD19-targeted CAR NK Cell Program Anticipated in 2H23."

Clinical • Hematological Malignancies • Oncology

Fate Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Business Updates (GlobeNewswire) - "Mid-2023 IND Submission Planned for FT522 NK Cell Program in B-cell Lymphoma; IND Submission for FT825/ONO-8250 CAR T-cell Product Candidate for Solid Tumors Planned for 2023 under Ono Collaboration."

IND • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Fate Therapeutics Features Multiple Novel Approaches to Eliminate Conditioning Chemotherapy for Off-the-shelf, iPSC-derived Cell Therapies at 2022 ASH Annual Meeting (GlobeNewswire) - "Fate Therapeutics...presented preclinical data of several novel strategies designed to enable administration of off-the-shelf cell-based cancer immunotherapies without conditioning chemotherapy at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition. Conditioning chemotherapy, commonly used throughout the field of cell therapy, often results in hematologic toxicities, can limit the potential for administration of multiple doses, and can prohibit adoption as part of early-line treatment....Novel strategies to reduce or eliminate the need for conditioning chemotherapy presented by the Company at ASH include arming iPSC-derived effector cells with an alloimmune defense receptor, which selectively targets and eliminates 41BB-expressing alloreactive host immune cells to promote expansion, persistence, and anti-tumor activity; the genetic ablation of CD38 in combination with CD38-targeted monoclonal antibody therapy, which uniquely targets and depletes..."

Preclinical • Oncology • Solid Tumor